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 most APP products. PolyCine products meet physico-chemical requirements of Ph.Eur. 3.1.3/3.1.6, ISO/DIS 15747, USP 661, and 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.