Purillex FEP Bottles
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.
Fluoropolymer bottles are used as single use systems for the freezing and storage of bulk drug substance (BDS), where the properties of the BDS require it to be stored under blast freeze conditions, i.e. down to -70°C. PurillexTM FEP bottles are the first fluoropolymer bottles designed specifically for the biopharma industry, manufactured using proprietary stretch blow molding technology, which produces a much superior seal, without the need for a cap liner. Purillex bottles are also manufactured in an ISO Class 7 clean room, for greatest freedom from particulate contamination, and backed up by internal and external testing and certification. Purillex bottles come with full manufacturing lot certification. An extensive validation binder is available under NDA.