Publications by Tim Sandle (3rd Revision)

Publications by Tim Sandle
This page lists all of my major publications.
Note: some of the listed publications are available as reprints free of charge, for others a
nominal reprint charge is required ($25). Please email me if you would like a copy of any of the
papers or chapters listed (timsandle@btinternet.com or tim.sandle@bpl.co.uk)
Books
Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance
in Pharmaceuticals and Medical Devices, New Delhi : Business Horizons
Sandle, T. (2011): Two extremes? Flexible working in Europe: A study of differences in Flexible
Working Time between two European Plasma Fractionators in Britain and the Netherlands,
Saarbrucken: VDM Publishing, IBSN 978-3-639-34965-8
Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms,
Grosvenor House Publishing: Surrey, UK (2nd edition published in 2016)
Sandle, T. (2012). Pharmaceutical Microbiology Glossary, Microbiology Solutions: UK (Kindle

only eBook ASIN: B0092G1246)
Sandle, T. (2012). E-Guide to Cleanrooms, Microbiology Solutions: UK (Kindle only eBook

ASIN: B009IXFJ92)
Sandle, T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and

Healthcare, Euromed Communications: Passfield, UK
Second edition:
Sandle, T. and Saghee, M. R. (Eds) Cleanroom Management in Pharmaceuticals and Healthcare,

2nd Edition, Euromed Communications, Passfield, U.K. (2017)
Sandle, T. (2013) Sterility Testing of Pharmaceutical Products, PDA / DHI, River Grove, IL,
USA
Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals:

Technology, Validation and Current Regulations, Woodhead Publishing Ltd.: Cambridge, UK
(ISBN 1 907568 38 7)
Sandle, T. (2014) Data Review and Analysis for Pharmaceutical Microbiology, Microbiology
Solutions, UK. ISBN 9781492235217
Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology, DHI/PDA: Bethesda, MD,

USA, ISBN: 1933722843
Hanlon. G. and Sandle, T. (Eds.) (2015) Industrial Pharmaceutical Microbiology: Standards and
Controls, Euromed Communications: Passfield, UK
Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality
Control, Woodhead Publishing, Cambridge, UK
Sandle, T. (2016). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, 2nd
Edition, Grosvenor House Publishing: Surrey, UK
Sandle, T. (2016) Introducing Cleanrooms, Microbiology Solutions: USA, ISBN: 978-1533-

16078
Sandle, T. (2016) Risk Assessment and Management for Healthcare Manufacturing: Practical
Tips and Case Studies, PDA / DHI, Bethesda, MD, USA.
Sandle, T. (2017) Sterilization: Establishing the Process, PDA/DHI, River Grove, Il, USA.
Sandle, T. (2017) Sterilization: Practical Approaches, PDA/DHI, River Grove, Il, USA
Chesca, A., Cengiz, M. and Sandle, T. (Eds.) Theory and Practice of Disease Diagnosis, LAP
LAMBERT Academic Publishing, Germany, ISBN-13: 978-3330084384
Sandle, T. and Tidswell, E. C. (Eds.) (2017) Aseptic and Sterile Processing: Control,
Compliance and Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN: 9781942911128
Booklets and monographs
Sandle, T. and Boschi, F. (2006): Environmental Monitoring Handbook,

Advanstar, Duluth, USA (HBEM06). Published in July 2006
(http://www.industrymatter.com/environmentalmonitoringhandbook.aspx)
Sandle, T. (editor) (2010): Current Perspectives on Environmental Monitoring: Pharmig Review

Number 1, Published by Pharmaceutical Microbiology Interest Group, UK. ISBN 978-0-
9560804-1-7
Sandle, T., Saghee, M.R. and Ramstrop, M. (2010): Environmental Monitoring and Cleanrooms,
IDMA-APA Guideline, Technical Monograph No.5, Indian Drug Manufacturers Association,
Mumbai
Sandle, T. (2011). Polls Apart? Flexible working in the European Pharmaceutical Sector,
Microbiology Solutions: UK (Kindle only eBook ASIN: B0090RIK6K)
Roberts, J. and Sandle, T. (2011). A Guide to Microbiology Laboratories in the Pharmaceutical

Industry. Pharmaceutical Microbiology Interest Group, Pharmig: Stanstead Abbotts, UK
Upton, A. and Sandle, T. (2012). Best Practices for the Bacterial Endotoxin Test: A Guide to the
LAL Assay, Pharmaceutical Microbiology Interest Group: Stanstead Abbotts, UK
Sandle, T. (2016) Guide to cleanroom operation and contamination control, Pharmaceutical

Microbiology Interest Group: Stanstead Abbotts, UK (ISBN: 978-0-9560804-6-2)
Blount, R., Gaurdi, L., Morwood, K. and Sandle, T. (2017) Pharmig Guide to Disifectants and
their us in the pharmaceutical industry, Pharmig, Stanstead Abbotts, UK
Sandle, T. (2017) Pharmig Guide to Cleanroom Operation and Contamination Control, Pharmig,
Stanstead Abbotts, UK
Contributor to:
IVT (2017) Utility Qualification Vol. II, Institute of Validation Technology, USA:
Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems - Tim

Sandle
Validation and Assessment of Computerized System Software in a Pharmaceutical
Facility - Tim Sandle
Risk Consideration for Aging Pharmaceutical Facilities - Tim Sandle
Microbiological Assessment of Compressed Gases in Pharmaceutical Facilities - Tim
Sandle
Sanitization of Pharmaceutical Facilities - Tim Sandle
The Rouging Effect in Pharmaceutical Water Systems: Causes and Strategies for
Prevention - Tim Sandle
Control of WFI and Clean Steam Systems for Bacterial Endotoxins - Tim Sandle
Ensuring Sterility: Autoclaves, Wet Loads, and Sterility Failures - Tim Sandle
Book chapters
Sandle, T. Selection and use of cleaning and disinfection agents in pharmaceutical

manufacturing in Hodges, N and Hanlon, G. (2003): Industrial Pharmaceutical Microbiology
Standards and Controls, Euromed Communications, England (chapter revised on several
occasions)
Sandle, T. Best practices for microbiological documentation in Hodges, N and Hanlon, G.

(2009): Industrial Pharmaceutical Microbiology Standards and Controls, Euromed
Communications, England, Supplement 9, S9.1 S9.24
Sandle, T. (2010): Best practices in microbiology laboratory training in Hodges, N. and Hanlon,
G. Industrial Pharmaceutical Microbiology: Standards and Controls, Supplement 11, ppS11.1 to
S11.16
Sandle, T. (2010): 'The Media Kitchen: Preparation and Testing of Microbiological Culture
Media' in Sutton, S. (ed.): Laboratory Design: Establishing the Facility and Management
Structure, Parenteral Drug Association, Bethesda, MD, United States, ISBN 1-933722-46-0,
pp269-293
Sandle, T. and Saghee, M. R. (2011): The Essentials of Pharmaceutical Microbiology, in

Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance
in Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp1-30
Sandle, T. (2011): Selection of Microbiological Culture Media and Testing Regimes in Saghee,
M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp101-120
Sandle, T. (2011): Practical Approaches to Sterility Testing in Saghee, M.R., Sandle, T. and
Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and
Medical Devices, New Delhi: Business Horizons, pp173-192
Vina, P., Rubio, S. and Sandle, T. (2011): Selection and Validation of Disinfectants, in Saghee,
M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp219-236
Sandle, T. (2011): Environmental Monitoring in Saghee, M.R., Sandle, T. and Tidswell, E.C.
(Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices,
New Delhi: Business Horizons, pp293-326
Ashtekar, D. and Sandle, T. (2011): Microbial Content Testing of Pharmaceutical and

Biotechnologically Derived Products in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.)
(2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, New
Delhi: Business Horizons, pp327-362
Sandle, T. (2011): Risk Management in Pharmaceutical Microbiology in Saghee, M.R., Sandle,

T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals
and Medical Devices, New Delhi: Business Horizons, pp553-588
Sandle, T. (2011). Assessment of Culture Media in Pharmaceutical Microbiology' in Hodges, N

and Hanlon, G. (2011 rev.): Industrial Pharmaceutical Microbiology Standards and Controls,
Euromed Communications, England, Supplement 10
Sandle, T. and Lamba, S. S. "Effectively Incorporating Quality Risk Management into Quality
Systems". In Saghee, M.R. (2012) Achieving Quality and Compliance Excellence in
Pharmaceuticals: A Master Class GMP Guide, New Delhi: Business Horizons, pp89-128
Sandle, T. (2012). "Qualification and Validation". In Saghee, M.R. (2012) Achieving Quality and
Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, New Delhi: Business
Horizons, pp169-206
Sandle, T. and Saghee, M.R. (2012). "Compliance Aspects of Sterile Manufacturing". In Saghee,
M.R. (2012) Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class
GMP Guide, New Delhi: Business Horizons, pp517-560
Sandle, T. (2012). Environmental Monitoring: a practical approach In Moldenhauer, J.

Environmental Monitoring: a comprehensive handbook, Volume 6, PDA/DHI: River Grove,
USA, pp29-54
Sandle, T. (2012). Introduction. In Sandle, T. (2012). The CDC Handbook: A Guide to

Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, ppxv-xxi
Sandle, T. (2012). Cleaning and Disinfection. In Sandle, T. (2012). The CDC Handbook: A
Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp1-
31
Sandle, T. (2012). Application of Disinfectants and Detergents in the Pharmaceutical Sector. In

Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms,
Grosvenor House Publishing: Surrey, UK, pp168-197
Sandle, T. (2012). Validation of Disinfectants. In Sandle, T. (2012). The CDC Handbook: A

Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK,
pp241-261
Sandle, T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic

Manufacturing - a road map to excellence, Pharmaceutical Manufacturing, USA, pp3-9
(http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
Sandle, T. and Saghee, M.R. (2013). Introduction. In: Sandle, T. and Saghee, M.R. Cleanroom
Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
(revised for second edition: pp1-6)

Sandle, T. (2013). History and development of cleanrooms. In: Sandle, T. and Saghee, M.R.
Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
Sandle, T. and Saghee, M.R. (2013). Cleanroom certification and ongoing compliance. In:
Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare,
Euromed Communications: Passfield, UK
Midcalf, B, Neiger, J. and Sandle, T. (2013). Fundamentals of pharmaceutical isolators. In:

Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare,
Euromed Communications: Passfield, UK
Sandle, T., Budini, M. and Rajesh, T. (2013). Airflow studies and airflow mapping. In: Sandle,
T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Communications: Passfield, UK
Sandle, T. and Saghee, M.R. (2013). Environmental monitoring in cleanrooms. In: Sandle, T.
and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Sandle, T. and Saghee, M.R. (2013). Cleaning and disinfection practices. In: Sandle, T. and
Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Sandle, T. and Saghee, M.R. (2013). Auditing cleanroom operations. In: Sandle, T. and Saghee,
M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
Sandle, T. and Saghee, M.R. (2013). Developments in cleanroom technology. In: Sandle, T. and
Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Sandle, T. (2013). 'Dimorph and Filamentous Fungi'. In Mascellino, M. T. (Ed.) Bacterial and
Mycotic Infections in Immunocompromised Hosts: Clinical and Microbiological Aspects,
OMICS Group Inc.: Henderson, NV, USA. In print: http://esciencecentral.org/ebooks/bacterial-
mycotic-infections/pdf/dimorph-filamentous-fungi.pdf
Sandle, T. (2013). Contamination Control Risk Assessment in Masden, R.E. and Moldenhauer, J.
(Eds.) Contamination Control in Healthcare Product Manufacturing, Volume 1, DHI Publishing,
River Grove: USA, pp423-474
Sandle, T. (2013). Contamination Control: Cleanrooms and Clean Air

Devices, Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition, Taylor and
Francis: London, pp634 - 643 (http://dx.doi.org/10.1081/E-EPT4-120050223)
Sandle, T. (2013). Microbial Control of Pharmaceuticals, Encyclopedia of Pharmaceutical
Science and Technology, Fourth Edition, Taylor and Francis: London, pp2122-2132
(http://dx.doi.org/10.1081/E-EPT4-120050301)
Sandle, T. and Saghee, M.R. (2013). Basic Concepts of GMP Requirements. In Saghee, M.R.
(Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications: Passfield, UK, pp1-76
Barr, D. and Sandle, T. (2013). System Based Approach to Inspections. In Saghee, M.R. (Ed.)
Pharmaceutical Regulatory Inspections, Euromed Communications: Passfield, UK, pp119-182
Brutsche, A. and Sandle, T. (2013). Preparing and Management of International Inspections. In

Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications:
Passfield, UK, pp285-328
Sandle, T., Saghee, M.R. and Barr, D. (2013). Handling and Responding to Post Inspection
Observations. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed
Communications: Passfield, UK, pp329-360
Sandle, T. (2013). Preparing for Regulatory Inspections of Sterile Facilities: the Focal Points. In
Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications:
Passfield, UK, pp361-462
Sandle, T. (2014). Microbial Identification: Laboratory Techniques and Methods. In Chesca, A.

