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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
PERFORMANCE QUALIFICATION PROTOCOL FOR BREATHING AIR SYSTEM
Revision Index Revision No. 00
O-QA008/F01-00
Date
CRN No. NA
Reason for revision New Document
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
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
Qualification Test Program and frequency:______________________________6
7.0
Qualification Test Procedure_________________________________________6
8.0
Records of Observations____________________________________________9
9.0
Re Qualification____________________________________________________9
10.0
Discrepancy and Corrective Action Report_____________________________10
11.0
Compilation, Review and Summary Report_____________________________10
12.0
Appendix_________________________________________________________10
13.0
Enclosure________________________________________________________11
O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
1.0 Protocol Approval 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 Production
Quality Assurance
Micro Biology Approved by Quality Assurance
O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
2.0 Objective The purpose of this protocol is to provide the procedure for the performance qualification of the BREATHING AIR SYSTEM.
To provide documented evidence that the system is capable to continuously supply the clean Breathing air with the specified quality attributes thereby establishing its dependability.
To prove the adequacy of the engineering design of the BREATHING AIR SYSTEMand the effectiveness of the operating control and maintenance procedures.
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.
To prove the adequacy of the engineering design of the system and the effectiveness of the operating control and maintenance procedures.
3.0 Scope This protocol covers all aspects of Performance Qualification for the Breathing air distribution System oncology formulation facility of Hetero labs Ltd, Jadcherla. This protocol will define the methods and documentation used to qualify the Breathing air Distribution System for PQ. 4.0 Equipment Description Department Name of the Supplier / Manufacturer Capacity
Engineering
Location
Utility
O-QA008/F01-00
M/s. Aswin Micro Filtration Pvt. Ltd. 1000 liters
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
4.1
Breathing Air filtration process Compressed air
3µ filter
Distribution line
1µ filter
1µ filter
0.1µ filter
Storage tank
CO filter
Carbon filter
CO2 filter
4.2
The breathing air system consists of filters for moisture, particle removal, Co2 & Co removal before storage air in the vertical receiver. An additional final filtration provided enables the system to deliver pure air for breathing. Filter elements with filter housing made of SS 316L with 11/2” tri clover connection.
4.3
Vertical air receiver of capacity 1000L made of SS316 is provided with safety valve and drain valve and pressure gauge
4.4
Pure air is distributed through pipelines to various identified areas and is installed with pressure regulators, pressure gauges and quick couplers at relevant points.
5.0 Responsibilities and Identification of Execution Team 5.1
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
Production
Checking of PQ protocol and Report Providing necessary support wherever required in execution
Quality control
Checking of PQ protocol and Report Performing air sampling Preparation of Analysis Report and submission to Quality Assurance
Engineering / Projects O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
5.2
Checking of PQ protocol and Report Preventive Maintenance of breathing air Systems per schedule Calibration of all measuring / test instruments Rectification of Breakdown during qualification study
Identification of Execution Team: All the identified executors involved with this protocol are to record name, designation, signature and date. Verify the training details in the respective procedures involved in the protocol. Record the observation in the data sheet attached as Annexure-1
6.0 Qualification Test Program and frequency: 6.1
Following test procedures are followed to qualify the equipment for its operation. S.No 1.
6.2
TEST PARAMETER Oxygen concentration
REVALIDATIO N TEST TIME FREQUENCY
SUGGESTED MAXIMUM TIME INTERVAL
12 months
NMT 15 Days
2.
Oil Mist
3 months
NMT 1 Week
3.
Carbon Dioxide Con.
12 months
NMT 15 Days
4.
Carbon Monoxide Conc.
12 months
NMT 15 Days
These test perform only core areas
7.0 Qualification Test Procedure 7.1
OIL MIST Objective: The Objective of this test is to determine the amount of oil mist content present in the Breathing air line. Equipments Used: Gastec Detector tube Gastec Detector tube method 1. Flush the Breathing air from the user point for 2 minutes, before sampling. 2. Make it assembled the air test kit. 3. Break tips off a fresh detector tube by using the tube tip breaker of the pump. 4. Inset the tube in to the pump inlet with arrow → on the tube pointing toward pump. 5. Read the concentration level at the interface where the stained reagent meets the unstained reagent.
O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
6. For oil mist follow the parameters as mentioned below (109AD): Measuring Range Sampling Volume Sampling rate Sampling Time Colour Change Reaction Principle
0.2 – 5.0 mg/ m3 20000 ml 1 Liter per minute 20 minutes Pale red → Pale Blue Oil Mist + Cr6+ → Cr3+
7. Coefficient of Variation: 15 % (for 0.2 to 1.0 mg/ m3), 10 % (for 1.0 to 5.0 mg/ m3) 8. As soon as the sampling time has finished, turn off the cylinder or compressor, and remove tube from the tube holder and then read the colour changed layer immediately. 9. If necessary, multiply the readings by the correction factors of the pump strokes and atmospheric pressure respectively To correct for pressure, use the formula below Tube reading (ppm) x 1013 (hPa) Atmospheric Pressure (hPa) 10. Sample volume exceeds the prescribed volume compensate the tube reading with the following formula 11.
True Concentration(mg/m3)=Tube Volume (ml)]
Reading
(mg/m3)x[20000(ml)/Sample
Acceptance Criteria: As per BP - Less than 0.10 mg/m3 As per EP - Less than 0.10 mg/m3 As per ISO 8573-1:2010 (Class – II) Less than 0.1 mg/m3 REFERENCES ISO-8573-1:2010 (Class-II), EUROPEAN PHARMACOPOEIA, BRITISH PHARMACOPOEIA 7.2
CARBON DIOXIDE CON (CO 2). Objective: The Objective of this test is to determine the amount of carbon dioxide content detection in the Breathing line.
O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
Equipments Used: Gastec Detector tube Gastec Detector tube method 1. Flush the Breathing air from the user point for 2 minutes, before sampling. 2. Make it assembled the air test kit. 3. Break tips off a fresh detector tube in the tube tip breaker of the pump. 4. Inset the tube in to the pump inlet with arrow → on the tube pointing toward pump. 5. Read the concentration level at the interface where the stained reagent meets the unstained reagent. 6. For Carbon Dioxide follow the parameters as mentioned below (Lot No.2LC ) Measuring Range 100 – 2000 ppm Number of pump stroke 1(100 ml for two minutes ) Stroke correction factor 1 Sampling Time 2 minutes Detecting Limit 20 ppm ( N=1) Colour Change Pale red → Yellow Reaction Principle CO2 + 2K0H+ → K2C003+H20 7. Coefficient of Variation: 150 % (for 100 to 600 ppm), 5% (for 600 to 2000 ppm) 8. If necessary, multiply the readings by the correction factors of the pump strokes and atmospheric pressure respectively 9. To correct for pressure, use the formula below Tube reading (ppm) x 1013 (hPa) Atmospheric Pressure (hPa) 10. As soon as the sampling time has finished, turn off the cylinder or compressor, and remove tube from the tube holder and then read the colour changed layer immediately. Acceptance Criteria: As per BP – Maximum 500ppm V/V As per EP - Maximum 500ppm V/V 7.3
CARBON MONOXIDE AND OXYGEN CONCENTRATION Objective: The Objective of this test is to determine the amount of O2 and CO gas concentration level present in the Breathing air line. Equipments Used: RAE Instruments
O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
Procedure: 1. Flush the Breathing air from the user point for 2 minutes, before sampling. 2. The gas is sampled through the probe with a primary pump powered at constant voltage. 3. The zero drift is automatically corrected by the instrument every time it is switched ON using fresh air as reference. 4. When analysis takes more time, a new auto zero procedure should be performed. 5. The measured and calculated parameters are indicated on a LCD alphanumeric display equipped with automatic back light device for easy readings. Gas Sensors: The analyzer uses long life sensors for O2 and CO measurements. The gas sensors are electrochemical cells composed by two electrodes (anode and cathode) and an electrolyte solution. The sampled gas goes through a selective diffusion membrane. The oxidation process produces an output electrical signal proportional to the gas concentration. The signal is evaluated by the electronics, converted to digital, processed by the microprocessor, displayed and printed with a 0.1 % volume resolution. Acceptance Criteria: 1. O2 concentration present per cubic meter of Breathing air should be > 20.4 % a 2. CO shall not be more than 5 ppm Reff: EUROPEAN PHARMACOPOEIA, IS 8.0 Records of Observations 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” 9.0 Re Qualification Performance Qualification of BREATHING AIR SYSTEMfor the tests mentioned above in test matrix of this protocol shall be followed. The qualification should also be performed additionally in case of following o Any major modification in equipment after the last performance qualification. This must be properly documented through a change control system. O-QA008/F01-00
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
o
Adjustments made in the instruments, to correct the non-compliance of operational parameters with respect to specifications.
10.0Discrepancy and Corrective Action Report Document any discrepancies observed during the qualification of the Equipment in the annexure. Include the corrective actions of the same. When all the 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. 11.0Compilation, 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. 12.0Appendix 12.1 Abbreviations and Definitions ABBREVIATION CFU PQ LPM ml m3 Mg SOP No. ppm URS CFM °C
O-QA008/F01-00
FULL FORM Colony Forming Unit Performance qualification Litter per minutes Millilitre Meter cube Mille gram Standard Operating Procedure Number Parts per million User requirement Specification Cubic feet per minutes Degree Centigrade
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Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name : BREATHING AIR SYSTEM Equipment Number : O-ENE-011
Facility : Oncology Formulation Facility
Protocol Number : VPO-EN011-00
Effective date :
12.2 References SOP No. : O-QA008 (Installation, Operational and Performance Qualification of Equipment / Instrument) 13.0Enclosure Annexure No. 1
Identification of the Executors
2
Breathing air sampling locations
3
Observation record of Oil mist and Carbon dioxide concentration Record Observation of Carbon Monoxide and Oxygen Concentration Discrepancy and Corrective Action
4 5
O-QA008/F01-00
Description
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