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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

PERFORMANCE QUALIFICATION PROTOCOL

FOR
B O D INCUBATOR
(MICROBIOLOGY LAB UNIT- VI FORMULATION FACILITY)
MAKE: NEWTRONIC

Revision Index

Revision No. Date CRN No. Reason for revision

00 NA New Document

O-QA008/F01-00 Page 1 of 16
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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

TABLE OF CONTENTS

1.0 Protocol Approval____________________________________________________3

2.0 Objective___________________________________________________________4
3.0 Scope______________________________________________________________4
4.0 Equipment Description________________________________________________4
5.0 Responsibilities and Identification of Execution Team______________________5
6.0 Test Procedures_____________________________________________________6
7.0 Records of observation______________________________________________14
8.0 Discrepancy and Corrective Action Report______________________________15
9.0 Compilation, Review and Summary Report______________________________15
10.0 Appendix__________________________________________________________15

1.0 Protocol Approval

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

Signing of this approval page of protocol indicates agreement with the qualification
approach described in this document. If any modification in the qualification approach
becomes necessary, a revision through change control shall be prepared, checked
and approved. This protocol cannot be executed until approved by following
personnel.

Department Name Designation Signature & Date

Prepared by

Quality
Assurance

Reviewed by

Engineering/
Projects

Microbiology

Approved by

Quality
Assurance

2.0 Objective

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

The purpose of this protocol is

To provide documented evidence that the equipment is capable to continuously
maintaining the desired conditions within the specified quality attributes thereby
establishing its dependability

To establish sufficient data, to assure that the BOD Incubator (ID.No: O-MBI-056)
supplied by M/s Newtronic Equipment Company Private Limited. Model. No: NEC
128RTSSI is suitable for maintaining the defined specifications when operated in
accordance with the established standard operating procedure O-MB066.

To establish the operating ranges for the system key control parameters that provide
the means of assessing when the system is operating outside established control
parameter limits and bringing the system back to state of control.

Scope

This protocol covers all aspects of Performance Qualification of BOD Incubator used
in microbiology lab of Hereto labs Ltd, Unit-VI formulation facility, Jadcherla.

This protocol will define the methods and documentation used to qualify the BOD
Incubator for PQ.

3.0 Equipment Description

The BOD Incubator is supplied by M/s NEWTRONIC EQUIPMENT COMPANY

PRIVATE LIMITED Model. No: NEC 128RTSSI to incubate the material with
temperature from 20-25C.
Equipment Name : BOD Incubator
Make : NEWTRONIC EQUIPMENT COMPANY PVT.LTD.
Model : NEC 128RTSSI
S. No. : BOD/1205
Capacity : 768 Lit.

Operation & Design feature:

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

A BOD Incubator is design to maintain the temperature thermostatically at the

selected position. A normal working temperature 20-25C is obtained by positioning
the thermostat knob at the position.

The temperature range of the thermostat is 5C to 60C.

The ambient temperature at the location of the BOD Incubator and the frequency
and duration of lid / door opening will have impact on the temperature in the BOD
Incubator. The temperature control knob should be adjusted so that, it must maintain
20-25C in the BOD Incubator.

4.0 Responsibilities and Identification of Execution Team

4.1 Responsibilities: The group comprising of representatives from each of the

following departments shown in the table below and they shall be responsible for the
overall compliance with this protocol.

Quality Assurance (Validation)

Preparation of PQ protocol
Approval of PQ protocol.
Execution of PQ protocol along with the co-ordination of other departments.
Review of results and compiling of reports.
Preparation and approval of PQ report

Quality Control

Review of PQ protocol and Report.

Man power support

Engineering

Review of PQ protocol and report

Technical support during qualification study

4.2 Identification of Execution Team: All the identified executors involved with this
protocol to record name, designation and signature & date. Verify the training details
in the respective procedures involved in the protocol refer annexure-1.

5.0 Test Procedures

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

5.1 Pre-Requisites

Prior to conducting / executing the Performance qualification protocol following

conditions must be fulfilled:
System should be safe for execution.
Approval of Operational Qualification report.
5.2 Pre-Qualification test
Standard Operating Procedure Verification
Calibration of all measuring instruments
Calibration of Test instruments
5.3 Qualification Test Program
The BOD Incubator will be considered qualified for consistent and reliable
performance (validated) on successful completion of the following tests

Temperature Mapping of the chamber of BOD Incubator

Open door study
To qualify these tests the equipment should fulfil the acceptance criteria described in
the individual test procedures. After completion of the qualification tests all the data
generated will be compiled together to evaluate ability of the BOD Incubator at the set
parameters and set loading pattern.

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

5.4 Test Matrix

Following test matrix is prepared for the initial performance qualification and
revalidation of BOD Incubator.

Pre- Qualification Test

S. No. Test Frequency Runs

Initial validation only /
1. SOP verification whenever there is any NA
major changes made
2. Calibration of Measuring Instruments Quarterly 1 week One

3. Calibration of test instrument Quarterly 1 week One

Qualification Test
Initial validation only /
Temperature mapping - Empty
1. whenever there is any Three
Chamber
major changes made
Temperature mapping - Loaded
2. Annually 1 month Three
Chamber
3. Open door study Annually 1 month One
Pre and post calibration of data logger Before and after
4 One
thermocouples validation
Revalidation Programme
Temperature mapping - Loaded
1. Annually 1 month One
Chamber
2. Open door study Annually 1 month One
Pre and post calibration of data logger Before and after
3 One
thermocouples validation

5.5 Qualification Test Procedure

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

Pre-Qualification Study

5.5.1.1 Standard Operating Procedure Verification

Objective

To verify the standards operating procedures required in the performance qualification

of Incubator shall be of current revision.

S. No. SOP Title

1 Procedure for operation, calibration and cleaning of BOD incubator

5.5.1.2 Verification of Calibration of all measuring instruments

Objective

To ensure that all the measuring instruments listed below are calibrated.

S. No. Item Description

1 All sensors attached to the instrument.

Acceptance criteria: All temperature measuring instruments shall be maintaining

1.0c with reference to standard instrument temperatures. If does not meet the
acceptance criteria shall be replace the measuring instrument.

Results

Record the observations and results in the format enclosed as Annexure-2.

5.5.1.3 Verification of Calibration of Test instruments

Objective

To ensure that all the test instruments attached to the BOD Incubator is to be
calibrated before and after validation study.

S. No. Item Description

1. All additional sensors (PT-100 type sensors) attached to the data logger.
2. Data Logger

Acceptance criteria: Pre and post calibration of all additional sensors (PT-100 type
sensors) shall agree to 0.5C with reference to standard instrument. In any test,

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

failure of thermocouple during post calibration does not invalidate the validation run/s
provided that there are not more than one thermocouple fails, however if at the time of
failure it was in the coldest location then the same run will be repeated. If it was not,
then accept the data and replace the TC before the next run. If more than one
thermocouple fails repeat the run, regardless which TC they are.

Results

Record the observations and results in the format enclosed as Annexure- 3.

Qualification Study

The following Test shall be carried out to establish the Performance Qualification of
Incubator.

Temperature Mapping of BOD Incubator

Open door study

5.5.2.1 Temperature mapping of empty and loaded chamber studies

Objective

The intent of this study is to establish uniform temperature distribution throughout the
empty chamber for the given set parameters that will be used for validating loads in
the incubator and establish the sufficient data for the evidence.

Test Requirements

Calibrated data logger.

Calibrated PT-100 type sensors.

Test Procedures

Distribute at least 16 pre-calibrated PT-100 type sensors throughout the

incubator chamber (Front, Middle and End portions of the incubator
chamber) through the access port provided on the incubator as shown in
the diagram and place one sensor outside of the chamber that will be
monitor the room temperature.

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

If necessary, use Teflon tapes or any mean to secure thermocouples in

position. Ensure that the tips of thermocouples, where the wires are
soldered, do not touch any metallic surface.
Set the parameters in the thermostat is 22.5C
Logger should be configured so that it starts data logging after the
prescribed time.
Record the temperatures of all thermocouples inside the chamber throughout
the cycle at an interval of 5 minute for not less than 24 hours.
Stop recording the data after completion of the cycle.
download the logged data and take the print outs of the data and attach with
the qualification report
Identify the cool and hot points in incubator chamber (i.e. front, middle and end
portions).

Locational diagram of the temperature sensors

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

11 12
6 7
1
2
16 15
10
3

8 13 14
9
4 5

: External temperature sensor

: temperature controller

LOCATION OF TEMPERATURE SENSORS

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

Location. No Location Name Location. No Location Name

Top front left side of the Bottom middle right side of the
L1 L9
chamber chamber
Top front right side of
L2 L10 Middle of the chamber
the chamber
Bottom front left side of
L3 L11 Top back left side of the chamber
the chamber
Bottom front right side
L4 L12 Top back right side of the chamber
of the chamber
Front middle of the
L5 L13 Bottom back left side of the chamber
chamber
Top middle left side of Bottom back right side of the
L6 L14
the chamber chamber

Top middle right side of

L7 L15 back middle of the chamber
the chamber
Bottom middle left side
Outside of the chamber (i.e. ambient
L8 of the chamber and L16
condition)
near to the control RTD

Acceptance Criteria

There should be uniform distribution of temperature within the Chamber during

the performance qualification study and the temperature at each location probe
should be within the 20-25C

Result

Record the observations and results in the format enclosed as Annexure -4.

