Volume 24, Number 4
by Timothy D Blackburn
This article offers a practical approach to commissioning and a method of synergy with qualification. Practical applications are explored, as well as the use of Enhanced Commissioning Documentation to minimize the qualification effort.
by George R. Johnson
This article explores the potential impact of PAT, HACCP, and Six Sigma on the Life Sciences Industry.
by Professor Roger S. Benson, Jim D.J. McCabe
This article was adapted from a presentation at the 2003 ISPE UK Affiliate Annual Seminar, Manchester. It demonstrates how the pharmaceutical industry is capable of improved manufacturing performance.
by Manuel A. del Valle
This article presents cleanroom classifications as defined in ISO 14644 and FED STD 209E and their application for designing aseptic processing pharmaceutical/biotechnology facilities as defined in both USA cGMPs and European Community GMPs.
by Katie Henchir, Cynthia Ingols
This article describes the importance of Validation Master Planning as it relates to the success of both project management and contractor coordination.
by Wael Allan
This article describes how a properly planned and executed commissioning strategy can eliminate downstream problems and accomplish much of the data required for qualifications and plant delivery.
by Arnie Grant, John Jermain
This article describes the results of the electrochemical corrosion testing of the as welded, mechanically polished, and electropolished AL-6XN fusion welded to Inconel 22. Also tested was a single electropolished weld segment, which was submerged in a ferric chloride solution in accordance with the ASTM G-48 procedure to further elucidate corrosion resistance and sites of attack.
by Jennifer L. Gaines
This article describes the effects of methyl jasmonate elicitation on the alkaloid production of Catharanthus roseus cell suspensions.
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