1.0 PURPOSE

The purpose of Performance Re-qualification is to confirm through the provision of objective evidence, that the performance requirements for the Compressed Air System with equipment ID.: XXXXXXXXXXX meet its intended use. 

2.0   SCOPE

The preparation of RQ applies to the Compressed Air System installed in Utility area having equipment ID.: XXXXXXXXX.

5.0   REASON FOR PERFORMANCE QUALIFICATION

The reason for preparing this document is:

Please click any one (or multiple) option(s) from the following                   

Purchase Utility Systems                                                                           

Purchase of equipment/utilities/system                                                      

Modification of equipment/utilities/system                                                

Change in location equipment/utilities/system                                           

Other (Specify) _____________________________________________ 

TEST MATRIX FOR PERFORMANCE REQUALIFICATION AND ITS ACCEPTANCE CRITERIA

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1.0 STUDY OVERVIEW

Air flow visualization studies are intended to demonstrate visual evidence of air flow direction. This test helps to identify stagnant areas within a clean room; these areas can further act as a channel or reservoir of contaminants. The test can also be used to demonstrate the effects on airflow caused by equipment.

2.0 STUDY OBJECTIVE

To provide documented evidence that air flows in critical zones under dynamic conditions does not cause any turbulence and stagnant air which will be act as a channel or reservoir for the accumulation of air borne contaminants.

3.0 STUDY PURPOSE

The purpose of this protocol is to describe the procedure and plans, also help to operating personal to demonstrates the air flow pattern test to verify and record during operation as follows

• The air flow pattern from terminal HEPA filters.
• The air flow from Laminar Air Flow Units HEPA filters (Under dynamic conditions)
• The direction of air flow from  high pressure room to adjacent low pressure room (Under Dynamic condition)
• The direction of air flow from terminal HEPA filter and Laminar air flow units, when sterilized part transfer from autoclave to machine setup area
• The direction of air flow from the terminal HEPA filter and Laminar air flow units during machine setup, connecting tube setup and API canister set up area

4.0 PROCEDURE TO CHECK THE AIR FLOW PATTERN OF TERMINAL HEPA FILTER & LAF UNITS.

• Ensure that AHU/LAF units is “ON”
• Start video recording
• Record the filter I.D. no. clearly
• Keep the smoke generator discharge Nozzles perpendicular and below the terminal HEPAs filters at a distance of 6" or 152 mm or at various heights as necessary to demonstrate unidirectional airflow patterns from supply air (terminal HEPA filter) through critical height and to low wall returns riser filters.
• Record the airflow pattern to capture the direction of air from terminal HEPA filter towards the return risers.
• Record the airflow pattern to capture the direction of air from room to the return risers.
• Place the smoke generator discharge Nozzles near the cutouts to demonstrate the flow of air from high pressure zone to low pressure zone.
• Place the smoke generator discharge Nozzles near the slightly opened door and demonstrate the flow of air from high pressure zone to low pressure zone
• Record the airflow pattern to capture the direction of air from high pressure zone to low pressure zone.
• To perform the air flow visualization during the dynamic condition, transfer the machine parts as per SOP “Procedure for Vial Filling Machine Setup.

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1.0 PURPOSE

The purpose of Performance Requalification is to confirm through the provision of objective evidence, that the performance requirements for the Heating Ventilated and Air Conditioning System meet its intended use. 

2.0 SCOPE

The preparation of RQ applies to the applicable Heating Ventilated and Air Conditioning System which includes air handling unit, ventilation system and exhaust system.

This RQ protocol is prepared as common protocol for all types of heating ventilation and air conditioning systems to be qualified, however content of the protocol shall be verified for compliance as per the design before execution.

6.0 PROCEDURE FOR PERFORMANCE REQUALIFICATION

All tests in rest condition shall be carried out, includes Air flow velocity, ACPH, Filter system integrity for one day, -NVPC, and viable count monitoring at rest condition only.

6.1 AIR FLOW VELOCITY:

6.1.1 Purpose: This test is to measure airflow velocity and uniformity, and supply airflow rates in rooms and zones.

6.1.2 Scope: This test is applicable to the all-terminal filters/supply grills of the each room/area catered by AHU.

6.1.3 Methodology/sampling

• Equipment: “Hot Wire Anemometer” or “Vane type anemometer”.

• Ensure that the instrument used is within the valid calibration period. In the event of a contractor carrying out the test then the certificate of calibration should be obtained from the contractor before the test is performed.

