ALTHOUGH MODERN DRUG PRODUCTION is a highly automated industry, it still requires large numbers of people, some of whom work in aseptic filling areas where they may at times be in direct contact with sterile components and product. Within these aseptic operations, there is the potential for each employee to adversely influence the outcome of a large amount of product. It has been said that one person can make a difference. In an aseptic operation, the risk is that this difference will lead to a negative outcome.

The concern for aseptic operations is not so much that the product will be blended incorrectly or put into the wrong container—although these concerns exist. The more serious concern is that the operator, through actions taken or omitted, may introduce contamination into a product that may ultimatelyharm the consumer.

Effective contamination control is the foundation of a successful aseptic operation, and it begins and ends with the personnel who work in these areas. Effective training is the foundation of personnel compliance, which ultimately leads to effective contamination control. Logically, then, it is not hard to see the important link between contamination control training and successful aseptic production operations.

The Elements of Training
Most definitions of training involve the goal of controlling or modifying behavior. The goal of the trainee is to acquire the knowledge or skills that lead tobehavioral changes.

One of the challenges that trainers face is how to take information and convey it to people in a manner that permanently modifies their behavior. There are several potential approaches for accomplishing this task, but the primary elementsof any successful training program are:

• Clarify the message
• Engage the trainee
• Reinforce the behavior
• Clarify the message