Cleanroom Supplies and Storage
Garments may be stored inside the cleanroom gowning area as well as the many cleanroom consumable supplies to support the cleanroom operators and the processes inside the cleanroom. Cleanroom supplies should be stored in cleanroom packaging until use. All chemicals and supplies used to clean the cleanroomshould also be stored in original cleanroom packaging until use. Used mops and mop heads should be properly disposed after use. It is recommended that the cleanroom supplies storage area be ventilated under vertical unidirectional air flow. Prior to introduction of any supplies into the cleanroom storageareas, proper wipe down of the exterior packaging should be performed.
CLEANROOM HOUSEKEEPING
An integral piece of the cleanroom management program is cleaning of the cleanroom. IEST-RP-CC018.3, “Clean-room Housekeeping” details aspects of proper cleaning of the cleanroom, selection of cleaning materials, equipment, and cleaning agents as well as auditing the cleaning of the cleanroom. A documented and controlled cleanroom cleaning program should be established and maintained to ensure the integrity of the cleanroom environment. Selection of cleanroom cleaning materials, equipment, and cleaning agents should be appropriate to the type of cleaning required (i.e., aseptic versus non-aseptic cleanrooms). All cleaning agents and subsequent cleaning protocols shouldbe validated to assure efficacy of cleaning.
CONTINUOUS MONITORING FOR EFFICACY
Monitoring and auditing the cleanroom management program assures that the documented procedures and protocols are understood, implemented and effective at all levels within the cleanroom manufacturing process. The audit program should provide documented and impartial evidence that the cleanroom management program is robust and reproducible. Tracking and trending this data will show shifts in the program which can be addressed prior to compromising the entire cleanroomprotocol program.
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