The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. 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 a description of how to address the challenges posed in design, control and evaluation 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.
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 operations should be designed and carried out.
Who Should Attend
This course will be of value to operational personnel who design, carry out and evaluate manual aseptic processing; including personnel involved with compounding, filling, packaging, and quality assurance operations. Support staff, such as engineering and validation personnel will also benefit. The course will be suitable for supervisors and managers as well as personnel engaged in manual processing operations.