Regulatory Affairs

For the registration of our customers product we have compiled a Master file (DMF) for most APP products. PolyCine products meet the requirements of the EU Ph 3.1.3/3.1.6, ISO 10993, ISO/DIS 15747 and USP Class VI. We have received licence approval of China CFDA and have lodged US FDA DMF, Type III packaging material.

Most APP formulations have been tested thoroughly according to the respective pharmacopeia and ISO tests. Our qualified staff is at your disposal to help with registration issues and provide the customer with all necessary documentation.

Interested in PolyCine products?

Please contact our sales team:

Christian Kunz Head of Sales and Marketing

Christian Kunz
Head of Sales & Marketing

Phone: +49 6821 964 77 0
E-mail: sales@polycine.de

PolyCine High Quality Products

Filling Tubes

APP107 IV-bag Filling Tubes are Multilayer Polypropylene based, for TPN, Infusion, and Dialysis solution bags.
Drainage

The APP-200 is a polypropylen based, special anti-blocking film that is suitable for various applications as for instance CAPD drainage bags, urological collection systems or wound drainage devices.
Port Granule / Medical Compound

PolyCine also offers a polypropylen based medical compound for ports. The APP-147 compound is designed to be used in combination with APP film and tubing. It is suitable for the injection molding process.
Overwrap Packaging

PolyCine's APP overwrap films are designed for the protection and overwrapping of sterile solution bags.
Hot Stamp Transfer Foil

For optimum performance in hot-stamping foil technology we recommend this high-grade product. It is widely used in the pharmaceutical industry and produces superior prints.
Nutrition

PolyCine’s polypropylen based APP-series provides high-quality films and tubes for parenteral nutrition. Here, the requirements for the packaging depend mostly on the type of solution and the method of sterilization.
IV and Pharmacological Applications

The flexible IV bag provides many advantages compared to the common glass bottle or blow molded plastic container. It is light, easy to handle, carry and store and – most important – collapsible which makes air vents redundant.