Auoclave Validation Protocol

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PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT

Equipment Name : MOIST HEAT STERILIZER Protocol No. : SGS/VPR/ATC/001
Equipment ID. No. : SGS/LIQ/WAV/ATC/001 Page No. : 1 OF 20
SGS PHARMACEUTICALS PVT.LIMITED, ROORKEE
QUALIFICATION PROTOCOL CUM-REPORT FOR
NAME OF EQUIPMENT : MOIST HEAT STERILIZER

(AUTOCLAVE)
MAKE : Lance Engineering
EQUIPMENT ID. NO. : SGS/LIQ/WAV/ATC/001
DEPARTMENT : PRODUCTION INJECTION
LOCATION / ROOM ID.NO. : Washing Area
PAGE NO. : 1 OF 206

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S. No. TITLE PAGE NO.

1.0 Protocol Cum-Report Pre-Approval 4
2.0 Introduction 5
3.0 Objective 5
4.0 Scope 5
5.0 Responsibility 6
6.0 Brief System Description 6-7
7.0 Reason of Requalification/Re-Validation 7
8.0 Frequency of Qualification 7
9.0 Training of Execution Team 7
10.0 Pre-Qualification & Validation Requirement 8
11.0 Validation Methodology 8
12.0 Acceptance Criteria 8
13.0 Machine Operation 9
14.0 Performance Test of Equipment 9
14.1 Test Equipment calibration 9-10
14.2 Vacuum Leak Rate Test 10
14.3 Bowie Dick Test 11
14.4 Heat Distribution Study 11-12
14.5 Heat Penetration Study 13
14.6 Biological Challenge Test (SAL) 14-15
15.0 References 15
16.0 Document to be attached 15
17.0 Change Control If any 16
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18.0 Deviation from pre defined parameters if any 16

19.0 Conclusion and summary 17
20.0 Abbreviations 18
21.0 Annexures 19
22.0 Execution Protocol cum report approval 20
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1.0 PROTOCOL CUM-REPORT PRE- APPROVAL
INITIATED BY:
DEGINATION NAME SIGNATURE DATE
CHEMIST
Q.A.
REVIEWED BY:
MANAGER
(PRODUCTION)
MANAGER
(ENGINEERING)
MANAGER
(QUALITY CONTROL)
APPROVED & AUTHORISED BY:
HEAD
(QUALITY ASSURANCE)
SGS PHARMACEUTICALS PVT. LTD.
162/1, Puhana - Iqbalpur Road, Village: Nanhera,
Roorkee (Uttarakhand)-247667
2.0 INTRODUCTION:
This document applies to the Moist Heat Sterilizer (Autoclave) Machine Specified by M/s SGS
PHARMACEUTICALS PVT.LIMITED, Roorkee, Haridwar-(U.K.)-247667-INDIA.
The system is designed considering as the basis for specification parameters with allowable
parameters at user end with suitable Design Limits.
3.0 OBJECTIVE:
 The process of MHS is evaluated on basis of Different Cycle Test design to demonstrate that
the sterilization and associated control procedure can reproducibly deliver a sterile product.
 To confirm/demonstrate the efficiency of sterilization process, which is capable of killing the
Micro-organisms & Pyrogene present in the article to sterilized in the Moist Heat Sterilizer.
 To establish documented evidence that the Equipment is capable of performing as per specified
acceptance criteria and is adequate to provide the assurance for which the process is in intended
 The performance shall be measured and evaluated by-
* Vacuum leak Rate Test (3 trials)
*Bowie Dick Test (3 Trials on different days)
* Heat Distribution Study in different three cyle.
* Heat Penetration Study
* Biological challenge testing for standard and reduced cycle loads
 The Heat distribution & Heat penetration studies shall be conducted to check the performance of
sterilization cycle.
 The validation protocol Cum-Report is designed to establish & provided the documentary
evidence, to assure that the Moist Heat Sterilizer, Make Lance Engineering is suitable for
Sterilizing different load. In addition, this validation protocol Cum-Report is intended to assure
the sterility of the items, when the established Standard Operating Procedure to maintain reliability
and repeatability.
 To confirm the suitability of the Standard Operating Procedure for all routine activities
associated with the system.
4.0 SCOPE
 The Performance Qualification is an essential part of the qualification mechanism. The scope of this
protocol Cum-Report is to provide the complete documentary evidence for the performance
qualification of the Moist Heat Sterilizer.
The protocol Cum-Reports cover all aspects of Performance Qualification for the Moist Heat Sterilizer
Serving M/s SGS PHARMACEUTICALS PVT.LIMITED , Roorkee Distt.haridwar ( U.K.) -247667 .
 This protocol Cum-Report will define the method and documentation used to quality the Moist Heat
Sterilizer for Performance Qualification.
 To ensure the Moist Heat Sterilizer meet the cGMP requirement.
 To confirm the appropriateness of critical parameters of the Moist Heat Sterilizer components.
 To validate the system and check its performance.
5.0 RESPONSIBILITY:
The Validation Group comprising of a representative from each of the following Department shall
be responsible for the overall compliance of this protocol Cum-Report.
DEPARTMENT RESPONSIBILITIES
 Preparation, Review, Approvel and Compilation of the Qualification Protocol
Cum-Report for Correctness, Completeness and Technical Excellence.
QUALITY  Protocol Cum-Report Training
ASSURANCE  Co-ordination with Quality Control, Production and Engineering to carryout
Qualification Activities.
 Monitoring of Qualification Activity.
QUALITY  Review of Qualification Protocol Cum-Report.

