Wanted: A standard that defines the requirements for compatibility of established stainless steel bioprocessing equipment and single‑use systems, based on agreement between disposables manufacturers and drug manufacturers. So says Mark Kruszynski, a tech transfer engineer at Baxter.
Kruszynski notes in Pharmaceutical Technology Europe that many of his clients are open to suggestions about the use of disposables, especially for clinical manufacturing. But for each case in which it's being considered, potential adopters must stage a stainless-vs.-disposables contest.
The top event in such a contest pits the processing technology choices against each other for extractable/leachables. Of concern is the effect of the product contact layer of a single‑use system on the quality attributes of the drug. Other concerns involve protein aggregation, bag absorption of preservatives and bag impact on product stability. Another consideration is the cost of lab analysis to resolve these concerns, and another process-element unknown that might be addressed in a compatibility standard.
- here's the article