In my last editorial, I talked about the importance of remaining vigilant and not letting things slip through the cracks. Health and lives could be endangered if cleanroom environments are allowed to fall below required standards of cleanliness and sanitation. Equipment and product can be damaged or destroyed. Money and jobs may be lost.
While it’s important for people to pay attention in the cleanroom, it’s natural that they may need a little help from technology. That’s where monitoring systems come in. Monitoring devices track cleanroom activity such as humidity, particle count, temperature, water/chemical/gas levels, and much more. Results may be viewed in the cleanroom itself, or they can be viewed remotely — in another room in the same facility, or in a different facility entirely, or on a smartphone or tablet device. Certain tasks may be able to be automated, while others require a more manual approach.
Monitoring standards will, of course, differ based on your industry. Expectations may be different if you’re in a pharmaceutical cleanroom versus, say, an aerospace-related cleanroom or a medical device facility. Organizations such as ISO, USP, and the FDA have their own standards that need to be followed. What may be applicable in the United States may not fly in Europe, and vice versa. Therefore, it’s important to know what your specific facility requires, and to obtain the correct equipment to fulfill these standards.
This issue of Controlled Environments will address monitoring systems in several articles. Our Facility Monitoring section discusses how setting inappropriate Alert and Action alarms on your facility’s Environmental Monitoring System could spell disaster, in terms of wasted product, time, and money. It’s imperative to follow cGMP guidelines right from the start, so you don’t set yourself up for immediate failure. We will also address particle monitoring — namely, how there are multiple guidance documents that can steer cleanroom facility managers in the right direction as to determining what processes need to be monitored. Managers must choose the correct locations for monitoring their processes, and use the proper formal risk assessments to determine the correct approach for monitoring their facilities. The Clean Environments section of this issue offers a primer on cleanroom classifications — what they mean, why we need to adhere to them, and how to accommodate your cleanroom facility’s needs in terms of equipment and maintenance.
Again, proper monitoring is needed to ensure that you achieve what’s required of your cleanroom’s specific classification requirements. As cleanroom monitoring is a popular and useful topic amongst our readership, you can find many more articles on the subject by visiting the Controlled Environments website at www.cemag.us.
Feature image: Lighthouse Worldwide Solutions