The adoption of disposable, or single-use technology (SUT), in biopharmaceutical manufacturing is growing rapidly. SUT offer improved flexibility, reduced risk of contamination and lower costs. Bags made from laminated polymers are widely used as disposable containers for the freezing and storage of bulk drug substance (BDS), but where the properties of the BDS require it to be stored at -70°C, fluoropolymer (PFA or FEP) bottles are the only choice due to their much wider working temperature range. And while single-use bags were purposely designed for biopharma manufacturing, the only fluoropolymer bottles available were originally designed for use in the chemical industry. Savillex’s PurillexTM PFA and FEP bottles are the first fluoropolymer bottles designed specifically for the biopharma industry. For full details, download the technical note at the bottom of this page. Below are some of the features that make them the best choice for use in bioprocessing.
Savillex offers a range of PFA stability vials in support of biopharmaceutical process validation through stability testing programs. Produced using the exact same resin manufacturer and resin grade as our Purillex PFA biopharma bottles to support regulatory filing. Savillex stability vials also come with full manufacturing lot certification.