Aseptic Process Validation /
Media Fills
Aseptic process validation is used verify that the manufacture of sterile products using aseptic processes can be performed without introduction of contamination to the product. We have aseptic process validation experts that can design a validation program to validate your aseptic manufacturing process. We have completed numerous aseptic process validation studies for the processes used to manufacture products that are unable to be terminally sterilized. We have extensive experience designing and executing aseptic process simulations for final formulation and fill/finish processes including processes for lyophilized products.
We can also develop a validation program for your facility that includes policies and procedures for the validation and re-certification of your aseptic processes. We are adept at using a risk based matrix approach to qualify multiple processes under the same aseptic process validation study.
Our programs are designed to comply with the FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice.