To provide the detail procedure for qualification of an area.
This SOP applies to qualification of all areas which are used for storage and process of material and which may affect the product quality, safety, efficacy and storage.
Officer/designee – QA: To prepare area qualification protocol and report. To execute qualification in co-ordination with other departments.
Officer /designee of user department shall be responsible for execution of area qualification.
Head of Department (HOD) of user department shall responsible for review of area qualification protocol and report.
Head – QA shall be responsible for approval of area qualification protocol and report.
4.1 Officer/designee – QA shall prepare, HOD of user department shall review and finally Head – QA shall approve.
4.2 Parameters shall be considered for area qualification (but are not limited to):-
Classification of area
Men and material movement
Electrical power point
Walls, floor and ceiling
Luminance in area
Utilities in area
Differential pressure in area
The above parameters shall be selected for area qualification as per designed area.
4.3 Men and material movement verification:
Methodology: Using a prototype movement in an area, verification of men and material movement shall be carried out with reference to the design qualification and documented on area layout.
Acceptance criteria: As per design qualification.
4.4 Electrical power point:
Methodology: All electrical power connection in an area shall be checked by using multimeter.
Single phase voltage: 230 V ± 10%. Frequency: 50 Hz ± 5%
Three phase voltage: 415 V ± 10%. Frequency: 50 Hz ± 5%.
Methodology: Earthing shall be checked by using calibrated multimeter.
Acceptance criteria: Not more than 10 Ω.
4.6 Walls, floor and ceiling:
Methodology: Finishing of the walls, floor and ceiling shall be verified as per the design.
Acceptance criteria: Walls, floor and ceiling shall be smooth, easily cleanable, and free from crevices and damages. All corners shall be rounded to provide easy and effective cleaning.
4.7 Door interlocks:
Methodology: Doors interlock (wherever provided) shall be identified in the general layout of area.
Acceptance criteria: Doors interlock shall be automatic closing systems. Doors shall be smoothly operated.
4.8 Luminance in area:
Methodology: Luminance in an area shall be measured at working height (4-6 feet from the floor). Five readings shall be taken by lux meter from different location as per below illustration.
Acceptance criteria: Not less than 300 lux at working level.
4.9 Sound level in area:
Methodology: Sound level shall be measured at personnel height (4-6 feet from the floor) in an operational area. Five readings shall be taken by Sound Level Meter from different location as per above illustration (point 4.8.1).
Acceptance criteria: Sound level in an area, not more than 80 decibels (dB) at personnel height.
Recommendation: If sound level is observed above 80 dB in an operational area, air muff should put on ears.
4.10 Safety devices:
Methodology: Safety devices/features like Fire extinguisher, Emergency exit door and breakable fire alarm window/ doors etc. shall be identified in the layout.
Acceptance criteria: All the devices should be verified as per the layout.
4.11 Utilities in area:
Methodology: Utility points including drain points in an area shall be checked and identified in the layout.
Acceptance criteria: Utilities like nitrogen gas, steam, potable water, purified water, and compressed air shall be identified in the layout. All the drain points shall also be identified on the plan layout. All drain points shall have water seal.
4.12 Differential pressure in area:
Methodology: Differential pressure (DP) across room/cubicle and corridor, primary corridor and atmosphere shall be recorded shown by magnehelic gauge.
- DP across room/cubicle and corridor : between 0.5 – 3.0 mm of wc
- DP across primary corridor and atmosphere: between 3.5 – 5.5 mm of wc.
4.13 User department shall execute area qualification study as per approved protocol.
4.14 During the execution of protocol, any discrepancy observed shall be recorded and impact assessment carried out as per the respective protocol. After the execution and compilation of protocol, a qualification report is prepared.
4.15 The parameters and acceptance criteria defined herein is for classified areas (ISO class-7 and class-8). For non classified area, depending upon the design qualification, test parameters and acceptance criteria may differ and elaborated in respective protocol.
4.16 Parameters and certificates, if provided by the vendor, the test may not be repeated. Data shall be reviewed and considered, if appropriate.
5.0 RELATED DOCUMENTS
8.0 REVISION RECORD
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