Selecting a cleaning agent that is effective against fungal contamination in cleanrooms is a full process. This series identifies your steps.
There are numerous types of fungi that can grow in your cleanroom. Selecting the right disinfectant(s) depends on several processes. In part one, we discussed the different type of relevant data you want to collect. Here we will discuss testing disinfectants for efficacy.
Many factors influence the effectiveness of the active ingredients in biocides. Some of them include:
- Surface type
- Contact time
- Organic soil
- Hardness of the water
The actives used against fungal spores will perform differently depending on the factors above. It is therefore necessary to perform in-house testing. For pharmaceutical environments in particular, a series of tests are necessary. Some agents that work against vegetative fungi aren’t effective against fungal spores. Here are three methods to consider.
- Suspension Tests: These tests work to determine the time necessary to reduce an acceptable amount of organisms. However, they do not address efficacy within various surface types. The microorganism is suspended in the appropriate dilution of the test disinfectant. This should be done at room temperature at selected time intervals. After neutralizing any remaining disinfectant from the sample, viable counts can be performed.
- Carrier Tests: Here is where you will test efficacy on hard surfaces. You use a carrier made of the type of surface(s) in your cleanroom (e.g. stainless steel) to test disinfection agents. Typical cleanroom surfaces include: stainless steel, terrazzo flooring, epoxy, vinyl, lexan, and glass.
- Statistical Comparisons: This is an ongoing test comparing the frequency of isolation and number of organisms isolated before and after disinfection. It’s important to carry these tests out throughout the year. You may find seasonal variations that alert you to facility or maintenance issues.
In the end, the disinfectant application process should be validated. If you need cleanroom validation or certification, or if you have questions about these processes, contact Gerbig Engineering Company at 888-628-0056 or firstname.lastname@example.org.