(Ed.) Methods for Diseases: Diagnostic with Applicability in Practice, Lambert Academic
Publishing, Germany, pp15-26
Sandle, T. and Saghee, M.R. (2014) Basic concepts of global GMP requirements. In Saghee,
M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Publications, Passfield, UK, pp1-
76
Barr, D. and Sandle, T. (2014) System based approach to GMP inspections. In Saghee, M.R.
(Ed.) Pharmaceutical Regulatory Inspections, Euromed Publications, Passfield, UK, pp119-182
Brutsche, A. and Sandle, T. (2014) Handling and responding to post inspectional observations. In
Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Publications, Passfield,
UK, pp285-328
Sandle, T., Saghee, M.R. and Barr, D. (2014) Handling and responding to post inspectional
observations. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed
Publications, Passfield, UK, pp329-360
Sandle, T. (2014) Preparing for regulatory inspections of sterile facilities: the focal points. In
Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Publications, Passfield,
UK, pp361-462
Sandle, T., 2014. Biochemical and Modern Identification Techniques: Enterobacteriaceae,
Coliforms, and Escherichia Coli. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food
Microbiology, 2nd edition, vol 1. Elsevier Ltd, Academic Press, pp. 232237
Sandle, T., 2014. Biochemical and Modern Identification Techniques: Food-Poisoning

Microorganisms. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, 2nd
edition, vol 1. Elsevier Ltd, Academic Press, pp. 238243
Sandle, T., 2014. Laboratory Design. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of
Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 393401
Sandle, T., 2014. Fungi: Classification of the Peronosporomycetes. In: Batt, C.A., Tortorello,
M.L. (Eds.), Encyclopedia of Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 4453
Sandle, T., 2014. Trichoderma. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food
Microbiology, vol 3. Elsevier Ltd, Academic Press, pp. 644646
Sandle, T. (2014) Bacterial Diseases and their Diagnosis. In Chesca, A. (Ed.) Techniques and
Procedures for Disease Diagnostic, Lambert Academic Publishing, Saarbruken, Germany, pp31-
60
Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G. and

Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 2.1-2.24
Sandle, T. (2014) The Use of Culture Media in Pharmaceutical Microbiology. In Handlon, G. and
Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 3.13.26
Sandle, T. (2014) Selection and use of Cleaning and Disinfection Agents in Pharmaceutical
Manufacturing. In Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology:
Standards & Controls, Euromed Communications, Passfield, UK, 9.19.32
Sandle, T. (2014) Microbiology of Pharmaceutical Grade Water. In Handlon, G. and Sandle, T.

(Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 10.110.19
Sandle, T. (2014) Biological Indicators, In Handlon, G. and Sandle, T. (Eds.) Industrial

Pharmaceutical Microbiology: Standards & Controls, Euromed Communications, Passfield, UK,
16.116.26
Sandle, T. (2014) Containment System Integrity: Microbial Challenges for Sterile Products. In
Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards &
Controls, Euromed Communications, Passfield, UK, 18.118.13
Sandle, T. (2014) The Regulatory Control and Quality Assurance of Immunological Products. In
Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards &
Controls, Euromed Communications, Passfield, UK, 22.122.14
Sandle, T. (2015) Cleanroom Design. In Moldenhauer, J. (Ed.) Environmental Monitoring: a

Comprehensive Handbook, Volume 7, pp3-28
Sandle, T. (2015) Bacterial Endotoxin Testing using the Limulus Amebocyte Lysate Assay. In
Kszegi, T. and Chesca, A. (Eds.) Laboratory Techniques with Applicability in Medical Practice,
Lambert Academic Publishing, pp19-32
Sandle, T. (2015) Investigating Sterility Test Failures. In McCullough, K.Z. and Moldenhauer, J.
(Eds.) Microbial Risks and Investigations, DHI/PDA, River Grove, USA, pp261-290
Sandle, T. (2015) Contamination Control Risk Assessment. In McCullough, K.Z. and

Moldenhauer, J. (Eds.) Microbial Risks and Investigations, DHI/PDA, River Grove, USA,
pp783-836
Contributor to Masden, R. E. and Jornitz, M. W. (2015) Lessons of Failure: When things go

wrong in pharmaceutical manufacturing, PDA/ DHI Books, Bethesda, MD, USA
Sandle, T. (2016) Antibiotic / Antimicrobial Resistance. In Boslaugh, S. (Ed.) The Sage

Encyclopedia of Pharmacology and Society, Volume 1, Sage Publications: Los Angeles, pp136-
139
Sandle, T. (2016) Antimalarials. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology

and Society, Volume 1, Sage Publications: Los Angeles, pp190-192
Sandle, T. (2016) Drug-Resistant Diseases. In Boslaugh, S. (Ed.) The Sage Encyclopedia of

Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp546-550
Sandle, T. (2016) European Medicines Agency. In Boslaugh, S. (Ed.) The Sage Encyclopedia of
Sandle, T. (2016) Lyme Disease. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology
and Society, Volume 2, Sage Publications: Los Angeles, pp842-844
Sandle, T. (2016) Medicines and Healthcare Products Regulatory Agency (UK). In Boslaugh, S.
(Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage Publications: Los
Angeles, pp899-902
Sandle, T. (2016) National Institute For Biological Standards and Control. In Boslaugh, S. (Ed.)
The Sage Encyclopedia of Pharmacology and Society, Volume 3, Sage Publications: Los
Angeles, pp948-950
Sandle, T. (2016) Smallpox Eradication. In Boslaugh, S. (Ed.) The Sage Encyclopedia of
Sandle, T. (2016) U.S. Pharmacopeial Convention. In Boslaugh, S. (Ed.) The Sage Encyclopedia
of Pharmacology and Society, Volume 4, Sage Publications: Los Angeles, pp1503-1505
Sandle, T, (2016) Tests for Antimicrobial Effectiveness, Chesca, A. and Cengiz, M. (Eds.)
Theory and Practice for Medical Diagnosis, Lambert Academic Publishing, Germany, pp7-19
Sandle, T. (2016) ISO 14644 Parts 1 and 2 - The revised cleanroom standard and contamination
control. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare
Product Manufacturing, Volume 4, DHI, River Grove, USA, pp3-32
Sandle, T. (2016) Risk of microbial spores, prevention measures and disinfection strategies. In
Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product
Manufacturing, Volume 4, DHI, River Grove, USA, pp59-95
Sandle, T. (2016) Disinfectants in the Pharmaceutical Industry. In Cardoso, A. S., Almeida, C. M.

M., Cordeiro, T. C. and Gaffney, V.J. (Eds.) Disinfectants: Properties, Applications and
Effectiveness, Nova Science Publishers, New York, pp109-142
Sandle, T. (2017) Clean room design principles: Focus on particulates and microbials. In Esteves,
S. C., Varghese, A. C., and Worrilow, K. C. (Eds.) Clean Room Technology in ART Clinics: A
Practical Guide, CRC Press, Boca Raton, U.S., pp75-91
Hallworth, M., Sahee, M.R. and Sandle, T. (2017) Cleanroom standards and GMP requirements.
In Sandle, T. and Saghee, M. R. (Eds.) Cleanroom management in pharmaceuticals and
healthcare, 2nd edition, Euromed Communications, Passfield, UK, Cleanroom standards and
GMP requirements, pp25-44
Sandle, T. (2017) Bow Street Runners. In Robertiello, G. (Ed.) In The Use and Abuse of Police
Power in America: Historical Milestones and Current Controversies, ABC-CLIO Books, U.S.,
pp13-15
Sandle, T. (2017) Southern Slave Patrols. In Robertiello, G. (Ed.) In The Use and Abuse of
Police Power in America: Historical Milestones and Current Controversies, ABC-CLIO Books,
U.S., pp15-17
Sandle, T. (2017) Environmental Control and Environmental Monitoring in Support of Aseptic

Processing. In Sandle, T. and Tidswell, E. C. (Eds.) Aseptic and Sterile Processing: Control,
Compliance and Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN: 9781942911128, pp447-
540
Sandle, T. (2017) The Sterility Test: Current Practice and Future Applications. In Sandle, T. and
Tidswell, E. C. (Eds.) Aseptic and Sterile Processing: Control, Compliance and Future Trends,
DHI/PDA, Bethesda, MD, USA, ISBN: 9781942911128, 645-702
Papers in peer reviewed journals
Sandle, T. The use of a risk assessment in the pharmaceutical industry the application of FMEA
to a sterility testing isolator: a case study, European Journal of Parenteral and Pharmaceutical
Sciences, 2003; 8(2): 43-49
Sandle, T. Practical Approaches to Sterility Testing, Journal of Validation Technology, Vol. 10,
No.2, 2004, pp131 141
Sandle, T. Grams Stain: History and Explanation of the Fundamental Technique of

Determinative Bacteriology, IST Science and Technology Journal, April 2004 (No. 54), pp3-4
Sandle, T. An Approach for the Reporting of Microbiological Results from Water Systems, PDA
Journal of Pharmaceutical Science and Technology, Vol. 58, No.4, July-August 2004, pp231
237 (Pub Med http://www.ncbi.nlm.nih.gov/pubmed/22293526)
Sandle, T. and Skinner, K. Examination of the optimal cultural conditions for the microbiological
analysis of a cold demineralised water system in a pharmaceutical manufacturing
facility, European Journal of Parenteral and Pharmaceutical Sciences, Vol. 10, No.1, 2005, pp9-
14
Sandle, T. Understanding Clean Air Devices, Science Technology Journal, April 2005, pp3 5
Sandle, T. Environmental Monitoring Risk Assessment, Journal of GXP Compliance, Volume 10,
Number 2, 2006, pp54-73 (Link: http://www.gxpandjvt.com/ivtnews/templates/templateblank.aspx?
articleid=1444&zoneid=18)
Sandle, T. The use of polymeric flooring to reduce contamination in a cleanroom changing

area, European Journal of Parenteral and Pharmaceutical Sciences, Vol. 11, No.3, 2006, pp75-80
[1]
Sandle, T. Selection of Laboratory Disinfectants: Part One, Science Technology Journal,

Institute of Science Technology, Summer 2006, pp16-18
Sandle, T. Selection of Laboratory Disinfectants: Part Two, Science Technology Journal, Institute
of Science Technology, Spring 2007, pp5-7
Tours, N. and Sandle, T. Comparison of dry-heat depyrogenation using three different types of
Gram-negative bacterial endotoxin, European Journal of Parenteral and Pharmaceutical
Sciences, Volume 13, No.1, 2008, pp17-20
Sandle, T. A method to determine the effect of dehydration on agar plates and microbial
recovery, The Institute of Science and Technology Journal, Spring 2008, pp24-27
Sandle, T. The assessment of air -cleanliness in cleanrooms and cleanzones using optical particle
counters, The Journal, Institute of Science and Technology, Winter 2009, pp4-7
Sandle, T. Selection of Active Air-Samplers, The Journal, Institute of Science and Technology,
Summer 2010, pp25-31
Note: A version of the paper was included on the BioSciences Quality Testing Forum (BioQT)
website: http://www.bioqtforum.com/Selection-of-active-air-samplers (accessed 15th September
2010)
Sandle, T. 'Selection of active air samplers', European Journal of Parenteral and Pharmaceutical
Sciences, Vol. 15, No.4, 2010, pp119-124
Note: The EJPPS paper is different to the paper on air-samplers published in The Journal (both
2010).
Sandle, T. (2011): 'Selection of active air samplers', Clean Air and Containment Review, Issue 5,
pp8-10
[Note: The paper is an alternate version of the one published in the EJPPS, 2010]
Sandle, T. (2011): 'History and development of microbiological culture media', The

Journal (Institute of Science and Technology), Winter 2010-2011, pp10-14
Sandle, T. (2011): 'Microbial recovery on settle plates in unidirectional airflow cabinets', Clean
Air and Containment Review, Issue 6, pp8-10
Sandle, T. (2011). A study of a new type of swab for the environmental monitoring of isolators
and cleanrooms (the Heipha ICR-Swab), European Journal of Pharenteral and Pharmaceutical
Sciences, Vol. 16, No.2, pp42-48
Sandle, T. (2011): A Review of Cleanroom Microflora: Types, Trends, and Patterns, PDA
Journal of Pharmaceutical Science and Technology, Vol. 65, No. 4, JulyAugust 2011, pp392-
403 (Pub Med: http://www.ncbi.nlm.nih.gov/pubmed/22293526)
Sandle, T. and Saghee, M. R. (2011): Some considerations for the implementation of disposable
technology and single-use systems in biopharmaceuticals, Journal of Commercial
Biotechnology, Vol. 17, No. 4: 319329 doi: 10.1057/jcb.2011.21 (view here:
http://www.palgrave-journals.com/jcb/journal/vaop/ncurrent/abs/jcb201121a.html)
Sandle, T. (2011): "A Practical Approach to Depyrogenation Studies using Bacterial Endotoxin",
Journal of GXP Compliance, Autumn 2011, electronic version: http://www.ivtnetwork.com/gxp-
journal/journal-of-gxp-compliance-2687
Sandle, T. (2011): Evaluation of two different types of contact plates for microbiological
environmental monitoring, European Journal of Parenteral and Pharmaceutical Sciences, Vol.
16, No.4, pp116-120
Sandle, T. (2012). "Real-time counting of airborne particles and microorganisms: a new

technological wave?", Clean Air and Containment Review, Issue 9, pp4-6
Sandle, T. (2012): Sterility Test Failure Investigations, Journal of GxP Compliance, Vol. 16,
No.1, electronic version: http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-compliance-
2011
Sandle, T. (2012). Microbiological control and monitoring of cleanrooms: Revised USP <1116>
chapter, Clean Air and Containment Review, Issue 11, pp22-23
Vijayakumar, R., Sandle, T. and Manoharan, C. (2012). A review of fungal contamination in

pharmaceutical products and phenotypic identification of contaminants by conventional
methods, European Journal of Parenteral and Pharmaceutical Sciences, Vol. 17, No.1: 4-19
Sandle, T. and Saghee, M.R. (2012). Application of Sterilization by Gamma Radiation for
Single-Use Disposable Technologies in the Biopharmaceutical Sector, Journal of GXP
Compliance, Spring 2012, Vol. 16, Issue 2, electronic journal: http://www.ivtnetwork.com/gxp-
journal/journal-of-gxp-compliance-2010
Sandle, T. (2012). A new wave of sporicidal disinfectants, Clean Air and Containment Review,
Issue 10, pp10-13
Sandle, T. (2012). Isolators in international GMP guidelines, Clean Air and Containment
Review, Issue 10, pp21-23
Vijayakumar, R., Kannan, V.V., Sandle, T., and Manoharan, C. (2012). In vitro Antifungal
Efficacy of Biguanides and Quaternary Ammonium Compounds against Cleanroom Fungal
Isolates, PDA Journal of Pharmaceutical Science and Technology, May/June 2012, Vol. 66, No.
3: 236-242
Sandle, T. (2012). Examination of air and surface particulate levels from cleanroom mats and
polymeric flooring, European Journal of Parenteral and Pharmaceutical Sciences 2012; 17(3):
110-11
Sandle, T. (2012). Speedier automated microbial methods for environmental monitoring of

cleanrooms, Clean Air and Containment Review, Issue 12.
Sandle, T. (2012). Application of Quality Risk Management To Set Viable Environmental

Monitoring Frequencies in Biotechnology Processing and Support Areas, PDA Journal of
Pharmaceutical Science and Technology, Vol. 66, No. 6, NovemberDecember 2012: 560 - 579
Sandle, T. (2012). Container Closures for Pharmaceutical Preparations: A review of Design and
Test Considerations, BioPharm International, Vol. 25, No. 12, pp32-36
Sandle, T., Leavy, C. and Needham, G. (2012). A Risk Matrix Approach for Media Simulation
Trials, Journal of Validation Technology, Vol. 18, No.4, pp70-78
Sandle, T. and Tours, N. (2013). Validation and Operation of a Sterility Testing Isolator: a Study
Proposal, Journal of validation Technology, Vol. 19, No.1, on-line edition available at:
http://www.ivtnetwork.com/article/peer-reviewed-validation-and-operation-sterility-testing-
isolator-study-proposal
Sandle, T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant microorganisms

isolated in cold rooms used for pharmaceutical processing, Journal of Applied Microbiology, 114
(4), 11661174
Sandle, T. (2013). In situ study of particles generated from the use of pharmaceutical grade
cleanroom wipes, European Journal of Parenteral and Pharmaceutical Sciences, Vol. 18, No.1,
pp5-11
Sandle, T. (2013). Revision of ISO 14698 - Biocontamination control: Personal reflections on

what might be desirable, Clean Air and Containment Review, Issue 14, pp20-21
Republished in Pharmig News: Sandle, T. (2013). ISO 14968 biocontamination control

standard revision, Pharmig News Number 51, pp6-8
Sandle, T. (2013). Bacterial Adhesion: an Introduction, Journal of Validation Technology,

Volume 19, Issue 2, June 2013, on-line: http://www.ivtnetwork.com/article/bacterial-adhesion-
introduction
Tim Sandle, Kerry Skinner, Jennifer Sandle, Barbara Gebala, Pavitra Kothandaraman (2013):
Evaluation of the GEN III OmniLog ID System microbial identification system for the
profiling of cleanroom bacteria, European Journal of Parenteral & Pharmaceutical Sciences
18(2): 44-50
Sandle, T., Skinner, K. and Yeandle, E. (2013). Optimal conditions for the recovery of bioburden
from pharmaceutical processes: a case study, European Journal of Parenteral and
Pharmaceutical Sciences, 18 (3): 84-91
Gebala, B. and Sandle, T. (2013). Comparison of different fungal agar for the environmental
monitoring of pharmaceutical-grade cleanrooms, PDA J Pharm Sci Technol.;67(6):621-33
Sandle, T. (2013). Pharaohs and Mummies: Diseases of Ancient Egypt and Modern Approaches,
Journal of Ancient Diseases & Preventive Remedies, 1 (4): e110. doi: 10.4172/2329-
8731.1000e110
Sandle, T. (2013). Global Strategies for Elimination of Leprosy: A Review of Current Progress,
Journal of Ancient Diseases & Preventive Remedies, 1 (4): e112. doi: 10.4172/2329-
8731.1000e112
Sandle T (2014) Novel Methods to Address Antimicrobial Resistance. SOJ Microbiol Infect Dis
2(1): 2-3 (see here: http://symbiosisonlinepublishing.com/microbiology-
infectiousdiseases/microbiology-infectiousdiseases11.pdf)
Sandle, T. (2014) Variations in the Resistance of Biological Indicators Used to Assess

Sterilization, Journal of Validation Compliance, Vol. 20, Issue 1, Mar 2014 (at:
http://www.ivtnetwork.com/printpdf/article/variations-resistance-biological-indicators-used-
assess-sterilization)
Sandle, T. (2014) Examination of the Order of Incubation for the Recovery of Bacteria and Fungi
from Pharmaceutical Cleanrooms, International Journal of Pharmaceutical Compounding, 18
(3): 242 247
Sandle, T., Banenko, D., Lavrinenko, A., Azizov, I. and Chesca, A. (2014) The current state of
PCR approach in detection and identification of carbapanem hydrolysis -lactamases genes,
European Journal of Parenteral and Pharmaceutical Sciences, 19 (1): 153-164
Sandle, T., Leavy, C., Jindal, H. and Rhodes, R. (2014) Application of rapid microbiological
methods for the risk assessment of controlled biopharmaceutical environments, Journal of
Applied Microbiology, 116 (6): 1495-1505
Chesca, A., Sandle, T. and Gyurka, G.A. (2014) Study on the incidence of certain neoplastic
diseases, Acta Medica Transilvanica, 2 (2): 168 172
Sandle, T. (2014) Approaching the Selection of Rapid Microbiological Methods, Journal of

Validation Technology, Vol. 20, Issue 2, Jun 2014. Published on-line:
http://www.ivtnetwork.com/article/approaching-selection-rapid-microbiological-methods
Sandle, T. (2014) The Lean Laboratory and Its Application for the Review of Environmental
Monitoring Samples, Journal of Validation Technology, Vol. 20, Issue 2, Jun 2014. Published on-
line http://www.ivtnetwork.com/article/lean-laboratory-and-its-application-review-
environmental-monitoring-samples
Sandle, T. (2014) The Test for Sterility of Medicinal Products, International Journal of
Microbiology and Allied Sciences, 1 (1): 1-9 (at: http://www.ijomas.com/wp-
content/uploads/2014/08/Editorial1-Issue1.pdf)
Sandle, T. (2014) Sterile Ophthalmic Preparations and Contamination Control, Journal of GXP
Compliance, 18 (3): 1-5
Sandle, T. (2014) Sanitation of Pharmaceutical Facilities, Journal of GXP Compliance, 18 (3):

6-10
Chesca, A. and Sandle, T. (2014) Functional Lung Disease, Acta Medica Transilvanica, 2 (3):
42-44
Sandle, T. (2014) The Possible Origins of Tuberculosis in South America, Journal of

Ancient Diseases & Preventive Remedies, 2 (2): 1-2
Sandle, T. (2014) Santitization of Pharmaceutical Facilities, Journal of GXP Compliance, 18 (3):

pp1-5
Chesca, A. and Sandle, T. (2014) Data on the examination of functions in pulmonary disease,
Acta Medica Transilvanica, 2 (3): 208 210
Sandle, T. (2014) Good Documentation Practice, Journal of Validation Technology, Vol. 20, Issue
3, pp1-11
Sandle, T., Vijayakumar, R., Saleh Al Aboody, M. and Saravanakumar, S. (2014) In vitro
fungicidal activity of biocides against pharmaceutical environmental fungal isolates, Journal of
Applied Microbiology, 117 (5): 1267 1273
Sandle, T. (2014) Assessment of the suitability of R3A agar for the subculture of microorganisms
isolated from pharmaceutical water systems, European Journal of Parenteral and
Pharmaceutical Sciences, 19 (3): 85-94
Sandle, T. (2014) Emergence of New Antibiotics, J J Microbiol Pathol., 1(1): 001
Sandle, T. (2014) Applying spectrophotometric monitoring to risk assessments in

biopharmaceutical cleanrooms, Clean Air and Containment Review, Issue 20, pp22-25
Sandle, T. (2014) The Antibiotic Crisis and the Need for New Forms of Antibiotics, EC
Microbiology, 1 (1): 1-3
Sandle, T., Azizov, I., Babenko, D., Lavrinenko, A., Chesca, A. (2014) Comparative Evaluation
of Traditional Susceptibility Testing for MRSA with the PCR Approach, Advances in
Microbiology, 4, 1204-1211 http://dx.doi.org/10.4236/aim.2014.416130
Sandle, T. (2014) People in Cleanrooms: Understanding and Monitoring the Personnel Factor,
Journal of GXP Compliance, 18 (4): 1-5
Sandle, T. (2015) Dracunculiasis and the Long Decline of an Ancient Disease, Journal of Ancient
Diseases & Preventive Remedies, 2 (3): 1-2
Sandle, T., Vijayakumar, R. , Saleh A Aboody, M. and Saravanakumar, S. (2015) In vitro

fungicidal activity of biocides against pharmaceutical environmental fungal isolates: a response
to the Letter of Rout and Humphreys (2015), Journal of Applied Microbiology, 118, 779-780
Sandle, T., Leavy, C. and Rhodes, R. (2015) Assessing airborne contamination using a novel
rapid microbiological method, European Journal of Parenteral & Pharmaceutical Sciences,
19(4): 131-142
Sandle, T. (2015) Teixobactin: A New Class of Antibiotic, SOJ Microbiology & Infectious
Diseases, 3 (1): 1-2 (http://symbiosisonlinepublishing.com/microbiology-
infectiousdiseases/microbiology-infectiousdiseases28.pdf)
Sandle, T., Gyurka, G.A. and Chesca, A. (2015) Medical conditions regarding heart failure,
ACTA Medica Transilvanica, 20(1):39-41
Sandle, T. (2015) Exhuming Skeletal Remains: How Cholera Deaths of the Past Could Shine a
Blue Light of Hope, Journal of Ancient Diseases & Preventive Remedies, 3 (1):
http://dx.doi.org/10.4172/2329-8731.1000e121
Sandle, T. (2015) The Rouging Effect in Pharmaceutical Water Systems: Causes and Strategies
for Prevention, Journal of GXP Compliance, Vol. 19, Issue 1, Mar 2015:
http://www.ivtnetwork.com/article/rouging-effect-pharmaceutical-water-systems-causes-and-
strategies-prevention
Sandle, T. (2015) Assessing Non-endotoxin Microbial Pyrogens in Relation in Pharmaceutical

Processing, Journal of GXP Compliance, Vol. 19, Issue 1, Mar 2015:
http://www.ivtnetwork.com/article/assessing-non-endotoxin-microbial-pyrogens-relation-
pharmaceutical-processing
Sandle, T. (2015): Aseptic Transfer Risk Assessment: A Case Study, Journal of Validation
Technology, 21(1): 1-10 Online: http://www.ivtnetwork.com/article/aseptic-transfer-risk-
assessment-case-study
Sandle, T. (2015): Risk Considerations for Installation of a New Autoclave in a Pharmaceutical

