Installation / Operational Qualification Protocol Insert Incubator Name & I.D

IOQ Centre logo can be inserted here
INSTALLATION / OPERATIONAL
QUALIFICATION PROTOCOL
INSERT INCUBATOR NAME & I.D.

Centre Name
HFEA Centre Number
Centre Address
Document Reference: IOQ- Insert document reference and revision

Issue Date: Insert issue date
Document Author
Name Position Signature Date
Populate Populate
Approval
Populate Populate
Populate Populate
1. APPROVALS
1.1 Implementation approval

Implementation approval is given following review of the submitted protocol and must be completed prior to execution
of the protocol. This approval is detailed on the cover page.
1.2 Interim approval
Equipment use will be suspended if non-conformances categorised as high have not been resolved.
Interim approval may be granted to permit continued equipment use if non-conformances categorised as high have been
resolved.
Interim approval may also be granted if non-conformances categorised as low are outstanding.
Populate Populate
Comments
1.3 Final Approval

Final approval is given when all non-conformances have been resolved.
Populate Populate
Populate Populate
Comments
IOQ-insert doc reference and revision

Page 2 of insert total pages up to list of appendices page
TABLE OF CONTENTS
Section Page
1. APPROVALS..............................................................................................................................................................2
2. DOCUMENT CONTROL..........................................................................................................................................3
3. INTRODUCTION & SCOPE.....................................................................................................................................4
4. DATA COLLECTION................................................................................................................................................5
5. NON-CONFORMANCES..........................................................................................................................................6
6. PERSONS PERFORMING IOQ................................................................................................................................6
7. PRE-REQUISITES TO COMMENCE IQ SECTION................................................................................................7
8. INSTALLATION CHECK (IQ)..................................................................................................................................8
9. COMMISSIONING CHECK (IQ)...........................................................................................................................10
10. PRE-REQUISITES TO COMMENCE OQ SECTION............................................................................................12
11. FUNCTION & ALARM CHECKS (OQ).................................................................................................................13
12. TEMPERATURE MAPPING STUDY (OQ)...........................................................................................................16
13. DETERMINATION OF CO2 CONCENTRATION (OQ)........................................................................................21
14. DETERMINATION OF O2 CONCENTRATION (OQ)...........................................................................................23
15. INTERNAL SOP AND TRAINING REVIEW (OQ)...............................................................................................25
16. SUMMARY OF TESTS PERFORMED..................................................................................................................27
17. list of Appendices......................................................................................................................................................28
2. DOCUMENT CONTROL
2.1 Revision History

Date Issued Revision Reason for Issue
Populate A Draft issued for internal review
1 Issued for approval

3. INTRODUCTION & SCOPE
3.1 Introduction
The purpose of this IOQ is to qualify the incubator (detailed below) to confirm that it has been installed according to the
design intent and operates in accordance with the manufacturers specifications, drawings and other relevant design
documents.
The IOQ will cover the following Incubator:
Equipment Name Make & Model Identification No. Location
Incubator
This incubator is used for .

3.2 Scope
This protocol will include the following IQ verifications:
Confirm availability of supporting documentation
Confirm correct installation of incubator and suitable utility connections
Review of commissioning report
This protocol will include the following OQ verifications:
Confirm correct functioning of all components such as the control of gas level and temperature control
Confirm correct alarm functionality
Temperature mapping of the incubator chamber to determine temperature distribution under normal operating
and breach conditions
Independent determination of the gas concentration inside the incubator
Standard Operating Procedures and training review
Note: Validation of the utilities supplying the incubator does not form part of this IOQ.

