PFA Stability Vials for Simplified Validation

The adoption of disposables or single-use technology (SUT) in biopharmaceutical manufacturing is growing rapidly. SUT offers improved flexibility, reduced risk of contamination, and lower overall costs. Bags made from laminated polymers are used widely as disposable containers for the freezing and storage of bulk drug substance (BDS). But if the properties of a BDS require it to be stored at –70 °C, then fluoropolymer (perfluoroalkoxy (PFA) or fluorinated ethylene propylene (FEP)) bottles are the only choice because those materials have much wider working temperature ranges. And although SUT bags have been designed for biopharmaceutical manufacturing, the only fluoropolymer bottles available until recently were designed originally for use in the chemical industry.

Savillex’s Purillex™ PFA and FEP bottles are the first fluoropolymer bottles designed specifically for the biopharmaceutical industry.

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