Charity

Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the cleanroom from the people working in the cleanroom. Whereas contamination may be due to the product, processes, or equipment in the clean-room, the people working in the cleanroom exercise the greatest control over the cause of and elimination of contamination. Therefore, all protocol programs address the functionality of the cleanroom, the behavior of the people working in the cleanroom,and the cleaning and maintenance of the cleanroom.

After the cleanroom has passed certification, cleanroom personnel must don the required cleanroom apparel applicable to the classification of the cleanroom. IEST-RP-CC003.3 contains a chart of recommended gowning configurations and frequency of change of garments based on the Air Cleanliness Classes of ISO 14644-1. Many clean-room operations require the cleanroom personnel to change from street clothes to 100% polyester building suits or tech suits to reduce the amount of particle contamination in the cleanroom environment. The garment system selected must meet the specifications for the clean-room applications. Facility requirements for changing areas, lockers, in-use garment storage, soiled garment storage, garment inventory storage, and internal inventory transit must be defined. Additionally cleanroom garment laundering and othergarment management services must be defined and subcontracted. 

Meticulous hiring practices for cleanroom personnel include screening potential operators for physical characteristics such as: smoker hiring policy, overweight or obese personnel, facial hair, sensitivity to heat, cold and humidity, and seasonal allergies including skin allergies. Also, when evaluating personal skills and language skills, the human resources department must also evaluate potential cleanroom candidates for mental characteristics such as claustrophobia. Recommendations for personnel behavior in the cleanroom are found in IEST-RP-CC027.2, “Personnel, Practices and Procedures in Cleanrooms and Controlled Environments.”

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. 

There is no GMP requirement in the EU and PIC/S (i.e. TGA) GMP guidance’s for the manufacture of non-sterile medicinal products in a “clean room”, but we do use clean areas that are effectively ventilated with filtered air where the products or open clean containers are exposed. On the other hand, for the manufacture of sterile medicinal products, clean rooms are mandatory, as defined in Annex 1 of the EU and PIC/S GMPs. This Annex defines a number of additional requirements besides the airborne particulate concentration limits used to classify clean rooms.