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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 ,

Investegate |Jangada Mines PLC Announcements | Jangada Mines PLC: ValOre Announcement

ValOre Drills Near-Surface PGE Mineralization at Trapia 2 Target, Pedra Branca:
45.62 metres grading 0.54 g/t 2PGE+Au from 9.10m and 52.15 metres grading 0.49 g/t 2PGE+Au from 4.85 metres
Vancouver, B.C. ValOre Metals Corp. ( ValOre ; TSX‐V: VO; OTC: KVLQF; Frankfurt: KEQ0, the Company )
today announced assay results for eight Trapia 2 core drill holes at ValOre s 100%-owned Pedra Branca Platinum Group Element ( PGE ) Project in northeastern Brazil. The target ultramafic ( UM ) Trapia 2 intrusion was intercepted in all eight core holes drilled, establishing geological continuity well beyond the currently defined resource area. Near surface mineralization was intersected along strike to the northeast and southwest of this existing resource, and mineralization remains open in all directions. ....

Estado De Mato Grosso , Minas Gerais , British Columbia , Pedra Branca , Santo Amaro , Servitec Foraco Sondagem , Colin Smith , James Spinney , Brian Mcmaster , Jamesr Paterson , Jim Paterson , Oliver Stansfield , Jack Botros , Servitec Foraco , Beth Melluish , Ritchie Balmer , Jonathan Evans , Valore Metals Corp , Nunavut Tunngavik Inc , Pedra Branca Platinum Group Elements , Baffin Gold Properties , Bc Valore Metals Corp , Discovery Group , St Brides Partners Ltd , Pedra Branca Platinum Group Element , Strand Hanson ,