  • Identify the terminal HEPA filters as per the location mentioned in the layout diagram for the specified HVAC system or area.

  • Switch “ON” the instrument. The battery level should be checked before starting the activity. Keep the instrument in meter/second or Ft/Min. measuring mode.

  • It is recommended to remove the filter grill to ensure that the airflow remains unobstructed in any manner that would significantly affect test results.

  • Measure the air flow velocity by placing the anemometer sensor 150 to 300 mm below from the filter face.

  • Hold the anemometer probe surface perpendicular to the airflow.   

  • Ensure that, there should not be any disturbance between the filter face and the anemometer.

  • Each measurement to be taken for at least 10 seconds duration or until a constant reading is displayed.

  • Record the observed values in Air velocity/Air volume measurement report.​

6.1.4 Acceptance Criteria:

• When the air velocity is measured with anemometer,

• The air velocity measured shall not be less than the required/designed air changes when calculated for air changes requirement for respective room.

6.2 AIR EXCHANGE RATE (AIR CHANGES PER HOUR):     

6.2.1 Purpose: The measurement of air exchange rate is carried out to ascertain the air volume supplied to the clean room per hour, and to ensure sufficient quantity of fresh air enters in each room.

6.2.2 Scope: This test is applicable to the each room/area catered by AHU.

6.2.3 Methodology/sampling

• Use validates excel sheet for the calculation of air exchange rate/air changes per hour.

• Obtain the details of the room/area volume from basic of design/DQ and effective filter area from installation qualification.

• Enter the raw data of the air velocity observed from “AIRFLOW VELOCITY/AIR VOLUME MEASUREMENT REPORT” of each filter/supply grill, room volume, filter area and required air changes for in the validated excel sheet.

• The excel sheet will calculate average air velocity, Total CFM and Total air change per hour.

• The excel sheet will calculate the average air velocity, Total CFM and Total air change per hour as per below procedure

Total average air velocity= Sum of each location/number of locations

    Total CFM = Average velocity of filter in ft/min x Filter effective area in ft². 

Or

Total CMH = Average velocity of filter in m/s x Filter effective area in M² x 3600 

Calculate the total room CFM or CMH if the number of filter is more than one in a room by adding the total CFM or CMH of individual filter. 

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1.0 PURPOSE

The purpose of Performance Requalification is to confirm through the provision of objective evidence, that the performance requirements for the Laminar Air Flow meet its intended use. 

2.0 SCOPE

The preparation of RQ applies to the applicable Laminar Air Flow installed in the microbiology testing lab.

6.0 PROCEDURE FOR PERFORMANCE REQUALIFICATION

6.1 Air Velocity Test

6.1.1 Objective:

• To ensure LAF meets velocity as per standard as per standard ISO-14644.

6.1.2 Test Instrument:

•  Anemometer.

6.1.3 Procedure:

• Ensure that the testing instrument is within the calibrated status and calibrated report shall be attached along with summary report.

• The anemometer shall be switch ON and allow some time for stabilization.

• The anemometer shall be kept in FPM mode.

• The probe pointing shall be position toward airflow and measuring shall be taken at a distance of 150 mm from the face of filter.

• Measurement time shall be minimum 10 second duration at each location.

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1.0 PURPOSE

The purpose of Performance Requalification is to confirm through the provision of objective evidence, that the performance requirements for the Dynamic Pass Boxes meet its intended use. 

2.0 SCOPE

The preparation of RQ applies to the applicable Dynamic Pass Boxes installed in the Store, Production and Quality Control lab.

6.0 PROCEDURE FOR PERFORMANCE REQUALIFICATION

6.1 Air Velocity Test

6.1.1 Objective:

• To ensure DPB meets velocity as per standard as per standard ISO-14644.

6.1.2 Test Instrument:

•  Anemometer.

6.1.3 Procedure:

• Ensure that the testing instrument is within the calibrated status and calibrated report shall be attached along with summary report.
• The anemometer shall be switch ON and allow some time for stabilization.
• The anemometer shall be kept in FPM mode.
• The probe pointing shall be position toward airflow and measuring shall be taken at a distance of 150 mm from the face of filter.
• Measurement time shall be minimum 10 second duration at each location.

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1.0 PURPOSE

The purpose of Performance Requalification is to confirm through the provision of objective evidence, that the performance requirements for the Reverse Laminar Air Flow meet its intended use. 

