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Fluoropolymer Bottles

Bottles made of fluoropolymer are a high-quality solution for filling, storage and transport of pharmaceutical products. They have an outstanding temperature and chemical resistance and offer an enormous amount of safety, which cannot be archived with alternative solutions.

GMPTEC offers high-purity Purillex® fluoropolymer bottles made by Savillex that consist of the materials PFA or FEP. These bottles fulfill even the highest requirements and secure the quality of your products!

Description

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
  • Autoclavable
  • 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
  • Autoclavable
  • ISO Class 7 Cleanroom Manufacturing
  • cGMP Standards

Details and Information about Purillex PFA Bottles

Purillex PFA Bottles
Bottle Size Closure Type Part Number
50 ml 33 mm 170-01-0050
100 ml GL45 170-01-0100
250 ml GL45 170-01-0250
500 ml GL45 170-01-0500
1000 ml GL45 170-01-1000
2000 ml GL45 170-01-2000

All bottles include a standard plain closure.

Purillex PFA Closures
Closure Type Description Part Number
GL45 Plain Threaded 670-045-01
33 mm Plain Threaded 670-033-01

Details and Information about Purillex FEP Bottles

Purillex FEP Bottles
Bottle Size Closure Type Part Number
50 ml 33 mm 170-02-0050
100 ml GL45 170-02-0100
250 ml GL45 170-02-0250
500 ml GL45 170-02-0500
1000 ml GL45 170-02-1000
2000 ml GL45 170-02-2000

 

Purillex FEP Closures
Closure Type Description Part Number
GL45 Plain Threaded 600-045-02
33 mm Plain Threaded 600-033-02

All bottles include a standard plain closure.

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