Fluoropolymer bottles are used as single-use systems for freezing and storing bulk drug substances (BDS), where the properties of the BDS require it to be stored under blast freeze conditions, i.e., down to -196°C.
Purillex® bottles are the first fluoropolymer bottles designed specifically for the bioprocess industry, manufactured using proprietary stretch blow molding technology, which produces a superior seal without the need for a cap liner. Purillex bottles are also manufactured in an ISO Class 7 cleanroom for the greatest freedom from particulate contamination and are backed up by internal and external testing and certification. In addition, Purillex bottles come with full manufacturing lot certification.
Purillex PFA and FEP bottles can come unsterilized or supplied as autoclaved and individually pre-packaged ready-to-use (RTU). In addition, Savillex has adapted its stretch blow molding process to work with ETFE, producing the Purillex ETFE bottle range. Purillex ETFE bottles also have the same cleanliness and low temperature working range as PFA and FEP but maintain the key benefit of being gamma stable, the preferred method of sterilization within the SUT industry.
As part of our new Integration Services offering, we can also provide porting, tube sets, aseptic connectors, and other single-use technologies with the bottles.
- An extensive validation binder is available under NDA. Please contact Savillex for more information.
- Minimum order quantity of 100 required on all 50 mL - 1000 mL 170 series bottles and quantity of 50 on all 2000 mL 170 series bottles.