Overview
Process security; Quick and qualified
Q-Clamp incorporates years of clamping technology experience, into a lightweight sanitary clamp, qualified for use in the biopharm industry.
- Quick, single handed and tool free clamping system
- Compatible with a wide range of connector geometry
- Closure mechanism supports junction validation
- Unique tamper evident identification technology
- Sleek, lightweight design to maximise operator comfort and eliminates any potential of damage to bags or gloves
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
Tamper evident cover
Q-Clamp introduces the first true tamper evident security solution for Tri-Clamp® connections.
The additional component can also be used for identification through colour, allowing procedures to specify relevant areas of the process:
- Can be applied pre or post clamp assembly
- Tool free application and removal
- Available in eight colours; blue, grey, orange, purple, green, red, yellow and clear
Validation
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. For a summary of the validation/qualification testing that has been carried out on Q-Clamp, please see the Q-Clamp 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
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, this is available on request by submitting a validation request form