Contract EO Sterilization Services
Contract sterilization services
RSD® proposes an advanced treatment for Ethylene Oxide sterilization (EO) for your pharmaceutical or medical products. We offer subcontracting services using Ethylene Oxide (EO/ETO) method.
We fulfill the following regulations:
- EN ISO 11135:2014
- EN ISO 13485:2003
- EN ISO 9001:2015
- ATEX directive 2014/34/UE
The EO installation is composed of one 4 Euro pallet sterilizer, fully ATEX certified, that can be adapted to your sterilization volume.
The chamber is certified to work with a maximum temperature of 55ºC.
In order to optimize cycle time, (and then to reduce sterilization costs), there is a Degassing room for product decontamination, eliminating the EO residuals (ppm’s) inside products/boxes before they are released.
We propose contract sterilization solutions, flexible and adapted to the customer requirements, ensuring the process quality and safety. In addition we fulfil the most stringent international normative and we are environmentally respectful.
RSD® develops customized solutions to their clients
- A cycle validation service adapted to the product technical requirements,
- Ethylene Oxide sterilization routine cycles, (chamber sterilization + separate degassing cell)
- A full report and very well detailed at the end of each sterilization cycle.