Quality Control for your high quality products

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

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Manufacturer/Innovator
Primary activities
Packaging materials
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.

PolyCine GmbH

  • DE
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Manufacturer/Innovator
Primary activities
Packaging materials

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PolyCine GmbH resources (1)

  • Whitepaper The Pharmaceutical Post N°13

     Do you know what it takes to package Intravenous drugs?

    Find out from our Head of Sales & Marketing, Christian Kunz how PolyCine is reshaping the future of IV-Drug Product Development and Innovation.


    You can check out the complete digital version of The Pharmaceutical Post 13 on the official website:http://thepharmaceuticalpost.com 
    Thank you Sylvie Ponlot for the feature.