Autoclave 545

Qualification of Autoclave
Name of Equipment Autoclave

Location of the Equipment Pimpri
Equipment Identification No. ADP1166
Model no. 1704
Make
Date of Purchase
Table of contents:
• Autoclave Definition
• Autoclave Parts/ Components
• a. Pressure Chamber
• o b. Lid/ Door
• o c.Steamgenerator
• o d. Vacuum generator (if applicable)
• o e. Wastewater cooler
• Autoclave Principle/ Working o
Introduction
An autoclave is a machine that provides a physical method of

sterilization by killing bacteria, viruses, and even spores present
in the material put inside of the vessel using steam under
pressure.
• Autoclave sterilizes the materials by heating them up to a
particular temperature for a specific period of time.
• The autoclave is also called a steam sterilizer that is
commonly used in healthcare facilities and industries for
various purposes.
• The autoclave is considered a more effective method of
sterilization as it is based on moist heat sterilization.
Parts of autoclave
a. Pressure Chamber
• The pressure chamber is the main component of a steam
autoclave consisting of an inner chamber and an outer
jacket.
• The inner chamber is made up of stainless steel or
gunmetal, which is present inside the out chamber made
up of an iron case.
• The autoclaves used in healthcare laboratories have an
outer jacket that is filled with steam to reduce the time
taken to reach the sterilization temperature.
• The inner chamber is the case where the materials to be
sterilized are put.
• The size of the pressure chamber ranges from 100 L to
3000 L.
b. Lid/ Door
• The next important component of an autoclave is the lid or
door of the autoclave.
• The purpose of the lid is to seal off the outside the
atmosphere and create a sterilized condition on ht inside
of the autoclave.
• The lid is made airtight via the screw clamps and
asbestos washer.
• The lid consists of various other components like:
Pressure gauge
• A pressure gauge is present on the lid of the autoclave to
indicate the pressure created in the autoclave during
sterilization.
• The pressure gauge is essential as it assures the safety
of the autoclave and the working condition of the
operation.
Pressure releasing unit/ Whistle
• A whistle is present on the lid of the autoclave is the same
as that of the pressure cooker.
• The whistle controls the pressure inside the chamber by
releasing a certain amount of vapor by lifting itself.
Safety valve
• A safety valve is present on the lid of autoclave, which is
crucial in cases where the autoclave fails to perform its
action or the pressure inside increases uncontrollably.
• The valve has a thin layer of rubber that bursts itself to
release the pressure and to avoid the danger of
explosion.
c. Steam generator/ Electrical heater
• An electrical steam generator or boiler is present
underneath the chamber that uses an electric heating
system to heat the water and generate steam in the inner
and the outer chamber.
• The level of water present in the inner chamber is vital as
if the water is not sufficient; there are chances of the
burning of the heating system.
• Similarly, if the water is more than necessary, it might
interfere with the trays and other components present
inside the chamber.
d. Vacuum generator (if applicable)
• In some types of autoclaves, a separate vacuum
generator is present which pulls out the air from the inside
of the chamber to create a vacuum inside the chamber.
• The presence of some air pockets inside the chamber
might support the growth of different microorganisms. This
is why the vacuum chamber is an important component of
an autoclave.
e. Wastewater cooler
• Many autoclaves are provided with a system to cool the
effluent before it enters the draining pipes.
• This system prevents any damage to the drainage pipe
due to the boiling water being sent out of the autoclave.
Working:
• The autoclave works on the principle of moist heat
sterilization where steam under pressure is used to
sterilize the material present inside the chamber.
• The high pressure increases the boiling point of water and
thus helps achieve a higher temperature for sterilization.
• Water usually boils at 100°C under normal atmospheric
pressure (760 mm of Hg); however, the boiling point of
water increases if the pressure is to be increased.
• Similarly, the high pressure also facilitates the rapid
penetration of heat into deeper parts of the material, and
moisture present in the steam causes the coagulation of
proteins causing an irreversible loss of function and
activity of microbes.
• This principle is employed in an autoclave where the
water boils at 121°C at the pressure of 15 psi or 775 mm
of Hg.
• When this steam comes in contact on the surface, it kills
the microbes by giving off latent heat.
• The condensed liquid ensures the moist killing of the
microbes.
• Once the sterilization phase is completed (which depends
on the level of contamination of material inside), the
pressure is released from the inside of the chamber
through the whistle.
Qualification protocol
User Design Installation Operational Performance

