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 sterilised 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-sterilisation 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 minimised.
 
Eurofins BioPharma Product Testing New Zealand can perform aseptic process validation as required by ISO 13408 - Aseptic Processing of Healthcare Products. Studies involve evaluating an aseptic process using a microbial growth medium.

Turnaround time

14 days.

Get in touch

Would you like to find out more about our testing solutions, or do you need tailored analytical support? Contact us today to get in touch with our experts.

Contact us