PRIVATE CIRCULATION LBI/30_10_0031

Draft for Public Comment

Form 36 DPC: 10 / 30152881 DC

BSI Group Headquarters 389 Chiswick High Road London W4 4AL Tel: +44 (0)20 8996 9000 Fax: +44 (0)20 8996 7400 www.bsigroup.com

Date: 02 December 2010 Origin: European

Latest date for receipt of comments: 11 April 2011 Responsible committee: LBI/30 Cleanroom technology Interested committees:

Project No. 2006/01839

Title:

Draft BS EN ISO 14644-2 Cleanrooms and associated controlled environments Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1

Supersession information: If this document is published as a standard, the UK implementation of it will supersede BSENISO14644-2 : 2000 (R05) . If you are aware of a current national standard which may be affected, please notify the secretary (contact details below).

WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 11 April 2011 This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. See overleaf for information on the submission of comments. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purposes. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or e-mail cservices@bsigroup.com. British, International and foreign standards are also available from BSI Customer Services. Information on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http://www.bsigroup.com.

Responsible Committee Secretary: Mr B Sheridan (BSI) Direct tel: E-mail: ben.sheridan@bsigroup.com

Introduction This draft standard is based on European discussions in which the UK has taken an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent British Standard. Comment is particularly welcome on national, legislative or similar deviations that may be necessary. Even if this draft standard is not approved by the UK, if it receives the necessary support in Europe, the UK will be obliged to publish the official English Language text unchanged as a British Standard and to withdraw any conflicting standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft.

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3.1

Definition 1

ed

Definition is ambiguous and needs clarifying.

Amend to read '...so that the mains connector to which no connection...'

EXAMPLE ONLY
6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer.

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CEN/TC 243
Date: 2010-11

prEN ISO 14644-2:2010

CEN/TC 243 Secretariat: BSI

Cleanrooms and associated controlled environments Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 (ISO 14644-2:2010)
Einfhrendes Element Haupt-Element Teil 2: Teil-Titel (ISO 14644-2:2010) Salles propres et environnements matriss apparents Exigences pour la surveillance et les contrles priodiques en vue de dmontrer le maintien de la conformit avec l'ISO 14644-1 (ISO 14644-2:2010)

ICS: Descriptors:

Document type: European Standard Document subtype: Document stage: CEN Enquiry Document language: E C:\Documents and Settings\smithchr\Desktop\41_e_stf.docm STD Version 2.4a

prEN ISO 14644-2:2010 (E)

Contents

Page

Foreword..............................................................................................................................................................3

prEN ISO 14644-2:2010 (E)

Foreword
This document (prEN ISO 14644-2:2010) has been prepared by Technical Committee ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with Technical Committee CEN/TC 243 Cleanroom technology the secretariat of which is held by BSI. This document is currently submitted to the parallel Enquiry. This document will supersede EN ISO 14644-2:2000.

Endorsement notice The text of ISO/DIS 14644-2:2010 has been approved by CEN as a prEN ISO 14644-2:2010 without any modification.

DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-2

ISO/TC 209 Voting begins on 2010-12-02
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

Secretariat: ANSI Voting terminates on 2011-05-02

ORGANISATION INTERNATIONALE DE NORMALISATION

Cleanrooms and associated controlled environments Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1
Salles propres et environnements matriss apparents Partie 2: Exigences pour la surveillance et les contrles priodiques en vue de dmontrer le maintien de la conformit avec l'ISO 14644-1

[Revision of first edition (ISO 14644-2:2000)]

ICS 13.040.35

ISO/CEN PARALLEL PROCESSING

This draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel five-month enquiry. Should this draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage. Pour acclrer la distribution, le prsent document est distribu tel qu'il est parvenu du secrtariat du comit. Le travail de rdaction et de composition de texte sera effectu au Secrtariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.