Manufacturing Facility, Journal of Validation Technology, 21(1): 1-10 Online:
http://www.ivtnetwork.com/article/risk-considerations-installation-new-autoclave-
pharmaceutical-manufacturing-facility
Sandle, T. Human Microbiome of the Skin: Advances in Metagenomics. EC Microbiology 1.3

(2015): 162-165.
Sandle, T. From Head to Toe: Mapping Fungi across Human Skin. EC Microbiology 2.1
(2015): 211-213
Sandle, T. (2015) Towards a Rapid Sterility Test?, Microbial & Biochemical Technology, 7 (4):
216-217 doi:10.4172/1948-5948.1000209
Sandle, T. (2015) Ensuring Sterility: Autoclaves, Wet Loads, and Sterility Failures, Journal of
GXP Compliance, 19 (2): 1-10 http://www.ivtnetwork.com/article/ensuring-sterility-autoclaves-
wet-loads-and-sterility-failures
Chesca, A., Gyurka, A., and Sandle, T. (2015) Data concerning the incidence of respiratory
pathology in different seasonal periods, Archives of the Balkan Medical Union, 50 (2): 208-212
Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of weight loss
upon microbial growth, European Journal of Parenteral & Pharmaceutical Sciences 2015;
20(2): XX
Sandle, T. (2015) Incidences and Treatments for Buruli Ulcer, Journal of Ancient Diseases &
Preventive Remedies, 3 (2): 1000e122 (http://dx.doi.org/10.4172/2329-8731.1000e122)
Sandle, T. (2015) Characterizing the Microbiota of a Pharmaceutical Water System-A Metadata

Study, SOJ Microbiology & Infectious Diseases, 3 (2): 1-8
Chesca, A., Sandle, T., Babenko, D. and Azzov, I. (2015) Structural aspects regarding surgical
pathology of children, Annals of the Romanian Society for Cell Biology, 14 (9): 65-69 doi:
10.ANN/RSCB-2015-0024:RSCB
Chec, A., Luculescu, M.C., Sandle, T. (2015) Considerations of melanocytic nevi in children,
Annals of the Romanian Society for Cell Biology, 19 (2): 19 - 22 doi: 10.ANN/RSCB-2015-
0001:RSCB
Antonella Chec, Tim Sandle, Dmitriy Babenko (2015) Ethical and Legal Aspects of Mediation
and the Involvement of Mediators in Conflicts Solution, Journal Plus Education, 12 (A): 14-19
Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of weight loss
upon microbial growth, European Journal of Parenteral & Pharmaceutical Sciences, 2015; 20
(2): 45-50
Sandle, T. (2015) FDA Signals a New Approach for Analytical Method Validation, Journal of
Validation Technology, 21 (2): 1-5
Also published in IVT Network Analytical Method Validation Vol. IV, 2017
Sandle, T. (2015) Assessing Process Hold Times for Microbial Risks: Bioburden and Endotoxin,
Journal of GXP Compliance, Vol. 19, Issue 3, Oct 2015, pp1-9
Sandle, T. (2015) Microbiological Assessment of Compressed Gases in Pharmaceutical

Facilities, Journal of Validation Technology, Vol. 21, Issue 2, August 2015, pp1-8
Vijayakumar, R., Saleh Al-Aboody, M. and Sandle, T. (2015) A review of melanized (black)
fungal contamination in pharmaceutical productsincidence, drug recall and control measures,
Journal of Applied Microbiology, 120(4): 831-841
Accepted Article: doi:10.1111/jam.12888
Sandle, T. (2015) Advances in Rapid Pathogen Detection, Journal of Microbiology &

Experimentation, 2 (5): 00063. DOI: 10.15406/jmen.2015.02.00063
Sandle, T. (2015) Microbiological Identification with MALDI-TOF MS, Journal of Validation
Technology, 21 (3): 1-10 at: http://www.ivtnetwork.com/article/microbiological-identification-
maldi-tof-ms
Sandle, T. and Satyada, R. (2015) Assessment of the disinfection of impaction air sampler heads
using 70% IPA, as part of cleanroom environmental monitoring, European Journal of Parenteral
and Pharmaceutical Science, 20 (3): 94-99
Sandle, T. (2015) Approaching Microbiological Method Validation, Journal of GXP Compliance,

19 (4): 1-15
Also published in IVT Network Analytical Method Validation Vol. IV, 2017
Sandle, T. (2015) Searching for Antimicrobials in the Unlikeliest of Places, J Pharm Microbiol, 1
(1): 1-3
Chesca, A., Sandle, T., Babenko, D. and Azizov, A. (2015) Structural issues of the tegument
regions adjacent to the melanocytic nevi, Annals of the Romanian Society for Cell Biology, 20
(1): 7-10
Sandle, T. (2016) Risk-Based Approach to Internal Quality Auditing, Journal of Validation

Technology, 22 (1): 1-10
Sandle, T. (2016) Bacteriophages offer an Antimicrobial Solution, Journal of Microbiology &

Experimentation, 3 (1): 1-2 (DOI: 10.15406/jmen.2016.03.00077)
Sandle, T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware in the
pharmaceutical microbiology laboratory, European Journal of Parenteral and Pharmaceutical
Sciences, 21 (1): 20- 28
Chesca, A., Chesca, S.A., Sandle, T., Babenko, D., and Azizov, I. (2016) Alzheimer's Medical
Considerations, Archives of the Balkan Medical Union, 51 (1): 90-93
Chec A., Chec S. A., Sandle T. (2016) Medical data regarding functional exploration in lung
pathology, Clinical Medicine, 78 (1): 67-71
Sandle, T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware in the
pharmaceutical microbiology laboratory, European Journal of Parenteral & Pharmaceutical
Sciences; 21(1): 16-22
Vijayakumar, R., Al-Aboody, M. S., AlFonaisan, M. K., Sandle, T. (2016) In vitro susceptibility
of multidrug resistant Pseudomonas aeruginosa clinical isolates to common biocides,
International Journal of Research in Pharmaceutical Sciences, 7 (1): 110-116
Babenko, D., Amirbekova, Z., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In silico
comparison serotyping and genotyping methods for Chlamydia trachomatis, Annals of Romanian
Society for Cell Biology, Vol. XX, Issue 2, 2016, pp. 1 4
Akhmaltdinova, L.L., Azizov, I., Sandle, T., Gyurka, A.G. and Chessca, A. (2016) Use of flow
cytometry for the evaluation of disinfectant effectiveness, Archives of the Balkan Medical Union,
51 (2): 213-215
Sandle, T. (2016) Risk Assessment for Intervention Scoring in Relation to Aseptic Processing,
Journal of Validation Technology, 22 (2): 1-10
Sandle, T. (2016) Risk Consideration for Aging Pharmaceutical Facilities, Journal of Validation
Sandle T. The Importance of Water Activity for Risk Assessing Pharmaceutical Products, J
Pharm Microbiol. 2016, 2 (1): 1-2
Chec A., Sandle T., Gyurka G. (2016) A. Medical considerations regarding chronic obstructive
pulmonary disease, Medicine and Ecology, 79 (2): 91-94
Gyurka A. G., Chec S. A., Sandle T. (2016) Statistical study on cardiopulmonary diseases,
Medicine and Ecology, 79 (2): 95-98
Sandle, T. (2016) Designing Aseptic Process Simulations: The Time and Container Number
Conundrum, Journal of GxP Compliance, 20 (3): 1-12
Lavrinenko, A., Tishkambayevi, Y., Serbo, Y., Shambilova, N., Azizov, I., Sandle, T., Gyurka, A.
and Chesca, A. (2016) Prevalence of urinary Tract Infections in Pregnant Women, Archives of
the Balkan Medical Union, 15 (3): 307-310
Sandle, T. (2016) Control of WFI and Clean Steam Systems for Bacterial Endotoxins, Journal of
GxP Compliance, 20 (4): 1-15
Babenko, A., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In silico comparison of
molecular typing methods for characterization of Staphylococcus aureus, Acta Medica
Mediterranea, 32: 1021-1027
Vijayakumar, R., Al- Aboody, M. S., AlFonaisan, M. K., Alturaiki, W., Mickymaray, S.,
Premanathan, M., Alsagaby, S. A. and Sandle, T. (2016) Determination of minimum inhibitory
concentrations of common biocides to multidrug-resistant gram-negative bacteria, Applied
Medical Research, 2 (3): 56-62 (DOI: 10.5455/amr.20161012082036)
Babenko, D., Omarkulov, B., Azizov, I., Sandle, T., Moraru, D. and Chesca, A. (2016) Evaluation
of sequence based typing methods (SPA and MSLT) for clonal characterization of
Staphylococcus aureus, Acta Medica Mediterranea, 32: 1851-1856
Sandle, T. (2016) Data Integrity Considerations for the Pharmaceutical Microbiology Laboratory,
Journal of GXP Compliance, 20 (6): 1-12
Chescha, A., Sandle, T. and Gyurka, G. A. (2016) Considerations on the structures involved in
the control of transmission mechanism mediated of calcium pulses, Annals of The Romanian
Society for Cell Biology, 21 (1): 1-6
Chec A., Chec S. A., Sandle T. (2016) An approach on chronic obstructive pulmonary
disease, Medicine and Ecology, 80 (3): 116-119
Chec A., Ciomeica A., Sandle T. Structural aspects on pathologic appendix versus normal
appendix, Medicine and Ecology, 80 (3): 120-123
Sandle, T. (2017) Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems,

Journal of GxP Compliance, 21 (1): 1-12 -
http://www.ivtnetwork.com/article/biodecontamination-cleanrooms-and-laboratories-using-
gassing-systems
Vijayakumar, R., Al- Aboody, M.S., Alturaiki, W. and Sandle, T. (2017) Review on endotoxin
mediated toxic anterior segment syndrome (TASS) in ophthalmic products- Outbreaks, product
recall and testing limits, European Journal of Parenteral and Pharmaceutical Science, 22 (1):
20-25
Chesca, A. and Sandle, T. (2017) Structural aspects of tonsillitis, Medicine and Ecology, 82 (1):
112-114
Chesca, A. and Sandle, T. (2017) A new approach related to structural aspects of pathological
appendix versus normal appendix, Medicine and Ecology, 82 (1): 115-118
Sandle, T. (2017) Santitization of Pharmaceutical Facilities, IVT Special Edition Utility

Qualification Volume II, pp56-62
Sandle, T. (2017) Validation and Assessment of Computerized System Software in a

Pharmaceutical Facility, IVT Special Edition Utility Qualification Volume II, pp13-20
Babenko, D., Turmuhambetova, A., Sandle, T., Pestrea, A.A., Moraru, D. and Chesca, A. (2017)
In silica comparison of different types of MLVA with PFGE based on Pseudomonas aeruginosa
genomes, Acta Medica Mediterranea, 33: 607-612
Vijayakumar, R., Al-Aboody, M.S., Alturaiki, W., Suliman A. Alsagaby, S.A., Sandle, T. (2017)
A study of airborne fungal allergens in sandstorm dust in Al-Zulfi, central region of Saudi
Arabia, Journal of Environmental and Occupational Science, 6 (1): 27-33 (DOI:
10.5455/jeos.20170120094512)
Sandle, T. (2017) Design and control of pharmaceutical water systems to minimize microbial
contamination, Pharmaceutical Engineering, 37 (4): 44-48
Akhayeva, A., Azizov, I., Kenzhetayeva, T., Zhupenova, D., Sandle, T., Gyurka, A. G., Pestrea,
S.A. and Chesca, A. (2017) Diagnostic value of IL-6 for community acquired pneumonia in
children, Archives of the Balkan Medical Union, 52 (2): 11-14
Sandle, T. (2017) Design and Control of Pharmaceutical Water Systems to Minimize

Microbiological Contamination, Pharmaceutical Engineering, 37 (4): 44-48
Sandle, T. (2017) Pharmaceutical Microbiology: Current and Future Challenges, Journal of GxP
Compliance, 21 (4): 1- 5: http://www.ivtnetwork.com/article/pharmaceutical-microbiology-
current-and-future-challenges
Sandle, T. (2017) Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave,
Journal of GxP Compliance, 21 (4): 1- 10: http://www.ivtnetwork.com/article/matrix-
approach-qualification-pharmaceutical-facility-autoclave
Sandle, T. (2017) Microbial Identification strategy for pharmaceutical microbiology, Journal of

GxP Compliance, 21 (4): 11-20: http://www.ivtnetwork.com/article/microbial-identification-
strategy-pharmaceutical-microbiology
University courses
Sandle, T. Environmental Monitoring Module for University of Manchester School of Pharmacy

PMAT MSc course (100,000 word module divided into nine units). First edition: 2007; revised
2011 and in 2013
Sandle, T. Sterility and Sterility Assurance Module for University of Manchester School of
Pharmacy PMAT MSc course. Written in 2013.
Sandle, T. Introduction to Pharmaceutical Microbiology for University of Manchester School of

