Holly Haughney

Disposable technology has been used effectively as a process solution for over 25 years and new uses and applications are constantly being developed. The key to all applications is the ability to pre-sterilize components and systems with gamma radiation and package them against contamination.

Disposable systems only require initial cleaning validation, and ongoing validation activities are typically limited to operator training and routine monitoring.

The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient manufacturing capacity, and the economic challenges of producing niche drugs and therapies.