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 (polyether ether ketone) 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 (polyarylamide) 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 (polyvinylidene fluoride) 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® PFA & MFA®
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.