specifications qualification qualification qualification qualification
Equipment
Description
Calibration Equipment Equipment
-Equipment
requirement control operation
Identification
function
-Utility Requirements
-Component
Specifications
-Component Material
- Lubricants
TABLE OF CONTENTS
1.0 Objective
2.0 Scope
3.0 Responsibility
4.0 User requirement specification
1.0 Objective
User requirements specifications Covers all the needs of the manufacturing department.
2.0 scope
The scope of this qualification document is limited to the design qualification of Autoclave
The equipment shall be used for Sterilization of Media, glasswares, product etc
3.0Responsibility
Roll no: 545
Name
: Pradnesh sandikar
Class: Fympharm(QAT)
4.0 User requirements specification
Sr. no Specifications Description
1 Type of autoclave Negative pressure displacement type (S-type)
2 Software Programmable Logic Controller (PLC)

3 Pressure vessel Jacketd type
4 Chamber Dimensions WxHxD =
26”x26”x37”
5 Trays dimension 12 x 29.5 x 2 cm
6 Volume of sterilization chamber 50 litres
7 Capacity of chamber 30 litre

8 Load capacity 10kg
9 Number of trays 1
10 Number of closing screw 8
11 Temperature range 250° F (121° C),
270°F (132°C) or
275°F (135° C)
12 Temperature distribution 0.5°c
13 Emergency Stop button
14 Max. Allowable Working Pressure 15 bar
(MAWP)
15 Alarms Buzzer
16 Safety Door sensing device
17 Vaccum system Gravity displacement type

18 Lid components Whistle, pressure gauge, handle,
19 Temperature detection Resistance thermal detector (RTD)
20 Pressure detection Pressure
Transducer
21 Snitary piping Sanitary TRI‐
CLAMP fittings
22 Piping connections Screwed
Sry. No Specifications Description
23 Chamber floor i Equipped with removable stainless

steel
24 Noise level Fulfill OSHA guideline

25 Induction coil Open end, C shaped
26 Lid screws Nut and bolt type
27 Whistle maintain temperature 15 pound per square inch
28 Lid type Rubber gasket
29 Pressure gauze display Pound per square inch
30 Utility
Power supply
Material Construction
Parts Material
Chamber Stainless steel 316 L
Lid stainless steel CF8.
Trays Stainless steel 316.
Handle Thermo-insulated.
Safety valve Rubber
Piping system AISI 316L stainless steel.
Insulation fiberglass insulation
D.Y.PATIL. COLLEGE OF PHARMACY, PUNE
DESIGN QUALIFICATION REPORT
Instrument: Autoclave (Instrument No. )
REPORT NO. DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/DQ/PC001/2016-17 PAGE NO. 1of 9
NO.
INSTRUMENT DETAILS
Model no. 1704
Make
Date of Purchase
TABLE OF CONTENTS
1.0 Objective
2.0 Scope
3.0 Responsibility
4.0 FAT Procedure
5.0 Design qualification approval
6.0 Reference documents
1.0 Objective:
To perform design qualification of Autoclave and assure that the machine is manufactured as
per the URS and it complies with the scope of supply.
2.0 Scope:
The scope of this qualification document is limited to the design qualification of Autoclave The
equipment shall be used for Sterilization of Media, glasswares, product etc.
3.0 Responsibility:
Roll No. 545
Name: Pradnesh P Sandikar
Class and department: FYMpharm (QAT department)
Prepared By Checked By Approved BY
Name & Pradnesh
Designation sandikar,
Sign & Date

3 june2021
D.Y.PATIL. COLLEGE
Prepared By OF PHARMACY,
Checked By PUNE
Approved BY
Name & Pradnesh P Sandikar
Designation
REPORT
Sign NO.
& Date DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
REF.PROTOCOL 3 June 2021
NO.
4.0 FAT Procedure:
After the completion of the erection work of the machine, client shall be informed to perform the FAT.
Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as
per details given below
1. Test criteria
2. Design verification check list
3. Deficiency and corrective action report
4. Pre installation requirement
5. Final report
5.0 Design qualification approval: According to the data collected as a result of this study,
equipment has been properly designed & qualified in accordance with standards and is now available
for process qualification.
Suppliers name Position Signature Date
APIS Technologies Manufacturing
REPORT NO. DYP/QAT/PV/DQ/RP001/2016-17 EFFECTIVE DATE
REF.PROTOCOL
NO.
Customer:
Student name Roll No. Signature Date
Pradnesh P 545 3june 2021
sandikar
6.0 Reference documents 1. Manufacturer

brochure:
2. DQ Protocol No.: 2
Written By Signature Date

Pradnesh P Sandikar 3 June 2021
Checked By Signature Date
Approved By Signature Date

Name &
Designation Pradnesh P Sandikar
Sign & Date 3 June 2021

INSTALLATION QUALIFICATION REPORT
REPORT NO. DYP/QAT/PV/IQ/RP001/2016-17 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/IQ/PC001/2016-17 PAGE NO.
NO.
INSTRUMENT DETAILS
Model no. 1704
Make
Date of Purchase
TABLE OF CONTENTS
1.0 Pre- Approval
2.0 Purpose
3.0 Scope
4.0 Responsibility
5.0 Requalification
6.0 System Description
7.0 Installation Qualification Procedure 8.0
Autoclave Major Component Results.
9.0 Conclusion
10.0 Appendix

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
1.0 PRE- APPROVAL :
Signing of this approval page of Installation Qualification Protocol No. DYPIPSR/ MQ-F / IQ/01,
indicates agreement with the installation qualification approach described in this document. If
modifications to the installation qualification become necessary, an addendum will be prepared and
approved.
Written by Signature Date

Arati ombase 3 June 2021
Komal padule
Checked by Signature Date
Approved by Signature Date

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
2.0 PURPOSE :
2.1 To provide record of the key features of the equipment and components as currently
installed.
2.2 To ensure that there is sufficient information available to enable the equipment to be
operated and maintained safely, effectively and consistently.
2.3 To verify the installation attributes of the equipment name critical to serve the intended
purpose of the equipment.
2.4 To establish the suitability of the draft SOP prepared for the operations of equipments.
2.5 To document the observation for future reference.
3.0 SCOPE:
The scope of this qualification protocol is limited to the installation qualification of
equipment name. This qualification protocol is part of a validation activity.
4.0 RESPONSIBILITY:
Roll No. 542
Name: komal padule
Class and department: Fympharm (QAT department)

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
5.0 REQUALIFICATION : Installation qualification to be repeated in case of :
 Replacement of any major component/ instrument.

 Major modification in the existing equipment.
 During monitoring, if equipment is found to be malfunctioning.
 Shifting of equipment from one location to another.
6.0 SYSTEM DESCRIPTION:
Sr.No. Specification
1 Pressure chamber
2 Lid
3 Pressure gauze
4 Pressure releasing unit
5 Safety valve
6 Steam generator
7 Vaccum Generator

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
LOCATION : pimpri
7.0 INSTALLATION QUALIFICATION PROCEDURE:
1. Verify the approved purchase order.

2. Verify invoice.
3. Check the manufacturer and supplier.
8 Waste water cooler
4. Verify the model no. and serial no.
5. Prepare a checklist for all the components and parts, including the spare parts according
to the purchase order and manufacturer’s specifications.
6. Record the information for each part, component, auxiliary equipment, supporting
facilities and compare to manufacturer’s specifications.
7. Installation should be done as per the instructions provided in the manual.
8. Record any deviations.

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
9. Prepare a deviation report including the justification of acceptance and impact on the
function.
10. Prepare an IQ report.
8.0 equipment name major component results.

