The last two weeks, we have been focusing on the steps of donning and doffing your cleanroom garments. Just as important is what to do with them once you’ve removed them. We will give a quick guide here. First and foremost, you should be working with a cleanroom garment processor to launder and repair your […]

We love taking advice from Jan Eudy, who is a Cleanroom/Contamination Control Consultant, ISO 9000/cGMP auditor, and HACCP/Food Safety Auditor. She offers a step-by-step protocol for cleanroom gowning in Controlled Environments. We used her model to create basic gowning procedures. We also found some great images on Wikipedia, which credits them to Dorothyboyd. Putting them […]

Water is one of the most widely-used ingredients in any cleaning solution. With the proper additives, water is an effective cleanser. However, in critical manufacturing, it is important to know that all water is different (even tap water in two different locations.) The quality of water directly impacts the quality of your product. Therefore, you […]

Last week, we began summarizing the main points of Tim Sandle, PhD’s article in Controlled Environments. His article provides a close look at what needs to be considered when building a pharmaceutical cleanroom. At the end, we provided a link to a full article on validation master plans, as one requires full comprehension of this […]

Contamination control in a cleanroom is reliant upon a number of factors. Pharmaceutical grade cleanrooms have a few more factors than some other controlled environments. There are a number of standard considerations in pharma cleanroom design to control contamination caused by the combination of airflow, sources of heat, and any objects present.   Tim Sandle, […]

If you’re maintaining a USP 797 compliant cleanroom, you’re required to have written cleaning STandard Operating Procedures (SOPs) and cleaning logs. Your SOP should include when to clean, how to clean, and what to clean with. Here are some guidelines on these categories. How Often? Surfaces of sterile compounding areas need to be cleaned with […]

Electronics manufacturers have a few things to consider when determining how to best clean electronics. These include the cleaning solvent, equipment, and whether to use a wet or dry process. Here is a short breakdown of these considerations. Cleaning agents The right cleaning agent depends on what you’re removing and what it’s stuck to. Doris […]

There are several criteria to consider when selecting equipment for your cleanroom. Making the best choice doesn’t need to difficult, but it does need to be well thought out. Here are some guidelines for you and your coworkers to follow when making this decision.   Compliance requirements: Your first concern with new equipment is that […]

Employees who work in labs that handle glassware know all too well the frequency of injuries that happen in this environment. Minor cuts are most often the result of an accident, but more serious injuries do occur. Flying glass, exposure to chemicals, and fires are all realistic scenarios that can inflict serious harm. According to […]