• Validation summary guide

泵sil validation summary guide

泵sil platinum-cured silicone tubing

泵sil and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:

  • USP Biocompatibilityin vivoand invitro
  • European Pharmacopoeia, 3.1.9
  • ISO 10993
  • EC 1935/2004

Additional testing carried out includes extractables testing.

The full validation guide including additional information regarding test methods and actual test reports is available on request.

泵sil, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the Pumpsil compliance guide.

泵sil additionally complies with the legal regulations laid down in theRegulation (EC) No. 1935/2004. The declaration of compliance can be foundhere.

Both the full validation guide and the compliance guide can be requested by submitting the below form.

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泵sil validation summary guide

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Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTS.