Purillex ETFE 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® bottles are designed specifically for the bioprocess industry, manufactured using proprietary stretch blow molding technology, which produces a much superior seal. 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.
ETFE is a fluoropolymer with the same cleanliness and low temperature working range as PFA, but has the key benefit of being gamma stable. Gamma irradiation is the preferred method of sterilization within the SUT industry. Savillex has adapted its stretch blow molding process to ETFE, producing the new Purillex ETFE bottle range. Bottles are supplied double-bagged and gamma sterilized RTU, or can be provided with porting, tube sets, aseptic connectors and other single-use technologies with the bottles as part of our new Integration Services offering.
An extensive validation binder is available under NDA. Please contact Savillex for more information.
Features
Specifications
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Compared with the traditional extrusion blow molding process used to manufacture all other fluoropolymer bottles, stretch blow molding produces a better seal, even at extreme low temperatures and allows the bottles to be produced inside a Class 7 cleanroom. A full 2.5 thread turns gives Purillex bottles greater thread engagement than any other fluoropolymer bottle and allows the large GL45 closure to be tightened more securely, eliminating the need for a cap liner and ensuring long term seal integrity. The smooth, injection molded inner neck shape and the absence of burrs, flash or other molding imperfections on the lip of the bottle allow controllable, drip-free pouring and complete removal of contents.
- Pre-sterilized (autoclaved), RTU
- Available as a RTU assembly – see Integration Services
- Manufactured specifically for bioprocess applications
- Extensive USP test certification and full manufacturing lot certification
- Ships with Certificate of Conformance
- Bottle includes a 33 mm closure with lugs
- For lab/trace metal applications see our 150 series bottles
