Ethylene oxide sterilisation
One of the most modern and environmentally friendly ethylene oxide (EO) sterilisation plants in Europe.
pfm medical msg offers a very reliable top quality sterilisation service for industrial clients from the fields of
- pharmaceuticals - to sterilise plastic packaging for medical products and medicines
- medical devices - to sterilise products that cannot be exposed to the high temperatures used in conventional steam sterilisation and are not suitable for sterilisation by irradiation
The service, which is quality assured in accordance with the most stringent international standards, includes
- the EO sterilisation process using negative pressure, gentle on the product and the environment,
- post-conditioning for extremely low residual gas levels – sometimes below the detection limit.
When products come close to people, or are inserted into them, sterility is an absolute necessity to ensure safety and tolerability. Therapeutic items cannot be allowed to introduce a bio burden into the treatment process. Sterilisation reduces the microbial burden to zero.
As medical products are becoming ever more complex and are often made from several different materials, this means that an increasing proportion can only be sterilised with ethylene oxide.
Cold sterilisation with ethylene oxide
EO penetrates both the packaging and the product itself, killing any microorganisms left over from the manufacturing process. Unlike sterilisation with steam or heat, EO sterilisation is a chemical process that prevents protein metabolism in bacteria and other microorganisms. It does not require high temperatures, making this form of sterilisation ideal for plastics.
We operate two separate fully automatic sterilisation plants. They represent the state of the art, with separate areas for preparation, actual sterilisation and degassing.
- Gentle sterilisation at low temperatures with almost no mechanical, physical or lasting chemical effects
- Precise temperature regulation throughout the cycle
- Dedicated client specifications for individual product treatment
- Very environmentally friendly because all modern environmental requirements are incorporated into the process itself
- Strict quality control certified in accordance with DIN EN ISO 13485
The service chain
Development of specially adapted sterilisation cycles via a certified quality management system from first contact up to implementation.
1. To help us prepare a quote please provide the following details:
- expected annual quantity
- product type: medical product, packaging, other
- required mode of delivery: Euro pallet, paperboard container, other
- packaging type: paper, Tyvek, film, vacuum packaging, other.
2. You will receive a detailed quote on:
- the cost of validation (once-only)
- routine Sterilisation.
3. You place an order.
4. We prepare a validation plan for approval by your validation authority.
5. Validation is carried out.
6. You receive a validation report.
7. You approve the report.
8. Moving on to routine sterilisation.
Sterilisation service. Find out what’s in it for you!
We’ll be glad to give you comprehensive and individual advice.
Mr Giuseppe Coccimiglio
T +49 6873 9011-0