SPECIFICATION Description ACTUAL DON DATE
Yes/ no E
BY
Accessories packed Power cable, outer stand, screw Yes
and nut,
Chamber Vertical in position, closed Yew
system, made up of stainless steel
of outer jacket and inner vessle
Lid With insulated coating, rubber Yee
gasket
Screw 8 in numbers with Yew
Pressure gauze Display pound per square inch Yes
Steam generator C shaped Yew
Waste water cooler At bootom of chamber Yes
Vaccum Generator On the lid Yes

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
Safety Alarm Yew

Button On/off Yes
Pipe connection Screwed type Yes
9.0 CONCLUSION :
The equipment name is qualifying the installation qualification test as per the guidelines
described in this Protocol No. DYPIPSR/ MQ-F / IQ/01. The operation qualification can be
followed now.
POST APPROVAL :
NAME SIGNATURE DATE
Written By : 3 June 2021
Arati ombase
Komal padule

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
Checked By:
Approved By:
10.0 APPENDIX:
ABBREVIATIONS AN DEFINITIONS:
1. SOP : Standard Operating Procedure
2. IQ : Installation Qualification

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.
3. QA : Quality Assurance
4. GMP : Good Manufacturing Practices
5. Acceptance criteria : The product , equipment, and / or process specifications nad limits,
such as acceptance quality level and unacceptable quality level, that are necessary for
making a decision to accept or reject.
6. Installation Qualification : Documented verification that the system or subsystem is
installed satisfactorily as per the recommendations of the manufacturers.
7. Validation : Establishing documented evidence that is system does what it purports to do.
8. Revalidation : Repetition of the validation process or a specific portion of it .

Name &
Sign & Date

3 June 2021
REF.PROTOCOL
NO.

Name &
Sign & Date

3 June 2021
OPERATIONAL QUALIFICATION REPORT
REF.PROTOCOL
DYP/QAT/PV/IQ/PC001/2016-17 PAGE NO. 1of 9
NO.
INSTRUMENT DETAILS

Location of the Equipment Parenteral Department
Equipment Identification No.
Model no.
Make
Date of Purchase
TABLE OF CONTENTS
1.0 Pre- Approval
2.0 Purpose
3.0 Responsibility
4.0 Requalification
5.0 System Description
6.0 Installation Qualification Procedure
6.1 Training
6.2 Key Functionality
6.3 Sop Verification
6.4 Deficiency (If Any) And Corrective Action Report
7.0 Acceptance Criteria
8.0 Conclusion
Name & Pradnesh P sandikar

REF.PROTOCOL
NO.
1.0 PRE- APPROVAL:

Signing of this approval page of Operation Qualification Protocol No. DYPIPSR/ MQ-F / OQ/01,
indicates agreement with the operation qualification approach described in this document. If
modifications to the operation qualification become necessary, an addendum will be prepared and
approved.
2.0 PURPOSE

2.1 To verify the operational attributes of the Autoclave critical to serve the intended purpose of
the equipment.
2.2 To establish the suitability of the draft SOP prepared for the operations of equipment’s.
2.3 To document the observation for future reference.
3.0 RESPONSIBILITY
Roll No.
Name:
Class and department:
Name & Pradnesh p Sandikar

Designation

REF.PROTOCOL
NO.
4.0 REQUALIFICATION:
Operation qualification to be repeated in case of:
▪ Replacement of any major component/ instrument.

▪ Major modification in the existing equipment.
▪ During monitoring, if equipment is found to be malfunctioning. ▪
Shifting of equipment from one location to another.
5.0 SYSTEM DESCRIPTION:
PARTS OF AUTOCLAVE:
Sr. PARTS / COMPONENTS

N
o.
1. Pressure Chamber
2 Lid / Door
3 Pressure gauge
4. Pressure releasing unit / Whistle
5 Safety valve
6 Steam Generator/ Electric heater
7. Vacuum generator
8. Wastewater cooler
LOCATION: Parenteral Department

Instrument: (Instrument No. )
REF.PROTOCOL
NO.
6.0 OPERATIONAL QUALIFICATION PROCEDURE:

6.1 A draft SOP should be prepared on the basis of supplier guide / manual for operation before the
qualification testing.
6.2 Prior to the qualification test, the personnel shall be trained by the Engineer from the supplier on
the operational features of the equipment/ system.
6.3 The trained personnel shall carry out the operational qualification following the procedure
mentioned under section 9.1.1 for key functionality and 9.1.2 for safety features. Record the
observations of qualification test in test data sheet of section 9.1.3
6.4 Operate the equipment/ system as per the draft SOP. Record the change if any and confirm the
SOP. Report the confirmation of SOP in section 10
6.5 Report the deficiency from the specified function in any section 11
7.0 OPERATING PROCEDURE OF AUTOCLAVE:

