In our cleanrooms, we have our own autoclave 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. The performance evaluation of new products, validation, revalidation and sterlilisation safety tests are part of the standard procedures in our company.
We can meet the demand for sterlilisation by means of ethylene oxide (ETO) and gamma with the help of cooperation partners.
The ethylene oxide sterlilisation of the products takes place in a validated cycle. The customer is informed about residual gas tests and resulting quarantine times.
Gamma sterlilisation 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.