• 验证总结指南

PureWeld XL validation summary guide

PureWeld® XL - high performance TPE tubing

PureWeld® XL - high performance TPE tubing is supported by an industry leading validation package and meets current industry requirements including:

  • Meets or exceeds USP Class VI requirements
  • Meets or exceeds ISO10993-1 requirements
  • Meets or exceeds FDA regulations CFR177.1810 for contact with foods
  • Full compendial data to USP <788> for sub-visible particulates
  • EP 2.6.14, USP<85> for bacterial endotoxins, ISO 11737-1 for Bioburden
  • Animal-derived content free (ADCF)
  • Suitable for sterilisation by Gamma irradiation

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.

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

PureWeld XL additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004.

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

 

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PureWeld XL validation summary guide

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免责声明:您在此同意所提供的验证指南仅供个人使用,以协助验证指南中列出的产品鉴定。

您还同意,未经 WMFTS 事先同意,您不得复制、重新分发、传输、转让、出售、传播、出租、共享、出借、修改、改编、编辑验证指南或将其转交给任何其他方。