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need for a Laboratory Protection System for an
AAIP: Analyzers; Spectrometers; Chromatographs; Sequencers; Synthesizers; Biorobot systems etc. used in laboratory for: -medical; -pharmaceutical; -food; -biotechnology; -etc. IF THE INPUT POWER IS NOT FOR 100 % IDENTIFIED AND CORRECT DURING THE WHOLE MEASURING PROCESS, YOU CANNOT BE SURE THAT THE RESULT IS RELATED TO THE SAMPLE ’s ASSAY ONLY The FDA rule on 21 CFR Part 11 is specific for the laboratory and instrumentation segments of the industry, saying that Environmental Conditions (Electrical Power and other Critical Utilities) must be stabilized and within (the instrument manufacturer’s) specifications.
LPS: Laboratory Protection System: Certified, category III-3 products are a guaranteed 100% clean, reliable Power Source for the AAIP, filtering out all possible utility problems like transients, Voltage and Frequency variations, brownouts and blackouts. Using the right Laboratory Protection System
for your AAIP saves money: The life science and agriculture technology industries have been working on global harmonization for some time. The FDA’s regulations affect the entire world since all life science companies desire to sell into the largest of the markets – the US. As the FAA has set the standards for aircraft, pilots and airline regulations globally, the FDA has set the standards for life science (healthcare) and food product regulations. “Principal Investigators/Researchers” in a university hospital or government agency are expected to keep their research and reportable results on track and within budgeted costs. While we are all aware that poor electrical power can corrupt computer data and information (results), it is the responsibility of them and/or the Laboratory Director (Manager) to assure that only validated reportable results are used for research reporting or for analytic diagnostics results reporting. If necessary, the suspected tests must be re-run to assure that the “results” obtained are truly “reportable results” that meet the requirements of current Good Laboratory Practice (cGLP) and current Good Clinical Practice (cGLP). Franek Technologies, Inc (FTI) is the leader in Certified Category III-3 Laboratory Protection Systems, and the organization recommended by key genomic/proteomic OEMs, to protect their customers’ valuable research time, 21 CFR Part 11 reportable results and instrumentation systems. FTI’s certified uninterruptible battery
backup power sources (LPS/UPS), for laboratory and instrumentation applications,
protect over $3 billion in laboratory assets worldwide. Our instrumentation
power engineers have configured LPS/UPS products for nearly 1300 instrumentation
applications, from more than 50 manufacturers, to meet 21 CFR Part 11
power requirements. FTI eliminates the power disturbances that affect instrument performance;
our Certified Category III-3 LPS products allow the instrumentation platform
to do its intended function cost effectively and free of corrupted results
due to power disturbances. The value our products perform in assuring
proper electrical power is measurable by the savings we deliver to our
customers in tangible savings and intangible state of mind.
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