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AUTOCLAVE VALIDATION DOCUMENTS CHECKLIST
(Ref SOP: VAL-175)
Procedure
Before commencement of validation tasks copy documents listed in the following tables. The following
documents are required.
Document
Document Name Sign/Date
Number
Form-780 Autoclave Validation Protocol
VAL-215 Critical Documentation Verification During a Validation Study

Change Control, Deviation, Preventative and Corrective Maintenance Summary
Form-775 Sheet
Form-765 Documentation Verification and Cycle Review
Form-770 Validation Cycle Review (electronic)
Form-810 Equipment Calibration Verification

Form-815 &
Autoclave Cycle Parameter – Dry and Wet
Form-820
The following documents are to be copied as many times as necessary.

Document Number
Number of Copies
Form-805 Vacuum Leak Test
Form-790 Steam Penetration/Air Removal (Bowie Dick) Test
VAL-180 Heat Penetration/Heat Distribution Study
Form-830 Biological Indicator Test Results Sheet

Autoclave Wet Cycle Acceptance Review Criteria (where
Form-755
applicable)
Autoclave Dry Cycle Acceptance Review Criteria (where
Form-835
applicable)
The following documents are to be copied if required.

Document Number
Number of Copies
Form-745 Validation Protocol Deviation Reporting Form
Form 785 Issue date: Version: 1 Page: 1 of 1

AUTOCLAVE VALIDATION PROTOCOL
(Ref. SOP VAL-175)
1. Procedure
Conduct all tests indicated. Attach all documents to this protocol. Any deviations raised during validation
must be recorded using Form-745 (Protocol Deviations/Deficiencies Report).
Sign/Date
Before commencement of the operational verification, Documentation Verification and
Cycle Review Form-765) must be completed and attached.
1.1 Cycle and Load Selection

1.1.1 List the cycles and loads selected for validation, in Table 1.
Table 1. Cycle and Load Description
Cycle Number of
Number Runs Load Description
1.2 Review Panel

The signatories in Table 2 have reviewed the selected cycles and found them to be acceptable for
validation.
Table 2. Signatories
Department Title Name Signature Date

Validation Validation Supervisor
System Owner
Engineering and
Engineering
Maintenance Manager
Quality Operations Manager-Quality
1.3 Operational Verification for all Autoclaves.

Complete Sections 1.3 and 2 only. Strikethrough Section 1.4
Sign/Date
1.3.1 Conduct an equipment calibration verification using Form-810 (Equipment
Calibration Verification).
1.3.2 Conduct a Vacuum Leak Test using Form-805 (Vacuum Leak Test). Record all test instances
conducted in Table 3.

AUTOCLAVE VALIDATION PROTOCOL
(Ref. SOP VAL-175)
Table 3. Vacuum Leak Test Summary
Deviation Number
Date (if applicable) Sign/Date
a
Sign/Date
1.3.3 Perform an initial Steam Penetration/Air Removal (Bowie Dick) Test using Form-
790 (Steam Penetration/Air Removal (Bowie Dick) Test).
Sign/Date
1.3.4 Conduct a Heat Penetration and Heat Distribution Study for EACH cycle using
VAL-180 (Heat Penetration and Heat Distribution Study) as listed in Table 1.
2. Completion
Upon completion of this protocol all executed test sheets must be attached and a report must be written (Ref
VAL-175).
3. Signature Verification
Designated personnel assigned the responsibility of executing or reviewing execution of this document will
sign, initial and date the corresponding sections in Table 3.
Table 3. Signature Verification
Print Name Signature Initials Dept/Company Title Date

Standard Operating Procedure
Title: Cleaning Validation Master Plan – Non Sterile Solid
Department Validation/Technical Services Document no VAL-215
Prepared by: Date: Supersedes:
Checked by: Date: Date Issued:
Approved by: Date: Review Date:
Table of Contents
Part A – Rationale and General Principles .............................................................................................. 2
1 Introduction ................................................................................................................................... 2
2 Responsibilities ............................................................................................................................. 3
3 Rationale and General Principles ................................................................................................. 4