In general, an autoclave is run at a temperature of 121° C for at least 30 minutes by using saturated
steam under at least 15 psi of pressure. The following are the steps to be followed while running an
autoclave:
1.Before beginning to use the autoclave, it should be checked for any items left from the previous cycle.
2.A sufficient amount of water is then put inside the chamber.
3.Now, the materials to be sterilized are placed inside the chamber.
4. The lid is then closed, and the screws are tightened to ensure an airtight condition, and the electric heater
is switched on.
5. The safety valves are adjusted to maintain the required pressure in the chamber.
6. Once the water inside the chamber boils, the air-water mixture is allowed to escape through the discharge
tube to let all the air inside to be displaced. The complete displacement can be ensured once the water
bubbles cease to come out from the pipe
7.. The drainage pipe is then closed, and the steam inside is allowed to reach the desired levels (15 lbs
in most cases).
8. Once the pressure is reached, the whistle blows to remove excess pressure from the chamber.
9. After the whistle, the autoclave is run for a holding period, which is 15 minutes in most cases.
10. Now, the electric heater is switched off, and the autoclave is allowed to cool until the pressure gauge
indicates the pressure inside has lowered down to that of the atmospheric pressure.
11. The discharge pipe is then opened to allow the entry of air from the outside into the autoclave.
12. Finally, the lid is opened, and the sterilized materials are taken out of the chamber.

REPORT NO. DYP/QAT/PV/IQ/RP001/2016-17 EFFECTIVE
DATE
REF.PROTOCOL
NO.
8.0 TRAINING:
Title: Date:
Name of the Trainer:
Sr .no Name of the Trainee Employee number Signature

1.
2.
3.
4.
Signature of the Trainer:

Date:

Name & 541. Aarti Ombase

REF.PROTOCOL
NO.
9.0 KEY FUNCTIONALITY:
A. Purpose:
The purpose of this procedure is to demonstrate that the control panel and other manual operations
of Autoclave.
B. Test Procedure : 9.1.1 Verification of Key functionality of Autoclave:
Sr. Procedure Acceptance criteria

No.
Controller time accuracy The The controller

parameter in PLC was set and sterilization time as
sterilization cycle was runned, the indicated in
1. hold time was checked with the sterilizer/printout should
help of stop watch. be within 1% of the
intended exposure period.
2. Door precondition indicator Both When door

the doors of the autoclave were precondition is
closed. fulfilled the indicator
should glow
3. Alarm Indication Switch An audio-visual alarm
An alarm was generated. should generate and the
alarm indicator should
glow.

Name &
Designation Pradnesh p Sandikar

4. Emergency Stop Push Switch The equipment should
Emergency Stop Push Button stop at current stage
was pressed. and all controls and
display is off.

Instrument: Autoclave (Instrument No.
REPORT NO. DYP/QAT/PV/IQ/RP001/2016- EFFECTIVE DATE
17
REF.PROTOCO DYP/QAT/PV/IQ/PC001/2016-
PAGE NO. 6of 9
L NO. 17
Non sterile Door open Push Button

Press the Non sterile door opens Push The non-sterile door should open.
5. Button when equipment is not in
process.
Non-Sterile close Push Button The non-sterile door should close

Non sterile Door close
6.
Push Button was pressed when door is
opened
Sterile Door close Push Button Sterile

Side Door Close Push Button was
7. pressed when sterile side door is Sterile side door should close
opened
Sterile Door close Push Button Sterile

Side Door Close Push Button was
8. pressed when sterile side door is Sterile side door should close
opened
Sterile Door open Push Button

Sterile Door Open Push Button was
9. pressed when equipment is not in Sterile side door should open
process

Designation

REF.PROTOCOL
NO.
9.1.2 Verification of safety feature
Sr. Safety Features Function / Verification Acceptance

Procedure
No. Description Criteria
First sterile door was opened Non sterile
and then non sterile door open door should not
Check that both the push button was pressed to open.
doors should not open at open it.
1 the same time.
Sterile door was closed and
nonsterile door was opened, Sterile door
then sterile door push open should not
button was pressed again, to open.
open it.
Check for the opening of During auto or manual mode

doors during manual & of operation sterile and non- Both doors
2 auto mode of operation sterile side doors buttons were should not
pressed to open. open.
During operation the cycle was

Check for sterile door aborted and sterile door open Sterile door
3. operation should not open
push button wad pressed.