2.0 SCOPE

The preparation of RQ applies to the applicable Reverse Laminar Air Flow installed in the Warehouse dispensing area.

5.0 SUMMARY OF TEST PERFORMANCE, ITS RATIONALE AND ACCEPTANCE CRITERIA

7.0 PROCEDURE FOR PERFORMANCE REQUALIFICATION

7.1 Air Velocity Test

7.1.1 Objective:

• To ensure RLAF meets velocity as per standard as per standard ISO-14644.

7.1.2         Test Instrument:

•  Anemometer.

7.1.3        Procedure:

• Ensure that the testing instrument is within the calibrated status and calibrated report shall be attached along with summary report.

• The anemometer shall be switch ON and allow some time for stabilization.

• The anemometer shall be kept in FPM mode.

• The probe pointing shall be position toward airflow and measuring shall be taken at a distance of 150 mm from the face of filter.

• Measurement time shall be minimum 10 second duration at each location

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1.0 PURPOSE

The purpose of this protocol is to provide documented procedure to establish that the facility is suitable for intended purpose and meets its pre-determined specification and the facility is in accordance with the principles of current Good Manufacturing Practices.

The protocol also intends to provide procedure and acceptance criteria for various test(s) to be performed for facility qualification so that facility at routine operation complies with the requirement of process, GMP and EHS.

Successful execution of this protocol and successive report compilation shall provide sufficient data to establish that the facility is qualified.                                                  

2.0 SCOPE:

The facility qualification document is applicable for the Site (Name of Facility/Block).

8.0 QUALIFICATION MATRIX

• Verification of Layout
• Room Data Sheet
• Verification of Facility Construction and Finishing 
• Verification of Installation of Utilities

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1.0 PURPOSE

The purpose of this protocol is to establish a standardized procedure for testing the HVAC duct to ensure compliance with industry standards, regulatory requirements, and to maintain optimal system performance. 

This protocol provide the method of testing to determine the air-leakage rate of HVAC ducts, prior to field installation.

2.0 SCOPE

This protocol applies to all HVAC/AHU/DHU systems within the [facility/company] and encompasses the testing of ductwork for air leakage.

7.0 OVERVIEW

The duct leakage test aims to verify compliance with established duct construction and installation standards. The design drawings indicate crucial details such as duct size, location, and permissible fittings. The test specifically focuses on pressure classifications, ensuring ducts adhere to those outlined in the contract drawings. In cases where designations are absent, compliance defaults to a 1" water gage pressure class. The sealing requirements emphasize the use of various methods, such as adhesives, gaskets, tape systems, or continuous welds, with considerations for pressure class, positive/negative pressure, and specific exclusions. For acceptance, the duct systems must meet specified pressure classifications, and sealing methods should align with prescribed standards. Field testing is recommended for systems constructed to 4" w.g. class and higher, ensuring accuracy in flow measurements and overall system performance. Contractors bear the responsibility of selecting appropriate sealing methods in line with design specifications to achieve effective and lasting performance.

General Requirements for Duct Leak Test

Design Drawings: Project drawings by designers indicate duct size, location, permissible fittings, and configurations, including those not explicitly illustrated but conforming to specified friction loss coefficients.

Duct Pressure Classifications and Pressure Class Compliance: Duct systems shall adhere to specific pressure classifications mentioned in contract drawings. The absence of designations defaults compliance to 1" water gage pressure class, with exceptions for variable volume ducts.

Duct Sealing Requirements

Sealing Standards: Ducts shall be sealed according to Table 1, specifying the use of adhesives, gaskets, tape systems, or continuous welds to prevent air leakage.

Sealing Criteria: Sealing methods consider pressure class, positive/negative pressure, chemical compatibility, movement of parts, workmanship, and surface conditions.

Airtightness: Emphasizes the necessity of adequate airtightness for system performance, considering factors like energy conservation, humidity control, and room air movement.

Leakage Tests: Recommends field testing for duct systems constructed to 4" w.g. class and higher, with specific criteria and considerations for accurate measurements.

Sealant Types: Use appropriate sealant, including liquids, mastics, gaskets, tapes, and heat-applied materials, with considerations for shelf life, surface preparation, and safety.

