Pharmaceutical Processing: Can you briefly describe the history and evolution of containment systems?
Sterling Kline: During the mid 1990s initial efforts were initiated to introduce isolator technology to the aseptic filling process. Stainless steel and glass containment units were constructed to segregate operators from the product to reduce the risk of contamination. H2O2 vapor was introduced as the sanitization agent to ensure all surfaces met regulatory expectations. The initial effort in the US known as the LUMs project was marginally successful with several issues including the lengthy eighteen hour sanitization cycle and unmet forecasts of cleanliness levels.
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