Thinking Inside the Box: The Application of Isolation Technologyfor Aseptic Processing

Aseptic processing is perhaps the most critical of all production activities performed within the healthcare industry (1, 2). The risks to patients are higher for aseptic processing than any other process in current use, and the technologies used for the aseptic production of sterile products are among the most complex and costly in the industry. Regulators worldwide recognize the importance of proper practices for aseptic processing and have established several guidance documents pertaining to its application (1, 3).

Firms that produce aseptic products, pharmaceuticals, or medical devices have attempted to reduce the microbial contamination risk associated with their assembly by using individually sterilized materials and packaging in pristine environments. Beginning in the 1950s, firms relied for years almost completely on cleanroom technology in which critical activities were performed by gowned personnel.

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