A 25-Year Retrospective on Cleanroom Management - Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management." - BioPharm International


A 25-Year Retrospective on Cleanroom Management
Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."

BioPharm International
Volume 25, Issue 10, pp. 22-23


Personnel working in a cleanroom environment require specific training. As an example, if the subject was aseptic gowning, the understanding of the risk during gowning and the cross-contamination to the product, process, and/or patient is important. Since 1988, limit for the allowable colony forming units (CFUs) per plate in qualifications has decreased dramatically. Common training in 1988 included brief training, practice, and qualification. Understanding the sequence of gowning and the techniques for performing gowning are crucial. Training for aseptic gowning must allow for the student to observe the complexities; therefore, the student must perform gowning to become proficient. The training must allow the students to practice. Today, practice requires time.

Electronic or eLearning was becoming popular in 1988, but some facilities lost interest because of an inability to maintain a current program. Many companies did not invest in the time or personnel required to maintain these programs. Some firms have eLearning available but only on a limited basis. The technical support for eLearning is GMP and standard operating procedures (SOPs). Federal regulations do not necessarily change dramatically every year, but hundreds of SOPs do change annually, making change control and management of any eLearning program difficult.

SOP training is performed every day in every cleanroom and controlled environment in all industries. The "read and understand" method of SOP training requires employees to read and sign a training form stating that they understand the information. For some SOPs, this may be sufficient. But for other SOPs, this may not be successful. Some SOPs must be taught and explained. Others will require a demonstration of the task to be performed. One example of this type of SOP would be for the admittance of items into an airlock or pass-thru. How do you sanitize? How do you remove a layer of wrap or bag? How do you unload a cart? How do you clean the cart? The admittance of items is the second largest source of contamination for any cleanroom or controlled environment, yet little time is spent in training on the proper transfer techniques.

Operator turnover is a way of life in many facilities. In 1988, there were many plants that had employees with tenure. Today, many companies are using temporary staffing because of the high benefit package for employees. This environment creates a challenge for the training staff. New employees may arrive on site monthly or, in some plants, weekly. Trainers must be available to handle the basic GMP courses, cleanroom courses, gowning, and the extensive number of SOPs.


What is the cleanroom of the future? The world of nanotechnology will lead us into the next evolution of cleanrooms and controlled environments. The design and operations of cleanrooms and the types of products to be manufactured are far more extensive than anyone could have imagined in 1988. The biopharmaceutical industry is rapidly growing, developing new products for future generations.

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