Quality Control for your high quality products

Product Description

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.

PolyCine GmbH

Country/Region:

Germany
On CPHI since:

2015
Certificates:

2
Employees:

100 - 249

Company types

Manufacturer/Innovator

Primary activities

Packaging materials

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Specifications

Details

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.