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We specialize in microbiology testing for the medical device and pharmaceutical industries. Saniter has NQA Registered, ISO 9001:2000 certified, and ISO 17025 certified. Our current list of test services includes more than 40 test offerings for medical device and pharmaceutical products. These include microbiological testing, sterilization validations, routine lot release tests (sterility, bioburden, B/F etc.), residuals, filter validations, biocompatibility, barrier properties (including BFE, VFE, NaCl, DOP, N95), reprocessed device validations and much more. Our Lab Director, Funda Senturk, has more than 15 years of microbiological testing experience. Our current staff of more than 20, including 8+ registered microbiologists. You’ll be pleased to find that Saniter maintains a high level of quality, capabilities and accessibility for its clients. Our constant goal has been to maintain the highest in quality testing services and technical expertise. We hope you will have a chance to experience the Saniter difference. We are sure you will be impressed. Standards Development organizations which the company is involved: TSE, KOSGEB, ISO, and other Standards Expertise: The working groups are: radiation sterilization, ethylene oxide sterilization, biological evaluation, microbiological methods, biological indicators, reusable devices, packaging, cleanrooms, and protective barriers. Please contact us for specific working group information. Hospitals, manufacturers of hospital and medical supplies, museums, libraries and archives, food processors, sterilization training institutions, veterinary hospitals and clinics, animal laboratories and herbaria may use ethylene oxide as a sterilizing or fumigation agent. A number of methods are available for monitoring employee exposures to ethylene oxide. Most involve the use of charcoal tubes and sampling pumps, followed by sample analysis using gas chromatography. Some of the essential differences in charcoal tube methods include; the use of different desorbing solvents; the use of different lots of charcoal and the use of different equipment for different sample analysis. A very long and difficult process with results usually based in the high ppb to low ppm range. Whole air samples are analyzed with state-of-the-art cryo-focusing and advanced GC/MS technology. The samples are in-theory frozen and quickly injected for maximum resolution. This analytical process allows for sub-parts per billion (ppb) detection limits. Saniter will provide results to you in one-business week by 6:00 p.m. for example, if samples are received on a Monday results are due on the following Monday by 6:00 p.m. Results are faxed or emailed to the location you indicate on your Chain of Custody. |