3.1 Rationale .........................................................................................................................4
3.2 General Principles ..........................................................................................................4
3.3 Cleaning SOP or Instructions .........................................................................................5
3.4 Risk Based Approach .....................................................................................................6
3.5 Selection of “Worst Case” - Product Bracketing Strategy ..............................................6
3.6 Assessment of New Products .........................................................................................7
3.7 Preparation and Approval of Protocols and Reports ......................................................7
3.8 Acceptance Criteria ........................................................................................................8
3.9 Priority, Schedules and Documentation .........................................................................9
3.10 Cleaning Strategies ........................................................................................................9
3.11 Clean Hold Time .............................................................................................................9
3.12 Dirty Hold Time .............................................................................................................10
3.13 Campaign Cleaning ......................................................................................................10
3.14 Re – Validation .............................................................................................................10
3.15 Manual Cleaning Procedures - Monitoring ...................................................................10
3.16 Cleaning Validation Program – Required Documents Table ........................................10
4 References .................................................................................................................................. 12
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2 Responsibilities
QC Laboratory
Development
Development
QC Manager
Engineering
Engineering
Production
Production
Assurance
Validation
Validation
Manager
Manager
Manager
Manager
Manager
Quality
Quality
Validation study design P P I I I I I I I I I I
Identifying and providing the appropriate level of resource in order
to execute the cleaning validation exercises P P (P) (P) (P) (P) (P)
Identification of process equipment trains and selection of worst
case products for validation P/A P I I I I I I I I I/A I
Calculation of cleaning limits for equipment / processes P/A P I I I A I
Training of Operators in Cleaning SOPs I I P P
Writing and execution of protocols P/A P I I A/I I I I I I A/I I
Review of QC results and final report writing P/A P A A
Rinse and Swab Sampling P P I A I I
Conduct analytical test method validation (P)/A/I (P) P/A/I P A/I
Testing of swab and rinse samples (P) I/(P) I I A/P P
Validation cleaning studies discrepancy resolution P/A P I I I I I I I I A/I A/I
Update of this CVMP when required P P I A/I I I A/I
Where A = Approver P = Primary Ownership (P) = Joint Ownership I = Input

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- Time, temperature, flow rates, pressures, volumes for cleaning or soak cycles (and technique for
manually cleaned systems)
- Time, temperature, flow rates, pressures, volumes for rinse cycles
- Sequence of cleaning, soak and rinse cycles or steps
- Additional Operating Instructions
- Routine data, samples to be collected during normal operation, including any end of cycle analytical
samples
- Assay methods for sample testing
- Maximum hold time after cleaning – Clean Hold Time
3.4 Risk Based Approach
3.5 Selection of “Worst Case” - Product Bracketing Strategy
3.5.1 A risk-based matrix approach will be used to determine the worst-case product for each cleaning
procedure. Cleaning validation will be performed for all equipment cleaning procedures associated
with that worst-case (highest risk) product. Acceptable validation of a cleaning procedure for the
worst-case product shall constitute validation for all other products that utilise the same cleaning
procedure. Cleaning validation will be performed on additional products, as necessary, to verify
performance of any cleaning procedures relating to equipment, which was not utilized during the
manufacture of the worst-case product.
3.5.2 The risk-based matrix takes into account the following factors (refer Diagram “Risk Matrix”):
 Solubility – solubility of the active ingredients in water, as noted in the Merck Index.
 Toxicity and Concentration – either based on available toxicology information or based on LD50
Oral (rat) - the amount of a substance required to kill half a given population and percentage of the
active ingredients in the formulation residue.
3.5.3 Carry- over calculations for the permissible residue quantities will be based upon available
toxicology information for the identified substance(s) of greatest toxicity, highest potency or
suitability as in indicating agent for common production equipment.
3.5.4 Swab analysis will generally be performed using the most difficult to remove active drug substance
or the most toxic substance, whichever is determined to be of greatest cross-contamination risk. The
most difficult to remove substance must be identified based on a combination of solubility in the
cleaning agent, and also on first hand experience. In instances where the most potent active used to
calculate the acceptance is potentially harmful as a contaminant in other products, swabbing for
residues of this active will be conducted as well as on the identified worst case (most difficult to
clean active) as an added precaution.
3.5.5 Where swabbing is performed on a worst case active, the acceptance criteria will still be based on
the most potent active, not the active being swabbed. This combination provides a high level of
The microbiological acceptance criteria for Total Plate Count (TPC) is based on a maximum allowable count
of 1/cm2 as for swabs and expressed as maximum count per 100mL for each sampling point.
TPC  1 cfu / cm2

Pseudomonas spp: Not Detected/ 100ml
Coliforms: Not Detected/ 100ml
E.coli: Not Detected/ swab
Salmonella spp Not Detected/ swab
Swabs
TPC:  1 cfu / cm2
Yeast & Mould:  1 cfu / cm2
Pseudomonas spp.: Not Detected/ swab
Coliforms: Not Detected/ swab
E.coli: Not Detected/ swab
Salmonella spp Not Detected/ swab
The target limits shall be:
a) Less than, or equal to, 1 cfu per cm2 for product contact surfaces.
b) Absence of E. coli., mould, yeast
3.9 Priority, Schedules and Documentation

