Bioburden parenteral preparations

Other grades of water may be present in parenteral facilities for use as initial rinses and detergent cleaning. The water utilized for these purposes is generally of relatively low bioburden and is often deionized, softened, ultra-filtered, or in some instances prepared by distillation or reverse osmosis, resulting in chemical purity similar to, if not identical to, WFI. Systems for the preparation of this water are subject to qualification, validation, and routine analysis to assure consistent quality. 

Water used in the final isolation and purification steps of nonsterile APIs intended for use in the preparation of parenteral products should be tested and controlled for bioburden and endotoxins. 

For irrigatiOTis steam sterilisation in its final container for 15 min at 121 °C (see Sect. 30.5.1) is preferred. These are the same requirements as for parenteral solutions. An aseptic preparation method with bacterial filtration through a 0.2 pm filter, followed by heating at 100 C for 30 min (or another proper combination of temperature and time or validated aseptic conditimis) is an alternative when one of the substances is sensitive to a higher temperature. If an active substance is not heat resistant at all, only an aseptic preparation with bacterial filtration over a 0.2 pm filter is possible. In such cases the starting materials should be sterile or have a low bioburden and the irrigation should be prepared asep-tically. See also Sect. 30.6. 

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