November 14th, 2019
For full article visit BioProcess International
Single-use systems (SUSs) are becoming increasingly common in bioprocessing operations because of their low capital requirements and validation costs. As this trend continues to develop, pharmaceutical manufacturers are asking SUS manufacturers to provide assurance that their products comply with current good manufacturing practices (CGMPs) and do not alter drug products by exceeding established operating ranges.
Certification of product cleanliness has become common for manufacturers of final packaging components such as vials and stoppers, but rarely are tubing products certified to meet endotoxin, bioburden, and particulate standards. In some cases, pharmaceutical manufacturers have taken their own risk-mitigation measures to reduce potential contamination, such as by rinsing tubing products with water for injection (WFI). However, such strategies are costly and, in some cases, unfeasible. Given the costs of this approach, the pharmaceutical manufacturing industry is primed for a change in the typical risk control strategy for tubing.