Media Fill Studies
When a health care product is intended to be sterile and cannot be terminally sterilized, aseptic processing provides an alternative. Media fill Studies are performed to validate the aseptic manufacturing process. Media fill studies should be conducted under worst case conditions including maximum processing and filling times, and should include simulation of all aseptic manufacturing processes, including those using previously sterilised components
PRINCIPLE OF TESTS:
There are two distinct situations in which aseptic processing is applied:
- the aseptic preparation and filling of solutions;
- the aseptic handling, transfer and packaging of solid products which cannot be terminally sterilized in their final containers.
Aseptic processing means handling the aseptic filling of product containers and/or devices in a controlled environment, in which the air supply, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. This process requires the pre-sterilization of all product parts or components that are in direct contact with the aseptically filled product.
The product is processed in a controlled environment in which microbial and particulate levels are maintained at defined levels and where human intervention is minimized.
We can assist clients in performing Aseptic Process Validation as required in ISO 13408-Aseptic Processing of Healthcare Products. Studies involve evaluating an aseptic process using a microbial growth medium.
These containers are then incubated at temperature between 20°C -35°C for up to 14 days either at one temperature or two different temperatures. If two temperatures are used, media filled containers are incubated at lower temperature for 7 days followed by incubation at higher temperature for another 7 days. Sampling plans and acceptance criteria are contained in ISO 13408.
- ISO 13408- 1: 2008 (E) Aseptic processing of health care products.
- BP Appendix XVI A / EP Supplement 2.6.1 – Current.