ValPlus™ – Confidence Through Validation
July 01st, 2017
Saint-Gobain’s Life Science Business Unit, the trusted leader in Single-Use components and assemblies for bioprocessing, introduces another industry first capability for critical fluid applications: the ValPlus™ Family of tubing products.
ValPlus™ products are available with an enhanced level of validation documentation, including USP <788> for Sub-visible Particulates; USP <85> and <161> for Endotoxin; and ISO 11737 for Bioburden, providing the highest level of assurance of cleanliness and compliance to industry guidelines for critical fluid processing applications.
"We recognized that there was a clear need in the Single-Use space for fluid handling components that were available with a greater level of quality certification, especially as it relates to the cleanliness of the product for biopharmaceutical processing steps. Our ValPlus™ family of products provides a higher level of quality assurance, and because we are able to offer this on our existing products, we believe it can be readily adopted without additional validation testing by our customers." said Steve Maddox, General Manager for Saint-Gobain’s Life Sciences Strategic Business Unit.
The fluid path of the tubing has been validated using a single, normal ANSI Level II sampling plan to meet the sub-visible particulate, endotoxin and bioburden requirements outlined in USP <788> , USP <85> and USP <161>, and ISO 11737. Further, an annual testing program has been established to routinely monitor compliance to these test specifications. The annual testing program is available for review during an onsite audit. "It was important that our validation claims are statistically substantiated by data that has been acquired through industry accepted test protocols." said Tony Perovsek, Worldwide Validation Manager within the Saint-Gobain Quality, Regulatory and Validation Group.
ValPlus™ certification is now available for select sizes and formulations of industry leading brands, including C-Flex® and Sani-Tech® tubings and hoses, with a plan to expand the ValPlus™ service to additional product families, including PharmaPure® and PharMed® TPE tubing products, as well as Sani-Tech® Ultra® silicone products.
About Saint-Gobain
Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in many industrial applications. They provide comfort, performance and safety while addressing the challenges of sustainable construction, resource efficiency and climate change. With 2016 sales of €39.1 billion, Saint-Gobain operates in 67 countries and has more than 170,000 employees. Saint-Gobain Performance Plastics is headquartered in Solon, Ohio, and employs more than 6,000 employees in 22 countries. It is a world leader in high-performance plastics, including flexible tubing, seals, coated fabrics, foams, window film, barrier/release films, tapes, medical components, fluid handling systems and bearings.
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Contact
Aaron Updegrove
Marketing Director, Saint-Gobain Bioprocess Solutions
aaron.updegrove@saint-gobain.com