Understanding the Importance of Sterility in Biopharmaceutical Applications

Realizing that contamination risks made 70% of recalls in the biopharma industry, was one of the most shocking statistics I had ever come across. This fact helped me comprehend how critical sterility is for biopharmaceutical applications, which in turn motivated me to explore ways that could help avoid such financially damaging obstacles. It was at that juncture that

I discovered what 'Aseptic Fluid Transfer' Is. It is the transfer of sterile liquids between two systems or containers without the introduction of any contaminants.

This method, which is increasingly getting attention, is designed to minimize contamination as it has become the primary goal across the industry.

The Overmoulded assemblies’ introduction:

Overmoulded assembly is the first product with which I have had both technical, and commercial encounters that disrupts the market industry. The Overmoulded assemblies’ components is designed by molding a secondary material over a substrate like tubing or connectors.

Silicone and Thermo-Plastic Elastomers (TPE) are the most frequently used materials due to their high flexibility, strength, biocompatibility, and good durability. The open-ended designs of these assemblies enable them to be integrated into other systems without increasing the risk of leakages or contaminations.

Therefore, they are ideal for Aseptic Fluid transfer in bio-pharmaceuticals. Contamination, mold, and any breach of sterility can lead to expensive regulatory non-compliance, recalls, or even serious consequences to patient health. The elimination of products that have been contaminated can result in considerable financial losses and production delays. In some cases, contaminated products in biopharmaceuticals can have adverse reactions in patients, which results in legal consequences and reputational loss.

Why Silicone and TPE and Silicone Are Optimal for Overmolding

Historically, plastic connectors along with nylon clamps were widely used in fluid transfer systems. Their usage comes with their fair share of problems related to leakage and contamination if not securely sealed. There is a notable advantage Overmoulded assemblies offer, which is the use of silicone or TPE as single material compounds.

With the usage of a single material, the chances of extractables and leachables (materials that can leach into the product due to the materials used in the fluid transfer device) are reduced significantly. Over the years, silicone and TPE have been known as materials with the least amount of contact towards biopharmaceutical products, making sure no undesirable contaminants are added into the system.

The construction and validation process of Overmoulded assemblies is seamless:

1. Joints which are often weak points for classic connectors are eliminated with Overmoulded assemblies. Thus, their construction is completely seamless.
2. This design makes sure that no external contaminants get access and therefore fluids can be transferred without compromising the environmental conditions internally and the flow remains smooth and uninterrupted.
3. Also, the use of a single material eliminates the need for extensive examination of different materials, therefore streamlining the validation process.
4. This increased efficiency not only speeds up the development timeline but also lowers costs.

Aseptic Connectors in Modern Biopharma Application:

• Overmoulded assemblies have many benefits, but it is also essential to examine the use of aseptic connectors in biopharma applications. Aseptic connectors ensure sterile connections between fluid pathways and preserve the system’s sterility. These connectors become crucial in processes with frequent changeovers or multiphase fluid handling.
• Sterile aseptic connectors allow for the maintenance of a sterile barrier during disconnection, and connection, which makes them suitable for use in media preparation, cell culture, and final fill/finish operations.
• Aseptic connectors come with protective caps and sterile barriers that eliminate the possibility of contaminants invading during the connection phase. The use of these connectors is rapidly becoming the norm in biopharma manufacturing.

Discover the Future of Biopharma with Ami Polymer:

At Ami Polymer, we specialize in Overmoulded assemblies – ImaLINK™, in which we apply high precision engineering techniques that guarantee sterility and meet the stringent requirements of biopharma applications. We are pleased to present ImaLINK™, our proprietary and patented T, Y, & Cross Overmoulded connection technology which is set to redefine the bioprocess industry. ImaLINK™ guarantees a leak-free connection with precision-engineered tubing across various diameters which is ideal for single-use bag assembly systems.

Like all of our products, ImaLINK™ is manufactured in compliance with FDA 21 CFR 177.2600 and USP Class VI certs, making it safe for use in all applications. The future of connection technology is here with Ami Polymer. Start working smarter with our innovative solutions and improve the speed of your bioprocessing operations, all while trusting the integrity of our products. Ready to elevate your operations? Visit our website at www.amipolymer.com or contact us to learn more at [email protected]