2024-05-23

As a definition, any biological macromolecule or cellular component that is able to exert or enhance a therapeutic, curative or protective property can be considered as a ‘Biopharmaceutical’. They are generally derived from living materials (e.g. human, animal, microorganism, or plant) and are much larger and more complex in structure. Biopharmaceutical include a wide variety of products, such as vaccines, therapeutic proteins, blood and blood components, and tissues & cells.

Manufacturing of Critical Fluids in Biopharmaceutical Industry generally utilizes three types of processing systems.

• The first type involves usage of stainless-steel systems. These are reusable, durable, and able to withstand exposure to the harsh chemicals used for sanitization (CIP: Clean in Place) & extreme temperatures for sterilization (SIP: Sterilization in Place). This requires considerable resources: labour, time, plant footprint, high cost of installation & maintenance. 
• The second type is usage of partly disposable systems where some parts are fixed & re-used while others are disposable & single-use. Reused parts undergo cleaning, sterilization & maintenance regimes like those used in traditional stainless-steel systems.
• The third type is “Single-use systems” ‘OR’ ‘Single-use Solutions’. In this system, all the process parts be it Tubings, Hoses, Bags, Filters, Seals etc. are disposed of after each production batch & are replaced with a new set. These systems are also available in pre-sterile or gamma irradiated form & hence are ‘Ready-To-Use’. This involves almost near-to-zero OR minimal risk of cross-contamination leading to generating higher throughput saving a great amount of energy, time & money.

The first and second system have a risk of cross-contamination between manufacturing processes.

Critical Fluid Transfer applications for Biopharma Industry involve biological liquid injectable products like Vaccines, Blood & blood products, Therapeutic proteins etc. can be referred as Critical Fluids.  For Biopharma Industry, critical fluid transfer applications involve a set of processes, equipment, and controls designed to handle and transfer fluids (liquids or gases) within the manufacturing and drug development processes.

This system plays a crucial role in ensuring the quality, safety, and efficiency of biopharmaceutical production. Critical fluid transfer is involved at various stages of Biopharmaceutical manufacturing including but not limited to Upstream, Media preparation, Buffer preparation, Downstream processes, Filtration, Chromatography, Viral clearance, Final Formulation & Filling.

Advantages of Critical Fluid Transfer Using Single-Use Systems

• The biggest advantages are near-to-zero OR minimal risk of cross-contamination and no need for cleaning or sterilization steps along the fluid path.
• The transfer of liquids across single-use manifolds can be performed in a very fast and precise manner.
• The use of sterile connections and tubings facilitates the fluid transfer of intermediates into single-use storage bags under sterile conditions without the need for SIP procedures.
• These systems are easy to scale-up as per specific needs of demanding processes.
• These systems ensure process safety & helps to improve process logistics & handling.
• According to one study, single-use systems lower operating costs by offering 46 percent water and energy reductions, a 35 percent more favorable CO₂ footprint due to lower facility emissions, and a 40 percent lower initial investment cost. They allow pharmaceutical manufacturers to push products to market faster by increasing throughput and making scalability easier.

The Freudenberg Medical Advantage

Freudenberg is a 175-year-old, family-owned, global technology group that is long-term oriented and responsible in its actions. As a trusted & reliable development partner to our customers, we set standards in technology, innovation and quality utilizing our leading-edge technology products, solutions and services & thereby making a valuable contribution to our customers’ long-term success & a sustainable future.

Freudenberg Medical is part of The Freudenberg Group. At Freudenberg Medical, we are a global contract manufacturer 100% focused on solutions that address the complex challenges of the pharmaceutical & medical device industry. All of our facilities are ISO 13485 certified and all manufacturing is conducted in either Class 7 or 8 clean rooms. 5 of our 11 facilities are FDA certified.

Freudenberg can design and build single-use assemblies for critical bioprocessing applications. With expertise in controlled cleanroom extrusion and molding, Freudenberg can create custom single-use assemblies to ensure safe fluid transport for biopharmaceuticals. As a one-stop shop, Freudenberg uses your design specification to provide custom solutions combining high purity tubing, connectors, over-molded sanitary ends, manifolds, T- and Y-molds, and other ancillary products.