Information about Fluoropolymer Bottles
Fluoropolymer bottles are especially suited for critical applications and processes in which highly expensive drug substances and final products are being filled and flash frozen via liquid nitrogen afterwards. Due to the Purillex® bottles enormous temperature resistance of -328 °F to 392 °F, they can withstand the freezing process without any problems, protect against expensive loss of batches and do not have any negative influence on the product quality. Alternatively, the bottles can be used for batch-wise retention sampling and storage. This assures that the samples will not be affected by external factors, which could adulterate the results.
Purillex® bottles made by Savillex are being manufactured by a special stretch blow molding process. This innovative manufacturing processes allows to accomplish a very high product quality and manufacturing accuracy. The bottles have a non-stick surface and no ridges or indentations, which allows complete drainability.
Both, the bottle and the closure, are made of the exact same FEP or PFA material and assure that there is no material mix for Purillex® products, which is a common issue for many bottles with closures. Unlike other bottles, the closures of the Purillex® bottles have a thread with multiple turns that highly increases the safety and perfectly seals the bottles. Due to their special design and highly precise manufacturing process, the bottles do not require a gasket within the closure.
The used material has been tested extensively and complies to the requirements of the USP Class VI as well as many other regulations. The bottles have outstanding extractables and leachables values, are pressure tested before shipment and nearly completely break-proof due to their robust design.
Purillex® fluoropolymer bottles feature a shelf life of 5 years from date of manufacture, which allows to perfectly stock larger quantities. We will gladly take care of keeping your personal stock of bottles in our storage and ship required materials to your facility within 48 hours. This allows you to save precious storage space, budget and administrative expenses!
The bottles are available in sizes from 50 – 2000 ml and can be equipped with several different types of closures. Further information and part numbers can be found in the product tabs.
Of course, our high purity fluoropolymer bottles can also be delivered as customized bottle assemblies. This means that the bottles will be equipped with tubing and connectors according to your individual requirements. This allows you to easily integrate a completely closed bottle into your existing processes.
Further information related to this can be found on the product page “Bottle Assemblies” or you just reach out to us and send your inquiry!
Features and Properties
- High Temperature Resistance
- High Chemical Resistance
- Extremely High Material Purity
- Low Extractables & Leachables
- Suitable for Freezing Applications
- Full Drainability
- „Drop Proof“
- No Material Mix
- Leakproof Testing
- Validation Binder available
Processes and Applications
- Single-Use Assemblies
- Filling Applications
- Flash Freezing Applications
- Transport and Storage
- Retention Sampling
- Bulk Drug Substances
- Drug Development
Conformities and Properties
- FDA 21 CFR 177.1550
- BSE/TSE Free
- USP <88> Class VI Biological Reactivity
- USP <87> Cytotoxicity Test
- USP <85> Bacterial Endotoxins Test
- USP <788> Particulate Matter in Injections
- USP <661.2> Physiochemical Tests of Plastics
- USP <891> Thermal Analysis
- Certificate of Conformance
- Batch Tracebility
- ISO Class 7 Cleanroom Manufacturing
- cGMP Standards