Table-I

10.0 INSTRUCTION FOR TEST APPARATUS FOR DUCT LEAKAGE TEST:

10.1 Test Apparatus Overview:

a) The test apparatus for the duct leakage test shall comprise: - Airflow measuring device - Flow producing unit - Pressure indicating devices - Accessories necessary to connect the metering system to the test specimen.

10.2 Accuracy and Calibration:

a) The test apparatus shall be accurate within ±7.5% at the indicated flow rate and test pressure.

b) Calibration data or a certificate signifying conformance with ASME Requirements for Fluid Meters is required, except for ASME qualified orifice meters, which do not require calibration.

10.2 Usage Guidelines:

a) The test apparatus shall be used as outlined in this section, following the guidelines in procedure , and adhering to recommended good practices.

10.3 Orifice Meters Construction Example:

a) Example:- Figures 2 illustrate typical construction. use of orifice meters and orifice selections.

• Orifice Meter-------------- 3inch. Tube connected with Flanges.

• Orifice Plates Thickness (Steel)------------ 1/8” or 3.175mm.

• Orifice Size –Square Edged – 2.1” (53.34mm)

• Orifice Opening is centered with tube, perpendicular to air flow.

• Taps for Pressure Indications (across Orifice) – are – 1/16” (1.587mm).

c) Orifice plates in tubes should have minimum thicknesses as specified for various diameters.

d) Steel or stainless-steel plate material is preferable.

e) Plates must be flat with holes having square edges (90°) and centered in the meter tube.

f) Taps for static pressure indication across orifices shall be made with neatly drilled holes.

11.0 PROCEDURE FOR DUCT LEAKAGE TEST.

11.1 PURPOSE:

This procedure outlines the steps for conducting a duct leakage test using positive pressure mode analysis to ensure that the duct system meets specified leakage criteria.

11.2 EQUIPMENT AND MATERIALS:

• Blower

• Flowmeter

• Temporary plugs (plates, sheets, balloons, bags, etc.)

• Soap solution

• Smoke bombs

• Variable inlet damper

• Test pressure gauge

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1.0 OBJECTIVE

The purpose of carrying out Performance Qualification of Pure Steam Generation & Distribution system is to establish documented evidence that the system is capable to consistently generate Pure steam with the specific quality attributes when operated as per Standard Operating procedure in accordance with manufacturer operation manual, thereby establishing its reproducibility.

2.0 SCOPE

This Protocol is applicable to Performance Qualification of Pure Steam Generation & Distribution system installed at site.

7.0 PERFORMANCE QUALIFICATION TEST PLAN

7.1 Performance qualification test shall include following test:

7.1.1 Performance Test Matrix

7.2 Performance Test which contains following test

7.2.1Phase I Validation Study

After the successful completion of Installation and Operation qualification, the initial phase of Pure Steam generation & distribution system validation shall be undertaken. In this phase Pure steam sampling shall be done from all sampling points i.e. all sampling points in generation unit, all sampling points in distribution system and all user points daily for a period of 14 consecutive days.

If there is any failure with respect to bio burden in between Phase I study, the study has to be re-initiated after investigation and rectification of the cause at the end of this phase SOP for operation (Developing appropriate operating ranges) and cleaning shall be confirmed.

7.2.2 Phase II Validation Study

This study is to demonstrate that the system shall consistently produce the desired quality of pure steam when operated in conformance with the SOPs.  The sampling shall be followed as similar to Phase-I validation study daily for a period of 14 consecutive days.

During Phase-II Pure steam shall be sampled for analysis as per the sampling point and user points.

After completion of Phase I and Phase II a provisional Alert Limit and Action limit shall be established for the microbial count, which shall be based on the results of Phase I and Phase II.

7.2.3 Phase III Validation Study

The third phase of validation is designed to demonstrate that when the pure steam generation & distribution system is operated in accordance with the SOPs over a long period of time (one year) with all seasonal variations, it shall consistently produce pure steam of desired quality attributes. During this period sampling shall be done as per the routine sampling plan, which shall be based on established procedures proven during phase I/II and shall include the at least the generation system sampling point for daily testing and other sampling or user points shall be sampled & tested at least once a week. The Pure Steam generator shall be operated at least 1 hour on every working day.

After successful completion of the Phase III, the Alert Limit and action limit for microbial count shall be revised based on the complete data obtained during Phase I, Phase II and Phase III.

8.0 TEST EXECUTION METHOD

8.1 Pre –Requisites

Prior to conducting/executing the Transport Validation protocol following conditions must be fulfilled:

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