#clean room process

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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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AUTOCLAVABLE GAUNTLETS FOR  PHARMACEUTICAL INDUSTRY

In a pharmaceutical manufacturing industry, working with biological materials is a fairly common practice. These materials may or may not be hazardous to the worker, but they can most certainly be sensitive to microbiological contaminants. Contamination is mostly originated by a personnel. It is important to use proper, germfree cleanroom garments in order to protect the products and the personnel from contamination. Researchers come in direct contact with various products, substance or material through their hands and hence, need to be protected from exposure to chemicals. This is where cleanroom gloves come into the picture. Various types of cleanroom gloves are used for various purposes and a certain type of cleanroom gloves must be used for a certain material. As a contamination-free environment leads to quality sterilization and prevents infections, Autoclaving is considered as the most effective and reliable sterilization method. Autoclave sterilization uses high pressure and high temperature steam to kill microorganisms and render bio hazardous material inactive. High-pressure heat, steam burns, hot fluid scalds, injuries to hands and arms from the door, and bodily injury in the event of an explosion are potential risks of using autoclaves. This becomes imperative for any pharmaceutical personnel to use appropriate Personal Protective Equipment (PPE) including autoclavable gloves and gauntlets. Let’s now understand the varied types of materials used while manufacturing autoclavable pharmaceutical gauntlets with studying their high-protection benefits. 1. Ethylene Propylene Diene Monomer (EPDM) Ethylene Propylene Diene Monomer or EPDM possess an excellent resistance to environmental factors like Ozone, UV and general weathering at higher temperatures that reaches maximum at 130°C (266°F). EPDM infused Autoclavable Gauntlets carry a high level of resistance to abrasion, solvents and perforation. The use of heat-insulating gloves helps and prevents burns while loading and unloading autoclave. Suffused with hydrogen peroxide, these gloves provide anti- septic for cuts and burns due to handling autoclaves or any high temperature material. 2. Hypalon Hypalon is made up of man-made rubber called CSM or chlorosulfonated polyethylene, generally fabric-coated that resists abrasion, UV rays and chemical very efficiently. Pharmaceutical gauntlets made of hypalon material are soft, flexible specially designed for high convenience. Hypalon Gauntlets possess high resistance against hydrogen peroxide and hence suitable for autoclaving. 3. Neoprene Also known as polychloroprene, neoprene is a kind of synthetic rubber made of polymerization of chloroprene. This material possess excellent chemical resistance and maintains flexibility over a wide temperature range. Neoprene Gauntlets give outstanding protection against heavy duty, abrasions and cut objects during autoclaving. These gauntlets are warm and feels good to wear in all the seasons. 4. Nitrile Nitrile is a medical-grade material in terms of pharmaceutical gauntlets. Nitrile is resistant to aliphatic hydrocarbons and it carries a high level of resistance to abrasion, solvents and perforation. Nitrile Gauntlets are manufactured from accelerator free nitrile with low levels of particles. They can be easily sanitized with VHP or IPA with being suitable for autoclaving. At June Enterprises, our pharmaceutical industry experts deliver the one-stop solutions for all your pharmaceutical discomfort and problems. We owe to serve you the best and so you can always feel free to seek our assistance and ease out your autoclaving process.

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