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Laminar Air Flow Operational Qualification

Laminar Air Flow Operational Qualification, Purpose

Laminar Air Flow Operational Qualification, To authenticate and document that the Laminar Air Flow Unit of Sterile production area of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) operates as designed and intended. The operational parameters should be consistent with the requirements for the manufacturing process.

Laminar Air Flow Operational Qualification, Scope

This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block. The scope will include the verification of previously calibrated instruments and the availability of operational, maintenance and cleaning procedures.

Responsibility

Preparation of protocol
-Engineering Department.
Executing the protocol
-Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
Providing documentation of the equipment
-Related departments i.e. Engineering Production, Validation or other appropriate departments and manufacturer.
Data documentation and preparation of the report
-Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and incorporation of data will be the responsibility of the Engineering Department.

Background

Project Description & Related issues
[][]This Laminar Air Flow Unit has been installed in the year 20xx in the sterile production area of Cephalosporin Block for dispensing of raw materials.

Purchasing Information

[][]Manufacturer: GUSU
[][]Local Agent: LS Techno Trade
[][]Model Number: GMP Standard

System Description

[][]A Laminar Air Flow Unit is used to provide unidirectional air flow. Grade A is ensured under LAF using H14 HEPA filter.

[][]A blower is used to circulate the air. The air flow direction of this LAF is vertical.

[][]There is a differential pressure gauge to see the differential pressure across the filters which indicate the blockage of filters.

Verification of Sops

[][]The standard operating procedure for operation and cleaning procedure of Laminar Air Flow Unit must be at least in draft format before commencement of OQ. The necessary information are recorded in the following table:

Sl. No.	SOP Name	Effective Date	Acceptable (Yes/ No)	Initials with date
01	Operation and Cleaning of Laminar Air Flow Unit.
02

Verification of Training

Training should have been given regarding operation, maintenance and cleaning of Laminar Air Flow Unit to all operators and must be documented.
The documentation status is to be recorded in the following tables.
The training is to be recorded in the following tables.

Trainer Name	Training course/SOP Name	Trainee Name	Initials	Date

Operational testing

Verification of start-up and normal sequence of operation
Record results of checks in the following table:

Criterion No.	Action to be taken	Acceptance Criteria
01	Switch ON the main power.	The voltage will be shown on the display.
02	Switch ON the blower by pressing the ON button.	The blower has to be ON and air will start flowing vertically.
03	Differential Pressure gauge for HEPA Filter is functioning properly.	The differential pressure gauge should show pressure from zero to positive direction.

Smoke Test

Purpose: The purpose of the smoke test is to justify the airflow direction under the HEPA Filter is unidirectional.
Test Method:
The smoke test will be performed by ______________________ According to the SOP No. _____________________________.
Test Equipment/Material: Dry Ice and water.
Acceptance Criteria: Airflow direction is unidirectional and vertical. Attach a copy of the report of Smoke test.

Filter Integrity Test

Purpose: Filter Integrity test is performed using Poly Alpha Olephin (PAO) to check any leakage of the filter.
Test Method: The test is performed by ____________________ according to the SOP NO. ______________________________.
Test Equipment: PAO generator, Optical Photometer.
Acceptance Criteria: Any leakage greater than 0.01% of the upstream challenge aerosol concentration is considered unacceptable and wants repairs and resetting.
Attach a copy of HEPA filter integrity test certificate in attachment.

Air Velocity Test

Purpose: The purpose of this test is to ensure the air velocity for laminar flow.

Test Method:
Measure the air velocity under each HEPA filter of the equipment at the distance of 6” below the filter grill and record the velocity at 5 locations (Shown in following figure) and take the average reading with the anemometer.
Measure the air velocity under each HEPA filter of the equipment at the operation level and record the velocity at 5 locations (Shown in following figure) and take the average reading with the anemometer.
Test Equipment: Calibrated anemometer.
Acceptance Criteria: Measured air velocity should be in the range of 0.36 m/sec ~ 0.54 m/sec.
Result:

No. 1 HEPA

No. 2 HEPA result shall be plotted.

