Validation of aseptic processing should include a simulation test using a nutrient medium, known as the media fill or media simulation test. The selection of the nutrient medium should be made based on the quantity of the product produced, and the selectivity, clarity, concentration and suitability for sterilisation. The process simulation test should imitate, as closely as possible, the routine aseptic manufacturing process, and include all the critical subsequent manufacturing steps. Normally process simulation tests should be repeated twice a year per shift and process. The number of containers used for media fills should be sufficient to enable a valid evaluation. For small batches, the number of containers for media fills should at least equal the size of the product batch.
- Ready to use media saves time and decreases the risks associated with media preparation
- Sterility and fertility according to international requirements and guidelines for media fill validation
Certifikace: In compliance with BSE/TSE requirements.