FEP Bottles

Description

Information about FEP Bottles

GMPTEC is the German-speaking partner of Savillex and offers a range of high-purity fluoropolymer bottles and vials under the brand name Purillex®. These bottles excel due to their very high temperature and chemical resistance, which cannot be archived by alternative products.

Depending on the application and specific requirements, there are three different materials available:

• PFA – autoclavable
• FEP – autoclavable
• ETFE – gamma sterilizable

Purillex® FEP bottles are especially suitable for critical applications and processes, in which valuable drug substances and final products are being filled and afterwards frozen by using liquid nitrogen. Due to their high temperature resistance of up to -200 °C to +200 °C, these bottles can be frozen without any problems. They don’t have any negative impact on the product quality and help to prevent costly loss of produced batches. The bottles and vials can also be used to keep and storage retention samples. This assures that the sample is not affected by uncertain factors, which could lead to the corruption of test results.

All Purillex® bottles made by Savillex are produced in a special stretch blow molding process. This innovative production process allows to reach a very high product quality and manufacturing accuracy. All bottles have a non-sticking surface and a smooth transition to the bottleneck, which allows to completely empty the bottle. This also means that the bottles can be cleaned very effectively. This is a very important factor, especially when the fluoropolymer bottles are being used multiple times, because it minimizes the risk of contamination from residues.

Both, the bottle and closure, are made from the exact same FEP material. This assures that there is no material mix when using Purillex® bottles, like it’s the case for almost every other bottle with closure. The closure of the Purillex® bottles has more threads than a regular bottle, which increases the process safety and seals the bottle perfectly. Their special design and the precise manufacturing process eliminate the need for an additional gasket within the closure.

Purillex® bottles made of FEP have a high temperature resistance and a material working temperature range of -200 °C to +200 °C. This is much higher than other commonly used plastic bottles, which will reach their temperature limit much earlier and therefore cannot be used for certain processes.

The used FEP material is extensively tested, certified, complies to USP Class VI and a vast number of other regulations. The bottles have outstanding leachable and extractable values and are nearly unbreakable due to their robust design. Validation data and test reports are available upon request.

Purillex® FEP bottles are available as pre-autoclaved ready-to-use version upon request. The sterilization process has been validated and allows to certify a sterility assurance level of 10^-6. All batches of pre-sterilized bottles will be tested for bioburden, endotoxins according to USP <85> and particulates according to USP <788>. Each bottle is individually double bagged.

The complete Purillex® data sheet can be found here.

Features and Properties

• High Temperature Resistance
• High Chemical Resistance
• Extremely High Material Purity
• Low Leachables & Extractables
• 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 Applicatisons
• 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