BioPure silicone transfer tubing validation summary guide

Validation Summary Guide

BioPure silicone transfer tubing is manufactured in ISO 14644-1 Class 7 cleanrooms according to GMP principles within a facility operating an ISO 9001 quality management system.

Silicone transfer tubing has a number of key features and benefits. These include:

• USP Class VI, EP 3.1.9 compliance testing
• Animal Derived Component Free
• Autoclave and gamma stable
• Lot traceability via labeling and packaging
• Laser-marking available on request

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

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