PendoTECH has developed sensors for single-use biopharmaceutical continuous processing applications using Solvay’s Udel® P-1700 polysulfone (PSU) polymer.
Through Udel P-1700 PSU, PendoTECH said, it has created biocompatible, transparent housings for a family of sensors intended for use in single-use biopharma development and manufacturing applications. PendoTECH’s single-use products are designed for discrete, inline measurement of pressure, temperature, conductivity, ultraviolet absorbance, and turbidity.
Because it is moldable and transparent, Solvay said, Udel P-1700 PSU allows PendoTECH’s sensor housings to provide better ease of use than stainless steel housings, in addition to thermal and chemical resistance and dimensional and hydrolytic stability.
PSU is compatible with both steam autoclave and gamma irradiation sterilization—giving it an advantage over transparent polymers, according to Solvay.
Udel P-1700 PSU is certified under United States Pharmacopeia (USP) Class VI test standards, both before and after gamma irradiation, helping to ensure that the molded housings used in PendoTECH’s sensors meet the industry’s stringent requirements for biocompatibility. Solvay’s PSU has also been tested under ISO 10993 biocompatibility standards for cytotoxicity, irritation, and acute systemic toxicity.
PSU is one of two materials used by PendoTECH as alternatives for different customer applications; the other is polycarbonate. However, PSU offers better chemical compatibility, including compatibility with sodium hydroxide, according to PendoTECH.
Single-Use Bioprocessing Market Growing
The market for global single-use bioprocessing systems has been projected to more than double from $2.3 billion in 2015 to $5.9 billion by 2024, according to a Transparency Market Research study published last year. That study foresaw a compound annual growth rate of 11.1% during its study period, though TechNavio has projected a much more robust 34.38% compound annual growth rate (CAGR) through 2019.
And as GEN recently reported, single-use sensors have gained widespread acceptance by offering the same ease of use and convenience as other single-use assembly components, while providing the accuracy and robustness of traditional measurement techniques.
“The shift toward single-use systems requires higher performing polymers, like those from Solvay that offer viable alternatives to traditional reusable metal parts,” Dennis Annarelli, Ph.D., technical and quality manager at PendoTECH, said in a statement. “Due to the success and performance of our sensor products, PendoTECH intends to continue using Udel PSU polymer in a range of new sensors and other products under development.”
The use of Udel P-1700 in PendoTECH’s sensors was one of two Udel-related announcements today by Solvay. The company also said Udel was one of its five product families from which it has assembled a new portfolio of medical-grade specialty polymers for single-use biopharmaceutical manufacturing applications. The other four families are Radel® polyphenylsulfone, AvaSpire® polyaryletherketone, KetaSpire® polyetheretherketone, and Ixef® polyarylamide.
Solvay said its portfolio was designed to help biopharmaceutical manufacturers achieve greater flexibility, faster product development, lower capital costs, and faster speed to market by supporting the industry’s shift toward single-use peripherals, filtration, bioreactors, and containment.
Solvay’s announcements come during BioProcess International Conference and Exhibition, which runs through Thursday at the Hynes Convention Center in Boston.