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 the increasingly preferred method. With some plastics, though, 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 our customer specify the right material for their parts.
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.
USP Class VI Post Gamma Irradiation Portfolio
- Udel® PSU
The high-strength nature of Udel® PSU (polysulfone) is a crucial specialty polymer biopharmaceutical production, specifically in single-use systems. Additionally, Udel® PSU is a semi-tough, transparent thermoplastic with excellent mechanical retention properties and thermal properties and chemical resistance. Beyond its excellent biocompatibility, Udel® PSU has been tested under gamma sterilization up to 50kGy, the preferred method of sterilization for single-use systems and meets the industry standard for post-gamma conditioning under the USP Class VI testing. Udel® PSU offers high-strength, transparency and excellent hydrolytic stability to meet the demands of single-use systems in biopharmaceutical processing.
Udel® PSU is widely used throughout the main components of biopharmaceutical processing including filtration, peripherals and containment. Here, Udel® PSU serves in the production of membranes and their additives, supports, and housings, connectors, valves, clamps and sensor housings and can be suitable for fill and finish needles, bioreactors and final product bags.
- Veradel® HC PESU
Veradel® HC PESU (polyethersulfone) is a biocompatible, heat-resistant sulfone polymer for the healthcare industry and is supported by an FDA Master Access File (MAF) for medical devices. Veradel® HC PSU serves a number of applications in biopharmaceutical processing but are most commonly found in filtration. The ability to retain transparency and toughness at high temperatures sets Veradel® PESU apart from other commercial transparent polymers.
Filtration and peripherals in biotechnology production all utilize Veradel® PESU. Additionally, Veradel® PESU can be found in medical monitoring and medical diagnostic equipment. This high-performance polymer is specifically utilized in membranes, membrane additives, supports and housing, connectors, valves, clamps, and sensor housings.
- Radel® PPSU
As the highest performing sulfone polymer in its class, Radel® PPSU (polyphenylsulfone) outperforms other sulfone polymers by offering greater chemical and high heat resistance. Radel® PPSU is tested under USP Class VI testing to ensure its ability to retain mechanical properties. Solvay performs USP Class VI testing to ensure Radel® PPSU maintains its mechanical properties following gamma irradiation as it is the preferred method of sterilization for single-use systems in biopharmaceutical processing. Additionally, Radel® PPSU undergoes testing to ensure the high-performance polymer offers great biocompatibility and high resistance to thermal and chemical changes.
Radel® PPSU is used in filtration and peripherals of bioprocessing, specifically in applications including membranes and their additives, supports, and housings, connectors, valves, clamps and sensor housings and are suitable for fill and finish needles, bioreactors and final product bags.
- KetaSpire® PEEK
KetaSpire® PEEK is an ultra-high performance material ideal for limited contact with bodily tissue or fluids. KetaSpire® PEEK is ideal for single-use technology in biopharmaceutical processing with excellent mechanical strength. In addition to excellent biocompatibility, KeatSpire® PEEK is examined for gamma stability under USP Class VI testing, as gamma irradiation is the preferred method of single-use system sterilization. Solvay offers two grades of KetaSpire® PEEK– KT 820 and KT880.
With qualities beneficial throughout filtration and peripherals in biotechnology production, KetaSpire® PEEK plays a significant role in biotechnology production. Some of its specific applications within these areas include membrane support and housings, connectors, valves, clamps, sensor housings & mixing elements and fill and finish needles.
- Ixef® PARA
In addition to being chemically inert, Ixef® PARA has superb tensile and flexural strength compared to any metal substitute in biopharmaceutical processing, specifically single-use technology. With compounds typically containing 50-60% glass fiber reinforcement, Ixef® PARA offers remarkable strength and rigidity. Ixef® PARA offers a low, slow rate of water absorption and ease of processing. Solvay performs USP Class VI testing to ensure Ixef® PARA maintains its mechanical properties following gamma irradiation as it is the preferred method of sterilization for single-use systems in biopharmaceutical processing. These qualities make it ideal single-use systems specifically for non-fluid contact peripheral components in biopharmaceutical processing.
The specific applications of Ixef® PARA include uses in connectors, valves, clamps and sensor housings and components.
USP Class VI Portfolio
- Solef® PVDF
As a fluorinated semi-crystalline thermoplastic, Solef® PVDF offers inherent intrinsic stability that allows it to withstand high temperatures and chemical exposure often found in the sterilization of single-use systems in biopharmaceutical processing. Additionally, Solef® PVDF is easily welded making it capable of thermoforming. This high-performance polymer’s ability to produce hollow fiber, flat sheet and tubular membranes with pore size and separation selectivity makes it ideal for bioprocessing and medical filtration membranes.
Solef® PVDF possesses qualities beneficial across the board in biotechnology production. Some of its specific applications within filtration, peripherals and containment include membranes and their additives, supports and housing, connectors, valves, clamps, tubing, gaskets, O-rings, sensor components and housings, stir rods and mixing elements, bioreactors and final product bags.
Hyflon® Perfluoroalkoxys are semi-crystalline, fully-fluorinated, melt-processable fluoropolymers that offer the greatest chemical resistance of all commercial, melt-processable fluoropolymers. Hyflon® MFA and Hyflon® PFA offer customized performance in order to meet the specific needs of biopharmaceutical processing efficiently.
The specific applications of Hyflon® MFA and Hyflon® PFA include stir rods and mixing elements.