Manufacturers of disposable systems for biotechnology applications choose PSU instead of PC to improve heat and chemical resistance. #processorsedge

Contributed by Lily Manolis Sherman

Polysulfone (PSU) is being used by SaniSure of Camarillo, California to manufacture custom three-clamp viewers for bioprocessing applications, after tests have shown that it performs better than polycarbonate. SaniSure is a global company that provides new disposable fluid systems and components for drug and vaccine manufacturing and other biotechnology applications. It chose transparent Udel P-1700 PSU resin from Solvay Specialty Polymers to achieve excellent strength, transparency, Heat resistance, hydrolytic stability and maintain mechanical properties under steam sterilization.

SaniSure's new three-clamp observer made of Udel P-1700 PSU claims to have high temperature stability and excellent chemical resistance.

SaniSure's capabilities include thermoplastic and thermoset extrusion, molding, assembly and manufacturing. Examples of its products include disposable components, bottles, pipes, fittings and manufacturing.

In addition to the transparent Udel P-1700 PSU (which is extruded into a disposable tube scope), SaniSure also selected the opaque white Udel PSU grade for the connection between the scope and the pipes used in various key bioprocessing applications . The product is overmolded onto the observation gauge by injection molding, in which the sanitary gasket is fixed together with the mechanical clamp. These materials do not contain any animal-derived ingredients (ADCF) and meet USP Class VI and ISO 10993 biocompatibility requirements.

Robert DuPont, product development manager of SaniSure, believes that Udel P-1700 PSU is a major breakthrough in the pharmaceutical industry. "A key factor in choosing Udel P-1700 PSU resin is Solvay's strict regulatory testing, especially for extractables and leachables under BioPhorum Operations Group (BPOG) standards. Solvay is the first to provide these data to its customers Based on the excellent performance of Udel PSU resin and our fruitful cooperation with Solvay, we plan to extend the use of this material to new products currently under development,” DuPont pointed out.

According to DuPont, PC was initially considered for use in this product, but due to various limitations, including sensitivity to stress cracking and fogging, and lack of chemical compatibility with cleaning-in-place (CIP), it was used in test applications Underperforming chemicals commonly used in biopharmaceutical applications. DuPont said: "After many extensive tests, we found that Solvay's Udel PSU is more suitable for our application. Several notable features of this material are its high temperature stability (240 F) and excellent chemical resistance. It is also widely used. Used in other biopharmaceutical products and has a good track record in the industry."

DuPont pointed out that for decades, SaniSure has developed many proprietary methods for processing PSU and has a wide range of special processing equipment for PSU materials, which has greatly accelerated the development process of this product. He pointed out that Udel PSU can also create smooth walls, which is essential for the transparency of the product and always maintain the required large outer diameter.

DuPont added that due to the critical nature of the application, SaniSure believes it is important to use the best available materials. "Therefore, cost is not a very important factor in the design process. The cost of materials used in such products often only accounts for a small part of the total cost. This is partly due to the extensive quality control and quality assurance involved in the production of products. Procedure. However, Solvay’s Udel PSU does promote an efficient manufacturing process with very little waste."

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