Technical Report No. 62: Recommended Practices for Manual Aseptic Processes

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. Processes using all or partial manual procedures must be evaluated by process verification testing. However, manual operations present unique operational and evaluation challenges not generally encountered with automated operations. For instance, manual aseptic processes rely heavily on individual operator proficiency, which is generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. This and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

Based on PDA’s Technical Report No. 62: Recommended Practices for Manual Aseptic Processes, this training course will provide insight into the technological challenges associated with designing, operating and evaluating manual aseptic processes. 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 at their own plants. Participants will also have the opportunity to design, test and evaluate a protocol to perform a manual process simulation.

1. Discuss the challenges associated with manual aseptic processing
2. Describe the elements involved in the design of a manual aseptic process
3. Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
4. Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
5. Design a protocol for the conduct of a process simulation test for manual processing
6. Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs