Purillex FEP Bottles
Purillex® FEP Bottles
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 -196°C. Purillex® FEP bottles are the first fluoropolymer bottles designed specifically for the bioprocess 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.
Purillex PFA bottles are available unsterilized, but also now can be supplied autoclaved and individually pre-packaged ready-to-use (RTU). We can also provide porting, tube sets, aseptic connectors and other single-use technologies with the bottles as part of our new Integration Services offering. Please contact Savillex for more information.