Market & applicationsLife sciencesAseptic cleanroom training

The problem
The aseptic cleanroom is a mission-critical facility in the pharmaceutical discovery and production processes.

Avoiding contamination is essential to aseptic cleanroom operations. In an ISO Class 5 aseptic cleanroom, no more than 10,200 particles larger than 0.3µm are permitted per cubic meter of air. Given that moving any part of the human body generates 500,000 such particles per minute, maintaining aseptic cleanroom conditions is a significant challenge:

Of the many potential sources of contamination in cleanrooms and other clean manufacturing environments, none is more persistent, pervasive or pernicious than the human beings who occupy them...

Of the many elements of cleanroom operations and processes, humans are the easiest to control, yet contribute the most contamination.

The costs for cleanroom mistakes—in both regulatory and financial terms—can be high. A single interruption of operations can have costs as high as $1 million. With this in mind, the training for cleanroom operators in aseptic techniques is critical. Current Good Manufacturing Practices (CGMPs) issued by the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) call for both initial and ongoing training for cleanroom operators:

Appropriate training should be conducted before an individual is permitted to enter the aseptic processing area and perform operations. For example, such training should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety hazards posed by a nonsterile drug product, and the specific written procedures covering aseptic processing area operations. After initial training, personnel should be updated regularly by an ongoing training program.

The very nature of cleanrooms makes training difficult. Given the potential cost resulting from an interruption of operations due to a simple mistake, training in aseptic procedures within the cleanroom itself is impossible. Students are typically expected to observe cleanroom operations from outside and imitate the aseptic techniques they have seen upon cleanroom entry. In practical terms, this is equivalent to having a student pilot observe a seasoned aviator and then solo without ever having taken the controls.

The solution
Simulation learning provides a solution to this critical problem. Simulation learning includes e-learning solutions based upon computer simulations of real-world facilities, equipment, and processes, and is based on the simple idea that people learn best when they learn by doing.

3Dsolve will apply these same principles to the mission-critical problem of training pharmaceutical industry workers in proper aseptic techniques for cleanroom operations. Using standard, off-the-shelf desktop personal computers, pharmaceutical firms can train their employees using learn-by-doing methodologies, enabling them to practice aseptic techniques before ever setting foot in a cleanroom.