Name &

Sterile door was kept open
Process should not start and then the process was tried
4 in auto or manual mode to start, and after that non Process should
if either door is open. sterile door was kept opened
not start
and tried to start the process
again. -

REF.PROTOCOL
NO.
Manual mode was selected & do

not pressure non sterile door gasket, Process should not
Process should not start in then try to start the process start on both
manual mode if the door occasions and
5 precondition is not indicates with
fulfilled. alarm
Now Select manual mode & do not

pressure sterile door gasket, then try
to start the process
Chamber steam
Increase the chamber pressure by
will blow off
15% of the working pressure
through safety
6 Working of safety valves
Valve
Increase the jacket pressure by Jacket steam will
blow off through
15% of the working pressure
safety valve

Designation

REF.PROTOCOL
NO.
Door should move
7 Door Obstruction back
When door is moving obstruct the
door with hand or material
OPERATIONAL QUALIFICATION TEST RESULT:
9.1.3 Operation qualification of autoclave.
Sr. No Features verified Complies/ not complies
1.
Key functionality Complies
2. Complies
Safety features
3. Operator interface, display, Complies
automation and control requirements
4. Alarms and warnings Complies
5. Emergency stop features Complies
10. SOP VERIFICATION:
Title: Autoclave
Operate the equipment as per the draft SOP and record the details given below:

Name &

Operated By:
Checked By:
The operating personnel understand and follow the SOP description (Yes / No):
Changes required in draft SOP (if any):
SOP to be revised (Yes / No):
If yes, Review
No.
Remarks: SOP Confirmed / Not Confirmed
Verified By:
Signature:
Date:
REF.PROTOCOL DYP/QAT/PV/IQ/PC001/2016-17 PAGE NO.
NO.
10of 9
11.0 DEFICIENCY (IF ANY) AND CORRECTIVE ACTION REPORT:

Designation

REF.PROTOCOL
NO.
Description of deficiency and date observed:
Person, responsible for corrective action and date assigned:
Corrective actions taken and date conducted:
Conducted By: Approved By:
Date : Date:
Comments (if any):
Verified by :
Signature:
Date:

Name &

REF.PROTOCOL DYP/QAT/PV/IQ/PC001/2016-17 PAGE NO.
NO.
11of 9
12.0 ACCEPTANCE CRITERIA:
Operational qualification should be considered acceptable when all the conditions specified in
various data sheets under section 6.0 have been met.
Any deviation from the acceptance criteria of the specific check point should be reported and
decision should be taken for rejection, replacement or rectification of equipment/ component.
13.0 CONCLUSION:
The Autoclave is qualifying the operational qualification test as per the guidelines described in this
Protocol No. DYPIPSR/ MQ-F / OQ/01. The Autoclave can be tested for its Performance
Qualification as per the Protocol No. DYPIPSR/ MQ-F / PQ/01.

Designation

PERFORMANCE QUALIFICATION REPORT
REPORT NO. DYP/QAT/PV/PQ/RP001/2016-17 EFFECTIVE DATE
REF.PROTOCOL
DYP/QAT/PV/PQ/PC001/2016-17 PAGE NO. 1of 9
NO.
INSTRUMENT DETAILS

Location of the Equipment Parenteral Department
Equipment Identification No.
Model no.
Make
Date of Purchase
TABLE OF CONTENTS
1.0 Pre- Approval
2.0 Objective
3.0 Performance Qualification Test: Procedure
4.0 Performance Qualification Test Results
5.0 Requalification
6.0 Responsibility
7.0 Conclusion
1.0 PRE- APPROVAL:
Signing of this approval page of Performance Qualification Protocol No. DYPIPSR/ MQ-F /

Designation

REF.PROTOCOL
NO.
PQ/01, indicates agreement with the performance qualification approach described in this document.
If modifications to the performance qualification become necessary, an addendum will be prepared
and approved.
2.0 OBJECTIVE:
The objective of this protocol is to collect sufficient data to establish that Autoclave
performs to meet the desired product quality in the consistent manner, when operated as
per standard operating procedure. Performance qualification protocol shall provide the
methodology of qualification studies, formats for recording the observation, criteria of
qualification and a guideline for documentation of the study.
3.0 RESPONSIBILITY
Roll No.

