• Validation summary guide

BioPure Q-Clamp validation summary guide

Validation - Q-Clamp sanitary Tri-clamp

Q-Clamp is supported by an industry leading validation package for non-wetted components and meets current industry requirements including ISO 10993: Parts 5, 6, 10, and 11, USP <88> & USP <87>.

  • Suitable for sterilisation by autoclave or gamma irradiation
  • Lot traceable from material to final product
  • Pressure rated up to 7 bar
  • Manufactured and packed in an ISO Class 7 cleanroom

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.

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

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



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BioPure Q-Clamp validation summary guide

Validation summary guide PDF - 469.6kb

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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.

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