Conclusion

[][]The Operational Qualification of Laminar Air Flow Unit of Cephalosporin Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained have been filled up in the respective table of each test.
[][]The Laminar Air Flow Unit of Cephalosporin Block is / is not qualifying the Operational Qualification test as per this Protocol. Hence, the system can be / cannot be used for Performance Qualification.

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Laminar Air Flow Operational Qualification

HVAC Operational Qualification

Operational Qualification, Performance Qualification Protocol

HVAC Operational Qualification, Purpose

HVAC Operational Qualification, To authenticate and document that the HVAC system of Sterile Production area of Cephalosporin Block of XX Pharmaceuticals Limited operates as per requirements and all the parameters of HVAC system meet the acceptance criteria of XX and manufacturer specifications.

HVAC Operational Qualification, Scope

This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the HVAC systems, comprising of Air Handling Units, Distribution / Return Ductworks, Chiller, Chilled Water Piping, Pumps, Control System etc. installed in the Cephalosporin Block of XX to serve the Sterile Production area of Cephalosporin Block.

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Responsibilities

[][]Protocol Preparation
[][]Validation (Engineering) Department of XX
[][]Protocol Execution
[][]Validation Team of XPL or other suitably qualified third party.
[][]Providing documentation on the equipment
[][]Related departments i.e. Engineering, Production, Validation, Microbiology department of PPL or other third party.
[][]Data documentation and preparation of the report
[][]Validation (Engineering) Department of PPL.

Project Description & Related issues

[][]The rooms of Sterile Production area have been classified as EU Class C and Class B. The air is supplied to the rooms of Class C area by AHU 2C.CE through three stages filtration by pre filter (G4), intermediate filter (F7 and F9) and finally HEPA (H14) filters.
[][]Furthermore, AHU 3B.CE supplies air to the class B area through 3 stages filtration such as pre filter (G4), intermediate filter (F7) and terminal filter (U15).

Operational Testing

Air flow verification

Test Method:
[][]Measure the supply air flow rate by using a flow hood. Assemble the flow-hood by firmly covering the whole supply diffusers. Open the flap of flow hood and switch on to get the readings of air flow.
[][]Set the flow-hood firmly to prevent air leakage over each individual supply air diffusers, HEPA filter and record the reading of the air flow volume in the result sheet.
Record the result in Appendix 1.

Acceptance Criteria:

[][]The air flow should be balanced throughout the area in such a way that it will produce an air volume not less than 10.00% of the design specification at each terminal.
[][]In some cases, exact air volume may be accepted at values lower or higher than 10.00% of design in order to meet room pressure requirements. Where the value is lower than the design, the value must be explained and justified.

Room Differential Pressure

Test Method:

[][]Prior to performing the test, verify that the design airflow volume tests have been carried out. HVAC system of the entire facility must be in continuous operation while performing this test.

[][]To avoid unexpected changes in pressure and to establish a baseline, all doors in the facility must be closed and no traffic is to be allowed through the facility during the test.

[][]Record the differential pressure from the calibrated magnehelic pressure gauge in the result sheet twice a day at rest and in operation conditions for three consecutive working days at each condition.
[][]Record the result in Appendix – 2.

Acceptance Criteria:

The acceptance criteria of differential pressure for each room have been stated in Appendix – 2.

Air change rate

Test Method:

[][]Measure the internal dimensions of each room and calculate the room volume.

[][]Calculate the total air supply to each room by summing the air supply from the individually measured HEPA filters or diffusers in above.

[][]Then calculate the number of air changes per hour for each room using the following formula:

=>Air change rate = Total measured room supply (m3/h)/ Measured room volume (m3)

Record the results in the result sheet in Appendix 3.

Acceptance Criteria:

[][]With reference to the previous section of ISPE Baseline Guide: Sterile Manufacturing Facilities the Air Change rate in all Classified area must be minimum 20.

Temperature and relative humidity

Test Method:

[][]Verify completion of HVAC system testing, adjusting and balancing work prior to performing these tests.

[][]Place calibrated thermometer/sensor and humidity device/sensor at the Return Air Grill.

[][]Allow time for the sensors to stabilize sufficiently for accurate readings.
[][]Measure the temperature and relative humidity at each processing room, twice a day under ‘at rest and in operation’ conditions for three consecutive working days each. Record the results in Appendix 4 and 5.

Acceptance Criteria:

[][]Temperature: 22deg.C±2deg.C for SPR058, SPR058, SPR066, SPR079 and NMT 25deg.C for other rooms in B area.
[][]NMT 25deg.C for C area.
[][]Relative Humidity (RH): NMT 30% for SPR058, SPR058, SPR066, SPR079 and NMT 55% for other rooms in B area.
[][]There is no limit of RH (%) in Grade C area as there will be no handling of Raw materials.

Particle count test

Test Method:

[][]Measure the particle count according to the procedure described in SOP and the printed data are attached with the report.
[][]Using the particle analyzer, count particles greater than or equal to 0.5 micron and also 5 micron in diameter at 1 m height at predefined number of positions in each room.
[][]The test will be performed for both at rest and at operation conditions and for three consecutive working days at each condition.
[][]The report is given from the Microbiology department which will be attached with the report.

Microbial count test:

Test method:

[][]Air borne microbial test is to be done according to the procedure described in SOP and the data are attached with the report.
[][]The test will be performed at rest and in operation conditions for three consecutive working days at each condition.
[][]All the results must be recorded on the appropriate forms of monitoring methodology.
[][]The limits of sterile and non sterile applications are recorded below.
[][]The report will be provided from the Microbiology department which will be attached with the report.

Clean up time or Recovery Test

Test Method:

[][]The recovery test is performed by………………according to the SOP No. …………. The results are recorded in Appendix – 6. The test will be performed only for the rooms where HEPA filter is installed in the supply terminal.

Acceptance Criteria:

[][]Clean up time will NMT 20 minutes. The “clean up” or “recovery” test should demonstrate a change in particle concentration by a factor of 100 within the specified time (according to ISO 14644-3 clause B.12).

Filter Integrity Test

Test Method:

[][]The test will be performed by……………………………..according to the SOP No. …………………………………..The copy of the test report is attached with the report.

Acceptance Criteria:

[][]Any leakage greater than 0.01% for H14 respectively of the upstream challenge aerosol concentration is considered unacceptable. HEPA Filter test report to be recorded in the Attachment.

Smoke test

Test Method:

=>The test will be performed by _______________________ according to the SOP No. ________________.

Acceptance Criteria:

[][]All the processing rooms are at positive pressure with respect to the adjacent corridor.

[][]Furthermore, in case of any two adjacent rooms of different classified areas, the higher classified area will be at positive pressure.

[][]So, the smoke will flow from positive to negative areas.

Instrument Calibration

=>The necessary instruments to complete the OQ of HVAC system of Sterile Production area of Cephalosporin Block is listed below:

Sl. No.	Instrument Type	ID No.
01	Thermo hygrometer	CC-000-000-TMH-001
02	Differential Pressure Probe	CC-000-000-PID-001 with B1
03	Aerosol Photometer

Deviation And Failure Investigation Summary

=>Record in the column below any deviations or failures that occurred during the OQ exercise.

Report Summary

=>The report summary of Operational Qualification of HVAC system of Sterile Production area of Cephalosporin Block Is as found.

Conclusion

[][]All / Some testing parameters of the Operational Qualification of HVAC system of Sterile Production area of Cephalosporin Block Comply / Do Not Comply with the acceptance criteria and the results obtained are attached with the protocol.
[][]The HVAC system of Sterile Production area of Cephalosporin Block is / is not qualifying the Operational Qualification test as per this protocol after proper justification of the deviation (if found). Hence, the system can be / cannot be used for production operation.

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HVAC Operational Qualification Protocol

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