You need to control fungal contamination in your cleanroom, and you need to test the disinfectants for validation. Here are three to consider. Controlling fungal contamination in your cleanroom requires cleaning and disinfection procedures. Your disinfectant application is a critical step that needs validation. Since many agents that are effective against vegetative fungi aren’t effective Read more…
Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1
There are a number of alternative methods to test container closer integrity for drug products. Start comparing these methods here. Container closure integrity (CCI) of a drug product must be preserved throughout its entire shelf life. There are a number of ways to conduct a CCI test, each with its pros and cons. Here is Read more…
3 Ways to Sterilize Cleanroom Apparel
Sterility is a major part of every cleanroom, be it the equipment, the tools, the product, or the structure. In aseptic cleanrooms, the garments must also be sterile. Most companies require all components in an aseptic cleanroom – including garments – to be terminally sterilized to 10-6SAL. There are three methods of achieving this: autoclaving, Read more…
Why Small Particles Stick – Clean the Cleanroom
We all know that the smaller the particle, the harder it is to clean. They always get stuck in those tiny, hard-to-reach spaces. Here’s why. Dispersion forces. They make a gecko’s feet stick to walls. They also make small particles get stuck in really tiny places and cause them to be so hard to clean. Read more…
Cleaning the Components in Electronics Manufacturing
Electronic components in adverse environments require careful cleaning to remain compliant. This article explores the means of doing so. Thanks to no-clean fluxes and soldering pastes, the need to clean components in electronics manufacturing has decreased significantly. However, this is only the case for components used in non-critical atmospheric environments. Adverse environments, like humid Read more…
Continuous Availability: Disaster Planning for your Controlled Environment
If you have critical data in your facility, you need to ensure it’s protected in the face of disaster. Here is a guideline on how. Whether it’s manmade or natural, many manufacturers with cleanroom facilities are vulnerable to disaster. Three main concerns should this occur are security, risk management, and business continuity. Should any of Read more…
ESD Flooring Options for your Cleanroom
If you are controlling ESD in your cleanroom, you need to choose the right protection for your floor. Here is a comparison of basic options. Electrostatic discharge (ESD) can cause damage to electrically sensitive equipment and analytic processes as well as cause a fire or explosion near flammable materials. Using ESD flooring helps ground personnel Read more…
Important Considerations for Cleanroom Vacuums
There are advantages to both portable and central vacuum systems for a cleanroom. Weigh your options with these comparisons. When looking at everything needed to clean a cleanroom, the initial removal of dust and particles comes before sanitation. In critical cleaning situations, vacuuming tends to be a more efficient method than swabs and cloths. Measurements Read more…
How to Swab Cleanroom Surfaces in a Reproducible Manner
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 Read more…
3 Tips on Testing for Fungal Control in Cleanrooms
There is a lot to consider when taking action to control fungus in a controlled environment. Make sure you know these three tips. Recently, we posted about controlling fungus in cleanrooms. This is a tricky subject because it depends on the form of fungus, the surface type, and environment specific to your controlled environment. We Read more…