Pharmacy PMAT MSc course. Written in 2013.
Tim Sandle is the tutor for each of the above courses.
Training materials
Training CDs produced for Pharmig (Pharmaceutical Microbiology Interest Group):
Sandle, T. and Alexander, B. (2011). Electronic Pack 1: Best Practices in Microbiological

Documentation, Pharmaceutical Microbiology Interest Group, Pharmig: Stanstead Abbotts, UK
Sandle, T. and Alexander, B. Electronic Pack 2: Setting up and managing an effective training
programme in the microbiology laboratory, Pharmaceutical Microbiology Interest Group,
Pharmig: Stanstead Abbotts, UK
Technical articles
Sandle, T. Environmental Monitoring in a Sterility Testing Isolator, PharMIG Newsletter No.1,
March 2000
Sandle, T. Microbiology Web-sites - A Survey, Institute of Science Technology Journal, July
2000
Sandle, T. Microbiological Culture Media: Designing a Testing Scheme, PharMIG News No.2,
August 2000
Sandle, T. Performance characteristics of Automated LAL Tests, PharMIG News No. 4, April
2001
Sandle, T. Repeatability and Precision - Necessary Factors in Standard Testing?, PharMIG News,
No.5, August 2001
Sandle, T. Conference Report: 2001, PharMIG News No. 7, December 2001
Sandle, T. LAL Test Method - Which Technique?, PharMIG News No.10, October 2002
Sandle, T. Particle Monitoring and Control, Pharmaceutical Manufacturing and Packaging

Sourcer, Spring 2003, pp8-11(extract
http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle, T. The Changing Role of the Pharmaceutical Microbiologist, PharMIG News, Issue 12,
June 2003
Sandle, T. Cleanroom Monitoring What, Where and How Often?, PharMIG News, Issue 13,
September 2003, pp9 12
Sandle, T. General Considerations for the Risk Assessment of Isolators used for Aseptic
Processes, Pharmaceutical Manufacturing and Packaging Sourcer, Samedan Ltd, Winter 2004,
pp43-47 (extract http://www.samedanltd.com/magazine/15/issue/60/article/1367)
Sandle, T. 50 Years of Providing the Lifeblood of the Nation, Around Radlett: The Newsletter of
Aldenham Parish Council, No. 63, Spring 2004, p5
Sandle, T. Review of Current Approaches for the Validation of Disinfectants, PharMIG News,
No. 15, March / April 2004, pp10-15
Sandle, T. Fifty Years of Continuous Achievement: The History of the Bio Products Laboratory
(BPL), Internal BPL Publication, April 2004 (limited print run: 1, 500 copies)
Sandle, T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System
Qualification. PharMIG News No. 16. June / July 2004, pp3-12
Sandle, T. A Golden Jubilee: BPL at 50, Circulation, August 2004, NationalBlood Service
Magazine, p8
Sandle, T. Training within the Microbiology Laboratory, PharMIG News, Issue 17, October
2004, pp3-6
Sandle, T. Notable Scientists Who Worked Locally, Around Radlett: The Newsletter of
Aldenham Parish Council, No. 66, Christmas 2004, p6
Sandle, T. Microbiological Environmental Monitoring in Clean Areas: Using Risk

Assessment, Pharmaceutical Manufacturing and Packaging Sourcer, Winter 2004, pp105-107
Sandle, T. Grams Stain: History and Explanation of the Fundament Technique of Determinative
Bacteriology, PharMIG News, Issue 18, January 2005, pp5-6
Sandle, T. Book ending surface sampling In Defence of Swabs, PharMIG News, Issue 19, April
2005, pp8-9
Sandle, T. Keeping It Clean, Circulation, National Blood Service, August 2005, p10
Sandle, T. A Microbiological Risk Assessment Case Study, PharMIG News, Issue 20, July 2005,
pp6-9
Sandle, T. Some Reflections on Trend Analysis, PharMIG News, Issue 21, October 2005, pp12-
15
Sandle, T. Active Air Sampling The Selection Process Made Easy, Pharmaceutical
Manufacturing and Packaging Sourcer, Winter 2005, pp30-33
Sandle, T. Constructing an Environmental Monitoring Programme: Part 1,PharMIG News, Issue

22, February 2006, pp2-6
Sandle, T. A final floor show for bugs, Cleanroom Technology, April 2006, 12 (4): 19-21
Sandle, T. Constructing an Environmental Monitoring Programme: Part 2,PharMIG News, Issue

23, May 2006, pp2-7
Sandle, T. Evaluation of two different types of contact plate, PharMIG News, Issue 24, pp4-7
Sandle, T. Micro Management: Monitoring the Cleanroom Environment,Pharmaceutical

Manufacturing and Packaging Sourcer, Autumn 2006, pp64-66
Sandle, T. Use of Risk Assessment to Assess Environmental Monitoring Data: Part

One, PharMIG News, Issue 25, pp8-11
Skinner, K. and Sandle, T. (2006): How Effective are Swabs? An Examination of Swab
Recovery, PharMIG News, Issue 25, pp4-5
Ross, S. and Sandle, T. (2007): Air Pattern Analysis of a Filtration Transfer,PharMIG News,
Issue 26, pp3-4

Two, PharMIG News, Issue 26, 2007, pp9-15

Three, PharMIG News, Issue 27, pp7-13
Sandle, T. A Breath of Fresh Air: the validation of active air sampling, Pharmaceutical
Manufacturing and Packaging Sourcer, Summer 2007, pp8-12 (extract:
http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle, T. Microbiology and the World Wide Web - Revisited, PharMIG News, Issue 28, pp10-
11
Sandle, T. Some Considerations on the Use of Endotoxin Indicators in Depyrogenation

Studies, Pharmaceutical Microbiology Forum Newsletter, Vol. 13, No. 10, November 2007, pp2-
11
Sandle, T. Calling Time on the Pyrogen Test, PharMIG News, Issue 29, 2007, pp03-04
Tours, N. and Sandle, T. A Comparative Study of Different Methods of Endotoxin

Destruction, Pharmig News, Issue 30, March 2008, pp4-8.
Sandle, T. and Skinner, K. A Practical Example Arising from the Harmonization of the
Microbial Enumeration Method for Water, Pharmaceutical Microbiology Forum Newsletter,
Vol. 14, No.4, pp2-5
Roberts, J. and Sandle, T. Assessment of the Potassium Hydroxide Test as a Complimentary Test
for the Gram-stain, Pharmig News, No. 31, June 2008, pp1-4
Sandle, T. The Sterility Test and other changes to the European Pharmacopeia,
6th edition, Pharmig News, No. 32, September 2008, pp1-3
Sandle, T. Biological Safety: The despatch of microbial cultures, Pharmig News, No. 32,
September 2008, pp5-7
Sandle, T. Calculation of warning (alert) and action levels for a water system, Pharmig
News, No.33, December 2008, pp1-4
Sandle, T. Book Review: Guide to Microbiological Control in Pharmaceuticals and Medical
Devices, 2nd edition edited by Stephen Denyer and Rosamund Baird, Pharmig News, No.33,
December 2008, pp9
Sandle, T., Roberts, J. and Skinner, K. (2009): 'An examination of the sample hold times in the
Microbiological Examination of Water Samples', Pharmaceutical Microbiology Forum
Newsletter, Vol. 15, No.2, pp2-7
Sandle, T. (2009): 'Biological Indicators for Steam Sterilisation', Pharmig News, No.34, pp10-14
(updated and reproduced on-line at: http://microbiologystudents.com/article.php?article_id=198,
6th December 2010 for Microbiology Students)
Sandle, T. and Roberts, J. The microbiologists dilemma: optimising time, temperature and
culture media, Pharmig News, Issue 35, 2010, pp1-5
Sandle, T. Cleanroom Operator Training: An Approach for Basic Hygiene, Pharmig News, Issue
37,2010, pp1-9
Sandle, T. Microbiology and the World Wide Web, Pharmaceutical Microbiology Forum
Newsletter, Vol. 15, Number 11, 2010, pp2-5
Sandle, T. Introduction to Antimicrobials, Pharmig News, Issue 39, 2010, pp5-7
Sandle, T. (2010): 'Choosing Disinfectants', Cleanroom Technology, August 2010, 18 98): 11-13
Also published at: http://www.schulke.co.uk/media/28/128-
disinfectants_in_pharmaceutical_industry_tim_sandle.pdf
Sandle, T. (2010): PIC/S Guide on Aseptic Processing, Pharmaceutical Microbiology Forum

Newsletter, Vol.16, No.2, pp10-11
Sandle, T. (2010): Effective and Efficient Hand Sanitisation, Inside Hospitals, December 2010
(reproduced on-line at: http://www.inside-hospitals.co.uk/ under features, infection prevention,
schulke)
Sandle, T. (2010): 'Cleaning Cleanrooms', Cleanroom Technology, December 2010, pp22-24

(reproduced on-line at: http://www.cleanroom-
technology.co.uk/technical/article_page/Cleaning_cleanrooms/57871) [26th November 2010]
Sandle, T. (2010): Changes to the European Pharmacopoeia: 2008 - 2010, Pharmaceutical

Microbiology Forum newsletter, Vol. 16, No.12, December 2010, pp10-14
Sandle, T. (2010): "Medical and social development of the English and Welsh Blood Service: the
evolving status of venepuncture", Wellcome History, Issue 45, pp17-18
Sandle, T. (2010): "Training within the Microbiology Laboratory", Global BioPharmaceutical
Resources Inc. Newsletter, December 2010, pp1-11 (available to view at:
http://www.gbprinc.com/pdf/TrainingWithinTheMicrobiologyLaboratory.pdf)
Sandle, J. and Sandle, T. (2011): Infection Control in Healthcare, Pharmig News, Number 42,
pp3-6
Sandle, T. (2011): A review of current developments in cleanroom standards, Pharmig News,

Number 42, pp12-14
Sandle, T. (2011): 'Investigating Sterility Test Failures', Global BioPharmaceutical Resources

Inc. Newsletter, February 2011, pp1-16
(http://www.gbprinc.com/pdf/InvestigatingSterilityTestFailures.pdf)
Sandle, T. (2011) "Glucans and the Bacterial Endotoxin Test", Global Pharmaceutical Resources
Inc Newsletter, April 2011, pp1-12 (available at:
http://www.gbprinc.com/pdf/Whitepaper041411-4.pdf)
Sandle, T. (2011): 'The Consequence of Failure to Monitor Air Quality in Cleanrooms: A Case
Study', Pharmig News No. 43, pp3-7
Sandle, T. (2011): Biological Indicators for Steam Sterilization: Failure Investigations,

Pharmaceutical Microbiology Forum Newsletter, Vol. 17, No.5, pp2-8
Sandle, T. (2011): 'Advances in Cleanroom Technology', Process India, Vol. 1, No.3, pp42-44
Sandle, T. (2011): Container-Closures for Pharmaceutical Preparations, GBPR, Inc. Newsletter,

August 2011, pp1-6 (available at: http://www.gbprinc.com/pdf/GBPRContainerClosures.pdf)
Sandle, T. (2011): Maintaining hygiene: keeping surfaces clean, Inside Hospitals, August 2011,
p40
Sandle, T. (2011). 'Validating surface cleaning agents', Cleanroom Technology, September 2011,
19 (9): 15-18
Sandle, T. (2011): "Characterization of Microbial Contamination in Pharmaceutical Facilities",

Global BioPharmaceutical Resources Inc. Newsletter, September 2011, pp1-15 (available at:
http://www.gbprinc.com/pdf/GBPRCharacterization092311.pdf)
Sandle, T. (2011). "Risk Management in Pharmaceutical Microbiology", Pharmaceutical

Manufacturing, September 2011, Vol 10, Issue 8: 30-36
(http://www.scribd.com/doc/95778970/PM-Sept2011)
Sandle, T. (2011): "Sterility Test Requirements for Biological Products", Pharmaceutical

Microbiology Forum Newsletter, Vol. 17, No.8, pp5-14 (available at:
http://www.microbiologyforum.org/PMFNews/PMFNews.17.08.1108.pdf)
Sandle, T. (2011): "Environmental Monitoring: Corrective and Preventative Actions", Global
BioPharmaceutical Resources Inc. Newsletter, October 2011, pp1-18 (available at:
http://www.gbprinc.com/pdf/GBPROctober2011NewsletterFeaturedArticleIssue2.pdf)
Sandle, T. (2011): Keeping Hands and Surfaces Clean, Arab Medical Hygiene, Issue 3, pp11-17
Sandle, T. (2011): "Cleanrooms and Air Quality A Risk-Based Approach", Global

Biopharmaceutical Resources Inc. Newsletter, December 2011, pp1-13 (available at:
http://click.icptrack.com/icp/relay.php?
r=37671113&msgid=1460557&act=RAB6&c=623139&destination=http%3A%2F
%2Fwww.gbprinc.com%2Fpdf%2FGBPRDecember2011FeaturedArticle.pdf)
Sandle, T. (2012) "Recent Developments in European Regulatory Requirements:

