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

- TSE and BSE Free

- 10/2011 EC

- 1935/2004 EC

- California Prop 65

- USP 661

 

 

 

- 21 CFR 178: 2010

- 21 CFR 178: 2550

- 21 CFR 178: 2650

- 21 CFR 175: 300

- US CONEG

- Ph. Copeia 3.1.11

 

APET Films

REGULATORY APPROVALS

 

- REACH updated January 2019

- USFDA CFR 21 : 177.1630

- BRC British Retail Consortium

- CONEG limits on heavy metal

 

 - ISO 9001/14001

 - SGS REACH

 - SGS EU 94/62

 - EU 10.2011. Migration