INSIDER INSIGHT
that is representative of the entire surface area of a piece of equipment, a rinse sample is taken from a set volume of solvent that has been routed throughout the equipment system and has come in to contact with almost all wet surfaces of the equipment system. Swab samples are taken by wiping predetermined locations of the equipment system (swab locations) with specialized swabs. Swab locations are usually those that are poorly or not covered by a rinse, such as geometrically restricted sites, and are deemed to be on the most difficult to clean pieces of equipment.
Ensuring Clean Room Operations
When working with Active Pharmaceutical Ingredients (APIs), special precautions must be taken to prevent contamination of final products. Strong quality assurance and quality control systems ensure raw materials and consumables meet internal and external standards. A key area that can be overlooked as a potential microbial or particulate contamination source is the packaging and production environment. To control this contamination, especially in final packaging and sensitive processes, cleanroom environments are often used.
The FDA defines a cleanroom as “a room designed, maintained, and controlled to prevent particle and microbiological contamination of drug
11 Pharmaceutical Outsourcing | Insider Insight 2016
products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.” Cleanrooms for API manufacturing are used for drug products with high sensitivity to airborne particulates and microbes. Cleanroom quality is maintained through room architecture, air filtration, and control of personnel.
One step companies take to ensure clean room operations is to have each room include its own air filtering unit which is maintained at a positive pressure in relation to the outside environment to protect the integrity of the atmosphere. Additionally, personnel working inside separate units can be connected via a hallway which is used as a gowning area. Only personnel trained on internal SOPs regarding GMP manufacturing should be permitted in this area. Other controls such as full-body suits, dust masks, respirators, and hairnets ensure human contact is not a source of biological contamination. Clean room operations should also not be confined to the lab. Production areas and packaging rooms should be FDA and ICH Q7-compliant to ensure that final products are packaged in a controlled environment.
By implementing processes to ensure that equipment is continuously clean and that clean room operations are in place, today’s chemical manufacturing operations not only ensures regulatory compliance, but also earn their spot as an organization that puts quality above all else.
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