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PERFORMANCE QUALIFICATION
Equipment Name
Protocol Number
Equipment ID
Effective Date
PERFORMANCE QUALIFICATION
PROTOCOL FOR
AUTOCLAVE (HPHV STEAM STERILIZER)
Format No:
Page 1 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 2 of 26
TABLE OF CONTENTS
1.0APPROVAL SIGNATURE:.....................................................................................................................3
2.0OVERVIEW:.............................................................................................................................................4
2.1 Introduction:....................................................................................................................................4
2.2 Objective:.........................................................................................................................................4
2.3 Purpose & Scope:............................................................................................................................5
2.4 Responsibility:.................................................................................................................................5
3.0EXECUTION TEAM:..............................................................................................................................7
4.0TRAINING RECORDS:...........................................................................................................................8
4.1 Purpose:............................................................................................................................................8
4.2 Scope:................................................................................................................................................8
4.3 Topics:..............................................................................................................................................8
5.0REQUIREMENT FOR PERFORMANCE QUALIFICATION:.........................................................8
6.0SYSTEM / EQUIPMENT DESCRIPTION:...........................................................................................9
6.1 System Equipment Details:............................................................................................................9
6.2 Generic Design of Double Door Autoclave:..................................................................................9
7.0QUALIFICATION PROCEDURE OR METHODOLOGY:.............................................................11
7.1 General Recording Instructions:.................................................................................................11
7.2 General Safety Instruction for Execution:..................................................................................12
7.3 General Steps and Precaution to be followed in Qualification Study:.....................................12
7.4 Selection Criteria for Locations of Thermocouples, Biological and Chemical Indicators for
Loaded Chamber Study:...........................................................................................................13
7.5 Calculation of F0 Values / Sterility Assurance Level:...............................................................13
7.6 Equipment Qualification:.............................................................................................................15
7.7 Steam Quality Test:.......................................................................................................................16
7.8 Vacuum Leak Test:.......................................................................................................................17
7.9 Bowie Dick Type Test:..................................................................................................................18
7.10 Empty Chamber Heat Distribution Study:...............................................................................19
7.11 Loaded Chamber Study:............................................................................................................21
8.0ACCEPTANCE CRITERIA:.................................................................................................................24
9.0REVALIDATION CRITERIA:.............................................................................................................24
10.0QUALIFICATION REPORT:.............................................................................................................24
11.0OBSERVED DEVIATION (IF ANY):................................................................................................24
12.0ABBREVIATIONS:..............................................................................................................................24
13.0LIST OF ANNEXURE:........................................................................................................................26
14.0REFERENCE DOCUMENT (IF ANY):.............................................................................................26
Format No.: QA004-F05-01
Page 3 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
1.0
APPROVAL SIGNATURE:
This is specific protocol for Performance Qualification of Autoclave (HPHV Steam Sterilizer) installed
in Media Preparation Room in Microbiology section of Quality Control department. The Author
signature indicates that this document has been prepared in accordance with existing project standards
and adequately reflects the tasks and deliverables necessary for qualification of the facility / equipment
/ process.
Prepared by / Functional area
Designation
Signature
Date
Microbiology Section
Quality Assurance
The reviewers signature indicates that, this document has been reviewed and it accurately and
completely reflects the tasks and deliverables necessary for process.
Reviewed by / Functional area
Quality Control
Validation QA
Designation
Signature
Date
Page 4 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
The approvers signature indicates that the documentation and information contained herein complies
with applicable regulatory, corporate, divisional / departmental requirements, and current Good
Manufacturing Practices.
Approved by / Functional area
Designation
Signature
Date
Quality Assurance
2.0
OVERVIEW:
2.1
Introduction:
This protocol defines the methodology for Performance Qualification of Autoclave (HPHV
Steam Sterilizer) installed in the Media Preparation room in Microbiology section of Quality
control department.
