High purity platinum-cured silicone gaskets – 5000 series
Manufactured and packed within an ISO 14644-1 Class 7 cleanroom, these high purity silicone gaskets are ideally suited for bioprocessing fluid paths. Demonstrating comprehensive knowledge of the materials involved in packaging components, the 5000 series gaskets have a low extractable profile. They are also gamma stable for irradiation up to 50 kGY, and autoclavable.
Product validation performed on post gamma-irradiated gaskets.
Extractable studies have been performed using a multi-solvent approach to BPOG guidelines.
- Laser etched lot numbering for full material traceability (non laser-etched version also available)
- Designed in accordance with ASME-BPE standards
- USP Class VI compliant and animal derived component free (ADCF)
- Compliant with FDA regulations CFR 21 177.2600
- Gamma stable and autoclavable
- Low extractable profile
- Double-bagged and heat-sealed
The 5000 series platinum-cured silicone gaskets and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:
- USP Biocompatibility in vivo and in vitro
- European Pharmacopoeia, 3.1.9
- ISO 10993
Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on the 5000 series silicone gaskets, please download the high purity gasket validation summary guide.
The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form.
BioPure high purity gaskets (5000 series silicone only), its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the compliance guide and is available on request by filling in the form found here.