Regulatory Compliance

PVC Pharmaceutical Films

All KP Tech PVC films are DMF registered and manufactured in a clean-environment, in accordance with cGMP.

 

REGULATORY APPROVALS

 

- REACH updated January 2019

- 94/62 EC                   - 21 CFR 178: 2010

- TSE and BSE Free   - 21 CFR 178: 2550

- 10/2011 EC               - 21 CFR 178: 2650

- 1935/2004 EC           - 21 CFR 175: 300

- California Prop 65     - US CONEG

- USP 661                   - Ph. Copeia 3.1.11

APET Films

REGULATORY APPROVALS

 

- REACH updated January 2019

- USFDA CFR 21 : 177.1630        - ISO 9001/14001

- CONEG limits on heavy metal  - SGS EU 94/62

                                                 - EU 10.2011. Migration