Life Sciences: Personnel training


by Douglas Theobald, CFM

The single most critical element of the cleanroom, or any controlled environment, is the human element. In previous discussions, I have referenced the need to control not only the environment but the processes and access in and out of the room, as well as product handling, equipment performance and maintenance. However, the one thing that I cannot stress enough is the importance of the interaction of personnel with the controlled environment.

Close encounters

The effect of the human body on the environment is a dynamic and untamed, almost untamable, encounter. In our cleanroom training sessions we place a majority of the emphasis on the effect of the human body on the environment. Much of the “control” is designed to minimize the exposure of products to harmful contamination. The contamination can range from larger, visible particulates such as hair, skin flakes, lint, etc., to microorganisms. Larger contaminants can cause problems in performance of computer chips or medical devices and even obscure the vision of pilots (in the case of protective coatings for airplane windshields). Microorganisms and biological excursions can contaminate compounded sterile preparations (CSPs), implantable devices and even experimental organic “switches and sensors.” Because of the proximity of the technician to a sterile preparation there is a need for substantial training in the area of handling as well as the need to verify the efficacy of the CSP. USP 797 restates the need for personnel to have “appropriate, expert training from professionals; including audio-video sources and professional publications.” To the best of my knowledge, technicians performing compounding today have received considerable “accredited” training prior to entering the field. While this is appropriate and necessary, there is more to understanding how we affect our environment.

Looking back

In a previous article entitled “Contamination sources-control and remediation” (see CleanRooms, August 2004, page 12), I made the following statement: “The term ‘human factor’ refers to an awareness of how our activities either enhance or devalue the quality of a compounded sterile preparation (CSP) and/or product in a controlled environment.

The USP 797 calls for stricter adherence to personnel hygiene, additional gowning components, gowning procedures, standard operating procedures and documentation verifying training and adherence to protocol. It is essential that all personnel working in the environment or coming in contact with the “product” are thoroughly trained in correct behavior and product handling.

The training elements will vary slightly based on product, material flow, equipment and room design.” Next to GMP, personal hygiene is the most critical element for the technician working in a controlled environment. There are some obvious practices such as not wearing make up, jewelry, and hair gel or spray; but others may not be so apparent. If you have animals (animal hair) or live in a particularly dusty area, this can also affect the potential for “cross-contamination.” Here are some examples that we use in our training: “A person speaking normally can send particulate and biological contamination (saliva) a distance of 2 to 3 feet, coughing (saliva and lung tissue) 4 to 6 feet, and sneezing 10 to 15 feet at a speed of up to 200 mph!”-hence the need for protective covering over the mouth and nose. An important part of the training and auditing program would be to verify the proper donning of gowning materials. Planning your activities to minimize movement is also important. A person standing motionless can generate 100,000 particles 0.3 micron and larger, while a persomoving at 2 to 5 mph can generate 10,000,000 particles 0.3 micron and larger. Some time ago, Eastman-Kodak performed a study on the use of tacky mats. They found that a person stepping one time on a tacky mat will remove approximately 55 percent of the friable, or potentially airborne, particulates from the bottom of his shoes, while someone stepping five times will remove as much as 95 percent. The point of the information I have just shared is to illustrate the fact that a good training program witH a focus on awareness can not only improve the quality of product (in this case CSPs) but also limit potential liability.

Planning ahead

USP 797 gives frequency guidelines of annual media fill tests for low to medium risk level CSPs, and every six months for high risk level CSPs. In addition to these critical practices, technicians should receive environmental training (gowning, behavior in a controlled environment, contamination control practices, etc.) on an annual basis at a minimum. Often we assume that because we have been trained previously it is not necessary to “re-train.” However, it is easiest to develop bad habits with the things that we do every day. A well-documented plan for training should be established as early as possible. If you are in the industry, you understand the importance of documentation for tracking and verifying activities. The training program should also include periodic scheduled and nonscheduled audits. Set a standard for each operation and activity, train technicians in good practices and then verify that the standards are being maintained.

Food for thought

I asked Tom Gonzales, one of our supervisors, what he thought was the most critical element of maintaining a “contamination-free” environment and his response was two-fold: “The first would be understanding the many variants of contamination and how they are potentially introduced into the environment, and second, the awareness of the critical nature of the activities or processes that are taking place in the controlled environment (i.e., how it affects the health and well-being of the recipients of the final product).” Much of what we have discussed this time has been a useful segue into the next topic of discussion, “micro-cleaning”-what it is, how it is done and why we do it. III

Douglas Theobald is a consultant and general manager with Controlled Contamination Services LLC (San Clemente, Calif.). He can be reached at dtheobald@cleanroom