Eliminating Ferrous Contamination In Critical And Sterile Equipment Maintenance

By Brian Pekarsky

Although the pharmaceutical industry today is a highly automated industry, key decisions are still made by individuals. What equipment you procure, which employees you hire and how well you train them are all important factors that will have a significant effect on achieving efficient production. In critical and sterile processing, even seemingly small decisions can affect productivity and compliance with regulatory standards. As a decision maker, your responsibilities are to identify all possible sources of contamination in your Cleanroom facility and maintain efficient production. Once a source of contamination is identified, you need to eliminate it at the lowest cost without compromising the integrity of the process. But, if it were as simple as that-- as identifying and eliminating contaminants-- anyone could do it. To "think outside the box," however, requires a new approach. To recognize the possibility of additional sources of contamination not previously identified requires progressive thinking and initiative. In the pages that follow, I will introduce a concept that will allow you to implement a simple, yet progressive Standard Operating Procedure for the maintenance and use of sterile processing equipment.

Sterile processing industries are unique compared to general industries and require a set of solutions to address their unique needs. As obvious as this may sound, you may be surprised to know how often this simple idea is overlooked and what efficiency is lost because of it. Sterile processing is not general industry. The procedures are different, the requirements and standards are different, and the expectations concerning the end product are different. In industries in which regulatory agencies such as the FDA oversee production and ensure the safety of the end product, you might expect the tools and equipment used would be different as well, held to strict industry-specific standards. But, with regard to tools used in the maintenance and installation of sterile processing line equipment, the industry as a whole is lagging behind the pace of the technological advances that define it in so many other aspects.