4. DATA COLLECTION
All written data will be entered using a blue or black indelible pen in clear handwriting at the time of testing or
completion.
All dates will be entered in the International Standard format, i.e. 01 Jun 2008. American format (MMM DD YY) must
not be used.
Mistakes and errors will be crossed out using a single line and correction made in blue or black pen. Correction fluid
must not be used.
The person responsible for the correction must initial and date any corrections, with any appropriate explanation, at the
time of change.
Ticks, crosses and dittos must not be used. The checker should indicate the appropriate response by his/her
initials.
Deviations from approved test procedures or acceptance criteria will be made by crossing out and a suitable explanation
for the change given. The change will be signed and dated by the person instigating the change. If there is a significant
change this may require a higher level of approval.
All empty or incomplete boxes will be scored through. They should be annotated as non applicable with N/A, and
initialled and dated.
All attachments and appendices will be cross-referenced in the protocol and signed and dated.
All drawings/schedules/quotations etc. will be marked up in accordance with the relevant protocol test instructions to
indicate compliance, non-compliance and deviations from the expected result.
The following highlighter pens will be used for marking up documents and drawings: -
Yellow indicates compliance with the drawing/schedule etc.
Blue indicates non-compliance with the drawing/schedule etc.
Green indicates areas that were unable to be checked and should be accompanied by a simple explanation
Where the documentation is to be stored electronically, any raw data or supporting documents must be scanned in.
If the protocol is to be completed electronically, the document must have adequate security to avoid amendment and
alteration to the completed protocol.

5. NON-CONFORMANCES
Where there are failures or deviations in meeting some or all of the agreed approved acceptance criteria during the
execution of protocols, the impact of the failure is assessed and categorised and formally documented on a non-
conformance form for control and close out.
The non-conformance solution must be approved by a responsible person before the protocol can reflect closure.
Comments on corrective action taken to resolve the non conformance are documented on the form and the form is held
with the appropriate protocol for traceability and reference
Non conformances are encountered when the equipment/system/process does not agree with or operate to the specified
design criteria.
A non-conformance also arises when the specification, test method or acceptance criteria has been incorrectly defined in
the protocol.
Categorising of non-conformance is as per the table below:
Category Description Required Action
Must be rectified immediately.

Non-conformances which could have a
High The process of qualification cannot continue
critical impact on gametes or embryos
until the non-conformance is resolved
Non-conformances which have either no The process of qualification may continue, only
Low impact or a negligible impact on gametes or following review of the non-conformance and
embryos with signed acceptance
6. PERSONS PERFORMING IOQ
All personnel entering information in this protocol must be identified in the table below by name, affiliation, full
signature and initials.
Personnel must be fully aware of all the procedures to follow, specifically procedures for data collection and recording
discrepancies.
Name Company Signature Initials Date

7. PRE-REQUISITES TO COMMENCE IQ SECTION
The following must be confirmed prior to commencing with the process of qualification detailed in further sections of
this protocol.
Pre-Requisite Description Initials Comments
Installation is complete with incubator in final location
Incubator has been commissioned by the supplier and a

commissioning report is available for review

8. INSTALLATION CHECK (IQ)
8.1 Objective
To verify that the incubator has been installed to a satisfactory standard and is safe to use.
To confirm there is adequate documentation to support the on-going operation and maintenance of the incubator.
8.2 Pre-Requisites
Incubator is installed and handed over for verification
8.3 Test Method

Record the documentation provided to support the on-going operation and maintenance in the result table 1 below.
Carry out physical inspection checks on the incubator and complete the result table 2.
8.4 Acceptance Criteria
Operating & Maintenance manual must be available.
The installation checks identified in result table 2 must have been suitably addressed.
8.5 Results
Table 1
Document Title Reference / Issue Date Location
Table 2
Check Comment
The incubator is uniquely identifiable
The incubator has been installed in the correct location

and has no visual signs of defects or damage
Any drawings supplied with the equipment are accurate
The specified services and utilities have been provided

and are suitably connected and electrical safety checks
have been performed
Gas regulators and isolation valves are suitably rated
The supply filter (if required) has been fitted correctly
Record any details of computer hardware and software

e.g. type/ versions (if applicable)
Performed By: Date: IOQ-insert doc reference and revision

