Oxygen Ingress: The Silent Threat to Parenteral Stability and Product Integrity
The stability of a drug product in parenteral manufacturing is inextricably linked to the primary packaging’s ability to maintain a strictly controlled internal atmosphere. For pharmaceutical executives and quality leads, failure in headspace control is far more than a technical glitch; it is an operational risk that directly threatens patient safety and regulatory standing. Oxygen […]
The Importance of CCIT in Maintaining Sterility for Injectable Drug Products
Container Closure Integrity Testing (CCIT) is a critical element especially for injectable drugs wherein even minor breaches in container closure integrity can jeopardize sterility potentially leading to contamination, patient hazard and even an expensive recall of product from marketplaces. Why Sterility Matters for Injectables? Injectable drug products or parenterals bypass the body’s natural defence barriers […]