February, 2018
www.us-tech.com Continued from page 72
water stream that requires expensive treatment. Higher temperatures are also required for effective cleaning, which means more energy is used. There are many conditions that can cause biobur-
den, but water is a primary growth medium for bacte- ria. Even trace amounts of moisture in hard-to-reach locations can encourage the growth of bacteria, compro- mising the ability to properly sterilize a device. Therefore, it is important to completely remove water from the cleaning process to minimize this threat. If not properly addressed, this can result in increased compli- cations during the product validation. A solvent-based cleaning process is a nonpyro-
genic environment. This feature alone significantly reduces the risk of bioburden. Solvents dry quickly and completely, leaving no residues on parts after they exit the vapor degreaser, and they do not require additional mechanical action or increased temperatures to be effective. The low viscosity and surface ten-
sion of solvents, combined with their volatility, allow them to clean very effec- tively, even in small gaps and areas that water in aqueous systems cannot easily penetrate. Medical device manufactur- ers can be sure that all surfaces of the finished product will be effectively cleaned and safe for the patient. As medical devices are evolving
into more compact and complex compo- nents, cleaning becomes more and more difficult. Perfecting and validat- ing a cleaning method that works effectively on the intricate parts of medical components is vital to ensur- ing patient safety. Vapor degreasing offers a simple, proven and reliable answer to cleaning processes within the medical manufacturing industry.
Simplicity of Vapor Degreasing A vapor degreaser is a relatively
simple machine, typically consisting of two chambers filled with a nonflamma- ble solvent. The “boil sump” heats the solvent to around 104°F (40°C) which generates a vapor cloud that rises upward in the machine. As the vapors rise, they contact cooling coils which are arrayed around the inner walls of the machine. The cooling coils con- dense the vapors into a liquid state. This distilled solvent then is direct-
ed back to the “rinse sump” where the parts are rinsed as the final step in the cleaning process. When filled with sol- vent, the rinse sump overflows back into the boil sump, completing the recycling loop. This closed-loop system has few moving parts and ensures that the sol- vent is ready for the next cleaning. Cleaning is fast and easy with a
vapor degreaser. A basket containing the contaminated components is low- ered through the vapors and into the boil sump for their first cleaning. The parts are then moved into the rinse sump, which always contains pure, clean solvent that has been distilled from the solvent vapors. Ultrasonics in the rinse sump can further ensure residue-free parts. This process is easily programmable and allows for excellent process control and repeatability. Com - ponents come out clean, dry, at room temperature, and immediately ready for packaging or further processing.
A “Greener” Cleaner Today’s solvents are much
improved over the products used 20 years ago. New products must meet strict environmental standards and regulations. Those containing environ- mentally-unfriendly chemicals, includ- ing HCFC-225, nPB and TCE are being phased out and cleaning meth- ods are being changed to newer, better and safer alternatives. MicroCare’s Tergo chlorine-free
cleaning fluid is an excellent replace- ment for high Kb-value solvents such as
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Page 77 Vapor Degreasing and Medical Device Cleaning
and packaged to be acceptable in almost every country around the world, making it a sound choice to replace both harmful solvents or aqueous cleaning methods. The benefits of using a vapor degreaser are
clear. It delivers high levels of cleanliness to ensure patient safety and product performance. It also is a safe, environmentally-friendly and affordable process. The systems are small, use little electricity and never use any water. A well-engineered solvent cleaning system is easy to validate and will simplify device sterilization by removing sources of bioburden from the finished products. Contact: MicroCare Corp., 595 John Downey
Drive, New Britain, CT 06051 % 860-827-0626 E-mail:
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