Issues Affecting the Microbiologist", Pharmaceutical Microbiology Forum
Newsletter, Vol. 18, No.1, pp5-15 (available
at: http://www.microbiologyforum.org/PMFNews/PMFNews.18.01.1201.pdf)
Sandle, T. and Sandle, J. (2012). Data Analysis Shewhart Chart, Pharmig News, Number 46,
pp2-5
Sandle, T. (2012). Cleanrooms and Clean Air, Arab Medical Hygiene, Issue 4, pp19-25
Sandle, T. (2012). "Approaching Risk Assessment: Tools and Methods", Global

Biopharmaceutical Resources Inc. Newsletter, February 2012, pp1-23 (available at:
http://www.gbprinc.com/pdf/GBPRFebruary2012FeaturedArticle.pdf)
Sandle, T. (2012). Cleanroom Cleaning and Disinfection: Eight Steps for Success, Controlled
Environments Magazine, March 2012 (http://www.cemag.us/print/5636)
Sandle, T. (2012). Introducing Antimicrobials, Arab Medical Hygiene, Issue 5: 37-41
Sandle, T. (2012). Airflow visualisation in an aseptic facility, Cleanroom Technology, May

2012, 20 (5): 13-17
Single-Use Disposable Technologies in the Biopharmaceutical Sector, Pharmaceutical
Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May 2012, S20-S27
(http://digital.findpharma.com/nxtbooks/advanstar/pt_201205_supp/index.php?startid=s30#/20)
Sandle, T. and Saghee, M. R. (2012). Cleanroom Technology: Setting the

Scene, Pharmaceutical Manufacturing and Packaging Sourcer, May 2012, pp38-42
Sandle, T. (2012). The Characterization of Microbial Contamination, Pharmig News Number

47, pp2-4
Sandle, T. (2012). FDA: Sterility Test Requirements for Biological Products, Pharmig News
Number 47, pp5-8
Sandle, T. (2012). Pyrogens, Endotoxin and the LAL Test: An Introduction in Relation to
Pharmaceutical Processing, Global BioPharmaceutical Resources Newsletter, May 2012, pp1-16
(http://www.gbprinc.com/pdf/GBPRMay2012FeaturedArticle.pdf)
Sandle, T. (2012). Pharmaceutical Microbiology and Pharmig, Innovations For Success, Issue
29, summer 2012, p35 (http://viewer.zmags.com/publication/ec07d7ab#/ec07d7ab/34)
Single-Use Disposable Technologies in the Biopharmaceutical Sector, Pharmaceutical
Technology, Volume 36, Issue 5, pp. s20-s30
Sandle, T. (2012). A silver lining? The use of antimicrobial bandages, Arab Medical Hygiene,
Issue 6, July 2012, pp19-25
Sandle, T. (2012). "Sanitization of Pharmaceutical Facilities", Global BioPharmaceutical

Resources Inc. Newsletter, July 2012, pp1-14
Sandle, T. (2012) "Contamination Control Underfoot", Controlled Environments, Vol. 15, No.7,
pp10-11 (http://www.cemag.us/print/6121)
Sandle, T. (2012). "Practical Selection of Cleanroom Disinfectants", Hospital Pharmacy Europe,

Issue 63, pp39-41
Also as:
Sandle, T. (2012). Desinfektionsmittel Auswahl fr den Einsatz in der Pharmaindustrie, IAB

Cleanroom GmbH website: http://www.iab-reinraumprodukte.de/info-
portal/fachartikel/desinfektionsmittel-pharmaindustrie.html (published 301st July 2012)
Sandle, T. (2012). Good practices for microbiology laboratories, GMP Review, Vol. 11, No.3,
October 2012, pp6-8
Reprinted in Logfile:
Sandle, T. (2013) Good practices for microbiology laboratories, Logfile, 1, pp1-4

(https://www.gmp-publishing.com/media/files/leitartikel_2013/LOGFILE-1-2013-good-
practices-for-microbiology-labs.pdf)
Sandle, T. and Saghee, M.R. (2012). Cleanroom Technology: Inside the Box Pharmaceutical
Manufacturing and Packaging Sourcer, Summer 2012, pp54-57
Sandle, T. (2012). Introduction to particle counting, Pharmig News, Number 48, pp6-9
Sandle, T. (2012). Cleaning endoscopes: Considering the risks and benefits of enzymatic and
non-enzymatic detergents, Inside Hospitals, June 2012, pp14-15
Sandle, T. (2012). Introduction to Particle Monitoring, Pharmig News, Issue 48, pp6-9
Sandle, T. (2012). An Air of Safety: The application of cleanrooms and clean air devices within
the hospital setting, European Medical Hygiene, Issue 1, pp11-17
Sandle, T. (2012). Wipe study measures particle shedding, Cleanroom Technology, September
2012, 20 (9): 26-29
Sandle, T. (2012). Detergent choices for endoscope reprocessing, The Clinical Services
Journal, Volume 11, Issue 8, pp71-75
Sandle, T. (2012). European Pharmacopeia Proposes Revision to Biological Indicators Chapter,

Pharmaceutical Microbiology Forum Newsletter, Vol. 18, No.5, pp4-7
Sandle, T. (2012). Ensuring Contamination Control: The validation of disinfectants, European

Medical Hygiene, November 2012, pp33-39
Sandle, T. (2012). Pharmig History: A Potted Guide (1992-2012), Conference Paper provided to
delegates at the 2012 Pharmig Conference (Chipping Norton, UK).
Sandle, T. (2012). Making the grade in filters, Cleanroom Technology, December 2012, 20 (12):
19-20
Sandle, T. (2012). Review of FDA warning letters for microbial bioburden issues (2001-2011),
Pharma Times, Vol. 44, No.12, pp29-30
Sandle, T. (2012). Making the grade in filters, Cleanroom Technology, December 2012, pp19-20
Sandle, T. (2012). Utilisation de la gamma, Salles Propes, Issue 81, pp42-54
Sandle, T. and Saghee, M.R. (2012). Gamma irradiation cleans up, Medical Device
Developments, October 2012, reproduced on-line at: http://www.medicaldevice-
developments.com/features/featuregamma-rays-irradiation/
Sandle, T. (2013). Revised FDA Guidance on Pyrogens and Endotoxin, Pharmig News, Number
51, p10
Sandle, T. (2013). Pharmig hosts successful twentieth anniversary conference, Pharmig News,
Number 51, p4-5
Sandle, T. (2013). Electron beam processing: A rapidly developing sterilisation technology,

European Medical Hygiene, February 2013, pp9-13
Sandle, T. (2013). Variability and the LAL assay, Pharmaceutical Microbiology Forum
Newsletter, Vol. 19(1), pp4-12
Sandle, T. (2013). New guidance for environmental monitoring in cleanrooms, GMP Review,
Vol. 11, No.4, pp9-11
Sandle, T. (2013). Sandle, T. (2013). Biocontamination control - Moves toward a better standard,
Cleanroom Technology, 21 (4): 14-15. Online: http://www.cleanroom-
technology.co.uk/technical/article_page/Biocontamination_control__moves_toward_a_better_sta
ndard/87172
Sandle, T. (2013). Avoiding Dilution Error With the LAL Assay, Pharmaceutical Microbiology
Forum Newsletter, Vol. 19(2), pp2-13
Sandle, T. (2013). 'A new ray of hope to address water pollutants', Industry 2.0, Vol. 12, Issue 8,
pp33
Sandle, T. (2013). 20 years of Microbiology, Cleanroom Technology, March 2013, 21 (3): 24-25
Sandle, T. (2013). Bacteria and temperature of growth: a simple introduction, Pharmig News
Number 51, pp2-3.
Siew, A. (2013): Ensuring Sterility of Parenteral Products: an interview with James Agalloco,
Tim Sandle and Benoit Verjans, Pharmaceutical Technology, Vol. 37, Number 4, pp62-67
Sandle, T. (2013). Single-Use: Sterile Disposable Technology, Industry 2.0, Vol.12, Issue 9,
pp45-47
Wilder, C., Sandle, T. and Sutton, S. (2013). Implications of the Human Microbiome on
Pharmaceutical Microbiology, American Pharmaceutical Review, 16 (5): pp17-21
Also: June 2013, on-line publication: http://www.americanpharmaceuticalreview.com/1504-

White-Papers-Application-Notes/140112-Implications-of-the-Human-Microbiome-on-
Pharmaceutical-Microbiology/?catid=6262
Sandle T (2013) Could the Black Death Become a Re-Emerging

Infectious Disease? J Anc Dis Prev Rem 1: e104. doi:10.4172/jadpr.1000e104
Sandle, T. (2013). Automated Microbial Identifications: A comparison of USP and EP

approaches, American Pharmaceutical Review, 16 (4): 56-61
Sandle, T. (2013): Risk assessment and monitoring of cleanrooms, Hospital Pharmacy Europe,
May / June 2013, pp54-56
Sandle, T. (2013). FDA Guidance on pyrogens and endotoxin, GMP Review, 12 (2): 7-9
Sandle, T. (2013). Understanding cleanroom microflora, The Journal: the Official Journal of the
Institute of Science and Technology, Summer 2013, pp35-45
Sandle, T. (2013). Avoiding Contamination of Water Systems, The Clinical Services Journal, 12
(9): 33-36
Sandle, T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic

Manufacturing - a road map to excellence, Pharmaceutical Manufacturing, USA, pp3-9
(http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
Sandle, T. and Sandle, J. (2013). An Important Aspect of Healthcare: Outlining the many
considerations of infection control, Arab Medical Hygiene, October 2013, pp34-39
Sandle, T. (2013): Pharmaceutical Product Impurities: Considering Beta Glucans, American

Pharmaceutical Review, 16 (5) Special Edition Supplement 'Furthering Pharmaceutical
Microbiology': 16-19
Sandle, T. (2013). Skin cleaning before cathererisation, Inside Hospitals, October 2013, pp40-41
Sandle, T. (2013). Water Quality Concerns: Contamination control of hospital water systems,
European Medical Hygiene, November 2013, pp14-19
Sandle, T. (2013). USP updates: cleanrooms and sterilization, Clean Air and Containment
Sandle, T. (2013). Single-use technology for biopharma, Cleanroom Technology, 21 (12): 15-19
Sandle, T. (2013). A comparative study of different methods of endotoxin destruction, American

Pharmaceutical Review, Supplement on Endotoxin Detection: techniques and developments,
November 2013, pp15-17
Sandle, T. (2013). Using an antimicrobial skin cleanser before catheterisation, Journal of

Community Nursing, Vol. 27, No.5, pp30-34
Sandle, T. (2013). Innovations in Cleanroom Technology, Pharma Times, 45 (12): 14-15
Sandle, T. (2014) Recent changes to bacterial taxonomy, Micrographia Today, 1 (1): 31-36
Sandle, T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments,

17 (1): 8-10
Sandle, T. (2014). Biologics and biosimilars: the regulatory environment, Clean Air and
Containment Review, Issue 17, pp20-21
Sandle, T. (2014) Selection of Laboratory Disinfectants, Lab World Magazine, 3 (2): 17-22
Sandle, T. (2014) Fungal contamination of pharmaceutical products: the growing menace,
European Pharmaceutical Review, 19 (1): 68-71
Sandle, T. (2014) The rise of antimicrobial resistant microorganisms, Microbiology World, Issue
2, pp10-16
Sandle, T. (2014) EU GMP Annex 15 Revisions: Improving Qualification and Validation,

Cleanroom Technology, April 2014, pp14-16
Sandle, T. (2014) Revision to EU GMP Annex 15: Qualification and Validation, Clean Air and
Containment Review, Issue 18, pp22-23
Sandle, T. (2014) WHO updates endotoxin guidance for parenteral products, GMP Review, 13
(1): 7-8
Sandle, T. (2014) Selecting cleanroom disinfectants, La Vague, Issue 42, pp28-31

Sandle, T. (2014) Assessment of Culture Media in Pharmaceutical Microbiology, American
Pharmaceutical Review, June 2014:
http://www.americanpharmaceuticalreview.com/Specialty/Microbiology/Featured-
Articles/163589-Assessment-of-Culture-Media-in-Pharmaceutical-Microbiology/?catid=6262
Sandle, T. (2014) Examination of air and surface particulate levels from cleanroom mats and
polymeric flooring, Pharmig News 56, pp2-8
Sandle, T. (2014) Non-sterile pharmaceutical manufacturing: USP chapter in development,

