Biopharmaceutical Processing: Test Standards and Best Practices
The introduction of single-use technologies in the biopharmaceutical industry provides healthcare professionals with a safer, higher-quality and more cost-effective material as an alternative to stainless steel medical equipment. OEMs are implementing more fully disposable single-use systems for greater production flexibility, increased speed to market, and lower capital wealth investment in a wide range of biopharmaceutical applications.
However, in order to ensure safety and reliability during biopharmaceutical manufacturing processes, single-use equipment must meet certain industry standards. Solvay’s broad portfolio of high-grade specialty polymers meets necessary test standards and is compatible with various industry practices and uses.
Gamma Irradiation For Biopharmaceuticals
The adoption of polymers for biopharmaceutical processes reduces the need for complex cleaning and sterilization processes. However, single-use equipment must undergo gamma irradiation for sterility assurance before use in biopharma applications. This sterilization method involves the ultraviolet light of a short, energetic wavelength to pass through the medical components being sterilized to decontaminate the workpiece. Gamma irradiation has replaced more costly and less accurate cleaning methods and is now the preferred method of sterilization for single-use systems.
Test Protocols For Biopharmaceuticals
For safe, reliable and effective use of polymers in biopharmaceuticals, single-use equipment must meet stringent industry requirements and comply with test protocols. The United States Pharmacopeia (USP) Class VI testing standards assess materials under three different examination processes to assure the safety of medical-grade raw materials for use in bioprocess manufacturing. Additionally, the BPSA-BPOG test for leachables and extractables analyzes worst-case scenarios for different biopharma applications to assess the risk of connectors and disconnectors and other components in single-use systems.
Solvay Specialty Polymers For Biopharmaceuticals
Solvay’s high-performance polymers are formulated with advanced chemical and mechanical properties that are suitable for gamma irradiation processes and comply with industry test protocols. Our portfolio of medical-grade polymers provides the healthcare market with higher-quality, more versatile materials that retain their reliability, integrity and functionality after sterilization. Additionally, Solvay specialty polymers are compatible with USP Class VI testing standards before and after gamma irradiation to assure that the material’s physical and chemical properties remain intact throughout a range of applications and sterilization methods.
In an effort to meet the demand for more sophisticated medical systems, the healthcare industry is incorporating single-use materials as an alternative to stainless steel. The single-use technology adoption provides the biopharmaceutical manufacturing process with greater flexibility, compatibility and reliability. Additionally, as a superior alternative to traditional stainless steel equipment, single-use systems simplify the sterilization process by eliminating the need for clean-in-place (CIP) and the risk of cross-contamination.
Solvay offers a broad portfolio of specialty polymers manufactured for single-use biopharmaceutical processing systems. Solvay’s specialty polymers offer excellent chemical and mechanical properties, tensile strength, chemical compatibility and scalability for easier and more versatile biopharmaceutical manufacturing processes than traditional stainless steel.