Quality Control for your high quality products
Polycine Advanced Polypropylene (APP) films and tubes for primary packaging are manufactured in a class C cleanroom environment from medical grade raw materials. The entire production process is monitored and controlled online to ensure the highest product quality.
For the registration of our customers’ products, we have compiled Drug Master files ( DMF ) for our products.
Polycine products meet physico-chemical requirements of EP 3.1.3/3.1.6, DIN EN ISO 15747, USP 661 / USP 661.1, and biocompatibility requirements of ISO 10993, and USP Class VI. We have received license approval of China CDE/ NMPA and have lodged US FDA DMF , Type III packaging material as well as Canada Health Master Files.
Our qualified staff is at your disposal to help with registration matters.
Polycine ’s whole manufacturing process is defined within its quality management system, which is certified according to current ISO 9001. Our own test specifications define a complete series of income inspections, visual, physical and chemical in-process as well as process and finished product controls.
All components and processes of your product are optimally configured to ensure high quality production with maximum efficiency and profitability.
Our own technicians will be happy to help you with the configuration of your machine to our product in terms of time, temperature, speed, pressure, etc., to ensure smooth and efficient production.
As specialists in the field of plastics, Polycine ‘s experienced polymer and process engineers are ready to assist you in the development of your customized products.
Our standard material is already registered on the worldwide markets and meets requirements of:
- European Pharmacopeia
- United States Pharmacopeia
- ISO 15747
- ISO 10993
- USP CLASS VI
- ISO 9001:2015 certified
- Chinese CDE / NMPA license
- US FDA, Type III packaging material
- Health Canada Master File