Clean Air and Containment Review, Issue 19, pp19-20
Sandle, T. (2014) Quality control of hospital water systems, Microbiolz India, Issue 7, pp20-25
Sandle, T. (2014) Medicines and the Microbiome, The Medicine Maker, Issue 1, p18-19:
http://themedicinemaker.com/issues/2100-a-medicine-manufacturing-odyssey/medicines-and-
the-microbiome/
Sandle, T. (2014) Quality Control of Hospital Water, The Clinical Services Journal, 13 (8): 47-51
Sandle, T. (2014) Variability and Test Error with the LAL Assay, American Pharmaceutical
Review, October 2014, pp1-5: http://www.americanpharmaceuticalreview.com/Featured-
Articles/167404-Variability-and-Test-Error-with-the-LAL-Assay/
Sandle, T. (2014) Are alcohol wipes effective in the presence of protein?, The Dentist, October
2014, pp92-94
Sandle, T. (2014) Pharmacopeial changes in relation to pyrogens and endotoxin, GMP Review,
13 (3): 10- 12
Sandle, T. (2014) Review Of cGMPs For Sterile Manufacturing, GMP Insight, Issue 1, pp2-4
Sandle, T. (2014) A Practical Approach to the Selection of Cleanroom Disinfectants, Pharma
Focus Asia, Issue 21, pp27-30 (http://www.pharmafocusasia.com/articles/practical-approach)
Sandle, T. (2014) The Risk of Bacillus cereus to Pharmaceutical Manufacturing, American

Pharmaceutical Review, 17 (6): pp-pp
Sandle, T. (2014) Taking on the Resistance, Laboratory News, March 2014, pp8-10:
http://www.labnews.co.uk/features/taking-on-the-resistance/
Sandle, T. (2015) Auditing Cleanrooms, Cleanroom Technology, February 2015, pp66-68
Sandle, T. (2015) Cleanroom wipes, European Medical Hygiene, February 2015, pp24-29
Sandle, T. (2015) Cleanroom Disinfectants, Cleanroom Technology, January 2015, pp10-11

(interview: http://flickread.com/edition/html/index.php?
pdf=54ba1a26714b8&dm_i=8EU,358EB,AW0FAO,B9QJX,1#62
Sandle, T. (2015) Cleanroom Wipes, European Medical Hygiene, Issue 9, pp24-29
Sandle, T. (2015) Real-time biological particle counting in environmental monitoring, European

Pharmaceutical Review, Vol. 20, Issue 2, pp39-42
Sandle, T. (2015) Sanitization of Pharmaceutical Facilities, Pharmig News, number 59, pp2-7
Sandle, T. (2015) FDA opens up review into hand disinfectants, GMP Review, 14 (2): 8-9
Sandle, T. (2015) Innovations in cleanrooms and environmental monitoring, Cleanrooms:

Express Pharma Special Supplement, July 2015, pp12-14
Sandle, T. (2015) Contamination control guidances under review, Clean Air and Containment
Sandle, T. (2015) European Sterile Products Guidance Under Review, American Pharmaceutical
Review, September / October 2015: 1-4
Sandle, T. (2015) Current Methods and Approaches for Viral Clearance, American
Pharmaceutical Review, September / October 2015: 1-4
Sandle, T. (2015) FDA issues revised guidance for analytical method validation, GMP Review,
14 (3): 8-10
Sandle, T. (2015) Importance of Risk Assessment for a Aseptic Transfer in Pharmaceutical

Compounding, Clean Air and Containment Review, Issue 24, pp18-23
Sandle, T. (2015) Safe use of disinfectants and detergents in cleanrooms, Innovation Into Success
(quarterly journal of UKSPA), Issue 38, pp81-84
Sandle, T. (2015) Embracing Rapid Microbiology, The Medicine Maker, Issue 12, pp18-19
Sandle, T. (2015) 10 Most influential microbiologists of the 21st Century, Microbioz India, Vol.
2, Issue 21, pp8-14: http://www.microbiozindia.com/top-10-most-influential-microbiologist-of-
21st-century.htm
Sandle, T. 2015 Development of a biocontanination control strategy, Cleanroom Technology, 23

(11), 25 - 30
Sandle, T. (2015) Current Developments with Disposable Technology and Single-Use Systems
for Aseptic Processing, BioPharma Asia, 4 (6): 5-11
Sandle, T. (2016) Calling time on the General Safety Test, GMP Review, 14 (4): 11-13
Sandle, T. (2016) Standards and controls for skin disinfection, The Clinical Services Journal, 15
(2): 25-28
Sandle, T. (2016) New estimates of microbial numbers in our bodies, Microbioz India, Vol. 3,
pp9-13
Sandle, T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American

Pharmaceutical Review, March 2016, pp1-5
Sandle, T. (2016) Beneath the surface of new cleanliness standard ISO 14644-13, Cleanroom
Technology, April 2016, pp27-28
Sandle, T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American

Pharmaceutical Review, 19 (2): 32-29
Sandle, T. (2016) , ,
- (Placing sedimentation plates in a unidirectional air flow and the effect of
the weight loss (dry agar) on the growth of microbes),
[Cleanrooms and technological environments], 56 (4): 46-53
Sandle, T. (2016)
( ) (The study
of the microflora of water used for pharmaceutical purposes, - meta analysis),
[Cleanrooms and technological environments], 56 (4):
30-39
Sandle, T. (2016) Revision to cleanroom standard: ISO 14644 Parts 1 and 2, GMP Review, 15
(1): 4-7
Sandle, T. (2016) Key Criteria for the Selection of Rapid and Alternative Microbiological
Methods, American Pharmaceutical Review, 19 (3): 46-48
Sandle, T. (2016) Improving microbiological assurance for bioburden tests, European
Sandle, T. (2016) New EMA draft guideline on sterilisation of the medicinal product, GMP
Review, 15 (2): 6-8
Vijakumar, R. and Sandle, T. (2016) Bacterial endotoxin contamination and testing limits in
ophthalmics, European Pharmaceutical Review, 21 (4): 16-18
Sandle, T. (2016) Top Cleanroom Advances, The Medicine Maker, July / August 2016 (issue 7),
pp403-404
Sandle, T. (2016) The importance of detergent selection, The Clinical Services Journal, 15 (8):
72-74
Sandle, T. (2016) Removal of Endotoxin from Protein in Pharmaceutical Processes, American

Pharmaceutical Review, 19 (8): 1-5 (http://www.americanpharmaceuticalreview.com/Featured-
Articles/190810-Removal-of-Endotoxin-from-Protein-in-Pharmaceutical-Processes/)
Sandle, T. (2016) Evaluation of Quaternary Ammonium Compound Disinfectants against

Mycobacteria in Dental Practices, Dental Update, 43, 723-726
Sandle, T. (2016) Risk of Microbial Spores in Cleanrooms. Part 1: Introduction to Microbial

Spores and Survival Mechanisms, Clean Air and Containment Review, 28, pp4-6
Sandle, T. (2016) The development of cleanrooms: an historical review. Part 1: From civil war to
safe surgical practice, The Journal Institute of Science & Technology, Autumn 2016, pp41-47
(ISSN 2040-1868)
Sandle, T. (2017) The European approach to disinfectant qualification, La Vague, No. 52, pp45-
48
Sandle, T. (2017) Risk of microbial spores to cleanrooms: Part 2: Selection of sporicidal

disinfectants, Clean Air and Containment Review, Issue 29, pp14-16
Sandle, T. (2017) Establishing a Contamination Control Strategy for Aseptic Processing,

American Pharmaceutical Review, 20 (3): 22-28
Sandle, T. (2017) Effective cleaning and disinfection of dental practices, Dental Practice
Magazine, March 2017, pp58-66
Sandle, T. (2017) Cleaning and disinfection of dental practice surfaces, Dental Nursing, 13 (2):
86-87
Sandle, T. (2017) Risk assessment and pharmaceutical processing hazards, Microbioz India 3 (3):
10-18
Sandle, T. (2017) Microbiological monitoring of pharmaceutical water systems, European
Sandle, T. (2017) The development of cleanrooms: an historical review Part 2 The path
towards international harmonisation, IST The Journal, Summer 2017, pp1-5
Sandle, T. (2017) European Pharmacopoeia revises Biological Indicator Chapter, GMP Review,
16 (1): 4-6
Sandle, T. (2017) Designing cleanroom equipment for particulate control, Cleanroom News,
Issue 2, pp22-23 (Turkish publication: "Parack kontrol iin temiz oda tasarm"). at:
http://www.cleanroomnews.org/sayi-2
Sandle, T. (2017) Antimicrobial copper surfaces in hospitals, The Clinical Services Journal, 16
(6): 47-51
Sandle, T. (2017) MHRA annual deficiency review highlights sterility assurance issues, GMP
Review, 16 92): 4-7
Sandle, T. (2017) Assessment of Bacterial Endotoxin by Fluorescent Labeling, American

Pharmaceutical Review, Endotoxin Supplement, October 2007, pp1-3
Sandle, T. (2017) Applying design and construction standards to cleanroom builds, Cleanroom
Sandle, T. (2017) The people factor: investigating the gown, European Pharmaceutical Review,
22 (4): 23-26
Technical articles (internet and on-line published articles)
Sandle, T. Microbiology and the Internet, PharMIG web-site(www.PharMIG.org.uk), November

1999
Sandle, T. Update on Bacterial Taxonomy, internet only article, published in the members
section of PharMIG (www.pharmig.org.uk), December 2005
Sandle, T. Dycem Flooring. On-line at: http://www.cleanroom-technology.co.uk/story.asp?

storyCode=39685 (first accessed 29th July 2006);
Also printed on-line at Lifesciences
News:http://www.lifesciencesnews.com/articleView~idArticle~73104_937924181052006.html(1
0th May 2006)
And in Packaging Today at:
http://www.packagingtoday.co.uk/story.asp?storyCode=39685 (accessed 29th July 2006)
And at the Dycem website:
http://www.dycem.com/latestnews.php (accessed 10th April 2007)
Sandle, T. Selection of Active Air-Samplers, BioSciences Quality Testing Forum (BioQT)
website: http://www.bioqtforum.com/Selection-of-active-air-samplers (accessed 15th September
2010)
Sandle, T. (2010): The use of risk assessment tools for microbiological assessment of cleanroom
environments, Internet article, GMP Guru, Insight Systems Inc.,
at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th
September 2010).
Saghee, M.R. and Sandle, T. (2010): 'Embracing quality risk management: The new paradigm',
Express Pharma, Pharma Technology Review, 16th - 30th September 2010, On-line paper at:
http://www.expresspharmaonline.com/20100930/pharmatechnologyreview02.shtml (accessed
30th September 2010)
Sandle, T. and Saghee, M.R. (2010): Advances in cleanroom technologies, Express Pharma,
16th-30th September, On-line Paper:
http://www.expresspharmaonline.com/20100930/expressbiotech13.shtml (accessed 30th
September 2010)
Sandle, T. (2010): The use of risk assessment tools for microbiological assessment of cleanroom
environments, Internet article, GMP Guru, Insight Systems Inc.,
at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th
September 2010).
Sandle, T. (2011): Nontoxic And Nonfuming Sporicide: Science At Its Best, on-line article
published by Go1Bio (February 2011): http://www.google.co.uk/url?
sa=t&source=web&cd=51&ved=0CC8QFjAAODI&url=http%3A%2F%2Fwww.go1bio.com
%2Fclientuploads%2Fdirectory%2Fnewsdirectory%2FSTERIPLEX%2520HC_Nontoxic
%2520Nonfuming%2520Sporicide.pdf&rct=j&q=tim
%20sandle&ei=K1MQTpqpCoWY8QPCsb2eDg&v6u=http%3A%2F%2Fdualstack.ipv6-
exp.l.google.com%2Fgen_204%3Fip%3D81.156.212.12%26ts%3D1309692715373476%26auth
%3Dpds7hrga6grshaf6rlfeatpwd464noyf%26rndm
%3D0.00039878398549886285&v6s=2&v6t=8449&usg=AFQjCNHAVVyROwwVYokmK-
QI3TKg5TiLIQ&cad=rja
Sandle T. (2011): Advances in Cleanroom Technology: Manufacturing Perspective, Process

Worldwide at: http://www.process-worldwide.com/index.cfm?pid=9963&pk=17888 (28th June
2011)
Sandle, T. (2011): 'Selection of Disinfectants for Use in the Pharmaceutical Industry', Online
article published by PharmaHireWire on 28th June 2011 at:
http://www.mypharmacareers.com/pharmajournal/archives/jun11.html
Sandle, T. (2011). Good Practices for Pharmaceutical Microbiology Laboratories: A review of

the 2011 WHO Guidance, Cryologics, Inc. Newsletter, August 2011 (re-printed at:
www.pharmig.blogspot.com) at: http://pharmig.blogspot.com/2011/08/good-practices-for-
pharmaceutical.html
Sandle, T. (2012). Quality Management System, A3P website, published 1st May 2012
(http://www.a3p.org/index.php/fr/base-documentaire/articles/203-a-la-une/3990-quality-
management-system)
Sandle, T. (2012). Cleaning endoscopes: Considering the risks and benefits of enzymatic and
non-enzymatic detergents, Hospital Bulletin website, published 1st July 2012 (see Hospital
Bulletin) http://www.hospital-bulletin.co.uk/features/Infection%20Prevention/shulke.htm
Sandle, T. (2012). "Desinfektionsmittel Eine Einfhrung", IAB website, published 27th July
2012 (see IAB) (http://www.iab-reinraumprodukte.de/info-portal/fachartikel/desinfektionsmittel-
eine-einfuehrung.html)
Sandle, T. (2012). Toward a Revised International Cleanroom Standard, Controlled