Page 8 of insert total pages up to list of
.... appendices page
8.6 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Pass Pass with comment Fail
Comments Non-conformance

9. COMMISSIONING CHECK (IQ)
9.1 Objective
To verify that the incubator has been satisfactorily commissioned and a commissioning report has been provided by the
supplier.
9.2 Pre Requisites
Commissioning report is available for review
9.3 Test Method

Record the documentation provided to support the commissioning activity in result table 1.
Review the commissioning report and complete the result table 2.
The commissioning report must be available.
The commissioning results must meet the specifications and criteria in result table 2.
9.5 Results
Table 1
Document Title Reference / Issue Date Location
Table 2
Check Comment
The commissioning report has been adequately
completed and is signed and dated
All the test instrumentation used has a current calibration

certificate
Temperatures have been independently verified
Gas concentrations have been independently verified
Alarms have been set, documented and verified

9.6 Conclusion

10. PRE-REQUISITES TO COMMENCE OQ SECTION
The IQ section of this protocol has been completed
No non conformances from the IQ section, categorised as

high, remain outstanding

11. FUNCTION & ALARM CHECKS (OQ)
11.1 Objective
To verify that all incubator components function correctly as specified for normal operation.
To verify that all alarms function as specified.
11.2 Pre Requisites
Incubator is installed and operational
11.3 Test Method

Carry out checks as detailed in result table 1 and record findings (including levels, limits and normal operating set
points).
11.4 Acceptance criteria
All functions must operate as specified and meet the criteria detailed in result table 1.
Environmental parameter operating and alarm limit set points must comply with the following:
Parameter Set Point Alarm Limit
Low Limit: 36oC
Temperature Level 37oC
High Limit: 38oC
CO2 Concentration 6% Low Limit: 5%
O2 Concentration 5% High Limit: 6%
Door open alarms must operate as specified.

Adjustments to environmental parameter operational set points must result in a corresponding response from the
incubator control system.
Environmental parameter alarms must trigger in accordance with the set points above.
11.5 Results
Table 1
Check Comment
Ensure all outer and inner doors operate as expected
Ensure ON/OFF switches function correctly
Record temperature set points (for both operating level Operating Set Point:
and the alarm limits) and also confirm these meet the Low Alarm Set Point:
acceptance criteria High Alarm Set Point:
Record CO2 set points (for both operating level and the Operating Set Point:
alarm limit) and also confirm these meet the acceptance
criteria Low Alarm Set Point:
Record O2 set points (for both operating level and the Operating Set Point:
alarm limit) and also confirm these meet the acceptance
criteria High Alarm Set Point:

Table 1
Check Comment
Hold door open to confirm the alarm activates and record
the delay time. Close door and confirm alarm de-
activates
Increase the temperature set point by 2oC. Confirm that
the incubator system responds to increase the
temperature and the alarm activates (visual and audible)
when temperature exceeds alarm high limit
Ensure temperature set point is returned to the original
value on completion and confirm alarm de-activates
Decrease the temperature set point by 2oC. Confirm
that the incubator system responds to decrease the
temperature and the alarm activates (visual and audible)
when temperature exceeds alarm low limit
Ensure temperature set point is returned to the original
value on completion and confirm alarm de-activates
Increase the CO2 set point by 1%. Confirm that the
incubator system responds to increase the CO2
concentration.
Ensure CO2 set point is returned to the original value on
completion and CO2 concentration also returns to within
limits
By opening the doors, allow the CO2 concentration to
decrease and confirm that the alarm activates (visual and
audible) when CO2 exceeds alarm low limit
Close doors and ensure CO2 concentration returns to
within limits and confirm alarm de-activates
By opening the doors, allow the O2 concentration to
increase and confirm that the alarm activates (visual and
audible) when O2 exceeds alarm high limit
Close doors and ensure O2 concentration returns to
within limits and confirm alarm de-activates
Decrease the O2 set point by 1%. Confirm that the
incubator system responds to decrease the O2
concentration.
Ensure O2 set point is returned to the original value on
completion and O2 concentration also returns to within
limits

