SaniSure Completes State-of-the-Art Extractables and Biocompatibility Testing For Multiple Product Lines

CAMARILLO, Calif., Sept. 28, 2021 /PRNewswire/ — SaniSure, a global developer and manufacturer of single-use technology for the biopharmaceutical industry, announces the completion of a comprehensive extractables and biocompatibility study for many key products commonly used in biopharma manufacturing and development. SaniSure contracted with The BioProcess Institute to conduct a thorough and independent extractables study for many products which were tested in accordance with USP <665> extractables protocols and USP Class VI and ISO 10993 (multiple parts) biocompatibility protocols.

Extractables testing was conducted per USP <665> with three solvents (Ethanol/Water, Acid, Base), and 21-day and 70-day timeframes. The components were qualified based on the current USP <665> draft, which has strong alignment with BPOG’s end-user best practices, with additional testing included to provide the best assessment of the materials’ capabilities. To assess potential extractables based on their intended use, SaniSure’s components were either pre-treated with gamma irradiation (at maximum dose), autoclaved (at 130°C), and/or aseptically welded (tubing), and then subjected to the extraction studies. The test protocols for biocompatibility included USP <87> and ISO 10993-05 for in vitro Cytotoxicity, and USP <88>, ISO 10993-06, -10, and -11 for in vivo testing. This major investment was essential to achieve SaniSure’s goal of enabling customers to conduct advanced and quantitative risk analyses for a broad range of applications.

"We understand that identifying extractable and leachable substances is extremely important to our biopharma customers," said Stefan Schlack, CCO of SaniSure. "When our customers are specifying our product-contact materials into their bio-process, it is critical to have state-of-the- art quantitative data to perform their risk assessments."

The products have also undergone additional physical, chemical, and biological testing to support their use. All studies were conducted by licensed outside laboratories and meet the applicable requirements of CGLP, FDA CFR Part 58, European Pharmacopoeia, ISO, and other special test requirements.

The following SaniSure products were included in the study:

  • PharmaTainerTM PET and Polycarbonate (PC) Containers
  • HDPE and PP Caps for PharmaTainerTM
  • Cap2V8® Molded Bottle Closures
  • Cellgyn® TPE Tubing
  • Pharma-Clear® 65 Platinum-Cured Silicone Tubing
  • Pharma-Clear® LH (Low Hysteresis) Platinum-Cured Silicone Tubing
  • Pharma-Clear® R Braided-Silicone Hose (inner-tubing tested)

SaniSure is a global leader in the design and manufacturing of single-use systems and components for drug and vaccine manufacturing and other biotech applications. With the consolidation of Cellon, Silicone Altimex, TBL Performance Plastics, and Sani-Tech West in to SaniSure, their resources, capabilities, and ability to create value for their customers is unmatched in the industry. Their core manufacturing capabilities include injection molding, injection-stretch blow molding, cleanroom assembly, tubing extrusion, fabrication, and many other proprietary technologies. They offer a wide range of single-use technology products including sterile single-use assemblies, PharmaTainerTM bottles and carboys, Mixed4SureTM mixing solutions, Cap2V8® bottle closures, Pharma-Clear® Silicone Tubing, Cellgyn® TPE tubing, aSURE® fittings and many more. SaniSure has a growing footprint of five manufacturing sites worldwide to provide customers with an unrivaled level of vertical integration and supply-chain security.

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Chris Ray
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