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Quality Standards

PolyCine runs a film and tube extrsion process which is unique in the world an Only special selected raw materials are used for our production and are controlled against strict specifications. The polymer melt is filtered with screen packs and the manufacturing process runs under clean room conditions following GMP requirements.

All critical production processes are on-line controlled. In addition the quality is tracked by a complete series of in-process and finished product tests. The results are reviewed for completeness to PolyCine specifications before release.

 



Regulations

  • PolyCine products meet the requirements of the EU Ph 3.1.3/3.1.6, ISO 10993, ISO/DIS 15747 and USP Class VI
  • PolyCine is ISO 9001:2008 certified
  • PolyCine production process follows the basic standards of GMP
  • PolyCine has received license approval of China SFDA
  • PolyCine has lodged US FDA DMF, Type III packaging material

 

Click to enlarge the DIN EN ISO 9001:2008 certificate.

English
DIN EN ISO9001:2008 PolyCine GmbH Schiffweiler
German
DIN EN ISO9001:2008 PolyCine GmbH Schiffweiler
Chinese
DIN EN ISO9001:2008 PolyCine GmbH Schiffweiler

 


 

Drug Master File

PolyCine describes all products related information necessary for your regulatory affairs process in a DMF. The DMF contains information on materials, formulations, production process, physical-, chemical- and toxicological investigations.