Validation relies on meticulous and accurate testing. When swabbing for residue samples, follow this advice for reproducible results. If you consider cleaning validation a three-step process, it will involve 1) cleaning/rinsing of necessary surfaces, 2) sampling any residues left behind after step 1, and 3) analyzing your samples. The greatest challenge in this 3-step process […]
Fungal issues are significant in controlled environments. To ensure your cleaning agent will be effective against mold and yeast, follow this series. Fungal contamination from mold and yeast are concerns for cleanrooms in any industry. Mold issues in particular have surfaced in cold rooms, door kick plates, incubators, and cleanroom startups in addition to the […]
With the variety of clean benches to choose from for cleanroom applications, this quick guide will point you in the right direction. One piece of equipment many cleanroom managers have to consider is a clean bench. Depending on the purpose of the bench, more than one may be necessary. When it comes to clean benches, […]
Wipers are necessary to cleaning any cleanroom, but they need to be tested to ensure they’re non-linting. Here is some information as well as good news on testing. Wiper-based cleaning is one of the most effective methods of cleanroom cleaning. Test data to confirm that wipers are non-linting is a USP 797 requirement. However, there […]
When it comes to your cleanroom, safety is multifaceted. Safety programs use OSHA standards, internal company requirements, and national consensus standards to ensure that work is performed ergonomically, efficiently, and safely. These programs are designed to protect employees and the integrity of the cleanroom. Your cleanroom safety plan should address appropriate employee behavior, functionality of […]
Chemicals, water, and energy consumption are cornerstones of nearly all cleanroom processes. They are also the three areas that most affect the “greenness” of these operations. Reducing the use of any of these would certainly result in cost savings for companies. The question is: how plausible is to alter these things and still leave the […]
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 […]
New light fittings can make all the difference when it comes to your space, whether it’s in your home, office, or even your cleanroom. Installing lighting systems in a cleanroom can be a challenge because of the air filtration systems used. Depending on the class of cleanroom, the ceiling may be covered with filters, leaving little room […]
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 […]
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 […]