Packaging, Sterilisation and Certification

Packaging With Added Value

Sterilgutverpackung
Example of sterile packaging

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)

Logistical Concepts to Increase Cost Effectiveness

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.

Sterilisation

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 conformity 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.
Zertifikate
Certificates

Certification

RAUMEDIC is able to 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.