Cleanroom qualifications performed as a result of new facility construction will be part of an overall project plan and associated validation master plan for the project. The purpose of facility qualification is to confirm through objective evidence that the facility is built in accordance with approved layout / room specifications and meets cGMPs requirements and its intended use.
A cleanroom (classified area) utilizes many interconnected systems (Heating ventilation and air conditioning, Water for injection, Environmental monitoring system) to operate properly. Prior to qualification of the classified rooms/areas, the associated utilities and systems must have successfully completed.
Any manufacturing equipment or systems located in the new facilities that have the potential to impact the classified environment must have a completed IQ/OQ prior to the start of classified room qualification. Together with the project validation master plan, the cleanroom user requirements specifications and associated specifications, referenced regulatory guidelines, documented risk assessments, and the requirements as applicable will provide the basis for the cleanroom qualification activities and their acceptance criteria.
Cleanroom qualification resulting from continual improvements or changes to an existing facility, as a part of the change control process, include a documented risk assessment on the impact of this modification to the existing facility and the assessment will be included with the change control documentation.
Prior to start the facility qualification, pre-requisites to be checked and verified for successful qualification as below:
- Approved project plan / User Requirements Specifications(URS)
- Approved General Layout / room design specifications
- Design /Installation / operational qualification documents
- Approved drawings for area classifications
- Man / Materials movements drawings
Procedure for execution of facility qualifications: The following design criteria have to be checked for each room / area and compare with design specification / data sheet,
- Room design details – Design dimension (Length / width / height)) and total area / volume
- Doors – Material of Construction / finish, opening direction, access controls & inter-locking facility.
- Floor / Wall / Ceiling / View Panel – Material of Construction / finish, color, border sealant and covings.
- Pass-box (Hatch) – Material of Construction / finish, door inter-locking, HEPA filter & UV lighting.
- Utilities – Pure steam, Potable water, Purified water, Water for Injection, chilled / cold water, Nitrogen gas, compressed gas and identification codes for utility lines.
- Lighting Requirements – Intensity of illuminations
- Environment / clean room controls – AHUs, number of supply & return grills / filters, temperature/ relative humidity/ differential pressure, availability of hygrometer / thermometer and cleanroom classifications.
- Drain points requirements – Sanitary type and air breaks mechanism
The facility qualification report shall include a statement recommending whether the area is suitable for its intended purpose. The discrepancies / deviations with respect to the specification mentioned should be explained in the facility qualification report and shall be justified. Upon approval of report, the facility shall be released for its intended purpose.