2.2
Objective:
The objective of this document is to provide written procedure and/or guidelines and respective
acceptance criteria for the Performance Qualification of Autoclave steam sterilizer /
demonstrate with documented evidence that the equipment produces the required output by
integrating procedures, personnel and systems, by verifying the following parameters
2.2.1
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
2.3
Page 5 of 26
the steam condensate (tested for physical, chemical and microbial parameters) is as per
the specifications.
2.2.2 Vacuum Leak Test:
To verify & demonstrate that the chamber is integral under vacuum conditions that are /
may be created as a part of air removal stage or drying stage at the end of the cycle.
2.2.3 Empty Chamber Study:
To assess the hottest & coolest locations and identify the locations those are fastest &
slowest to attain the sterilization temperature. This study shall be carried out for standard
steam sterilization and HPHV process.
2.2.4 Bowie Dick Test:
To demonstrate that the steam penetration of the test pack is rapid, there-by implying
that air and other non-condensable gases are not present.
2.2.5 Loaded Chamber Studies (Distribution & Penetration):
To assess the hottest & coolest locations and identify the locations those are fastest &
slowest to attain the sterilization temperature and demonstrate that every point in the
loaded chamber attains F0 value (lethality) of 15 minutes.
To establish that the equilibration time to achieve sterilization temperature between the
drain probe and coldest part of the load does not exceed 1 minute (for porous loads
only).
This study shall be done for each defined loading pattern [separate for porous,
unwrapped instruments & fluids] wherein the distribution & penetration study will be
done as a combined cycle. The requirements of automatic control test shall also be
evaluated.
Purpose & Scope:
After completion of successful Operation Qualification, start the Performance Qualification to
ensure that Autoclave (HPHV Steam Sterilizer) is performing as per its intended use and will
perform reproducibility.
The scope of this Protocol is limited to outline procedure /provide methodology for the
Performance Qualification of HPHV Steam Sterilizer.
2.4
Responsibility:
The validation group comprising of representatives from each of the following departments
shall be responsible for the overall compliance with this protocol:
Quality Control (Microbiology)
Engineering & Maintenance Department
Quality Assurance Department
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 6 of 26
Page 7 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Head QA
Executive QC (Microbiology)
Head QA
3.0
EXECUTION TEAM:
Following personnel are involved in the completion of this qualification with defined responsibilities
as follows:
Name
Designation
Department
Sign/ Date
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
4.0
Page 8 of 26
TRAINING RECORDS:
4.1
Purpose:
The purpose of the training is to familiarize the trainees with the principle of working, technical
specifications of Equipment and overall strategy of Performance Qualification.
4.2
Scope:
This Training is applicable to the Autoclave (HPHV Steam Sterilizer) installed in Microbiology
Section of Quality Control department of ABC Pharma Pvt. Ltd. Bhiwadi.
4.3
Topics:
The following topics shall be covered during training:
4.3.1 Principle of working of system
4.3.2 Technical specifications of the system
4.3.3 Overall strategy of Qualification process
4.3.4 General precautions / guidelines to be followed during qualification
4.3.5 Documentation Procedure to be followed
Attach training record with the report as Annexure 01.
5.0
5.2
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
5.2.2
5.2.3
6.0
Page 9 of 26
Procedure:
5.2.2.1 Following instruments/ indicators shall be required for the Performance
Qualification of Autoclave (HPHV Steam Sterilizer):
5.2.2.1.1 Data Logger
5.2.2.1.2 Thermocouples
5.2.2.1.3 Bowie-Dick test pack
5.2.2.1.4 Geobacillus stearothermophilus ampoules and strips
5.2.2.1.5 Chemical OK indicators
5.2.2.2 Verify the calibration status of the data logger / thermocouples.
5.2.2.3 Record the details of the indicators (chemical / biological etc) & verify their
appropriateness for use.
5.2.2.4 Record the observations & details in the appropriate format and attach (along
with the reports) as Annexure 03.
Acceptance Criteria:
The data logger should be calibrated as per the procedure; sensitivity of data logger shall
be better that or equal to 0.5C. The indicators used shall be within their expiry period.