International Organization for Standardization, 2010

ISO/DIS 14644-2

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Contents

Page

Foreword ............................................................................................................................................................iv Introduction.........................................................................................................................................................v 1 2 3 4 4.1 4.2 4.3 5 6 Scope ......................................................................................................................................................1 Normative references............................................................................................................................1 Terms and definitions ...........................................................................................................................1 Demonstration of continued compliance............................................................................................2 Principle .................................................................................................................................................2 Monitoring and periodic testing plan ..................................................................................................2 Records ..................................................................................................................................................3 Testing for continued compliance.......................................................................................................3 Monitoring for continued compliance .................................................................................................5

Annex A (informative) Matters to consider when developing the monitoring aspects of a "monitoring and periodic testing plan"...............................................................................................6 A.1 A.2 A.3 Airborne particle monitoring system ..................................................................................................6 Pressure differential monitoring..........................................................................................................7 Airflow velocity and volume monitoring .............................................................................................7

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14644-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. This second edition cancels and replaces in whole the first edition (1999), which has been technically revised. ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness by particle concentration Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1:XXXX Part 3: Test methods Part 4: Design, construction and start-up Part 5: Operations Part 6: Vocabulary Part 7: Separative devices (clean air hoods, gloveboxes, isolators, and mini-environments) Part 8: Classification of airborne molecular contamination Part 9: Classification of surface cleanliness by particle concentration Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments Biocontamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of biocontamination data

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Introduction
This part of ISO 14644 provides a process to prove continued compliance with ISO 14644-1:XXXX and specifies minimum requirements for testing and monitoring. In any testing plan, consideration should also be given to the particular operational requirements, risk assessment of the installation, and its use. Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, food and others. Many factors besides airborne particulate cleanliness should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. In some circumstances, relevant regulatory agencies may impose supplementary policies or restrictions. In such situations, appropriate adaptations of the standard testing procedures may be required.

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ISO/DIS 14644-2

Cleanrooms and associated controlled environments Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1

Scope

This part of ISO 14644 specifies requirements for testing and monitoring of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1:XXXX for the designated classification of air cleanliness by particle concentration. These requirements invoke the test described in ISO 14644-1:XXXX for classification of a cleanroom or clean zone. Additional tests are also specified (see 5.2), to be carried out in accordance with the requirements of this part of ISO 14644. This part of ISO 14644 also specifies requirements for monitoring of a cleanroom or clean zone to provide evidence of its continued compliance with ISO 14644-1:XXXX for the designated classification of airborne particulate cleanliness.

Normative references

The following normative documents contain provisions, which, through reference in this text, constitute provisions of this part of ISO 14644. Subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. ISO 14644-1:XXXX, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration ISO 14644-3:2006, Cleanrooms and associated controlled environments Part 3: Test methods

Terms and definitions

For the purposes of this part of ISO 14644, the terms and definitions given in ISO 14644-1:XXXX and the following apply. 3.1 test procedure undertaken in accordance with a defined method or procedure to determine the performance of a` cleanroom or clean zone or an element thereof 3.2 monitoring routine collection of information and data by measurement or observation of critical parameters in accordance with a defined method and plan to provide evidence of the performance or condition of an cleanroom or clean zone

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NOTE 1 One example of monitoring would be the use of a fixed particle monitoring system to sample from certain selected critical locations in order to confirm compliance with or detect deviation from expected levels to achieve process control. NOTE 2 support. Information derived from monitoring may be used to detect trends in operational state and to provide process

4
4.1

Demonstration of continued compliance

Principle

Continued compliance with air cleanliness (ISO class) requirements specified for the cleanroom or clean zone shall be demonstrated by implementing a predetermined documented monitoring and periodic test plan. Development of the monitoring and periodic testing plan requires consideration of both monitoring of parameters and the performance of specified periodic tests. Monitoring data is used as an indication of cleanroom or clean zone status and may be used to adjust the frequency with which periodic tests are carried out. Automated systems shall be considered for monitoring of air pressure difference and concentration of airborne particles.

4.2

Monitoring and periodic testing plan

A documented monitoring and periodic testing plan for the cleanroom or clean zone, based on assessment of risks, shall be prepared and approved. The following shall be considered when developing the monitoring and periodic testing plan. 4.2.1 a) b) c) d) e) f) g) h) i) j) k) Monitoring

A written rationale recording the reasons and justification for the monitoring. A schedule of parameters to be monitored. Definitions of measurement methods, accuracy and instruments required. Schedule of monitoring locations, including their location in three dimensions. Frequency of sampling and measurement. Requirements for storage and archiving of raw data. Specification of techniques to evaluate the data, including statistical methods and preparation of reports. Requirements for calibration of instruments and performance of systems. Acceptance criteria, including levels and rationale for alert and action values. Pre-defined action plan in event of alert-level and action-level alarms. Definition of responsibility for acceptance and approval of monitoring data, alert-level alarms, action-level alarms and reports. Periodic testing

4.2.2 a)

Written rationale recording the reasons and justification for the periodic testing, including any correlation with the monitoring results.

