Manufacturers of medical devices must meet ever higher standards to ensure the safety and efficiency of their products. These specifications require controlled production conditions – as your packaging partner, we can also guarantee this thanks to our cleanrooms.
In order to deliver the quality you need, we manufacture our products in state-of-the-art cleanrooms. We also ensure consistently high standards via our certified quality management system in accordance with EN ISO 13485.
To ensure we can supply clean packaging systems for your products, we manufacture within a strictly controlled environment that complies with cleanroom classification ISO Class 9 (EN ISO 14644-1) and ISO Class 8. In addition, our comprehensive standard product range is manufactured within the framework of EN ISO 9001.
Our cleanrooms are located at our headquarters in Hergensweiler (Germany) and in California (Pennsylvania, USA). We also offer production in a clean environment at our location in Sorocaba (Brazil). Naturally, we use medical grade materials to meet our customers’ exacting demands. These include, in particular, common materials such as PETG, PE, PP and TPE.
At our location in Hergensweiler (Germany), rose plastic medical packaging is certified in accordance with the following international standards:
- EN ISO 13485, Quality management systems for medical devices
- DIN EN ISO 50001, Energy management systems
- DIN EN ISO 14001, Environmental management systems
- DIN EN ISO 9001, Quality management systems
Our current, valid certificates can be found in our download area.