Iq-Oq: Installation / Operational Qualification Protocol Muffle Furnace

IQ-OQ AURIK PHARMACEUTICALS
SUPPLIER: UNITED TECHNOLOGIES
INSTALLATION / OPERATIONAL
QUALIFICATION PROTOCOL
MUFFLE FURNACE
AURIK PHARMACEUTICALS
NATIONAL INDUSTRIALZONE RAWAT ISLAMABAD .
Document Reference: IOQ- AURK- 10-019

Issue Date: 22-10-2019
Document Author
Name Position Signature Date
FAWAD AHMED CALIBRATION ENGINEER
Approval
TAIMOOR ALI SERVICE MANAGER
DR KHALID QCM AURIK PHARMA

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.
DR.KHALID QCM
Comments
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
IOQ-insert doc reference and revision

Page 2 of insert total pages up to “list of appendices” page
10. PRE-REQUISITES TO COMMENCE OQ SECTION............................................................................................12

11. FUNCTION & ALARM CHECKS (OQ)................................................................................................................13
12. TEMPERATURE MAPPING STUDY (OQ)...........................................................................................................15
13. INTERNAL SOP AND TRAINING REVIEW (OQ)..............................................................................................20
14. SUMMARY OF TESTS PERFORMED..................................................................................................................22
15. list of Appendices.....................................................................................................................................................23
2. DOCUMENT CONTROL
2.1 Revision History

Date Issued Revision Reason for Issue
22-10-2019 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 refrigerator (detailed below) to confirm that it has been installed according to
the design intent and operates in accordance with the manufacturer’s specifications, drawings and other relevant design
documents.
The IOQ will cover the following refrigerator:
Equipment Name Make & Model Identification No. Location
MUFFLE FURNACE CHEMICAL LAB
FURNACE IS USED FOR HEATINGON HIGH TEMPERATURE

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

4. 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
FAWAD AHMED UNITED TECHNOLOGIES

5. PRE-REQUISITES TO COMMENCE IQ SECTION
Pre-Requisite Description Initials Comments
Installation is complete with FURNACE in final location
Furnace has been commissioned by the supplier and a

commissioning report is available for review

6. INSTALLATION CHECK (IQ)
6.1 Objective
To verify that the Furnace 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 Furnace.
6.2 Pre-Requisites
Furnace is installed and handed over for verification
6.3 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 refrigerator and complete the result table 2.
6.4 Acceptance Criteria
Operating & Maintenance manual must be available.
The installation checks identified in result table 2 must have been suitably addressed.
6.5 Results
Table 1
Document Title Reference / Issue Date Location
Table 2
Check Comment
The Furnace is uniquely identifiable
The Furnace 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
Record any details of computer hardware and software
e.g. type/ versions (if applicable)
IOQ-AURK-10-019UNITED TECHNOLOGIES
6.6 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
7. COMMISSIONING CHECK (IQ)
7.1 Objective
To verify that the refrigerator has been satisfactorily commissioned and a commissioning report has been provided by
the supplier.
7.2 Pre Requisites
Commissioning report is available for review
7.3 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.
7.5 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
Alarms have been set, documented and verified
7.6 Conclusion
8. 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
9. FUNCTION & ALARM CHECKS (OQ)
9.1 Objective
To verify that all Furnace components function correctly as specified for normal operation.
To verify that all alarms function as specified.
9.2 Pre Requisites
Furnace is installed and operational
9.3 Test Method

Carry out checks as detailed in result table 1 and record findings (including levels, limits and normal operating set
points).
9.4 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: +980oC
Temperature Level +1000oC
High Limit: +1020oC
Adjustments to environmental parameter operational set points must result in a corresponding response from the
Furnace control system.
Environmental parameter alarms must trigger in accordance with the set points above.
9.5 Results
Table 1
Check Comment
Ensure all 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:
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 ≥3oC. Confirm that
the Furnace system responds to increase the temperature
and the alarm activates (visual and audible) when
Table 1
Check Comment
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 ≥3oC. Confirm
that the Furnace 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
9.6 Conclusion
10. TEMPERATURE MAPPING STUDY (OQ)
10.1 Objective
To verify that the Furnace 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 refrigerator, this will provide data to support Performance Qualification requirements.
10.2 Pre Requisites
Furnace is filled with simulated product to represent a
typical full load
10.3 Test Method

Initial Setup
Set up a minimum of six (6) temperature datalogging sensors (with downloadable data functionality) and confirm an
accuracy of +/-5ºC. Record the details of the test instrumentation on the test instrumentation table below.
Place a minimum of three (3) of those sensors inside the refrigerator 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 refrigerator (where applicable).
Ensure the Furnace temperature has stabilised to the required operating range of 1000C ± 10C.
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 Furnace door, for 3 minutes (to simulate worst case conditions). Close the door and allow the temperature to
recover to the set limits.
Record the highest 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 highest temperature measured during the door open test, 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 Furnace 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 1000C ± 10C.
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.
10.5 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
10.6 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)
10.7 Simulated Product

List the type and quantity of simulated product items placed within the refrigerator during this mapping study.
Description Quantity
10.8 Results
Maximum Temp Rise Maximum Recovery Time

Door Open Simulation
(3 min)
C Sensor No. Minutes Sensor No.
Sensor (Free Space)
Sensor (Simulated Product)
Maximum Temp Rise 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)
Furnace Set Point (C) Furnace Display (C)

(logged at start of test) (logged at start of test)
10.9 Conclusion
11. INTERNAL SOP AND TRAINING REVIEW (OQ)
11.1 Objective
To verify that appropriate Standard Operating Procedures (SOP’s) have been identified to operate, clean and maintain
the refrigerator and these should be at least in draft format.
To confirm that a suitable level of training to operate, clean and maintain the Furnace has been identified.
11.2 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
11.3 Test Method

Review operating procedure records to verify that SOPs have been identified for the operation, cleaning and
maintenance of the refrigerator 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 refrigerator.
Record the training requirement including identification of personnel requiring training in result table 2.
There should be suitable SOP’s available to operate, clean and maintain the Furnace. A draft issue will be acceptable.
Any training requirements have been identified and have been performed or programmed.
11.5 Results
Table 1
SOP Reference Title / Description Pass / Fail
Table 2
Date
Personnel Identified Description Pass / Fail
Performed/Planned
Table 2
Date
Personnel Identified Description Pass / Fail
Performed/Planned
11.6 Conclusion
12. 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)
Internal SOP & training Review (OQ)
13. LIST OF APPENDICES
No Details
I Non Conformance Forms
II Test Instrumentation Calibration Certificates & Calibration Data
III Temperature Mapping Result Data
IV Additional Data

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IQ-OQ AURIK PHARMACEUTICALS

SUPPLIER: UNITED TECHNOLOGIES

Document Reference: IOQ- AURK- 10-019

FAWAD AHMED CALIBRATION ENGINEER

TAIMOOR ALI SERVICE MANAGER

DR KHALID QCM AURIK PHARMA

1.1 Implementation approval

IOQ-insert doc reference and revision

10. PRE-REQUISITES TO COMMENCE OQ SECTION............................................................................................12

2.1 Revision History

22-10-2019 A Draft issued for internal review

1 Issued for approval

IOQ-insert doc reference and revision

3. INTRODUCTION & SCOPE

MUFFLE FURNACE CHEMICAL LAB

FURNACE IS USED FOR HEATINGON HIGH TEMPERATURE

IOQ-insert doc reference and revision

4. PERSONS PERFORMING IOQ

FAWAD AHMED UNITED TECHNOLOGIES

IOQ-insert doc reference and revision

5. PRE-REQUISITES TO COMMENCE IQ SECTION

Pre-Requisite Description Initials Comments

Installation is complete with FURNACE in final location

Furnace has been commissioned by the supplier and a

IOQ-insert doc reference and revision

6. INSTALLATION CHECK (IQ)

Furnace is installed and handed over for verification

6.3 Test Method

The Furnace is uniquely identifiable

The Furnace has been installed in the correct location

Any drawings supplied with the equipment are accurate

The specified services and utilities have been provided

Pass Pass with comment Fail

7. COMMISSIONING CHECK (IQ)

Commissioning report is available for review

7.3 Test Method

All the test instrumentation used has a current calibration

Temperatures have been independently verified

Alarms have been set, documented and verified

Pass Pass with comment Fail

8. 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

9. FUNCTION & ALARM CHECKS (OQ)

Furnace is installed and operational

9.3 Test Method

Ensure all doors operate as expected

Ensure ON/OFF switches function correctly

Pass Pass with comment Fail

10. TEMPERATURE MAPPING STUDY (OQ)

10.3 Test Method

Power Failure Simulation Test

10.6 Sensor Locations

10.7 Simulated Product

Maximum Temp Rise Maximum Recovery Time

Sensor (Free Space)

Sensor (Simulated Product)

Maximum Temp Rise Maximum Recovery Time

Sensor (Free Space)

Sensor (Simulated Product)

Time For First Sensor Out Of Limits

Sensor (Free Space)