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b) c) d) e) f) g) h) i) j) k)

Definitions of test methods, accuracy and instruments required. Schedule of test locations. Frequency of testing. Requirements for calibration of instruments. Acceptance criteria, including levels and rationale. Pre-defined action plan in event of deviation from acceptance values. Evidence of the competence of the tester. Requirements for storage and archiving of test data. Specification of techniques for evaluation of data, including preparation of test reports. Definition of responsibility for acceptance and approval of test data and reports.

4.3

Records

The retention of records shall conform to quality control procedures or the requirements of applicable regulatory authorities, and be agreed upon between the customer and the supplier.

Testing for continued compliance

5.1 Classification of air cleanliness by particle concentration, using the test method specified in Annex A of ISO 14644-1:XXXX, shall be undertaken annually for all classes unless extended as defined in clause 5.4. This shall be undertaken in either the at rest or operational state. 5.2 Where the application requires them, additional tests as given in Table 1 shall be carried out to demonstrate compliance. The requirement to perform each of these tests shall be determined by agreement between the customer and the supplier. Table 1 Schedule of additional tests for all classes
Test parameter Airflow volume a or airflow velocity Air pressure difference b
a b

Frequency Annually Annually

Test procedure ISO 14644-3:2006, clause B.4. ISO 14644-3:2006, clause B.5.

Airflow volume will be determined by either velocity or volume measurement techniques. This test will not apply to clean zones which are not totally enclosed.

5.3 In addition to the normative tests given in clauses 5.1 and 5.2, optional tests and their frequencies may be included by agreement between customer and supplier, as considered appropriate to the cleanroom or clean zone. Lists of optional tests that may be used can be found in ISO 14644-3. The rationale for and frequency of testing shall be defined in the monitoring and test plan. 5.4 Where the cleanroom or clean zone is provided with instrumentation for monitoring of the airborne particle concentration at an interval no greater than 60 minutes, and, where applicable, air pressure difference, the maximum time interval as stated in 5.1 may be extended, provided that the results of the monitoring remain within the specified level(s) as defined in the monitoring and testing plan.

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5.5 In those cleanrooms or clean zones that require additional tests, and where the cleanroom or clean zone is provided with instrumentation for automated monitoring of the test parameter applicable, the maximum time interval(s) as stated in Table 1 may be extended, provided that the results of the monitoring remain within the specified level(s) as defined in the test and monitoring plan. 5.6 Instruments used for testing shall have a current calibration certificate.

5.7 If the test results are within the limits specified, then the cleanroom or clean zone is in a condition of continued compliance. If any of the test results exceeds the limits specified, the cleanroom or clean zone is not in compliance and appropriate remedial action shall be taken, including as required notification of the event. Following remedial action, appropriate testing shall be undertaken. 5.8 a) Remedial action(s) and testing shall be undertaken after abnormal events such as: A significant change from the current performance specification, such as a change in operational use. The significance of a change should be determined by agreement between the customer and the supplier. Any significant interruption of air movement which affects the operation of the cleanroom or clean zone. The significance of an interruption should be determined by agreement between the customer and the supplier. Maintenance that significantly affects the operation of the cleanroom or clean zone, (e.g. change of final filters).

b)

c)

The significance of an effect should be determined by agreement between the customer and the supplier. 5.9 The results from periodic testing of each cleanroom or clean zone to prove continued compliance shall be recorded and submitted as a comprehensive report, along with a statement of compliance or noncompliance with the specified limits. The test report shall include the following: a) b) c) d) name and address of the testing organization; operator(s) identification and the date on which the test was performed; reference to the current edition of ISO 14644-2; clear identification of the physical location of the cleanroom or clean zone tested (including reference to adjacent areas if necessary) and schedule of sampling locations in plan and elevation; specified designation criteria for the cleanroom or clean zone, including the ISO classification and considered particle size(s), relevant occupancy state(s), airflow volume or velocity, and air pressure difference; measuring instruments used and proof of calibration; test results, including particle concentration data for all sampling location coordinates; date of the preceding test to prove continued compliance; where the maximum time intervals are extended in accordance with 5.4, the results of the monitoring shall also form part of the documentation; an evaluation of the test results, and any associated revision to the monitoring and testing plan that may be required.

e)

f) g) h) i)

j)

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6.1

Monitoring for continued compliance

Monitoring of the parameters defined when 4.2.1 b) has been implemented.