Environments, on-line article August 2012, pp1-3. Available at: http://www.cemag.us/print/6201
(accessed 3rd August 2012)
Sandle, T. (2012). "Risk Management in Pharmaceutical Microbiology: at look at how HACCP

and FMEA can make a difference in the pharma micro lab.", Pharmaceutical Manufacturing
Magazine on-line: http://www.pharmamanufacturing.com/articles/2011/126.html?page=full
(accessed 9th October 2012).
Rapid Microbial Methods: A Q&A with Dr. Tim Sandle, Rapid Micro Biosystems:
http://www.rapidmicrobio.com/blog/rapid-microbial-methods-a-qa-with-dr.-tim-sandle (July
2014)
Microbiological Monitoring Roundtable - conversation with Tim Sandle and other

microbiologists, with American Pharmaceutical Review
http://www.americanpharmaceuticalreview.com/Featured-Articles/167343-Microbiological-
Monitoring-Roundtable/
Sandle, T. (2010) Cleanroom Particle Counting: The 5 Micron Issue, Pharmaceutical Online
(online publication): http://www.pharmaceuticalonline.com/doc/cleanroom-particle-counting-
the-5-micron-iss-0001
Tim Sandle - participant (2016) LAL Roundtable, American Pharmaceutical Review, 19(6): 47-
51 http://www.americanpharmaceuticalreview.com/Featured-Articles/239887-LAL-Roundtable/
Tim Sandle Q&A - in conversation with Institute of Validation Technology, April 2017 at:
http://www.ivtnetwork.com/article/meet-ivt-board-tim-sandle
Sandle, T. (2017) Risk and Microbiological Contamination, PDA Letter, Volume LIII (7), (July
2017, pp8 at: https://www.pda.org/pda-letter-portal/archives/full-article/pda-summer-reading-
for-2017
Technical guides
Author of Pharmig LAL Fact Sheet Series (series editor). 2005 -2007 (sheets 1 to 6) [re-designed
and re-printed 2010]
Technical adviser to publication: Microbiological Control for Non-Sterile Pharmaceuticals,

published by Pharmig and PQG, 2008
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to the Microbial
Examination of Non-Sterile Products, written by Tim Sandle and issued in November 2013.
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to the Objectionable
Microorganisms, written by Tim Sandle and issued in November 2014.
Contributing author / editor to PHSS (2014) Bio-contamination, Technical

Monograph No. 20, Pharmaceutical and Healthcare Sciences Society,
Wiltshire, U.K. https://phss.site-ym.com/store/ViewProduct.aspx?id=3427062
PDA Technical Report #69: Bioburden and Biofilm Management in Pharmaceutical

Manufacturing Operations, 2015
PDA Technical Report #70: Fundamentals of Cleaning and Disinfection Programs for Aseptic
Manufacturing Facilities, 2015
Contributing author to The Cosmetic, Toiletry and Perfumery Association & Pharmig
(2015) Rapid and Alternative Microbiological Methods, published by the CPTA, London
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to pharmaceutical
important fungi, written by Tim Sandle and issued in November 2015.
Author of Pharmig Microorganism Fact Sheets. 8 full colour sheets relating to important
environmental isolates, written by Tim Sandle and issued in November 2016
Written conference papers
Sandle, T. Cleanroom Monitoring What, When and How Often, included in Pharmaceutical
Cleanrooms conference pack for the Cleanrooms 2003 Conference 16 19th March 2003,
Cambridge
Sandle, T. Sterility Testing A Practical Approach. Written paper presented to PharMIG

Microbiological Methods Validation Conference, St. Albans, 4th June 2003
Sandle, T. Points to Consider In Performing Risk Assessments Of Isolators Used For Aseptic
Processes. Written paper presented to the AUDITS 13 conference, organised by La Calhene,
Brussels, 16th September 2003
Sandle, T. Current Practices in Sterility Testing. Written paper presented to Institute of Validation
Technology Microbiology Event of the Year, December 2003, Dublin
Sandle, T. Sterility Testing A Practical Approach (Revised). Written paper presented

to PharMIG Microbiological Methods Validation Conference,Dublin, 25th March 2004
Sandle, T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System
Qualification. Written paper presented to PharMIG Endotoxin Course, Waltham Abbey, 3rd June
2004.
Sandle, T. Microbiological Environmental Monitoring in an Isolator Used for Aseptic Filling or

Sterility Testing, written paper presented to the La Calhene Audits 15 Conference, Brussels,
21st September 2004
Sandle, T. Environmental Monitoring Risk Assessment. Written paper presented to Institute of

Validation Technology Microbiology Event of the Year, Amsterdam, November 2004
Sandle, T. The Use of Risk Assessment in Developing a Viable Environmental Monitoring

Programme. Written paper presented toPharmaceutical Cleanrooms 2005, Cambridge, September
2005
Sandle, T. A guide to the Pharmaceutical Microbiology Interest Group Web Forum, paper
presented to the PharMIG Conference, 23rd November 2005
Sandle, T. The Distribution of Microbiological Data, Written Paper for the PharMIG Irish
Conference, Cork, 7th June, 2006
Alexander, B. and Sandle, T. Managing a Microbiology Laboratory Training Programme, a

PharMIG training package (issued to delegates with the one-day workshop papers on 29th March
2007)
Sandle, T. Applying Failure Mode and Effects Analysis (FMEA) to a Sterility Testing Isolator: A
Case Study, written paper included with the PharMIG Risk Based Management in
Pharmaceutical Microbiology, 27th June 2007
Reports
Sandle, T. (2011): Pharmig Conference Summary: November 2010, Pharmig News, Number
42, pp10-11
Contributing interview to Ensuring Sterility of Parenteral Products, along with James Agalloco
and Benot Verjans. Published in Pharmaceutical Technology, April 2013, pp2-6
Cox, B. (2013). Are Cleanrooms Clean? Human Microbiome Project Raises Some
Questions, The Gold Sheet, 47 (11): 16-18 - a review of Tim Sandle's 2013 PDA Microbiology
presentation.
Interviews
An interview with Tim Sandle, conducted by Pharmaceutical Bioprocessing

(http://www.future-science.com/doi/pdf/10.4155/pbp.13.64):
Sandle, T. (2014). Pharmaceutical Microbiology, Pharmecutical Bioprocessing; 2(1): 1721
Interview with Tim Sandle for Microbiology Today by Saumyadip Sarkar.
Sakar, S. (2014) Portrait - an interview with Dr. Tim Sandle, Micrographia Today, 1 (2): 16-20
http://www.wethemicrobiologist.in/uploads/9/4/5/2/9452624/06._magazine_feb_-_mar_1.pdf
Regulatory updates
Tim Sandle writes a quarterly column on regulatory updates for Pharmig News. The series began
in 2008 and continues to date.
Poster abstract
Poster abstract Assessing airborne contamination using a novel rapid microbiological method
by Tim Sandle, Clare Leavy and Rachel Rhodes. Published in Helapet Newsletter, Issue 4, 2015,
p2.
Notes
[1] This paper was featured in a book about marketing:
Title Principles of direct and database marketing

Author Alan Tapp
Edition 4, illustrated
Publisher Pearson Education, 2008
ISBN 0273713027, 9780273713029
Length 517 pages

Publications by Tim Sandle (3rd Revision)

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This page lists all of my major publications.

Sandle, T. (2012). Pharmaceutical Microbiology Glossary, Microbiology Solutions: UK (Kindle

Sandle, T. (2012). E-Guide to Cleanrooms, Microbiology Solutions: UK (Kindle only eBook

Sandle, T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and

Sandle, T. and Saghee, M. R. (Eds) Cleanroom Management in Pharmaceuticals and Healthcare,

Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals:

Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology, DHI/PDA: Bethesda, MD,

Sandle, T. (2016) Introducing Cleanrooms, Microbiology Solutions: USA, ISBN: 978-1533-

Booklets and monographs

Sandle, T. and Boschi, F. (2006): Environmental Monitoring Handbook,

Sandle, T. (editor) (2010): Current Perspectives on Environmental Monitoring: Pharmig Review

Roberts, J. and Sandle, T. (2011). A Guide to Microbiology Laboratories in the Pharmaceutical

Sandle, T. (2016) Guide to cleanroom operation and contamination control, Pharmaceutical

Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems - Tim

Sandle, T. Selection and use of cleaning and disinfection agents in pharmaceutical

Sandle, T. Best practices for microbiological documentation in Hodges, N and Hanlon, G.

Sandle, T. and Saghee, M. R. (2011): The Essentials of Pharmaceutical Microbiology, in

Ashtekar, D. and Sandle, T. (2011): Microbial Content Testing of Pharmaceutical and

Sandle, T. (2011): Risk Management in Pharmaceutical Microbiology in Saghee, M.R., Sandle,

Sandle, T. (2011). Assessment of Culture Media in Pharmaceutical Microbiology' in Hodges, N

Sandle, T. (2012). Environmental Monitoring: a practical approach In Moldenhauer, J.

Sandle, T. (2012). Introduction. In Sandle, T. (2012). The CDC Handbook: A Guide to

Sandle, T. (2012). Application of Disinfectants and Detergents in the Pharmaceutical Sector. In

Sandle, T. (2012). Validation of Disinfectants. In Sandle, T. (2012). The CDC Handbook: A

Sandle, T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic

(revised for second edition: pp1-6)

(revised for second edition: pp7-24)

(revised for second edition: pp155-170)

Midcalf, B, Neiger, J. and Sandle, T. (2013). Fundamentals of pharmaceutical isolators. In:

(revised for second edition: pp361-376)

(revised for second edition: pp401-432)

(revised for second edition: pp433-464)

(revised for second edition: pp553-568)

(revised for second edition: pp569-581)

Sandle, T. (2013). Contamination Control: Cleanrooms and Clean Air

Brutsche, A. and Sandle, T. (2013). Preparing and Management of International Inspections. In

Sandle, T. (2014). Microbial Identification: Laboratory Techniques and Methods. In Chesca, A.

Sandle, T., 2014. Biochemical and Modern Identification Techniques: Food-Poisoning

Sandle, T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G. and

Sandle, T. (2014) Microbiology of Pharmaceutical Grade Water. In Handlon, G. and Sandle, T.

Sandle, T. (2014) Biological Indicators, In Handlon, G. and Sandle, T. (Eds.) Industrial

Sandle, T. (2015) Cleanroom Design. In Moldenhauer, J. (Ed.) Environmental Monitoring: a

Sandle, T. (2015) Contamination Control Risk Assessment. In McCullough, K.Z. and

Contributor to Masden, R. E. and Jornitz, M. W. (2015) Lessons of Failure: When things go

Sandle, T. (2016) Antibiotic / Antimicrobial Resistance. In Boslaugh, S. (Ed.) The Sage

Sandle, T. (2016) Antimalarials. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology

Sandle, T. (2016) Drug-Resistant Diseases. In Boslaugh, S. (Ed.) The Sage Encyclopedia of

Sandle, T. (2016) Disinfectants in the Pharmaceutical Industry. In Cardoso, A. S., Almeida, C. M.

Sandle, T. (2017) Environmental Control and Environmental Monitoring in Support of Aseptic

Papers in peer reviewed journals

Sandle, T. Grams Stain: History and Explanation of the Fundamental Technique of

Sandle, T. The use of polymeric flooring to reduce contamination in a cleanroom changing

Sandle, T. Selection of Laboratory Disinfectants: Part One, Science Technology Journal,

Sandle, T. (2011): 'History and development of microbiological culture media', The

Sandle, T. (2012). "Real-time counting of airborne particles and microorganisms: a new

Vijayakumar, R., Sandle, T. and Manoharan, C. (2012). A review of fungal contamination in

Sandle, T. (2012). Speedier automated microbial methods for environmental monitoring of

Sandle, T. (2012). Application of Quality Risk Management To Set Viable Environmental

Sandle, T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant microorganisms

Sandle, T. (2013). Revision of ISO 14698 - Biocontamination control: Personal reflections on

Republished in Pharmig News: Sandle, T. (2013). ISO 14968 biocontamination control

Sandle, T. (2013). Bacterial Adhesion: an Introduction, Journal of Validation Technology,