If you’re creating a disinfectant program for your cleanroom, be sure to check these six points before making a decision.
Disinfectant programs are vital to pharmaceutical and medical device manufacturers. Cleanrooms must not only be cleaned, but also disinfected to remain compliant. A program entails a disinfectant rotation as well as the disinfectants themselves. Here is a checklist to consider when choosing disinfectants.
Know the efficacy level of your options. Whether using a disinfectant or a sporicidal agent, it needs to be effective against the specific microorganisms present in your facility.
Know the contact times required to work. Each product will vary in the length of time it needs to make contact to kill microorganisms. For compliance, contact times less than 5 minutes is ideal. Anything longer than that will likely require re-wetting of the surface, which can increase chemical costs.
Test one-step cleaners … Read More »
There are many varieties of pass-through systems for cleanrooms, and each meets different unique needs. Here are 3 common varieties.
Pass-through systems are an important part of many cleanrooms. They are necessary for a variety of parts, materials, documents, critical applications, equipment, and even personnel. The type of system you need depends on what you need to move from one side to the other as well as your cleanroom class. Here are three very different kinds of pass-through systems to consider.
Chamber. These provide transfer for a number of critical applications, including requirements to ISO 4 and bio/pharmaceutical operations requiring frequent cleaning and sterilization. No external fasteners or caulking are needed, as a bracket mounts the chamber against the cleanroom wall. There are no horizontal surfaces to collect dust. The internal surfaces are optimized for easy cleaning and sterilization. There are … Read More »
A conclusion of comparing air sampling methods for the cleanroom –choose right method for your specific validation and compliance
When it comes to cleanroom air sampling methods, you will find different methods are appropriate for different classes of cleanrooms. It is important to analyze each option to find the best fit for your needs. In parts 1 and 2, we covered sedimentation and most impactor methods. In this article, we will conclude the list with impingement and gelatin membrane filtration.
Impingement – This method draws air through the curved section of a glass impinger and accelerates it through a jet at the bottom. This bottom is filled with a liquid that is suitable for capturing particles. The amount of collection liquid will vary depending on how concentrated you want your collected microorganisms. After sampling, the liquid is filtered and processed as usual. … Read More »
A continuation of comparing air sampling methods for the cleanroom – be sure to choose the one that can be validated for your compliance.
When it comes to choosing an air sampling method for your cleanroom, you need to do your homework. Depending on your cleanroom class and other needs, some options will be more suitable than others. In part 1, we covered sedimentation and slit-to-agar. We will pick up here with two more impactor methods.
Sieve Samplers – These come in several varieties, allowing up to six stages of perforated plates and agar plates. The multiple-stage capabilities offer benefits over other impactors. A six-stage unit has a 40% higher recovery rate than one and two-stage versions. The holes in the successive plates get smaller, allowing larger particles to impact the first stage, and smaller to impact the last. Therefore, a … Read More »
When it comes to air sampling for the cleanroom, there are many options. Consider each before choosing the right one for your class of cleanroom
Proactive companies know the importance of an active air-sampling program in a cleanroom. As with anything, each method has different benefits and problems specific to compliance needs. Here are the first two of the six methods we will discuss.
Sedimentation – This is one of the oldest methods available today. It entails exposing a petri dish to the atmosphere to collect bacteria-laden particles. This passive, non-volumetric method imprecisely represents larger particles because of their rapid settling rate. Plates have to be left out longer to collect smaller particles because air turbulence can cause it to resist settling. This can cause desiccation. In this case, bacterial growth would be poor, reducing the viable count. As a pre-screening … Read More »