Aseptic Process Simulation/Media Fill Design, Protocols, Failure Investigations and Reports

Microrite’s highly experienced aseptic processing consultants understand the importance of media fill simulation and meeting current regulatory requirements as related to aseptic process simulation. They are well versed in PIC/S PI 007-6, ISO 13408-1, FDA 2004 Aseptic Guidance, EU GMP Annex 1 and principles of contamination control in manufacturing of sterile products utilizing aseptic processes.

Microrite’s experts develop media fill plans and identify aseptic steps that could potentially affect the sterility of the product. This risk based study design approach is considered an equally integral part of the media fill study alongside simulating the filling of containers. The study design is documented in a protocol or procedure that explains the rationale or justification for the planned study elements. The protocols and procedures developed by our experts also provide the reader and personnel executing the study with a thorough and complete understanding of the processes being simulated; including detailed steps and methods to be executed. Once the study has been executed, our experts review the steps taken and results achieved after which they thoroughly, completely and accurately generate a study report to eliminate the need for questions from regulators. We also assist in investigating media fill failures to ensure that all deficiencies are addressed with scientific merit and there is assurance of sterility for batches made subsequent to media fills.