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cleanroom cleaning and disinfection

While operating in a highly-regulated Cleanroom industry, even the smallest of point matters and when you are dealing with the pharmaceutical industry, you need to maintain it wisely. Cleanroom is an area that should be cleaned in terms of both particle counts and microbial counts as defined in the International Cleanroom Standard ISO 14644 and in the second Cleanroom Standard ISO 74698 respectively. The regulatory requirements for the same are detailed by EU GMP and the FDA Guidelines.
Cleaning and disinfecting your Pharmaceutical Cleanroom is a crucial part of Good Manufacturing Practices along with protecting your pharmaceutical equipment from personnel contamination. It is always advisable to run gentle hands through your valuable materials and products to ensure that they don’t get damaged. Cleanroom supplies must meet your cleaning needs with sterile products that attributes to low endotoxin counts, fast-drying agents and maximum effects.
This blog examines the key steps to be followed in helping to keep your Cleanrooms clean.

Step 1- Understand the difference between Cleaning and Disinfection
Cleaning refers to the physical removal of dirt and dust with killing the germs dwelling on the surface. It is usually processed with cleaning detergents and other Critical Cleaning products. But, cleaning is always followed by Disinfection.
Disinfection refers to applying disinfectants that intimates the surfaces and kills maximum bacteria within five minutes of exposure. Disinfectants are available in two chemical compounds- Denatured Ethyle Alcohol (DE) and (IPA) that are bactericidal, fungicidal and virucidal but they are not effective against bacterial spores. To combat this exception, the sterile disinfectant solution is recommended for disinfecting your cleanrooms.

Step 2- Selecting the appropriate agents
Sterile NeutraClean is a non-foaming and a non-ionic solution that is specially deployed to remove dirt, dust and grease from a surface. Detergents reduces the surface tension by penetrating soils to allow its removal and hence, it should be applied prior to disinfectant. Because, the lower the degree of soil remains on the surface, the greater the results of disinfectants in cleanroom cleaning.

On the other hand, Sterile TechChlore solution is a perfect blend of hypochlorous acid and hypochloride ions, with limited pH value for higher effectiveness in disinfecting your pharmaceutical cleanroom. It is specially produced for the pharmaceutical surfaces that can withstand the harsh chlorine based disinfectants.
While selecting disinfectants for your Cleanrooms, always look in the following criteria:
1. Identify the surface you are going to apply disinfectant on, as not every pharmaceutical surface can withstand the harsh chlorine based disinfectants.
2. Your detergent should always be neutral, non-foaming and a non-ionic solution.
3. Your cleaning detergent should be compatible with your disinfectant so that it won’t inactive your disinfectant.
4. Similarly, your disinfectant should have a wide spectrum of activity to kill all the microorganisms with the rapid speed of action.
5. Your disinfectant should be compatible with your Cleanroom temperature.
6. It is advisable to know your materials before applying disinfectants on it. For an instance, chlorine based disinfectants can damage stainless steel material. Select the agent that suits your Cleanroom material.
7. Go for the result-oriented and cost-effective cleaning and disinfectant agents.

Step 3- Selecting the appropriate cleaning materials
Make sure you use cleaning materials that are Cleanroom certified and non-particle shedding like sterile and non-sterile wipes and non-woven and lint-free mops that would effectively help ease your cleaning and disinfection activity.

Step 4- Appropriate cleaning techniques
Analyze your pharmaceutical Cleanroom and apply the cleaning techniques that suits it, right from applying a detergent solution through wiping or moping to adding the accurate amount of disinfectant solution to the cleaning water. Use double or triple-bucket system that has wringer to avoid cross contamination while cleaning your cleanroom.

Step 5- Monitor your cleaning and disinfection efficiency
Until and unless you don’t get your desired results after cleaning, you should not settle down on your actions. It is highly recommended to monitor your cleaning techniques, agents and materials about how well it has been working in your Cleanroom cleaning program. Use the best hygiene control and analysis swab for environmental monitoring your cleanroom. Once you attain your desired results, you can say that your pharmaceutical cleanroom is ‘Clean’.

The above five-step approach towards Cleanroom cleaning program is not only result-oriented, but also associates with the GMP Standards and Regulations. Practicing this within the appropriate time period will help you keep your Cleanrooms clean.
For more details and customized product services, Contact us. We are here to assist you for your Cleanroom cleaning program.

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