CONTROL  Analytical Support (Microbiological Testing/Analysis)
 Review of Qualification Protocol Cum-Report.
PRODUCTION
 To co-ordinate and support Performance Qualification Activity.
 Review of Qualification Protocol Cum-Report.
ENGINEERING  To co-ordinate and support Performance Qualification Activity.
 Responsible for Trouble shooting during execution(If occurs)
6.0 BRIEF SYSTEM DESCRIPTION

Performance Qualification shall be performed after completion and approval of Operational
Qualification.
The equipment shall be used for Moist heat sterilization of pharmaceutical requirements to be used in
the formulation of sterile area. The equipment shall operate under dust free environment and conditions
as per the GMP requirements. The machine is designed to perform efficient Moist heat sterilization in
minimum time.
 Standard Moist heat Sterilizer is a Jacketed Vessel. In Moist Heat Sterilization cycle is introduced into
the jacket which insures preheating of chamber and effective utilization of Moist heat energy.
 After fixed no. of pulses, Moist heat in the chamber is increased till the sterilization temperatures is
reached .The control system in place then control this chamber temperature for sterilization time.
 After sterilization hold period is completed, temperature up to a pre-determined level is created in the
chamber .When this temperature level is reached, the control system ensure that the temperature is
maintained for the specified time.
The Moist Heat Sterilizer Process consists of following phases:-

 Heating phase to 121˚c .
 Pressure limit for sterilization NLT 1.5 kg
 Sterilization temperature 121˚c .
 Sterilization time 30 min .
 Cooling time 15 min .
* EQUIPMENT USE:
It is industrial Moist heat sterilizers especially design for:-

 Sterilization of machine parts, Membrane holder, rubber bungs, garments ,gloves ,utensils and
assembly .
7.0 REASON FOR QUALIFICATION/ VALIDATION:

 Periodic qualification/validation as per frequency mentioned in Validation master plan.
 Substitution of existing system or its components with a new one.
 Any major modification in the existing system design & operational parameters.
 If the system found to be malfunctioning.
 Shifting of the system from one location to another.
 Periodic qualification/ validation.
 If Installation of new Equipment.
 (Specific Reason)
……………………………………………………………………………………………
……………………………………………………………………………………………
8.0 FREQUENCY OF QUALIFICATION:-
 Yearly as per Master Validation Plan.
 After any major breakdown or modification.
9.0 TRAINING OF EXECUTION TEAM:

 Training to the Execution Team shall be provided for execution of Protocol Cum-Report before
starting the Re-qualification/Re-validation activity.
 The Training shall be recorded in the training record.
10.0 PRE-QUALIFICATION & VALIDATION REQUIREMENTS:

To Conduct Re-qualification/Re-validation of Moist Heat Sterilizer, the following requirements must
be fulfilling:-
 Calibrated data logger with calibrated sensors.
 Calibrated thermocouples .
 Qualified pure steam .
 Integrity of vent filter at cooling zone
 All part of MHS used for measurement like temperature sensors, gauges, timers must be calibrated.
 All other instruments used for qualification must be calibrated.
11.0 VALIDATION METHODOLOGY:

The Moist Heat Sterilizer shall be considered Qualification /Validation successful completion on the
following test:
 Empty Chamber Heat Distribution Studies (1 cycles) with Temperature sensor at different location of
the Sterilizer Chamber.
 Loaded chamber Heat Distribution Studies (1cycles) for each sterilization load of possible layer of the
load subjected for sterilization.
 Half Loaded chamber Heat Distribution Studies (1cycles) for each sterilization load of possible layer
of the load subjected for sterilization.
 After Successfully of Heat Distribution study, shall perform Bio-challenge studies using Geobacillus
stearothermophilus spore Ampoule (containing 106 more spore) during the heat penetration studies in
different three cycles as empty chamber, half load and full load.
 Estimation of the F0 value achieve during the sterilization hold period at each temperature mapping
probe.
 To quality these tests, the Equipment should fulfill the acceptance criteria described in the individual
test procedure.
 To quality these tests, the Equipment should fulfill the acceptance criteria described in the individual
test procedure.
12.0 ACCEPTANCE CRITERIA

Performance qualification shall be considered acceptable when requirements of this protocol Cum-
Report have been fulfilled and all the components of the Moist Heat Sterilizer performed as per the
design specifications and as per manufacturer recommendations.
13.0 MACHINE OPERATION

The machine operation consists of the following operations:
 Load the chamber and close the door
 Up coming temperature for sterilization 121˚c at the pressure between 15-18 lbs or NLT 1.5
kg/cm2.
 Hold the sterilization temperature for minimum 15 min to maximum 30 min sterilization time .
 After completion of sterilization process put on hold for 15 min . as a cooling phase .
 Unload the lot in sterile buffer zone under LAF .
14.0 PERFORMANCE TEST OF EQUIPMENT

The performance qualification test should be performed for different parameters of Moist Heat
Sterilizer.
All tests and those classifications are given below:-
Test Equipment Calibration
Vacuum Test (3 trials)
Bowie Dick Test (3 Trials on different days)
Heat Distribution Study in different three cycle
 Heat Distribution Study In Empty Chamber
 Heat Distribution Study in Full Load.
 Heat Distribution Study In Half Load
Heat Penetration Study with Bio-challenge test in different three cycle.
 Heat Penetration Study in Empty Chamber with biological Indicators
 Heat Penetration Study in Full Load with biological Indicators with Ampoules/Vials.
 Heat Penetration Study in Half Load with biological Indicators with Ampoules/Vials.
Biological challenge testing for standard and reduced cycle loads
14.1 TEST EQUIPMENT CALIBRATION:

Review the calibration status for the test equipment (Data-Logger with sensors) to be utilized and
record the calibration due . All Equipment /Instrumentation must remain within the calibration due date
for the duration of Revalidation Study for which the item is used. If a due date potential occurs during
the testing period than the instrument must be re-calibrated before it is utilized .Record the calibration
details .
14.1.1 PRE & POST CALIBRATION OF TEMPRATURE MEASURING SENSOR:

Pre & post calibration shall be carried out before starting and after completion of Heat Distribution
cycle as well as Heat Penetration cycle.
» PREPARATION OF ICE BATH:-
 Prepare a container with crushed Ice and add enough purified water to ensure a proper slush solution.
 Allow the temperature to stabilize; ensure to add sufficient crushed Ice to maintain the equilibrium
state of Ice and water.
» PROCEDURE:
 Temperature sensors which are to be used for qualification study shall be Calibrate in Ice Bath at
approximately 0ºC and in High Temperature reference data logger block at 50,100,121&150ºC prior to
its usage in the qualification.
 Record the temperature of all the sensors while putting them in Ice Bath after 1 minute of temperature
stabilization.
 Put individual sensor to the slot of High temperature Reference block which is stabilized at required
temperature Record the reading at least one minute after stabilization of temperature.
 Record the temperature for five minute by data logger and record the temperature from data logger
display
.
» ACCEPTANCE CRITERIA:
 No temperature sensor should vary by 1ºC in Ice Bath from the means of temperature shown by the
calibrated thermometer during the Data-logging period.
 No temperature sensor should vary by 1ºC in High temperature reference block from the mean of
temperature shown by calibrated thermometer during data-logging period.
» Results:
» Record the calibration details in .
14.2 VACUUM LEAK RATE TEST
» Objective
● To verify integrity of the chamber and door seals via pressure hold test under vacuum .
» Procedure :
● Shut the door of autoclave properly .
● Apply the 100 m bar or 0.93 kg /cm2 pressure and record the P1 ,P2,P3.
● P1( achieved desired vacuum ),
● P2 ( at hold 5 min .or after 5 min .
● P3 (after 10min of P2).
● Calculate the vacuum drop / min . by use following formula .
(P3 –P2) / 10
» Acceptance criteria :
● The rate of vacuum drop at the end of 10 min not more than 30 m bar or 1.3 m bar /min .
14.3 BOWIE DICK TEST :

» Objective
● The bowie dick test the demonstrates proper air removal from the chamber of a pre vacuum
autoclave .
» Procedure :
● To run the test ,a pack is placed in an empty chamber on the lowest shelf above the drain ( the
coldest point in the chamber ) and a bowie dick cycle is initiated .the sterilization cycle consist of three to four
prevacuum pulses reaching the set point of Temperature 121˚c .The termochromatic paper put inside the
pack will indicate if steam has penetrated the porous load .A bowie dick test pack that shows a uniform dark
black color pattern indicates a successful vacuum and full steam penetration .where as no or partial color
change indicates an unsuccessful test cycle .
● Bowie dick test pack should be uniform dark black color pattern indicates .
14.4 HEAT DISTRIBUTION STUDY
 HEAT DISTRIBUTION STUDY IN EMPTY CHAMBER
» Objective
 Physical qualification of the production sterilization cycle to demonstrate that heat distribution with in
the empty chamber is consistent .
 The Sterilizer is capable of at training a temperature and pressure of 121 ºC and 1.5 kg/cm2 or 15 lbs
during the sterilization hold period.
» Procedure
 Fit the 16 thermocouple probes ( S1,S2,S3…….S16) through the validation port in the autoclave door
and check the connection to the autoclave data recorder the position each probe.probe replacement
inside the chamber shall reflect the result for determination of hot and cold point with in chamber .
● Record over all time for cycle and verify that heating time is consistent .
● Leak rate test remain within specification .
Stratification within is the a chamber is acceptable. that is thermocouple probes mesure within ±2˚C
of each other.
All measured thermocouple temperature show 121˚C +3/-0˚C and do not fluctuate by more than 1˚C
During the sterilization hold phase.
At least 10 thermocouples probes remain active during the study.
Correlate autoclave temperature and pressure readings during the sterilization hold time, against
saturated steam tables and record the result.
Verify that the accumulated heat loads for each probe as indicated by F0 are consistant.
FPhys=ΔtΣ10 (T0-T ref) /Z
Where
Δt = 1 minute
T
0 = Thermocouple temperature (˚C)
T
ref = 121˚C
Z = Value specific to biological indicator used or 10˚C if not specified.
 HEAT DISTRIBUTION STUDY IN LOADED CHAMBER
 Physical qualification of the production sterilization cycle to demonstrate that heat distribution within
the loaded chamber is consistent.
 The Sterilizer is capable of at training a temperature and pressure of 121 ºC and 1.5 kg/cm2 or 15 lbs
during the sterilization hold period.
» Procedure
 Define the Load pattern as Loaded cycles
 Load cycles 1 : 15 pairs of Sterile dress , 30 pairs of gloves .
 Load cycle 2: Machine parts , one filling vessel , one filter assembly .
 Load cycle 3 : Maximum 50000 rubber plugs/ 50000 flip off seals.
● Record over all time for cycle and verify that heating time is consistent .
● Leak rate test remain within specification .
of each other.
Where
Δt = 1 minute
T
T
ref = 121˚C

 Verify that the “cold-spot” location is constant, in three consecutive cycles, for defined load pattern .
14.5 HEAT PENETRATION STUDY:

» Objective
 Physical qualification of the sterilization cycle to demonstrate that heat penetration equipment load
items effectively for the standard load configuration set out in this protocol.
 To ensure that if sterilization temperature (121ºC) is not achieved throughout the cycle, load
configuration or size of the load has to be reviewed and sterilization cycle to be repeated.
 Heat Penetration Studies shall be carried out with the following the different load.
* Load cycle 1
* Load cycle 2
* Load cycle 3
» Procedure
 Open the door and put the defined load and thermocouples probe and run the cycle for standard
time after shutting the doo properly .
 Verify the consistency of operation of sterilization production cycle parameters –
Heating phase 121ºC
Sterilization temperature 121ºC
Sterilization time 15 Min
Vacuum Leak Rate test remain within specification .
of each other.
Where
Δt = 1 minute
T
T
ref = 121˚C

 Verify that the “cold-spot” location is constant, in three consecutive cycles, for defined load pattern .
14.6 BIOLOGICAL CHALLENGE TEST (SAL – STERILITY ASSURANCE LEVEL) FOR

LOADED CYCLE :
» Objective
Biological qualification of the sterilization cycle to demonstrate that the delivered lethality measured by
the actual kill of micro-organism on a biological indicator system results in PNSU ≤ 10-6.
 PNSU : Probability of a non-sterile unit .

 SAL : Sterility Assurance Level .
» Guidelines for handling Biological Indicators

 Collect the required number of GPT (Growth Promotion Test ) passed Biological indicators from the
Microbiological Laboratory. Transfer the ampoules in a sealed bag to the facility.
 Handle the glass ampoules carefully. Keep spare gloves and sample jar close by case of damage. If an
ampoule is damaged , than transfer immediately to the sample jar and seal . Change the gloves, and
notify production , so that the area can be cleaned down accordingly , using a sporicidal sanitant (10%
H2O2 in 70 % solution and leave to soak for 60 minutes. Contaminated gloves, and samples shall be
transferred to the microbiology Laboratory for disposal .
 Treat all autoclaved biological indicators as potentially viable an handle as described about .places in
a sealed bag for transfer back to the microbiology lab .
 Verify that the number if biological indicators issued and the no. returned from /to the microbiology
laboratory are the sam,e (100% accountability ) .infrom the production manager on duty immediately
,of any discrepancies .
» Procedure :
This test is run concurrently with the test of heat penetration ( i.e. temperature probes and biological
indicators placed adjacently in the same loads )
Record the position and tag of each biological indicators
Complete the sterilization cycle as heat penetration study .
Stop the heat penetration study after the first sterilization cycle has completed .
Open the door prepare and prepare the next test cycle removing by the used biological indicators and
placing a fresh biological indicators adjacent to each temperature probes .
Transfer the used BIs to the microbiology lab for incubation an testing
Calculate the actual log reduction ( Nf =actual PNSU ) of micro-organisms using :
FBIO = D121(Log N0 –Log NF)
Where FBIO = Fphys ( as found from heat penetration study )
D121 and N0 ( From BI data )

There shall be no growth of BIs ,which have undergone the sterilization cycle .
There shall be positive growth of the controlled biological indicators ,which have not undergone the
sterilization cycle .
Bio-indictors shall comply with specification before use .Glass ampoules G.stearothermophilus ,the
biological indicators shall have :
Population > 5 x 105 G.stearothermophilus ( ATCC7953) per ampoules ,
With a D value of not less than 1.5 min and not more than 2 min.
15.0 REFERENCES:
The Principle Reference is the following:
 Master Validation Plan
 Schedule –M-“Good Manufacturing Practices” and Requirement of Premises, Plant and Equipment
for Pharmaceutical Product.
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol.-2 Good Manufacturing
Practices and Inspection.
The following references are used to give addition guidance:
 Code of federal regulation(CFR),title 21,Part 210 current-Good Manufacturing Practices (cGMP) in
Manufacturing,Processing,Packing,of Holding of Drugs,General.April1,1998.
 Code of federal regulation (CFR), title 21,Part 211 current-Good Manufacturing Practices (cGMP) for
Finished Pharmaceuticals April1,1998.
 EU Guide to Good Manufacturing Practices, Part 4, 1997.
16.0 DOCUMENT TO BE ATTACHED:

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17.0 CHANGE CONTROL, IF ANY:
……………………………………………………………………………………………………………
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18.0 DEVIATIONS FROM PRE-DEFINED PARAMETER (IF ANY):
……………………………………………………………………………………………………………
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19.0 CONCLUSION AND SUMMARY

Based on the validation results and reports, conclusion shall be drawn on the overall Performance of the
Moist Heat sterilizer. The summary Protocol Cum-Report shall be reviewed and approved by Quality
Assurance Team.
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Verified By: Reviewed By:

Signature & Date Signature & Date
(Production) (QA)
20.0 ABBREVIATIONS
CFM : Cubic Feet Meter
Pvt. : Private
Ltd. : Limited
D.M. : Demineralized
Maint. : Maintenance
QA : Quality Assurance
No. : Number
◦C : Degree Celsius
GMP : Good Manufacturing Practices
WHO : World Health Organization
CFR : Code of Federal Regulation
BIs : Biological indicaors
PNSU : Probability of a non – sterile unit
SAL : Sterility Assurance Level
21.0 ANNEXURES:
S.NO. ANNEXURE NO. ANNEXURE TITLE
1 Annexure-01 Training record
2 Annexure-02 Calibration detail
3 Annexure-03 Vacuum Leak rate Test
4 Annexure-04 Bowie Dick Test
5 Annexure-05 Heat distribution study
6 Annexure-06 Heat penetration study
7 Annexure-07 Biological challenge Test ( Sterility Assurance Level)

22.0 EXECUTED PROTOCOL CUM-REPORT APPOROVAL:

The below listed review and approval signatures indicate approval of this protocol Cum-Report from
page no. 1 to 20 of 20 and its attachments and certify that it may be executed.
REVIEWED BY:
MANAGER
(PRODUCTION)
MANAGER
(ENGINEERING)
MANAGER
(QUALITY CONTROL)
APPROVED & AUTHORISED BY:
HEAD
(QUALITYASSURANCE)

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PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT

SGS PHARMACEUTICALS PVT.LIMITED, ROORKEE

QUALIFICATION PROTOCOL CUM-REPORT FOR

NAME OF EQUIPMENT : MOIST HEAT STERILIZER

EQUIPMENT ID. NO. : SGS/LIQ/WAV/ATC/001

DEPARTMENT : PRODUCTION INJECTION

LOCATION / ROOM ID.NO. : Washing Area

PAGE NO. : 1 OF 206

PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT

S. No. TITLE PAGE NO.

PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT

18.0 Deviation from pre defined parameters if any 16

PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT

1.0 PROTOCOL CUM-REPORT PRE- APPROVAL

DEGINATION NAME SIGNATURE DATE

APPROVED & AUTHORISED BY:

DEGINATION NAME SIGNATURE DATE

QUALITY  Review of Qualification Protocol Cum-Report.

6.0 BRIEF SYSTEM DESCRIPTION

The Moist Heat Sterilizer Process consists of following phases:-

It is industrial Moist heat sterilizers especially design for:-

7.0 REASON FOR QUALIFICATION/ VALIDATION:

9.0 TRAINING OF EXECUTION TEAM:

10.0 PRE-QUALIFICATION & VALIDATION REQUIREMENTS:

11.0 VALIDATION METHODOLOGY:

12.0 ACCEPTANCE CRITERIA

13.0 MACHINE OPERATION

14.0 PERFORMANCE TEST OF EQUIPMENT

14.1 TEST EQUIPMENT CALIBRATION:

14.1.1 PRE & POST CALIBRATION OF TEMPRATURE MEASURING SENSOR:

14.3 BOWIE DICK TEST :

Z = Value specific to biological indicator used or 10˚C if not specified.

 HEAT DISTRIBUTION STUDY IN LOADED CHAMBER

Z = Value specific to biological indicator used or 10˚C if not specified.

14.5 HEAT PENETRATION STUDY:

Z = Value specific to biological indicator used or 10˚C if not specified.

14.6 BIOLOGICAL CHALLENGE TEST (SAL – STERILITY ASSURANCE LEVEL) FOR

 PNSU : Probability of a non-sterile unit .

» Guidelines for handling Biological Indicators

Calculate the actual log reduction ( Nf =actual PNSU ) of micro-organisms using :

FBIO = D121(Log N0 –Log NF)

Where FBIO = Fphys ( as found from heat penetration study )

D121 and N0 ( From BI data )

16.0 DOCUMENT TO BE ATTACHED:

17.0 CHANGE CONTROL, IF ANY:

18.0 DEVIATIONS FROM PRE-DEFINED PARAMETER (IF ANY):

19.0 CONCLUSION AND SUMMARY

Verified By: Reviewed By:

S.NO. ANNEXURE NO. ANNEXURE TITLE

1 Annexure-01 Training record

2 Annexure-02 Calibration detail

3 Annexure-03 Vacuum Leak rate Test

4 Annexure-04 Bowie Dick Test

5 Annexure-05 Heat distribution study

6 Annexure-06 Heat penetration study

7 Annexure-07 Biological challenge Test ( Sterility Assurance Level)

22.0 EXECUTED PROTOCOL CUM-REPORT APPOROVAL:

DEGINATION NAME SIGNATURE DATE

APPROVED & AUTHORISED BY:

DEGINATION NAME SIGNATURE DATE

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