 |
|
 |
||||||||||
|
Pharmaceutical Engineering Archives |
||||||||||
May/June 1995
|
||||||||||
| Auger Surface Line Scan to Evaluate Element Segregation in and Chelant Passivation of a 316L Weld by Kenneth B. Balmer This study uses a unique quantitative Auger Line Scan technique to show the surface segregation of elements across the HAZ of a 316L autogeneous weldment and the effectiveness of a chelant passivation technique to repassivate the surface.  Download Article... |
Impact of Research & Development on Validation, GMP and Registration of Biopharmaceuticals by Dr. Rudolf F. Bliem Compliance development of biopharmaceuticals begins with research. Download Article... |
Clinical Material Manufacturing Process Verification/Validation by Charles F.Carney, Sue Galloway-Ludwig & Michael J. Killeen The theory of process validation as it applies to clinical supplies manufacturing. Download Article... |
A Novel Approach to a Pharmaceutical R&D High Purity Water System by John M. Finlay, PE, John T. Hango, PE & Roy A. Hango, PE Evaluation and design of an R&D laboratory high purity water system utilizing RO and CDI. Download Article... |
Definitions and Controls for Labeling of Investigational Clinical Trial Materials and Clinical Supply Operations by Diane R. Hansen, Donald F. May & Jeri L. Weigand Definition of terms, interpretations and a suggested compliance approach regarding the August 3, 1993 Federal Register labeling regulations. Download Article... |
Pharmaceutical Engineering Interviews Al Larson, CEO and Chairman of TL Systems by Al Larson An interview with the CEO and Chairman of TL Systems Download Article... |
Strategies in Pharmaceutical Packaging Line Automation by Howard R. Leary, PE To be able to take full advantage of present and future technological opportunities, certain strategic factors must be considered in designing a new packaging line. Download Article... |
Precision System for Batch Filling or Dosing Offers Bottom-Line Benefits to Pharmaceutical Processors by Charles Rose & Gabor Vass Advanced filling technique utilizing magnetic technology increases productivity and reduces downtime. Download Article... |
EU GMP Requirements and the Good Automated Manufacturing Practice (GAMP) Supplier Guide for the Validation of Automated Systems for Pharmaceutical Manufacturing by Anthony J. Trill This article describes the GAMP Guide, provides EU GMP background for suppliers of computerized systems and maps the GMP compliance features of GAMP to the relevant EU GMP. Download Article... |
|
|
|
 |
|
