We have our own autoclave within our cleanrooms and can steam sterilise the containers (bags) we fill in-house (e.g. for 15 minutes at 121°C). In addition, we have a validated process for aseptic filling of solutions. Performance evaluations of new products, validation, revalidation and sterilisation safety tests are part of the standard procedures in our company.

We can meet the demand for sterilisation by means of ethylene oxide (ETO) and gamma with the help of cooperation partners. Ethylene oxide sterilisation of products takes place in a validated cycle. Customers are informed about residual gas tests and resulting quarantine times.

Gamma sterilisation usually takes place with intensities of 25-40 kGy. The determination of the required dose can be defined e.g. by means of the VDmax-25 method.

 

 

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