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

The goal of aseptic 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 products is evaluated by 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. Such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on the individual operator proficiency. Operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during a process. Reproducible human performance cannot be assumed over time. These and other challenges posed by manual aseptic processes must be considered when designing the evaluation protocol.

This training course, based on PDA Technical Report No. 62: Recommended Practices for Manual Aseptic Processing, will provide a tutorial of suitable physical techniques, equipment uses, 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 process simulations will be covered.

1. Explain the differences between an automated process simulation vs a manual process simulation
2. Discuss the different environments MAP can be performed in as well as the personnel training requirements specific to a MAP
3. Recognize the application of different equipment used in a MAP and how to handle the challenges of a manual process not presented during an automated process
4. Evaluate a MAP case study