The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated process simulation testing (media fills). This course, which is based on Technical Report No. 22, Process Simulation for Aseptically Filled Products, will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.
Process simulation testing is expected as part of a firm’s quality system to ensure the sterility of products manufactured using aseptic processing techniques. Participants in this course will come away with an up to date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs.
Who Should Attend
This course will be of value to managers and supervisors involved in the design, operation, evaluation and approval of process simulation testing. This includes persons working in operations, quality assurance, microbiology, and regulatory affairs. Individuals in facility engineering will also benefit from attendance.
Individuals taking this course should have a basic understanding of aseptic manufacturing operations. This is not a course designed to teach the basic fundamentals of aseptic processing.