6.2
:
:
:
:
:
:
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 10 of 26
Door interlocks are provided to prevent simultaneous opening of both the doors and process
lock to prevent opening of the door during the operation.
The sterilization chamber is insulated with glass wool, which helps in reducing the heat loss to
the environment and ensuring uniform distribution of temperature inside the chamber. This
insulation is covered with SS plate.
A Stainless steel pipe stand support is provided for the equipment thus requiring no special
foundation. All Joints, Crevices are filled with Epoxy/Silicon sealant to prevent any leakage.
The High Pressure High Vacuum Steam Sterilizer is provided with the following systems and
accessories for the desired functioning.
6.2.1 Water-ring type vacuum pump with suitable electric motor. (SS shell and tube type
condenser for condensation of steam prior to entering the housing of the vacuum pump).
6.2.2 Sterilizing grade vacuum break filter on the non-sterile side.
6.2.3 One number of Laminar Air Flow workstation is provided for unloading of the
sterilized articles in the aseptic area.
6.2.4 Chambers compound gauge on the sterile area side (Grade B, Buffer Room) and the
washing and sterilization area side (Grade C, Loading side).
6.2.5 Jacket pressure gauge, Gasket pressure gauge for both the doors, Safety valve for
jacket and chamber, Steam trap with strainer and NRV for chamber and steam trap for
jacket, on the washing & sterilization area side (Grade C, loading side).
6.2.6 Control panel consisting of Mitsubishi PLC, Digital Temperature input to the
microprocessor from 5 nos of temperature transmitters (RTDs), 1no of Pressure
transmitter, pressure and vacuum switches for transmitting digital Pressure/Vacuum
signals to the microprocessor, provision of auto-override for manual operation in case of
microprocessor failure.
The Sterilization cycle can be automatically controlled by the PLC, which can be programmed
and protected for four different types of cycles (i.e. 1st Vacuum Leak test, 2nd Std. Steam
sterilization 3rd HPHV, 4th Bowie Dick cycle). The required cycle can be selected on the
control panel and the selected cycle is automatically governed by the PLC.
The High Pressure High Vacuum Steam Sterilizer (Equipment ID QC/AUT-01) is located in
the Media Preparation Room of Microbiology Laboratory. The Media Preparation Room is
designed as per the specifications for cleanliness Grade D. The equipment is located such that, it
can be attended easily for routine operational, monitoring and maintenance purpose. The NonSterile door of the sterilizer opens into the Media Preparation Room (Grade D) for loading and
the Sterile Door opens into the Cool Zone (Grade B) for unloading. The major components of
the Control panel and utility lines are located in the Media Preparation side, for better
accessibility.
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.0
Page 11 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 12 of 26
7.2
7.3
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 13 of 26
7.1.12 If during a thermometric test the thermocouples inserted for profiling purposes are
damaged / short / open / faulty; review & evaluate the total data. If the location where
the sensor was placed is a critical one requiring monitoring, repeat the cycle.
7.1.13 The minimum time for which a cycle should operate in sterilization mode shall be based
upon the validation reports / experience (this will be the time for which the temperature
at the controlling probe / location will be in the range of sterilization temperature band).
7.4
Selection Criteria for Locations of Thermocouples, Biological and Chemical Indicators for
Loaded Chamber Study:
7.4.1 At-least one part/item in the chamber that is fastest to attain the sterilization temperature.
7.4.2 At-least one part/item in the chamber that is slowest to attain the sterilization
temperature.
7.4.3 At-least one part/item in the chamber that is hottest during the sterilization hold period.
7.4.4 At-least one part/item in the chamber that is coolest during the sterilization hold period.
7.4.5 The part of the chamber that is slowest to cool to 90C (applicable for sterilizers with
thermal door interlock and loads containing Fluids only).
7.4.6 In the active chamber discharge (Drain).
7.4.7 In the centre of the porous load.
7.4.8 Ensure that there is a temperature sensor located in the chamber free space [to be used as
a reference probe in the loaded chamber studies].
