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Introduction To ASTM E3263-20 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues


Introduction To ASTM E3263-20:
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
Part of the
series
Visual inspection has been widely used for many years by the pharmaceutical, biologics, and medical device industries after cleaning to release manufacturing equipment and devices. However, visual inspection has never been demonstrated to be an effective, reliable, or safe method to use for these inspections. Recently, the European Medicines Agency (EMA) issued a Q&A
1 to its guideline on determining health-based exposure limits (HBELs) that describes what criteria have to be met for visual inspection to be acceptable to the EMA for release of manufacturing equipment. Some form of guidance or a standard has been needed to guide these industries on how to meet these criteria and demonstrate that operators/QA inspectors are capable and qualified to accurately assess the absence or presence of residues on m ....

United States , United Kingdom , Ester Lovsin Barle , Miquel Romero Obon , Andreas Flueckiger , Davidg Dolan , Gabriela Cruz , Ioana Gheorghiev , Igor Gorsky , Prakash Patel , Zimmer Biomet , Robert Kowal , Mallory Degennaro , Vander Weilen , Stephen Spiegelberg , Delane Dale , Andrew Walsh , Spiro Megremis , Bristol Myers Squibb , Rodney Parker , Van Nostrand , Michel Crevoisier , Thomas Altmann , Sarra Boujelben , Norma Turner , Mariann Neverovitch ,

Detailed text transcripts for TV channel - FOXNEWS - 20160111:01:22:00

You know, the defense is the vial of blood and spraying it all over the place. no suggestion at all they had a vial of sweat. okay. and the whole idea of the edta, which is a preservative to preserve blood in criminal cases. i ve seen it a lot. the fbi comes in and they say we didn t find any evidence of the preservative therefore suggesting it was his blood. but everybody says the fbi is wrong. what is your take on that? the fbi was careful to develop a test for this case. they were able, within and their measure was within 1/50th of a drop of blood to tell a detection limit whether or not there was edta in the blood that is certainly enough. the vial of blood is just chuck full of this preservative edta. ....

All Over The Place , Preservative Edta , Detection Limit , 1 50 ,

CNN The Situation Room April 7, 2014 22:40:00

Investigation where black boxes were found without debris. reporter: indeed, questions about the fleeting signals the chinese picked up remain. for instance, how could a relatively rudimentary detector, this one cost no more than $16,000, designed for use in shallow water pick up pulses potentially miles deep? it s technically possible, but not likely says the pacompany tt makes the detector. it would be right at the edge of the detection limit of that system. reporter: the signals are the right frequency, but the ocean is noisy. the chinese team wasn t operating in ideal conditions. using earbuds instead of more reliable headsets to listen for the pulses. the team was also traveling with a spare pinger onboard which could have been emitting a signal of its own. and the chinese said they did not have time to record the pulses. making a scientific analysis impossible. one thing is certain, china is eager to show it s working on behalf of the 154 chinese citizens onboard flight 370 ....

Towed Pinger Detector , Shallow Water , Detection Limit , Pacompany Tt , Ear Buds , Team Wasnt Operating , Malaysia Airlines Flight 370 ,