Our validations are conducted in accordance with ISO 11135-1:2007. This defines the physical parameters (gas concentration, residuals, relative humidity, temperature and aeration conditions) as well as the microbiological parameters, that will be required during routine processing.
Andersen Products run the qualifications (installation, operational, performance) for in-house use of a Andersen sterilisers.
Each application will have its own particular requirements. Andersen provides a range of testing services to support our customers.
- Bioburden
- Sterility testing
- Population assays of biological indicators
- EtO residual testing
- Shelf life testing
Product can be packaged in a Class 5 clean room, ready for sterilisation. For purchased items this means a customer receives a complete solution to their sourcing problem.