Validation

Expanding Considerations in Cleaning Validation: Risks Posed By Indirect Product-Contact Surfaces on Pharmaceutical Equipment

Cleaning validation receives a great deal of attention within the biopharmaceutical industry, not least because of the risks of product adulteration and hence patient harm from improperly cleaned surfaces (notwithstanding additional concerns such as operator protection). Traditionally, cleaning validation efforts focus on direct product-contact surfaces. However, the hazard and resultant risk posed from indirect product-contact surfaces should not be underestimated. Consideration of the risks presented by indirect surfaces should figure into every contamination-control strategy. Understanding of these risks cannot be…

IVT Journal Archive

IVT Network Archive The Journal of Validation Technology, The Journal of GXP Compliance, and the IVT Network have served proudly for nearly 30 years as a global knowledge base for validation and compliance professionals in FDA-regulated industries. To make peer-reviewed validation resources available to the broader biomanufacturing community, the IVT Network is joining sister publication BioProcess International. Starting in July 2022, articles from the past two years of JVT and GXP can be accessed here on the BioProcess International website.…