The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns

As biopharma embraces flexible, multi-product manufacturing, particularly with high-potency APIs (HPAPIs), the risk of cross-contamination escalates. A critical, yet often underestimated, vulnerability lies in the seals of synthesis columns. If degraded or incompatible, these seals can trap and transfer residues between batches, jeopardizing patient safety and GMP compliance, even with robust cleaning protocols. Ensuring seal integrity through diligent monitoring, maintenance, and validation is paramount in these dynamic environments.

Don't let this hidden threat compromise your operations. Access the full article to learn more about robust seal management.