Summary

Attach the data logging reports of temperature mapping to the performance

qualification report as Annexure-4

5.5.2.2 Open door Study of BOD Incubator

Objective

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

The objective of this test is to identify the impact of the temperature fluctuations
once after the door is opened and the time taking to attain the desired
temperature in the chamber to assess and establish the sufficient data for the
evidence.

Test Requirements

Calibrated data loggers.

Calibrated temperature sensors.

Test Procedures

Place one temperature sensor (PT-100 type sensors) in incubator

chamber where the maximum temperature recorded in temperature
mapping of loaded chamber studies.

Place one thermocouple in outside of the chamber (room) to monitor the

room temperature.

If necessary, use Teflon tapes or any mean to secure thermocouples in

position. Ensure that the tips of thermocouples, where the wires are
soldered, do not touch any metallic surface.
Set the parameters in the thermostat is 22.5C.
Open the incubator door until the chamber temperature sensor attains for
not less than 25C.

Allow the instrument to get the desired temperature in the chamber.

Close the incubator door after chamber temperature sensor attained by more
than 25C.
Record the temperature sensor inside the chamber at an interval of 1 minute
until maximum temperature recorded in loaded chamber study.
Stop recording the data after completion of the cycle.
Download the logged data and take the print outs of the data and attach
with the qualification.

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

Determine the time taken by the temperature sensor inside the chamber
to attain the desired temperature and time taken to reach maximum
temperature recorded in loaded chamber.

For routine operations set the maximum door open allowable time and
close time.
Accordingly impact need to be assessed.

Result

Record the observations and results in the format enclosed as Annexure -5.
Summary
Attach the data logging reports of temperature mapping to the performance
qualification report as Annexure 5.

6.0 Records of observation

Record the observations of after execution of each test procedures, in the annexure
(Recording of Observations for Performance Qualification).If any specification is not
meeting against required specification / acceptance criteria, write No in the Meeting
Requirement column, specify the discrepancy under comments and must be
explained in Discrepancy and Corrective Action Report

6.1 Re Qualification

Performance Qualification of BOD Incubator shall be done once in a year as per the
re-validation matrix mentioned above in this protocol.

The qualification should also be performed additionally in case of following

Any major modification in equipment after the last performance qualification.

This must be properly documented through a change control system.
Adjustments made in the instruments, to correct the non-compliance of
performance parameters with respect to specifications.
Equipment intended to any other set temperatures.
7.0 Discrepancy and Corrective Action Report

Document any discrepancies observed during the performance qualification of the

equipment in the annexure. Include the corrective actions of the same. When all the

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

discrepancies are satisfactorily resolved or an approved action plan is developed

which ensures that the discrepancy will be resolved, document that the system is
ready for next step in the qualification.

8.0 Compilation, Review and Summary Report

Compile and review that all test procedures have been completed, reconciled and
attached to this protocol. Verify that the approvals for deviations (if any) have been
taken and are resolved appropriately to the satisfaction.
Performance Qualification shall be considered acceptable when all the conditions
specified in the qualification procedures have been met.
Prepare the Performance Qualification report as per the SOP No. O-QA008 and
submit this for review and approval to the Validation Core Team.

9.0 Appendix

9.1 Abbreviations and Definitions

Abbreviation Full Form

PQ Performance Qualification
C Degree Centigrade
SOP Standard operating procedure
QA Quality Assurance
ID Identification
M/s Messers
Ltd. Limited
No. Number
CRN Change Request Note

9.2 Enclosure

Annexure 1: identification of execution team and training details.

Annexure 2: Verification of Calibration of all measuring instruments

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PERFORMANCE QUALIFICATION PROTOCOL
Equipment Name : B O D Incubator
Facility: Microbiology Lab Unit-VI
Equipment Number : O-MBI-056
Formulation Facility
Protocol Number : VPO-MB033-00 Effective date :

Annexure 3: Verification of Calibration of Test instruments

Annexure 4: Temperature mapping of BOD Incubator

Annexure 5: Open door study

9.3 References

SOP No.: SOP No.: O-QA008 (Installation, Operational and Performance

Qualification of Equipment / Instrument)
SOP No.: O-MB066 (Procedure for operation, calibration and cleaning of BOD
incubator)

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