11.6 Conclusion

12. TEMPERATURE MAPPING STUDY (OQ)
12.1 Objective
To verify that the incubator functions correctly in maintaining the correct temperature conditions throughout.
To determine how quickly temperature limits are exceeded when the door is opened or when there is a significant loss
of power, and how quickly temperature returns to within operating limits once the door is closed or and/or power
restored.
Note: By simulating a loaded incubator, this will provide data to support Performance Qualification requirements.
12.2 Pre Requisites
Incubator is filled with simulated product to represent a
typical full load
12.3 Test Method

Initial Setup
Set up a minimum of six (6) temperature datalogging sensors (with downloadable data functionality) and confirm an
accuracy of +/-0.5C. Record the details of the test instrumentation on the test instrumentation table below.
Place a minimum of three (3) of those sensors inside the incubator in free space making sure there is a good distribution
around the edges and in the middle. Identify high risk areas and ensure sensors are located in these areas. If possible
attach one of the sensors to the controlling probe.
Place a minimum of three (3) of those sensors in simulated product (media dishes) to monitor simulated product
temperature (where applicable).
Record the locations of each sensor in the sensor location table below.
List the quantity and type of simulated product in the incubator (where applicable).
Ensure the incubator temperature has stabilised to the required operating range of 37C 1C.
Set the sensors to record temperatures at one minute intervals.
Following completion of the three tests identified below, remove the sensors and perform calibration verification (if
applicable).
Append all raw data from the sensors suitably signed/dated to this protocol.
Note: The order of the tests below can be changed to suit individual test environments.
Door Open Simulation Test
Start the logging and allow all the sensors to stabilise.
Open the outer incubator door, including at least 3 inner doors (if fitted) for 3 minutes (to simulate worst case
conditions). Close the door and allow the temperature to recover to the set limits.
Record the lowest temperature measured during the door open test and the maximum time taken for all sensors to
recover to within the set limits.

Power Failure Simulation Test

Start the logging and allow all the sensors to stabilise.
Turn off the power and leave for 3 hours (to simulate worst case conditions). Re-instate the power supply and allow the
temperature to recover to the set limits.
Record the lowest temperature measured during the power failure simulation, the time taken for the first sensor to fall
outside the limit and the maximum time taken for all sensors to recover to within the set limits.
Mapping Study
Start the logging and allow the sensors to stabilise.
Leave the incubator on (with door closed throughout) for a minimum of a 12 hour period with the sensors monitoring as
programmed.
Record the highest and lowest temperatures measured during the study period.
Note: The above three tests should be carried out to provide data over at least a 24 hour period (in total).
During normal operation, all sensors are in the range 37C 1C.
Following the door open simulation test and once the door is closed, sensors recover efficiently to within the set limits.
Following the power failure simulation test and once the power has returned, sensors recover efficiently to within the
set limits.
Note: The effect on temperature of opening the door is for information only to determine recovery times. This
information may be used to determine standard operating procedures.
12.5 Test Instrumentation
Enter details of the test instrumentation (sensors) used in the table below and append calibration certificates to this
protocol
Test Instrument Serial Number Date Calibration Due

12.6 Sensor Locations

Enter details of the sensor locations in the table below.
Sensor Number Shelf Number Left/Centre/Right Front/Centre/Rear In Product (Y/N)
12.7 Simulated Product

List the type and quantity of simulated product items placed within the incubator during this mapping study.
Description Quantity

12.8 Results
Maximum Temp Drop Maximum Recovery Time

Door Open Simulation
(3 min)
C Sensor No. Minutes Sensor No.
Sensor (Free Space)
Sensor (Simulated Product)
Maximum Temp Drop Maximum Recovery Time

