- 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.
Download summary guide
BioPure Q-Clamp validation summary guide
Validation summary guide PDF - 469.6kb