3.9.1.1 Schedules for equipment cleaning validation must be based on the following priority:
 Assessment of all new products before initial manufacture (refer Part 3 above)
 Product or product groups assessed as having a high clean ability risk
 Product or product groups assessed as having a medium clean ability risk (if required)
 Product or product groups assessed as having a low clean ability risk (if required)
3.9.1.2 Schedules must be prepared listing line/equipment (groups) train, product(s) or product group(s),
and SOP(s) or procedure(s).
3.9.1.3 The following minimum documentation should be available for review on the completion of validation:
 cleaning validation protocol, including location maps of swab sampling
 published cleaning procedure used in the validation
 validation report referenced to raw data
 reference to method validation and active product surface recovery studies
3.10 Cleaning Strategies

Hold times are the times a piece of equipment or system is allowed to remain idle, either after it has been
utilised for production processes (dirty-hold time) or after an equipment or system has been cleaned (clean
hold-time).
3.11 Clean Hold Time
Clean hold times are the maximum time a piece of equipment or systems are allowed to remain idle between
the end of the cleaning process and the beginning of usage. The primary concern is with an adverse change
in the cleanliness of the equipment over a period of time.
Clean hold times will be evaluated where the equipment or system is considered to be at risk of change of
the cleanliness state when left idle for extended periods of time. Equipments or systems have acceptable
hold times evaluated via microbiological or chemical testing as appropriate. Where equipment is sterilised
prior to use, a validated overkill sterilisation cycle for the equipment or system would be considered sufficient
justification to negate the necessity for microbiological evaluation of a hold time. The requirement to conduct

Document / Definition
(Definitions may be found in Purpose
specific documents)
The CVMP provides the specific rationale concerning- selection of
allowable carry over limits, grouping of products and equipment,
rationale for selection of “marker” or exhibit products. It also defines
who is responsible.
The schedule itemises and prioritized the cleaning validation activities

Cleaning Validation Schedule
and any supporting activities which are required to achieve the cleaning
validation program. Schedules usually cover a 2 – 3 year period.
(Attached to CVMP)
A document which documents the process of evaluating the
effectiveness of a specific cleaning procedure. This protocol is specific
Cleaning Validation Protocol to a cleaning procedure, the marker product (representing a group) and
the equipment train.
The risk assessment reviews the risks associated with the cleaning
program i.e. what level of cleaning needs to be achieved, toxicity of
Risk Assessment (Protocol)
actives, worse case scenarios of cross contamination potential.
An assessment of all equipment used during the manufacture of a

Identification of Equipment Train particular product (or group of products) identifying worse case
(Protocol) scenarios and equipment trains.
Clean Limit – Rational for setting A limit for acceptable level of “clean”, which is defined in the cleaning
Limit validation protocol, and defined in terms of (a) maximum carryover
levels to the next product and (b) allowable residues per unit are of
equipment surface.
Methods used for cleaning analysis must be appropriately validated i.e.

Limit of Quantitation (LOQ) and Limit of Detection (LOD) must be
assessed for each analyte and possibly degradant. An assessment of
the precision, accuracy and linearity must also be performed at the LOD
Validated Analytical Methods
and LOQ. Pre-requisites to analytical method validation include
qualification and calibration of all equipment/lab instruments used in the
analysis.
In order to ensure consistent and reproducible recovery, a procedure

for the sampling (be it swabbing, rinse collection or placebo approach)
Procedure for Sampling
must be written and trained to.
When swabbing is used as a sampling technique, as well as training to

the procedure, it is a requirement to perform recovery studies which
evaluate the ability of the sampling procedure to recover a specific
Recovery Studies – Swabbing
analyte from specific surfaces.
Protocol
The recovery study is also used to quality the analysts or samplers
performing the swab per the protocol.
This may be achieved in the above document Recovery Study –

Swabbing protocol. Its purpose is to show the effectiveness of training
Qualification of Swabbers
of “swabbers” to take samples in a reliable and reproducible manner.

CHANGE CONTROL, DEVIATION, CAPA SUMMARY SHEET
(Ref. SOP VAL-175)
PROCEDURE
Record all Change Controls, Deviations, Preventative and Corrective Maintenance documents that have been raised since the last validation activity and execute a cycle
parameter and load matrix review (see VAL-175 - Validation of Autoclaves, Autoclave Loads and Cycles).
Impact on
Document Validation
Description of Change/Deviation/Maintenance
Number (Yes/No)

Documentation Verification and Cycle Form
(Ref. SOP VAL-175)
1. Procedure
Conduct SOP, Change Control, Deviation, Preventative and Corrective Maintenance reviews as
described in VAL-175 (Validation of Autoclave, Autoclave Loads and Cycles).
1.1 Documentation Verification

Sign/Date
1.1.1 Conduct an SOP review as per VAL-215 Critical Documentation
Verification during a Validation Study.
1.1.2 Conduct a review of all change controls, deviations, preventative and corrective
maintenance logs using Form-775 (Change Control, Deviation, Preventative and Corrective
Maintenance Summary) Sheet.
Yes/No Sign/Date
1.1.3 Have any change controls been raised?
Yes/No Sign/Date
1.1.4 Have any deviations been raised?
Yes/No Sign/Date
1.1.5 Have any preventative maintenance been undertaken?
Yes/No Sign/Date
1.1.6 Have any corrective maintenance been undertaken?
If yes, conduct cycle and load review and describe in Form-770 (Validation Cycle Review).
Yes/No Sign/Date
Attach Review to this document
2. Completion
Attach this document to Autoclave Validation Protocol.

VALIDATION CYCLE REVIEW
(Ref. SOP VAL-175)
PROCEDURE
Conduct a review of the cycles and loads.
Matrix Review
Documented by Position Date

EQUIPMENT CALIBRATION VERIFICATION
(Ref. SOP VAL-175)
Project Number Autoclave Number
1. Procedure
Equipment calibration verification must be performed prior to the commencement of autoclave

validation.
1.1 Calibration Checks

1.1.1 Verify the autoclave is within calibration (VAL-220). Print out Equipment Sign/Date
Maintenance Status Report (Engineering Department) and attach to this
document.
Sign/Date
1.1.2 Complete a list of test equipment used (Table 1). Attach a copy of
calibration certificates to this document.
Table 1. Test Equipment

Calibrated Certificate
Equipment Name Serial Number
(Yes/No) Attached
Pressure Transducer
Eurothern Chessel 6000 Graphic Recorder
Hart Scientific HDCR Calibrator
Graphtec GL midi logger CL220/820
Sign/Date
1.1.3 Calibrate thermocouples (VAL-210). Copy Calibration Verification Record
(Form 825) and attach to this document.
Sign/Date
1.1.4 Sign and attach all printouts of the thermocouple calibrations to this
document.
2. Completion
Upon completion of this test attach document to the Autoclave Validation Protocol (Form 780).

AUTOCLAVE CYCLE PARAMETERS RECORDING SHEET - DRY
(Ref. SOP VAL-175)
DRY - CYCLE # Parameters
Verify that all cycle parameters are set as listed in the table below.
Actual Acceptance
Expected Parameter Set
Parameter Description Parameter Set Criteria Met
Point
Point (Yes/No)
Cycle Number (Enter number)
Cycle Name (Enter Name)
Value (kPa) ≤ 30
DRY-PreC: Evacuate 1
Delay (s) 60
Value (kPa) ≥ 150
DRY-PreC: Charge 1
Delay (s) 60
Value (kPa) ≤ 25
Delay (s) 60
Value (kPa) ≥ 150
DRY-PreC: Charge 2
Delay (s) 30
Value (kPa) ≤ 20
Delay (s) 60
Value (kPa) ≥ 150
DRY-PreC: Charge 3
Delay (s) 1
Heating Ramp-Up to Value (kPa) ≥ 219.3kPa (equiv. 123.0°C)
S.P (pressure) Delay (s) 1
Value (min) ≥ 15
DRY: Sterilisation
Delay (s) 1
Value (kPa) ≤ 120
Chamber Exhaust
Delay (s) 1
Value (min) ≥10
Vacuum Drying
Delay (s) 1
Value (kPa) ≥ 110
Chamber Equalisation
Delay (s) 60
Value (min) ≥ 15
Vacuum Drying
Delay (s) 1
Value (kPa) ≥ 110
Delay (s) 60
Value (min) ≥ 10
Vacuum Drying
Delay (s) 1
Value (kPa) ≥ 105
Delay (s) 1
Sterilisation Control Chamber Chamber Pressure @
Method Pressure @ 219.3kPa
Acceptable Verification
Action (Yes/No) Sign/Date Sign/Date
All cycle parameters are set correctly

