Aseptic Processing: A Vision of the Future

Aseptic processing is the met h od used for producing sterile products if terminal sterilizati on would advers ely affect the produ ct . Because terminal steri l i z a ti on processes k i ll microor ga n i s m s , t h ey are more certain to preven t produ ct con t a m i n a ti on than aseptic processing met h ods, wh i ch aim to exclu de microor ganisms from the operating envi ronment. Even if the active pharmaceutical ingredient is compati ble with terminal steri l i z a ti on, however, aseptic processing s om etimes is the preferred processing ch oice. For example, a drug delivery system that is incompatible with terminal sterili z a ti on may be a good ch oi ce because it redu ces the risk of contamination when the product is administered to a patient. Mi c robial contaminati on in aseptic processing is mainly caused by personnel. It is estimated that more than 99% of all microorganisms detected in cleanrooms are of human origin. The passage of m i c robes thro u gh the HEPA filters su pp lyi n g air to the cl e a n room is high ly unlikely given the filter ’s ef fectiveness for parti cle reten ti on (typically >99.997% for particles .0.3 mm ) . Ot h er items pre s ent in the cl e a n room—such as produ cti on equ i pm en t—might gen erate nonvi a ble parti cl e s during operation but cannot be considered significant sources of viable contamination.

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