Designation

REF.PROTOCOL
NO.
Name:
Class and department:
4.0 PERFORMANCE QUALIFICATION TEST: PROCEDURE

4.1.1 Vacuum leak test for sterilizer chamber:
➢ The vacuum leak test parameters were checked and ensured are as mentioned in the
authorized protocol.
➢ The cycle for “Vacuum leak test” in PLC was selected and performed.
➢ The process was monitored and observations were collected.
➢ The vacuum leak test was performed before and after the validation execution to ensure
the chamber integrity. ➢ Acceptance Criteria:
➢ The drop in the vacuum shall not be more than 0.013 bar after 10 minutes of hold period.
4.1.2 Air removal test:

Designation

REF.PROTOCOL
NO.
➢ A ready “Bowie and Dick test kit” was used to perform the test.
➢ The Bowie and Dick test cycle in PLC was selected and the test was performed as per the
following parameters.
After completion of the cycle, the test sheet was retrieved and the compliance against the
acceptance criteria was examined.
Acceptance Criteria:
▪ The indicator color shall change from light brown to dark brown / black in the Bowie-Dick test
sheet & shall be uniform throughout the sheet.
4.1.3 Heat distribution and heat penetration studies with loaded chamber.
➢ Multi point data logger was used with T- type RTD for heat penetration studies.

Designation

REF.PROTOCOL
NO.
➢ Number of temperature sensors were used to check heat distribution in loaded chamber
(including one at drain point), and rest 12 probes were be used to check heat penetration
inside the load.
➢ The temperature sensors were placed with identification number inside the sterilizer
chamber and inside the sterilization load where the steam penetration could be difficult.
The overall rationale for probe placement would be combination of two or more of the
following as appropriate: ➢ Corners of sterilizer
➢ Cartage filters, Tubing’s / Product contact parts
➢ Center of sterilizer and loaded units.
➢ The temperature sensors were placed with identification number inside the sterilizer
chamber and inside the sterilization load as per the temperature sensor location
diagram.
➢ pre enumerated biological indicators of Geobacillus stearothermophilus

➢ (minimum10 spores per strip) were placed with properly marked details in the middle of
the sterilization load near each temperature sensor kept to check heat penetration, and
also at the locations where sensor cannot be placed but the location is defined as difficult
for steam penetration. ➢ The sterilization cycle was selected and cycle parameters are
verified.

Designation

REF.PROTOCOL
NO.
➢ The heat penetration and distribution studies were carried out by using the Multi point
data logger with temperature logging interval of 10 seconds.
➢ After completion of sterilization cycle the data logger was stopped and the nonsterile
door of the sterilizer was opened.
➢ The Biological indicators were taken out from the load and sent to
Microbiological Lab.
➢ The Temperature profile from the Data logger and temperature recorder was taken out.
➢ The F0 value for each temperature sensor of data logger was checked. Calculation
of F0 value is based on the given formula. Check the results against the
➢ Formula: F0 = summation [dt 10 (Ta- Tb)/Z]
Where, Tb = 121.1°C, Z = 10℃, Ta = Actual temperature

➢ dt = Time interval between two successive temperature measurements.
➢ After getting the reports of biological indicator check it for compliance against
acceptance criteria and attach with the qualification report.
➢ Temperature sensors which are used are be calibrated after completion of activity (post
calibration) to ensure that the temperature measurement system is accurate and precise.