AUTOCLAVE CYCLE PARAMETERS RECORDING SHEET - WET
(Ref. SOP VAL-175)
WET - CYCLE # Parameters
Verify that all cycle parameters are set as listed in the table below.
Expected Parameter Set
Parameter Description
Point
Cycle Number (Enter number)
Cycle Name (Enter Name)
Pressure Regulated @
Control Method
212.3kPa (122.0°C)
Sterilisation Control Method 1st deadband SP 0.7kPa
2nd deadband SP -0.7kPa
WET: Free Steaming 1 Delay (s) 180
WET: Free Steaming 2 Delay (s) 600
Value (°C) ≥ 122.1

Heating Ramp-Up to S.P. Using
Coldest Temperature Load Probe
Delay (s) 1
Value (°C) 122.0
Holding Time
WET: Sterilisation (Load Probe 2) ≥ 35
(min)
Delay (s) 1
Cooling 3 Value (sec) 2700
Value (kPa) 110

Delay (s) 2
Acceptable Verification
Action (Yes/No) Sign/Date Sign/Date
All cycle parameters were set correctly
and match the print out from the
Autoclave.

Vacuum Leak Test
(Ref. SOP VAL-175)
1. Procedure
A Vacuum Leak Test is performed to test the integrity of the autoclave. This form must be printed
for each consecutive test.
1.1 Vacuum Leak Test Performance
Sign/Date
1.1.1 Synchronise the time of the Graphic Recorder (Eurotherm Chessell 6000
Multichannel Graphic Recorder) to within 1 minute of the autoclave.
1.1.2 With the autoclave in standby state and the side door slightly open, install Sign/Date
the test equipment (thermocouple harness, independent pressure
measurement device) onto the autoclave validation port(s) located on the
side of the autoclave.
Cycle Number
1.1.3 Perform a Vacuum Leak Test and record cycle
number.
Yes/No
Was test conducted successfully without alarm?
If no, fill out Vacuum Leak Test Summary table in Deviation Number
Autoclave Validation Protocol (Form-780 Autoclave
Validation Protocol), record deviation number and
repeat test again (Note: upon retest print off this form
If yes, continue to point 1.1.4.
Sign/Date
1.1.4 Retrieve the autoclave printout(s) and chart recorder trace, sign all
printouts and attach to this document.
2. Completion
Upon completion of this test attach document to the Autoclave Validation Report.
Form: 805 Issue date: Version: 1 Page: 1 of 2

Vacuum Leak Test
(Ref. SOP VAL-175)
Table 1. Vacuum Leak Test Parameters

Acceptanc
e Criteria
Actions Expected Results Actual Results Sign/Date
Met
(Yes/No)
The Vacuum Leak Test Yes/N
Verify the autoclave
Cycle parameters from Verify
Vacuum Leak Test Cycle
the autoclave are parameters
parameters.
verified.
Test Date
Autoclave cycle starts
Start Vacuum Leak Test Cycle
and information is
Cycle. Number
documented in the
spaces provided
Time of Run
Initial Vacuum Test
Observe and record the Chamber Pressure is
initial Vacuum Test recorded at start of Initial
Chamber Pressure (1st Vacuum Hold Phase Pressure
recorded print of the and is: Value (kPa)
Vacuum Hold Phase). ≈15kPa
Once evacuated, the Start Time

chamber holds the The chamber holds the
established vacuum level established vacuum End Time
for 30 minutes without level for 30 minutes.
further action from the Total Time
vacuum pump (min)
Observe and record the

Final Vacuum Test
final Vacuum Test Final
Chamber Pressure is
Chamber Pressure (last Pressure
recorded at end of
recorded print of the Value (kPa)
Vacuum Hold phase.
Vacuum Hold Phase).
∆P = Final Vacuum
Calculate the ∆P for the
= (Pressure – Initial
Vacuum Hold Phase. ∆P =
Vacuum Pressure).
∆P is ≤3.5 kPa
The cycle Yes/N
completed o
The cycle is completed with no alarm
with NO alarm conditions.
conditions. The Printo
Retrieve the autoclave
autoclave
printout and chart
The autoclave printout recorded a
recorder chart, label and
displays a reading of reading of
attach as specified in the
“CYCLE COMPLETED”. ‘Cycle
test procedure.
Completed’.
The printout and chart The printout Chart
recorder chart are and chart
stamped and attached. recorder are
stamped and
attached.
Form: 805 Issue date: Version: 14 Page: 2 of 2

STEAM PENETRATION/AIR REMOVAL (BOWIE DICK) TEST
(Ref. SOP VAL-175)
Project Number Autoclave Number
1. Objective
This test is to be completed once in order to confirm the qualified state of the autoclave for air removal.
2. Procedure
Sign/Date
2.1 Ensure that a Vacuum Leak Test has been successfully completed.
Sign/Date
2.2 Place the Bowie Dick Pack in the chamber and perform Bowie Dick
Cycle.
Cycle Number
2.3 Record Cycle Number.
Batch Number Expiry Date

2.4 Record pack Batch Number
and Expiry Date.
Sign/Date
2.5 Retrieve the indicator card and complete Table 1.
Table 1. Results- Bowie Dick Pack

Acceptable
Acceptance Criteria Sign/Date
(Yes/No)
The indicator card shows a uniform colour change (See Figure 1
and 2) throughout the indicator (attach a picture of the test sheet to
this document).
The card was exposed to the specific temperatures and duration as

per the manufacturer’s instructions.
Figure 1. Test sheet BEFORE processing Figure 2. Test sheet showing PASS condition
(Blue colour) (Pink colour)

STEAM PENETRATION/AIR REMOVAL (BOWIE DICK) TEST
(Ref. SOP VAL-175)
Sign/Date
2.6 Complete End Cycle Checks (Table 2).
Table 2. End of Cycle Checks- Bowie Dick Pack

Acceptable
Acceptance Criteria (Yes/No) Sign/Date
No alarms observed during cycle.
The process record, chart recorder print out, indicator card and
picture has been attached to the protocol.
Sign/Date
2.8 Attach a picture of the test sheet result to this document.
3. Completion
Upon completion of this test attach all documentation to the Validation Protocol.

Title: Heat Penetration/Heat Distribution Study
Department Validation/Technical Services Document no VAL-180
Prepared by: Date: Supersedes:
Checked by: Date: Date Issued:
Approved by: Date: Review Date:
Autoclave
Project Number Number
1. OBJECTIVE
Using a Heat Penetration Study, demonstrate that each of the proposed cycles will, with a high degree of
assurance, sterilise a defined load configuration for the worst-case load. Similarly, conduct a Heat
Distribution Study simultaneously to determine the cold spots and uniformity of heating in the loaded
autoclave chamber.
THIS DOCUMENT MUST BE REPRODUCED FOR EACH CYCLE
Cycle Number Number of Runs
Load Description
2. PROCEDURE
2.1 Pre-requisite to the Heat Penetration Study
2.1.1 Synchronise the time of the Graphic Recorder (Eurotherm Chessell 6000 Sign/Date
Multichannel Graphic Recorder) to within 1 minute of the autoclave.
2.1.2 Ensure pre-cycle checks have been successfully performed. Record in Table 1.
Table 1. Pre-Cycle Check

Acceptance Criteria
Acceptance Criteria Achieved Sign/Date
(Yes/No)
Vacuum Leak Test is successfully performed.
Steam Penetration/Air Removal Test is successfully

performed.
2.2 Run Execution
2.2.1 Record BI details in Table 2.

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Title: Heat Penetration/Heat Distribution Study
Note: Eurotherm Chessell 6000 Multichannel Graphic Recorder can be

used to produce consistent and accurate results at all times in setting
up configurations, calibrating, recording, saving, and monitoring of the
real time data during validations of temperature and pressure
environments.
2.3 Post Cycle
2.3.1 Verify that the recorded cycle parameters are consistent with the Sign/Date
programmed cycle parameters. Attach the completed form(s) to this
document.
2.3.2 Retrieve each exposed BI from the load. Submit the exposed and control Sign/Date
BIs with Biological Indicator Test Results Sheet (Form-850) to Quality
Control for sterility testing.
2.3.3 Attach all autoclave printouts and graphs to this document. Sign/Date
2.3.4 Record whether the test has met the acceptance criteria using either Form- Sign/Date
835 Autoclave Cycle Acceptance Criteria. Attach the completed form to this
document.
2.3.5 Record post-calibration verification results in Table 4.
Table 4. Thermocouple Post-Calibration Verification Results

Acceptance
Criteria
Test Description Acceptance Criteria Sign/Date
Achieved
(Yes/No)
All T/C’s are within r0.80qC of

Check Point Verification (121qC)
reference
3. COMPLETION
Upon completion of test, attach this document to Form-780 Autoclave Validation Protocol.
4. REFERENCED DOCUMENTS
VAL-175 Validation of Autoclaves, Autoclave Cycles and Loads

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BIOLOGICAL INDICATOR TEST RESULTS SHEET
(Ref. SOP VAL-175, VAL-200)
Project Number Equipment ID
Procedure
Fill out table and transfer sheet to Quality Control with all samples.
Cycle Number: Run #: Initials/Date:

QC Serial Number:
oC
Commenced Incubation at Time: Initials/Date:
1. To activate the media, place the indicator in an upright position in a plastic crusher. Gently squeeze the
crusher to break the glass ampoule. Place the activated indicator in the incubator rack and incubate
immediately.
2. Examine the indicator for any colour change at 24h. Record the examining time and results in the table.
Acceptance Criteria - Geobacillus stearothermophilus

• Yellow colour indicates bacterial growth.
• No colour change indicates adequate sterilisation.
Biological Indicator
Position Op. Init. Date/Time Purple = - Yellow = + Initial/Date
24h
Control
Operator Initial/Date
Test Result: Pass Fail
Comment:
Tested By/Date
Verified By/Date

Autoclave Cycle Acceptance Review Form
(Ref. SOP VAL-175)
Run Number Cycle Number Project Number Autoclave Number
Acceptance Criteria
Achieved
Acceptance Criteria (Yes/No/Accepted under
deviation or N/A)
Recorded cycle parameters are consistent with programmed cycle parameters.
The Department of Agriculture (DoA) requirements are met for DoA regulated loads. (If load
core measured, all points ≥121°C for 15min, else all points ≥121°C for 30min and all
biological indicators do not show growth).
The sterilisation phase time is not less than 15 minutes for non DoA regulated loads and
temperature regulated cycles.
The measured chamber pressure is within ± 1°C of the mean chamber temperature at the
midpoint of the sterilisation phase.
Mean chamber Temperature = ________oC
Chamber Pressure = _________ kPa Saturation Temperature = _______ oC
Steam Penetration Studies (Load)
A minimum accumulated F0 of 22 minutes is obtained at all load measurement (penetration)
locations at the end of the cooling phase on the autoclave printout (with the exception of F0
regulated cycles which must have a minimum F0 of 15min).
Min F0 Obtained T/C Location
All exposed BIs must test negative for growth, except for the positive control.
Record the greatest load temperature and T/C location °C T/C #:_______
Wet Cycles Only: All liquid volumes are <90ºC ± 1ºC at the end of the cooling cycle.
Dry Cycles Only: The autoclave load is visibly dry. (“visibly dry” being defined as the load
items and all layers of sterile wrapping material are free of pooled liquid upon visual
inspection)
Heat Distribution Studies (Chamber)
The autoclave drain probe achieves a minimum temperature of ≥1oC below the
sterilisation set point temperature. Set Pt. Min. Temp.
The measured temperatures within the chamber are within (+2/-1)°C of the sterilisation
temperature set point.
Lower Upper
Set Point
Temperature Temperature
The measured temperatures of the thermocouples within the chamber are within ±1°C of
the mean chamber temperature at each time point.
Trial Acceptance (Circle) Met Criteria – Pass Did not meet Criteria - Fail
Comments
Conducted By: Reviewed By:

(Sign/Date) (Sign/Date)

Autoclave Cycle Acceptance Review Form
(Ref. SOP VAL-175)

AUTOCLAVE DRY CYCLE ACCEPTANCE REVIEW CRITERIA
(Ref. SOP VAL-175)
Run Number Cycle Number Project Number Autoclave Number
Acceptance
Criteria
Achieved
(Yes/No/
Accepted Under
Acceptance Criteria Deviation)
Recorded cycle parameters are consistent with programmed cycle parameters.
The Department of Agriculture (DoA) requirements are met for DoA regulated loads (If
load core measured, all points ≥121°C for 15min, else all points ≥121°C for 30min and
all biological indicators do not show growth).
The sterilisation phase time is not less than 15 minutes for non DoA regulated loads
and temperature regulated cycles.
The measured chamber pressure is within ± 1°C of the mean chamber temperature at
the midpoint of the sterilisation phase.
Mean Chamber Temperature = ________oC
Chamber Pressure = _________ kPa Saturation Temperature = _______ oC
Steam Penetration Studies (Load)
A minimum accumulated F0 of 22 minutes is obtained at all load measurement

