by Elaine Kopis
As a trainer, I have found that focusing on standard operating procedures (SOPs) alone, while important, does not benefit an organization as much as providing a holistic approach to training cleanroom personnel.
Control of cleanrooms begins and ends with effective training of the personnel who work within these highly controlled environments. To put it simply, training equals compliance.
It is through training that cleanroom personnel gain an understanding not only of specific job functions but also of the foundational rationale for the restrictions that govern cleanroom operations.
This foundational education should include training in the core competencies required for proper operation of drug manufacturing environments. These core competencies include: Current Good Manufacturing Practices (cGMP) requirements; basic microbiology; particle control principles; and principles of cleaning and microbial control. An understanding of these core competencies will provide a strong foundation for training in other specific practices designed to prevent contamination, such as gowning and aseptic practices.
Current GMPs govern the production of drugs and medical devices. These are the laws they apply to manufacturers. Training in cGMPs is not only a legal requirement but also makes sense from the perspective of enforcing and justifying specific required functions and behaviors.
In many facilities, cGMP training for all full-time employees and even vendors is routine. Current GMP training should include a brief history of the development of the Food, Drug and Cosmetics Act in order to reinforce the need for this legislation and the events that led to the development of these laws. Bringing this historical element to the training program adds a sense of importance to the training and provides a key element of successful training driven by the human element of this storya story that illustrates that lack of appropriate control in drug production can lead to serious injury and death.
Anyone involved in cleanroom operations for drug or medical device products should receive training in basic microbiology principles. The value of this training is that it provides a foundational understanding of the nature of microorganisms, including growth properties and risk factors associated with microorganisms. Compliance is greatest where understanding is complete.
Cleanrooms are classified by particle counts and size. Cleanroom staff should be trained on particle sources and the fact that most microorganisms do not exist as discrete cells, but rather as aggregates attached to particles of some type.
Measures to minimize particle shedding should be addressed during training and through SOPs. These measures should include gowning practices, traffic flow, personnel movement practices and personnel hygiene.
Training should focus on the nature of particles, the sources of particles and prevention of particles. Additionally, the risk factors contributed by particle contamination should be included. This is the issue that ties together the relevant SOPs with the core issues being addressed by the SOPs, namely prevention of contamination.
Nowhere is an understanding of these principles more important than in drug and medical device manufacturing areas. This is especially true of aseptic manufacturing areas. In addition to training on specific job functions and cleaning SOPs, cleanroom personnel should be given an overview of the chemistry of cleaning and microbial control. This will allow for a greater appreciation for the technology involved in cleaning and decontaminationand for the necessity of using harsh and potentially toxic materials.
A thoughtful, holistic approach to training cleanroom personnel, which includes core competencies and job functions, will lead to compliance based on a complete understanding of the issues behind the procedures.
Elaine Kopis is the Director of the Technical Services Department for the Scientific Division of STERIS Corporation. Her focus area is microbial control in cleanrooms and other critical environments. She is a member of the CleanRooms Editorial Advisory Board.