Understanding the importance of sterility in biopharmaceutical applications

Khushi Gandhi, Senior Executive International Marketing, Ami Polymer, introduces the company’s overmoulded assemblies ImaLINK™ that are designed to meet the stringent requirements of biopharma applications, engineered for precision and built for sterility

- 

When I learned that 70 per cent of product recalls in the biopharma industry are caused by contamination risks, it became clear how critical sterility is in biopharmaceutical applications. This insight propelled me to explore solutions that could prevent such costly setbacks. It was during this exploration that I came across the term "Aseptic Fluid Transfer" This process involves the movement of sterile liquids between systems or containers without introducing contaminants, a method gaining significant attention as minimising contamination has become a primary goal across the industry.

Introducing overmoulded assemblies

The first product that technically and commercially fulfills this crucial need is the Overmoulded assembly. Overmoulded assemblies are innovative components created by molding a secondary material over a base substrate, such as tubing or connectors. The most commonly used materials are Silicone and Thermo-Plastic Elastomers (TPE), which are selected for their flexibility, durability, and exceptional biocompatibility. These assemblies provide a seamless and integrated solution that minimises the risk of leakage and contamination, making them ideal for aseptic fluid transfer in biopharma applications.