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Isolators include an automated bio-decontamination system and are suitable for long-lasting campaigns. A RABS, on the other hand, is an appealing solution for cleanrooms and guaranties the quality needs for applications which require more flexibility. If necessary, a RABS can be opened to allow for process intervention, while the Isolators must be kept closed during the entire operation.CLOSED-SYSTEM TRANSFER DEVICES, OR CSTDS, are defined by the National Institute for Occupational Safety and Health (NIOSH) as, “A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”
These systems are important in protecting health care professionals from exposure to potentially cytotoxic and teratogenic medications both during product preparation and administration.1At Sychem, we are specialists in Disinfection, Sterilisation and decontamination, and operate in a wide range of industries. Despite many people using the terms Sterilisation and Disinfection interchangeably, there are significant differences between both types of high-level cleaningThe Glove Company wants to clear the air around gloves and hand protection. We will explain the industry jargon and provide you with a helpful guide to remember when trying to find the best gloves for your needs. Every situation and glove is different though, so if you have the smallest amount of doubt that the glove you are using is not suited to your use, then please reach out to our Glove Experts, who are specially trained to find the best fit for every situation.The Membrane Filtration Sterility Test is the method of choice for pharmaceutical products. An appropriate use of this test is for devices that contain a preservative and are bacteriostatic and fungistatic under the direct transfer method. With membrane filtration, the concept is that the microorganisms will collect onto the surface of a sub-micron pore size filter. This filter is segmented and transferred to appropriate media. The test media are fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). FTM is selected based upon its ability to support the growth of anaerobic and aerobic microorganisms. SCDM is selected based upon its ability to support a wide range of aerobic bacteria and fungi (i.e., yeasts and molds). Incubation time is 14 days.