6.2 The airborne-particle and pressure-differential monitoring programmes shall be based on risk assessment of the cleanroom or clean zone and its operation. Annex A.1 identifies matters to consider when configuring a particle monitoring system and Annex A.2 considers pressure-differential monitoring systems. 6.3 Monitoring of other attributes (e.g. flow rate, temperature and humidity) may also be undertaken based on risk assessment of the cleanroom or clean zone and its operation. 6.4 If monitoring results exceed specified action levels, the cleanroom or clean zone shall be considered non-compliant and appropriate remedial action shall be taken. Following remedial action, appropriate tests shall be performed to determine if the cleanroom or clean zone is in compliance. If compliance has been achieved, the monitoring may be resumed. 6.5 Instruments used for monitoring shall be in a current calibrated state.

6.6 The following features of the monitoring system should be documented in addition to the monitoring and periodic test plan: a) b) c) d) an as-installed record of the system; the maintenance and calibration requirements; the commissioning records; the maintenance records.

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Annex A (informative) Matters to consider when developing the monitoring aspects of a "monitoring and periodic testing plan"

A.1 Airborne particle monitoring system

The following aspects should be considered: a) b) c) d) manual or automated monitoring system; location of system components; particle size or sizes to be counted; suitability of the system to monitor the selected particle size(s), e.g. a local particle counter or manifold system; frequency of sampling in order to detect deviations; number of sample locations (position and height); minimum volume of air per sample; duration of the collection of each air sample (determined by the sampling rate); sample probe configuration and orientation with respect to airflow, e.g. isokinetic or an-isokinetic; sample probe materials of construction; consideration of processes that may influence the monitoring system or the results obtained, such as temperature, humidity, cleaning procedures and agents, fumigation agents, product materials or process hazards; any potential adverse impact of the sampling system on the process or the process environment, e.g. possible effects of the extraction of the sample volume on enclosed environments;

e) f) g) h) i) j) k)

l)

m) data logging and data management, including data integrity, storage and retrieval; n) establishment of suitable statistical techniques for the evaluation of raw data, assessment of trends and production of reports; definition of acceptance criteria and establishment of alert and alarm values; the resolution, accuracy and calibration requirements of the measurement system; definition of the commissioning and qualification requirements of the system; definition of the maintenance and calibration requirements.

o) p) q) r)

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A.2 Pressure differential monitoring

The following aspects should be considered: a) b) c) d) manual or automated monitoring; location of system components; frequency of monitoring to detect deviation events; method of minimising or managing fluctuations caused by disturbances such as door opening, intermittent operation of local exhaustion systems or wind pressure; measurement of differential pressure between spaces or against a common reference pressure; number of measuring points; time interval between measurements if the system is non-continuous; data logging and data management, including data integrity, storage and retrieval; establishment of suitable statistical techniques for the evaluation of raw data, assessment of trends and production of reports; definition of acceptance criteria and establishment of alert and alarm values; the resolution, accuracy and calibration requirements of the measurement system; definition of the commissioning and qualification requirements of the system;

e) f) g) h) i)

j) k) l)

m) definition of the maintenance and calibration requirements.

A.3 Airflow velocity and volume monitoring

The following aspects should be considered: a) b) c) d) e) f) g) h) i) manual or automated monitoring; location of system components; frequency of sampling in order to detect deviation events if the system is non-continuous; airflow measuring technique; sample probe location, configuration and orientation; conditions, such as air filter loading or temperature variation, that might influence the monitoring results; occurrences of significant airflow variations; data logging and data management, including data integrity, storage and retrieval; establishment of suitable statistical techniques for the evaluation of raw data, assessment of trends and production of reports; definition of acceptance criteria and establishment of alert and alarm values;

j)

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k) l)

the resolution, accuracy and calibration requirements of the measurement system; definition of the commissioning and qualification requirements of the system;

m) definition of the maintenance and calibration requirements.

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