7.4.9 In tubes/containers containing fluids the temperature sensors should be placed such that
they are located approximately at the centre of the tube/container.
7.4.10 In silicon tubing the temperature sensors should be placed such that they are located
approximately at the centre of the tubing.
7.4.11 In items like large vessels / tanks, sensors should be inserted inside the item so as to
reach middle.
7.4.12 In item like housings with filter the sensors should be placed in the centre of the
cartridge.
7.4.13 If number of items in the load pattern is less than 6, keep indicators and sensors in all the
items.
7.5
F0 = L dt = 10 (TA-121)/10 dt
Where
Fo
L
TA
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 14 of 26
dt
7.5.2
7.5.3
SALDesired = 10-6
7.5.4
SLRMeasurable (Spore log reduction that can be measured by the biological indicator used):
7.5.5
SLRMeasurable
SALDesired
N0
SLRActual =
Where
7.5.6
F0
D121
Page 15 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.6
2.
3.
4.
5.
6.
7.
8.
9.
No. of
Runs
03
01
Superheat test
01
Dryness test
01
Chemical
and
Microbiological tests
Calibration of the data logger &
temperature sensors used for
temperature profile /
thermometric tests
Vacuum leak test [Chamber
03
integrity testing]
Bowie Dick type test
03
01 (details in
Vacuum leak test [Chamber
the remarks
integrity testing]
column)
01 (details in
Bowie-Dick type test
the remarks
column
Empty chamber study [heat
03
distribution study]
Loaded chamber studies
distribution & penetration studies 03
[Thermometric tests]
Automatic control test
Remarks
May be done simultaneously with
the Empty chamber temperature
profile
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
S.
No.
No. of
Runs
Tests
Remarks
Page 16 of 26
01
The purpose of performing the tests & the methodology of performing / executing of each test
along with the provision of recording the observations is given in the following pages.
7.7
7.7.4
Requirement:
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.8
Page 17 of 26
01 run; with sensors for validation study inserted into the chamber
and without chamber furniture (carriage).
7.8.3.2.3
7.8.3.2.4
7.8.3.3
7.8.3.4
7.8.3.5
7.8.3.6
7.8.3.7
7.8.3.8
Page 18 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.8.3.9
After a further 600 sec 10 sec, observe and record the pressure (P3) and the
time (T3).
7.8.3.10 Allow the cycle to proceed normally to completion.
7.8.3.11 Calculate the vacuum leak rate as per the equation below
P - P2
-1
LR = 3
mbar.min
10
Where-
7.8.4
7.9
LR
P
P2
Holding time
Page 19 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
121
7.9.3.4
7.9.3.5
7.9.3.6
7.9.3.7
7.9.3.8
7.9.4
17 minutes
When the cycle is complete, remove the indicator paper from the test pack and
observe for colour change.
Mark the details on the paper viz. the load no., Cycle no., date, etc. & attach
the same to the protocol.
In case of improper colour change rectify the machine; repeat the test as per the
procedure mentioned above. Do not use the machine till the fault has been
rectified.
Record the observations & data in the Annexure 07.
Repeat the procedure on each day of the PQ study & attach the data as per
Annexure 06.
Acceptance Criteria:
7.9.4.1 Visual indication of the cycle completion should be there at the end of the
cycle.
7.9.4.2 There should be a uniform colour change over the entire pattern of the
indicator sheet.
7.10 Empty Chamber Heat Distribution Study:
7.10.1 Purpose:
The purpose of this test is to
7.10.1.1 Demonstrate that the temperature / pressure conditions required for sterilization
are achieved in all the parts of the chamber i.e. every point in the empty
chamber attains an F0 value (lethality) of 15 minutes and that the minimum
lethality provided by the sterilization cycle is sufficient to provide at least 12
Log reduction of micro organisms having a D value of 1 minute at 121 C.
7.10.1.2 Assess the hottest & coolest locations in the chamber.
7.10.1.3 Identify the locations that are fastest & slowest to attain the sterilization
temperature.
7.10.2 Requirement:
Data logger, temperature probes, chemical indicators etc.
7.10.3 Procedure:
7.10.3.1 Insert thermocouple probes through the validation port into the autoclave.
Seal the port with silicone sealant so that steam leakage does not occur.
7.10.3.2 Label all the thermocouples properly with location no. and the indicators
with Batch No., Cycle no., Location no. etc. and then attach/ position the
thermocouples at specified locations (as per Annexure 10) along with
chemical indicators . Ensure that the thermocouples do not touch any metallic
surface and chemical indicators are within their expiry period.
Format No.: QA004-F05-01
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.10.3.3
Page 20 of 26
Record the locations in the format of location details. (The locations of the
indicators and thermocouples shall be as per the feasibility of positioning
them).
7.10.3.4 Operate the autoclave for HPHV Sterilization Cycle with a hold time of 15
minutes (for 121C cycle); record the settings in the format for operational
parameters (as per Annexure 08). Set the data logger to record
temperatures for all the channels at a frequency not exceeding 5 second
duration for 121C cycle.
7.10.3.5 After completion of cycle, remove the chemical indicators from the autoclave
and check for the labels. If the labels have faded then properly mark the
location on the same. Observe & document whether the sensors have retained
their original positions.
7.10.3.6 Observe the Chemical indicators for the specified colour change and
document it as per Annexure 08.
7.10.3.7 Compile the complete data generated during the qualification test for
complete evaluation of the system. Examine the collected data to identify7.10.3.10.1 the locations in the chamber that are fastest and slowest to attain
the sterilization temperature
7.10.3.10.2 the locations in the chamber that are hottest and coolest during
the sterilization hold time
7.10.3.10.3 the location in the chamber that is slowest to cool to 90C
7.10.3.8 If the thermometric data is acceptable perform two additional runs for same
cycle to demonstrate cycle and sterilizer reproducibility. In the next two runs
interchange the locations of the thermocouple, so as to verify the
thermometric data of a particular location. Attach the data, along with
printouts and indicators as Annexure 08.
7.10.3.9 Similarly, perform the Empty cycle heat distribution study for Gravity
process also and attach as per Annexure 08.
7.10.4 Acceptance Criteria:
7.10.4.1 A visual indication of the cycle completion should be there at the end of the
cycle.
7.10.4.2 At the end of the cycle, the sensors should have retained their original
positions.
7.10.4.3 The holding time is 15 minutes for 121C cycle / 3 minutes for 134C
cycle.
7.10.4.4 All the locations / sensors should achieve the sterilization temperature within
1 minute. (determined w.r.t the 1st location / sensor achieving the sterilization
temperature).
Format No.: QA004-F05-01
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.10.4.5
7.10.4.6
7.10.4.7
7.10.4.8
Page 21 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
7.11.3.6
7.11.3.7
7.11.3.8
7.11.3.9
7.11.3.10
7.11.3.11
7.11.3.12
7.11.3.13
7.11.3.14
7.11.3.15
Page 22 of 26
The locations shall be as per Annexure 10. (The locations of the indicators
and thermocouples shall be as per the feasibility of positioning them in the
loaded articles).
Operate the autoclave for sterilization hold time as per the requirements;
record the settings in the format for operational parameters. Set the data
logger to record temperatures for all the channels at a frequency not
exceeding 10 second duration for 121C cycle.
During the holding time of the cycle observe the details w.r.t the
temperatures & pressure in the chamber & the active chamber discharge
drain.
Remove the biological indicator strips & chemical indicators from the
autoclave and properly mark the location on the same again, in case the
earlier marking has been erased. Observe & document whether the sensors
have retained their original positions, and that the items in which the sensors
were placed are intact.
Observe the Chemical indicators for the specified colour change and
document it as per Annexure 09.
Send the biological indicators for incubation. In no case there should be a
time lag of more than 2 hrs between completion of cycle and incubation of
Biological indicators. Also, incubate one positive control along with each lot
of tested biological indicators. The tested biological indicators are to be
incubated at 55-60C for a period of 7 days, while the positive control
indicator should be incubated for a period of 2 days. Attach the report as
Annexure 09.
