RAUMEDIC offers more than simply packaging with a protective function. The packaging is an integral part of the product. We implement your specific instructions in accordance with DIN EN 868 and DIN EN ISO 11607.
RAUMEDIC offers a large number of packaging options:
- Bulk or individual packaging
- Sterile packaging
- Disposable or re-usable packaging
Our focus is on adherence to standards. In particular, the following standards are central to the packaging process:
- DIN EN 868 and DIN EN ISO 11607 (standard requirements)
- DIN EN 980 (implementation of the labelling of your products according to standards)
- DIN EN 799 (barcode labelling using EAN Code 128)
A strategy for optimum exploitation of the loading area and minimisation of transport and storage costs are essential to the implementation of a good logistical concept. If required, we will work out complete logistical concepts in consultation with you.
Upon request, RAUMEDIC will deliver your products in sterilised form. The preferred sterilisation procedures are ethylene oxide (EO) or gamma irradiation sterilisation. The sterile products are packaged in sterile barrier systems in accordance with DIN EN 868 or DIN EN ISO 11607. In addition, microbiological tests are carried out.
- Ethylene oxide sterilisation (ETO sterilisation)
Validation and revalidation activities regarding sterilisation with ethylene oxide are conducted in accordance with the harmonised standard, DIN EN ISO 11135.
- Gamma irradiation sterilisation (γ sterilisation)
Validation and revalidation activities regarding sterilisation with gamma irradiation are conducted in accordance with the harmonised standard, DIN EN ISO 11137, or AAMI TIR 33, if requested by the customer.
RAUMEDIC can support you by providing documentation for the certification of your product. You can find further details on certification and on our comprehensive quality management system under quality management.