The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. For large scale automated operations where operator interventions are infrequent, the verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated media fills in a manner analogous to normal production. Processes using all or partial manual procedures must also be evaluated by process verification testing. However, such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on individual operator proficiency. However, operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. Reproducible human performance cannot be assumed over time. These and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

This course will provide valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operation should be designed and carried out.

This course will provide a lab-based tutorial of suitable physical techniques, equipment use, and processing operations that can be used to address the challenges posed in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

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