Cleaning and disinfection are two separate but equal processes in cleanroom compliance. Know these 8 steps.
Our last two posts addressed some common concerns and issues in choosing cleanroom disinfectants. Achieving the appropriate microbiological cleanliness levels for a class of cleanroom is paramount to industries like medical device assembly and pharmaceutical manufacturing. Disinfectants and applicators are only two pieces of the puzzle. Here are 8 steps to keep in mind when ensuring your cleanroom is kept clean.
- Know the difference between cleaning and disinfection. Cleaning surfaces is basically removing soil, like dirt, dust, and grease. Detergents are typically used in this process, and it must be completed before disinfection. Chemical germicides used to disinfect eliminate vegetative microorganisms. Both steps are important, and they must be done in the right order.
- Choose the right agents. Between class, purpose, and equipment, cleanrooms differ in the kind of cleaning and disinfectant agents that are most appropriate for compliance and validation. We wrote this article about considerations for disinfectants. For your cleaning detergent, make sure:
- It is neutral and non-ionic
- It does not foam
- It’s compatible with the disinfectant
- Understand the difference among disinfectants. Specifically, you need to know how the agent acts against parts of the microbial cell. You need to know how to choose between non-sporicidal and sporicidal disinfectants, or non-oxidizing and oxidizing chemicals.
- Validate your disinfectants. This is especially important for pharmaceutical facilities. You need to challenge the disinfectant solution as well as different surface materials and ranges of microorganisms. The manufacturer can perform some testing, but some should be performed in-house.
- Know the factors affecting disinfection efficacy. There are a number of things that will challenge efficacy:
- Concentration
- Time
- Number and type of microorganisms
- Temperature and pH
- Cleaning materials. We discussed applicators in this post.
- Cleaning techniques. Whether it is the direction you sweep/mop, method of application, allowing product to dry, or any other protocol, be certain that you clean/apply exactly as is specified.
- Monitoring efficiency. As with any protocol for a cleanroom, test and monitor your method with microbiological sampling of surfaces.
If you need validation or certification, or if you have questions about these processes, consult Gerbig Engineering Company. Our 30 years of experience makes us experts at cleanroom construction, certification, and validation. Contact us at 888-628-0056 or info@gerbig.com.