Designation

REF.PROTOCOL
NO.
Acceptance Criteria: The F0 - value of all the temperature sensor of data logger should be equal
to or more than sterilization hold time set. (except liquid or nutrient media load

Designation

REF.PROTOCOL
NO.
PERFORMANCE QUALIFICATION TEST RESULT:

1. Verification of Data logger and RTD Sensors calibration (Pre calibration and post calibration
details):
Acceptance complies/
Sr. Instrumen
Sr. Instrument Acceptance criteria doesn’t
No t
No criteria complies
Data
1 Logger + 0.20C complies
1 Data 0
+ 0.2 C
Logger
2 RTD +0.25% complies
sensors
2 RTD +0.25%
sensors
2.Vacuum Leak test -
Sr. Run Max Leakage Acceptance criteria Complies/Doesn’t

No No. observed (bar) complies
1. 1 0.004 The drop in vacuum should not complies

be more than 0.013 bars during
2. 2 0.000 10 minutes hold period complies
3. 3 0.000 complies
5.4.2 Air Removal Test
Sr. Run
no No. Test Observations Acceptance criteria Inference
Uniform dark
1. 1 black color Complies
observed
Uniform dark Bowie-Dick test kit should show
2. 2 black color uniform dark brown/ black color complies
observed development
Uniform dark
3. 3 black color complies
observed
REF.PROTOCOL
NO.
5.4.3 Heat Distribution and Penetration Studies
Observations
Steril Max. Max.
izer Min. Max. Min. Equilibr Max. fluctuation difference
Run temp temp F0 ium deviation of temp on a between Result
No. value time from average RTD sensors two RTD
temp sensors
122. 32. complies complies complies
1 121 30 complies
9 4
complies complies complies
2 121 123 32 30 complies
3 121 122.9 32.6 30 complies complies complies complies

Name & 541. Aarti Ombase
Designation 542. Komal Padule
Sign & Date June 3, 2021

REF.PROTOCOL
NO.
6.0 REQUALIFICATION:
Performance qualification to be repeated in case of:
▪ Replacement of any major component/ instrument.

▪ Major modification in the existing equipment.
▪ During monitoring, if equipment is found to be malfunctioning.
▪ Shifting of equipment from one location to another.

Designation

REF.PROTOCOL
NO.
6.0 CONCLUSION: Finally, conclusion should be drawn based on the results of above test
and documented.
Designation

Autoclave 545

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Autoclave 545

Uploaded by

Copyright:

Available Formats

Qualification of Autoclave

Name of Equipment Autoclave

An autoclave is a machine that provides a physical method of

User Design Installation Operational Performance

4.0 User requirements specification

Sr. no Specifications Description

1 Type of autoclave Negative pressure displacement type (S-type)

2 Software Programmable Logic Controller (PLC)

6 Volume of sterilization chamber 50 litres

7 Capacity of chamber 30 litre

17 Vaccum system Gravity displacement type

19 Temperature detection Resistance thermal detector (RTD)

20 Pressure detection Pressure

23 Chamber floor i Equipped with removable stainless

24 Noise level Fulfill OSHA guideline

26 Lid screws Nut and bolt type

27 Whistle maintain temperature 15 pound per square inch

28 Lid type Rubber gasket

29 Pressure gauze display Pound per square inch

Sign & Date

4.0 FAT Procedure:

6.0 Reference documents 1. Manufacturer

Written By Signature Date

Checked By Signature Date

Approved By Signature Date

Prepared By Checked By Approved BY

Sign & Date 3 June 2021

Prepared By Checked By Approved BY

Sign & Date

1.0 PRE- APPROVAL :

Written by Signature Date

Approved by Signature Date

Prepared By Checked By Approved BY

Sign & Date

Prepared By Checked By Approved BY

Sign & Date

5.0 REQUALIFICATION : Installation qualification to be repeated in case of :

 Replacement of any major component/ instrument.

6.0 SYSTEM DESCRIPTION:

Prepared By Checked By Approved BY

Sign & Date

7.0 INSTALLATION QUALIFICATION PROCEDURE:

1. Verify the approved purchase order.

Prepared By Checked By Approved BY

Sign & Date

8.0 equipment name major component results.

Prepared By Checked By Approved BY

Sign & Date

Safety Alarm Yew

Prepared By Checked By Approved BY

Sign & Date

1. SOP : Standard Operating Procedure

Prepared By Checked By Approved BY

Sign & Date

4. GMP : Good Manufacturing Practices

Prepared By Checked By Approved BY

Sign & Date

Prepared By Checked By Approved BY

Sign & Date

Name of Equipment Autoclave

Name & Pradnesh P sandikar

D.Y.PATIL. COLLEGE OF PHARMACY, PUNE

1.0 PRE- APPROVAL: