10 Steps to Prepare for Commissioning and Qualifying your Cleanroom

Compliance in a cleanroom relies on proving you have good engineering practices (commissioning), and verifying facility/systems aspects that affect product quality (qualification). Carrying out these verifications can be quite overwhelming. John R. Butterfield describes each process in cemag.us’ “Commissioning and Qualification of Existing Facilities.” He also offers advice on how to prepare your facility for […]

Onsite Cleanroom Laundry Facilities

Cleanroom garments are an integral part of any controlled environment. For some, hiring a laundering service is the most efficient way to get these garments clean. For others, having onsite laundry facilities is the best answer. If you decide to clean your own cleanroom garments, here is what you need to know. Cleanroom Washers & […]

Non-Sterile Cleanrooms and Microbial Monitoring Programs

There are several reasons one would establish a microbial monitoring program for a non-sterile cleanroom. Among them are evaluating sanitization and disinfection efficacy, monitoring cleanroom production and lab environments, monitoring and qualifying personnel, and validating the cleaning process in and of the cleanroom. One should always consult industry references for guidance, but we will outline […]

How to Properly Handle Soiled Cleanroom Garments

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 […]

Basic Cleanroom Gowning Procedures

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 […]