Pharmaceutical products, steril environmental contamination

Areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate level of microbial and particulate cleanliness four grades (Table 22.1) are specified in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997), defined by measures of airborne contamination (Table 22.2). Environmental quality is substantially influenced by the air supplied to the manufacturing environment. 

Clean rooms are environmentally controlled areas within the pharmaceutical facility in which critical manufacturing steps for injectable/sterile (bio)pharmaceuticals must be undertaken. The rooms are specifically designed to protect the product from contamination. Common potential contaminants include microorganisms and particulate matter. These contaminants can be airborne, or derived from process equipment, personnel, etc. 

Roesti D (2012) Objectionable micro-organisms in non-sterile pharmaceutical drug products risk assessment and origins of contamination. In Moldenhauer J (ed) Environmental monitoring, vol 6. PDA/DHI, Bethesda... 

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