Power Failure Simulation
(3 hours)
C Sensor No. Minutes Sensor No.
Sensor (Free Space)
Time For First Sensor Out Of Limits

Power Failure Simulation
(3 hours)
Minutes Sensor No.
Sensor (Free Space)
Max Temp Min Temp

12 Hour Mapping Study
C Sensor No C Sensor No
Sensor (Free Space)
Incubator Set Point (C) Incubator Display (C)

(logged at start of test) (logged at start of test)

12.9 Conclusion

13. DETERMINATION OF CO2 CONCENTRATION (OQ)
13.1 Objective
To verify that the incubator control system is maintaining the internal environment gas concentration at 6% +/- 1% CO 2
during normal operation.
13.2 Pre Requisites
Incubator is running under normal operating conditions
with the CO2 control setting at 6%
13.3 Test Method

Enter details of the CO2 test instrumentation used in the test instrumentation table below.
Set the instrument up centrally inside the incubator chamber, allow the chamber to stabilise and record the CO 2
concentration within the chamber over a period of at least one minute.
Record the result in the table below.
Compare this value with the value shown on the incubator control system display indicator.
Samples taken during normal operation confirms the CO2 concentration to be within 6% 1%.
The results are in agreement with the incubator CO2 level display indicator.
Enter details of the test instrumentation used in the table below and append calibration certificates to this protocol
13.6 Results
Check Recorded Value Acceptance Criteria Pass/Fail/Comment
Incubator CO2 display value under normal
6% 1% maintained
conditions
CO2 concentration of samples taken under
6% 1%
normal conditions (range)

13.7 Conclusion

14. DETERMINATION OF O2 CONCENTRATION (OQ)
14.1 Objective
To verify that the incubator control system is maintaining the internal environment gas concentration at 5% +/- 1% O 2
during normal operation.
14.2 Pre Requisites
Incubator is running under normal operating conditions
with the O2 control setting at 5%
14.3 Test Method

Enter details of the O2 test instrumentation used in the test instrumentation table below.
Set the instrument up centrally inside the incubator chamber, allow the chamber to stabilise and record the O 2
concentration within the chamber over a period of at least one minute.
Record the result in the table below.
Compare this value with the value shown on the incubator control system display indicator.
Samples taken during normal operation confirms the O2 concentration to be within 5% 1%.
The results are in agreement with the incubator O2 level display indicator.
Enter details of the test instrumentation used in the table below and append calibration certificates to this protocol.
14.6 Results
Check Recorded Value Acceptance Criteria Pass/Fail/Comment
Incubator O2 display value under normal
5% 1% maintained
conditions
O2 concentration of samples taken under
5% 1%
normal conditions (range)

14.7 Conclusion

15. INTERNAL SOP AND TRAINING REVIEW (OQ)
15.1 Objective
To verify that appropriate Standard Operating Procedures (SOPs) have been identified to operate, clean and maintain
the incubator and these should be at least in draft format.
To confirm that a suitable level of training to operate, clean and maintain the incubator has been identified.
15.2 Pre Requisites
A system is in place to formally issue and control
operating procedures and instructions
There is a system for identifying and documenting
training
15.3 Test Method

Review operating procedure records to verify that SOPs have been identified for the operation, cleaning and
maintenance of the incubator and that it is available in at least a draft format.
Record the SOP reference numbers and titles in result table 1.
Review the training records to confirm that training has been identified to cover operation, cleaning and maintenance of
the incubator.
Record the training requirement including identification of personnel requiring training in result table 2.
There should be suitable SOPs available to operate, clean and maintain the incubator. A draft issue will be acceptable.
Any training requirements have been identified and have been performed or programmed.
15.5 Results
Table 1
SOP Reference Title / Description Pass / Fail
Table 2
Date
Personnel Identified Description Pass / Fail
Performed/Planned

15.6 Conclusion

16. SUMMARY OF TESTS PERFORMED
The following provides an outline summary of the test sections in this protocol.
Non
Check Pass / Pass with Comment / Fail
Conformance
Installation Check (IQ)
Commissioning Check (IQ)
Function & Alarm Checks (OQ)
Temperature Mapping Study (OQ)
Determination of CO2 Concentration (OQ)
Determination of O2 Concentration (OQ)
Internal SOP & training Review (OQ)

17. LIST OF APPENDICES
No Details
I Non Conformance Forms
II Test Instrumentation Calibration Certificates & Calibration Data
III Temperature Mapping Result Data
IV Additional Data

APPENDIX I
NON CONFORMANCE FORMS

Appendices
APPENDIX II
TEST INSTRUMENTATION CALIBRATION
CERTIFICATES & CALIBRATION DATA

Appendices
APPENDIX III
TEMPERATURE MAPPING RESULT DATA

Appendices
APPENDIX IV
ADDITIONAL DATA

Appendices

Installation / Operational Qualification Protocol Insert Incubator Name & I.D

Uploaded by

Document Information

Original Description:

Original Title

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

Installation / Operational Qualification Protocol Insert Incubator Name & I.D

Uploaded by

Copyright:

Available Formats

IOQ Centre logo can be inserted here

INSERT INCUBATOR NAME & I.D.

Document Reference: IOQ- Insert document reference and revision

1.1 Implementation approval

1.3 Final Approval

IOQ-insert doc reference and revision

2.1 Revision History

Populate A Draft issued for internal review

1 Issued for approval

IOQ-insert doc reference and revision

3. INTRODUCTION & SCOPE

This incubator is used for .

IOQ-insert doc reference and revision

IOQ-insert doc reference and revision

Must be rectified immediately.

6. PERSONS PERFORMING IOQ

IOQ-insert doc reference and revision

7. PRE-REQUISITES TO COMMENCE IQ SECTION

Installation is complete with incubator in final location

Incubator has been commissioned by the supplier and a

IOQ-insert doc reference and revision

8. INSTALLATION CHECK (IQ)

Incubator is installed and handed over for verification

8.3 Test Method

The incubator is uniquely identifiable

The incubator has been installed in the correct location

Any drawings supplied with the equipment are accurate

The specified services and utilities have been provided

Gas regulators and isolation valves are suitably rated

The supply filter (if required) has been fitted correctly

Record any details of computer hardware and software

Performed By: Date: IOQ-insert doc reference and revision

Pass Pass with comment Fail

Performed By: Date: IOQ-insert doc reference and revision

9. COMMISSIONING CHECK (IQ)

Commissioning report is available for review

9.3 Test Method

All the test instrumentation used has a current calibration

Temperatures have been independently verified

Gas concentrations have been independently verified

Alarms have been set, documented and verified

Performed By: Date: IOQ-insert doc reference and revision

Pass Pass with comment Fail

Performed By: Date: IOQ-insert doc reference and revision

10. PRE-REQUISITES TO COMMENCE OQ SECTION

Pre-Requisite Description Initials Comments

The IQ section of this protocol has been completed

No non conformances from the IQ section, categorised as

Performed By: Date: IOQ-insert doc reference and revision

11. FUNCTION & ALARM CHECKS (OQ)

Incubator is installed and operational

11.3 Test Method

CO2 Concentration 6% Low Limit: 5%

O2 Concentration 5% High Limit: 6%

Door open alarms must operate as specified.

Ensure all outer and inner doors operate as expected

Ensure ON/OFF switches function correctly

Performed By: Date: IOQ-insert doc reference and revision

Performed By: Date: IOQ-insert doc reference and revision

Pass Pass with comment Fail

Performed By: Date: IOQ-insert doc reference and revision

12. TEMPERATURE MAPPING STUDY (OQ)