The initial spore population is also to be determined for each lot of indicator
used, as per SOP QC026 Total Viable Spore Count of Biological Indicator
of Microbiology section. Alternatively the Indicators can be sent to an
external lab for determination of Total viable spore count.
If the thermometric data is acceptable perform two additional runs for the
said load pattern to demonstrate reproducibility.
Compile the complete data generated during the qualification test for
complete evaluation of the system.
Examine the collected data to identify7.11.3.15.1 the locations in the chamber that are fastest and slowest to attain
the sterilization temperature
7.11.3.15.2 the locations in the chamber that are hottest and coolest during
the sterilization hold time
7.11.3.15.3 the location in the chamber that is slowest to cool to 90C.
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 23 of 26
7.11.3.16 Repeat the above procedure for each defined load pattern, as per Annexure
10. Attach the data, along with printouts and indicators as Annexure 09.
7.11.4 Acceptance Criteria:
7.11.4.1 During plateau period[determined from the recorded chamber
temperature]7.11.4.1.1 The indicated and recorded temperature should be in the range
121C 124C.
7.11.4.1.2 The difference between indicated and recorded chamber
temperature shall not exceed 2C.
7.11.4.2 During the holding time7.11.4.2.1 The holding time is 15 minutes for 121C cycle / 3 minutes
for 134C cycle.
7.11.4.2.2 The temperature is within 121-124C for 121C cycle.
7.11.4.2.3 The temperature measured in each load item does not fluctuate
more than 1C, and does not differ from that in other load
items by more than 2C.
7.11.4.2.4 The indicated and recorded chamber temperatures are within
2C of the temperature measured in the active chamber
discharge.
7.11.4.2.5 Pressure in the chamber shall be between 1.0 1.5 kg/cm 2 (for
121C cycle).
7.11.4.3 On completion of cycle7.11.4.3.1 A visual indication of the cycle completion should be there.
7.11.4.3.2 The temperature sensors should have retained their original
positions.
7.11.4.3.3 The items containing sensors are intact.
7.11.4.3.4 The chemical indicators show a uniform color change as
specified by the supplier at end of cycle.
7.11.4.3.5 The biological indicator exposed to sterilization cycle shows no
growth at the end of the incubation time and the unexposed
inoculated carrier shows growth within 48 hours.
7.11.4.3.6 The actual SAL (Sterility Assurance Level) calculated should be
10-6.
7.11.4.3.7 The F0 at all points shall be 15 minutes.
7.11.4.3.8 The temperature of fluids in the load should be less than 90C
(applicable for fluid loads only)
7.11.4.3.9 The autoclave door shall not open till the temperature falls to
less than 90C.
Format No.: QA004-F05-01
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
Page 24 of 26
7.11.4.3.10 The equilibration time between the drain / reference probe and
coldest part of the load for achieving sterilization temperature
should not exceed 1 minute (applicable for Porous loads only).
8.0
ACCEPTANCE CRITERIA:
The HPHV Steam sterilizer should meet all the acceptance criteria of each specified test as per
section 7.0.
9.0
REVALIDATION CRITERIA:
Revalidation shall be carried out in case of
HPHV
14.1
GA
General Arrangement
14.1
P&ID
14.1
FAT
14.1
PLC
14.1
DQ
Design Qualification
14.1
MOC
Material of Construction
14.1
HMI
14.1
PW
Purified Water
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
14.1
VF
Vent Filter
14.1
BI
Biological Indicator
Page 25 of 26
QUALITY CONTROL
Equipment Name
PERFORMANCE QUALIFICATION
Autoclave (HPHV Steam Sterilizer)
Equipment ID
Protocol Number
Effective Date
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Annexure Title
01
Training Record
02
03
04
05
06
Report for Daily Vacuum Leak Test and Bowie Dick Test
07
08
09
10
11
12
END OF DOCUMENT