(penetration) locations at the end of the cooling phase on the autoclave printout.
Min F0 Obtained T/C Location
All exposed BIs must test negative for growth, except for the positive control.
The autoclave load is visibly dry. (Note-visibly dry is defined as, upon visual inspection
of the load at the end of the cycle, the load items and all layers of wrapping material are
found to be free of pooled liquid).
Heat Distribution Studies (Chamber)
The measured temperature of the thermocouples within the chamber is within ±1°C of
the mean chamber temperature at each time point.
The measured temperatures within the chamber are within (+2/-1)°C of the
sterilisation set point. Set Point Temp.
Lower Temperature Upper Temperature
The autoclave drain probe achieves a minimum temperature of ≥1oC below the
sterilisation set point. Set Point Min. Temp.
Test Acceptance  Pass Fail

Comments
Tested by/Date Reviewed by/Date

Validation Protocol Deviation Report Form
(Ref. SOP VAL-175)
Project Number Protocol Deviation Report Number
Does this Deviation directly affect product status? Yes No  If yes, raise a quality deviation
Deviation ID
A. Identification of the Section of the Protocol Affected
B. Description of the Protocol Deviation
C. Discussion of the Deviation Occurrence
D. Reason (Root Cause) for the Deviation Occurrence and Impact on the Validation Study
E. Resolution of the Deviation
F. Attachments
Note: This form may be reproduced in both “hardcopy” and in an electronic format. The authorisation of this form is located
on a separate page to permit reproduction of this form electronically.
Deviation Report Prepared By: Sign Date

Reviewed and Approved By: Sign Date
Quality Assurance Approval: Sign Date

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AUTOCLAVE VALIDATION DOCUMENTS CHECKLIST

(Ref SOP: VAL-175)

Form-780 Autoclave Validation Protocol

VAL-215 Critical Documentation Verification During a Validation Study

Form-770 Validation Cycle Review (electronic)

Form-810 Equipment Calibration Verification

The following documents are to be copied as many times as necessary.

Form-805 Vacuum Leak Test

Form-790 Steam Penetration/Air Removal (Bowie Dick) Test

VAL-180 Heat Penetration/Heat Distribution Study

Form-830 Biological Indicator Test Results Sheet

The following documents are to be copied if required.

Form-745 Validation Protocol Deviation Reporting Form

Form 785 Issue date: Version: 1 Page: 1 of 1

1.1 Cycle and Load Selection

1.2 Review Panel

Department Title Name Signature Date

Quality Operations Manager-Quality

1.3 Operational Verification for all Autoclaves.

Form 780 Issue date: Version: 1 Page: 1 of 2

Table 3. Signature Verification

Print Name Signature Initials Dept/Company Title Date

Form 780 Issue date: Version: 1 Page: 2 of 2

Part A – Rationale and General Principles .............................................................................................. 2

3 Rationale and General Principles ................................................................................................. 4

Copyright©www.gmpsop.com. All rights reserved

Copyright©www.gmpsop.com. All rights reserved

3.4 Risk Based Approach

3.5 Selection of “Worst Case” - Product Bracketing Strategy

TPC  1 cfu / cm2

The target limits shall be:

b) Absence of E. coli., mould, yeast

3.9 Priority, Schedules and Documentation

3.10 Cleaning Strategies

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The schedule itemises and prioritized the cleaning validation activities

An assessment of all equipment used during the manufacture of a

Methods used for cleaning analysis must be appropriately validated i.e.

In order to ensure consistent and reproducible recovery, a procedure

When swabbing is used as a sampling technique, as well as training to

This may be achieved in the above document Recovery Study –

Copyright©www.gmpsop.com. All rights reserved

Form 775 Issue date: Version: 1 Page: 1 of 1

1.1 Documentation Verification

1.1.3 Have any change controls been raised?

Attach this document to Autoclave Validation Protocol.

Form 765 Issue date: Version: 1 Page: 1 of 1

Documented by Position Date

Form 770 Issue date: Version: 1 Page: 1 of 1

Project Number Autoclave Number

Equipment calibration verification must be performed prior to the commencement of autoclave

1.1 Calibration Checks

Table 1. Test Equipment

Eurothern Chessel 6000 Graphic Recorder

Hart Scientific HDCR Calibrator

Graphtec GL midi logger CL220/820

Form 810 Issue date: Version: 1 Page: 1 of 1

Form 815 Issue date: Version: 1 Page: 1 of 1

Cycle Number (Enter number)

Cycle Name (Enter Name)

Sterilisation Control Method 1st deadband SP 0.7kPa

2nd deadband SP -0.7kPa

WET: Free Steaming 1 Delay (s) 180