Packaging, Sterilisation and Certification

Packaging, Sterilization and Certification

Packaging With Added Value

As to packaging, RAUMEDIC offers more than simply 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 the adherence to standards. The following standards in particular are central to the packaging process:

  • DIN EN 868 and DIN EN ISO 11607 (standard requirements)
  • DIN EN 980 (implementation of the labeling of your products according to standards)
  • DIN EN 799 (barcode labeling using EAN Code 128)
  • Example of sterile packaging

Logistical Concepts to Increase Cost Effectiveness

A strategy for the optimum exploitation of the loading area and minimization of transport and storage costs are essential to the implementation of a good logistical concept. If required, we will work out, in collaboration with you, a comprehensive logistical concept.

Sterilization

Upon request, RAUMEDIC will deliver your products in sterilized form. The preferred sterilization procedures use ethylene oxide (EO) or gamma irradiation. 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 sterilization (ETO sterilization) Validation and revalidation activities regarding sterilization with ethylene oxide are conducted in accordance with the harmonized standard, DIN EN ISO 11135.
  • Gamma irradiation sterilization (γ sterilization) Validation and revalidation activities regarding sterilization with gamma irradiation are conducted in accordance with the harmonized standard, DIN EN ISO 11137, or AAMI TIR 33, if requested by the customer.

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.