Single-Use Pharmaceutical and BioProcessing Technologies
The bioprocessing and pharmaceutical industries strive to improve flexibility in manufacturing and speed to market, while meeting the demands of strict quality assurance. With over 30 years of experience as a raw material supplier to the FDA-regulated healthcare market, Solvay is equipped to advance innovative and more efficient production technologies by supporting the development of robust single-use products with: High-purity polymers that are resistant to a range of chemicals; Regulatory support with adherence to USP Class VI (post gamma irradiation), ISO 10993-1, and alignment with BPOG leachable & extractable protocol.
Regulatory Testing & Biological Safety
Solvay’s broad range of biocompatible, medical grade polymers has made us a leader in supplying materials for components used in biopharmaceutical single-use technology. As a result of increased biopharmaceutical demand, manufacturers are experiencing rapid growth and implementing single-use bioprocess manufacturing based on reduced capital investments, scalability, increased productivity, less energy demand and eliminating the need for cleaning-in-place (CIP) or sterilization-in-place (SIP). Single-use bioprocessing applications includes filtration (membranes, membrane additives and membrane housings), peripherals (connectors, tubing, and sensor housings) and containment (bioreactors and final containment bags).
To ensure a pure environment, single-use equipment must be sterilized before use, and gamma irradiation is becoming the preferred method. With some plastics, however, gamma sterilization can compromise the polymer and increase the occurrence of leachables and extractables, which can affect the purity and performance of biomaterials in processing and in patients. Our specialty polymers for bioprocessing systems have been tested for post gamma integrity and this documentation is available to help you specify the right material for your biopharma processing applications.
Leachables & Extractables
Solvay recognizes that our materials are an integral part of the value chain in single-use systems. We have tested our polymers in accordance with the most aggressive conditions defined by the BPSA-BPOG leachables & extractables guideline.
In addition to gamma sterilization's impact on leachables and extractables, mechanical performance can be affected. Solvay evaluated the effect of 50 kGy gamma irradiation on our medical-grade polymers and results for the following products: Udel® PSU • Veradel® HC PESU • Radel® PPSU • AvaSpire® PAEK • KetaSpire® PEEK • Ixef® PARA. The results are available in the technical bulletin, Effects of Gamma Irradiation Mechanical Properties of Specialty Polymers, and demonstrate nominal changes in mechanical performance.
Gamma irradiation is the preferred method of single-use equipment sterilization. In order to meet stringent industry requirements, single-use equipment must undergo gamma irradiation. Solvay’s specialty polymer portfolio for biopharmaceutical processing is tested under United States Pharmacopeia (USP) Class VI testing standards prior to and following gamma irradiation. Based on our test results, we can confidently recommend our materials for a range of biopharma processing applications. In addition, we have performed post-gamma mechanical performance testing for key materials. All of this data is made available to customers through our FDA Master Access File. To ensure the quality of their high-performance plastics for biopharmaceuticals, Solvay follows BPSA-BPOG leachable and extractable test protocols, evaluating the worst-case scenarios to assess the presence of leachables and extractables.
Single-use systems that were only viable options for clinical scale operations, scale-up manufacturing or in tubing and filtration technology are now practical for a wide range of scales from clinical to commercial. However, advancements in biopharma technology have increased yields and reduced the need for fixed-volume tanks. Today, Solvay’s specialty polymers are used to manufacture single-use systems that cater to a broad range of scales from clinical scale systems to commercial manufacturers.
The decision to use high-performance polymer single-use devices or stainless steel devices for biopharmaceutical manufacturing is often based on having flexible production capacity, quick product turnovers and the ability to scale production. Parameters such as energy, labor, materials, maintenance, consumables, quality and contamination also play a part in deciding between specialty polymers and stainless steel. Additionally, single-use technology reduces production time from days to hours. When considering all these factors, high-performance specialty polymers are not only stable, inert and reliable, but they enable the biopharma manufacturer to reduce capital investment and speed up the clinical trials or biopharma production.
Gamma irradiation is the preferred method of single-use system sterilization due to its high penetration capability. High-performance polymers can be sterilized following packaging and sealing with gamma irradiation allowing for single-use equipment to be sanitized without risking possible contamination. Each of Solvay’s specialty polymers is evaluated under the effect of gamma irradiation up to 50 kGY to ensure their ability to retain critical mechanical performance following sterilization. Solvay high-performance polymers meet the industry needs of gamma irradiation compatibility and have been tested using the United States Pharmacopeia (USP) Class VI testing standards prior to and following gamma irradiation.
Standard manufacturing methods of biologics involve the use of stainless steel-based components. The repeated sterilization required of stainless steel equipment has perpetual labor expenses. In addition, sterilization increases the use of raw materials such as chemicals and water. The implementation of single-use systems eliminates the need for clean in place technology (CIP), which increases manufacturing productivity and reduces costs by reducing cleaning and validation phases from days to hours.
With demand for biopharmaceuticals increasing, manufacturers are continuously striving for opportunities to reduce initial capital investments and manufacturing research and development costs. Solvay’s polymers for single-use technology enable biopharmaceutical manufacturers to increase speed to market, reduce capital costs and accelerate product development.
Stainless steel systems require sterilization of equipment, cleaning validation and cleaning maintenance all of which contribute to energy consumption. In contrast, biopharma manufactured with single-use systems are not subject to these additional energy resources.
The most pronounced difference between a single-use system and a traditional stainless steel manufacturing operation is the sanitation process. Traditional manufacturing operations require cleaning in place (CIP), sterilization in place (SIP) and increase the risk for product cross-contamination. Single-use systems are exempt from the burden of these routine requirements.