Article CommentaryCOMMENTARY
Reverse Osmosis as a Means of Water For Injection Production: A Response to the Position of the European Medicines Agency
T. H. Meltzer, R. C. Livingston, R. E. Madsen, M. W. Jornitz, R. M. Johnson and M. W. Mittelman
PDA Journal of Pharmaceutical Science and Technology January 2009, 63 (1) 1-7;
T. H. Meltzer
R. C. Livingston
R. E. Madsen
M. W. Jornitz
R. M. Johnson
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 1
January/February 2009
Reverse Osmosis as a Means of Water For Injection Production: A Response to the Position of the European Medicines Agency
T. H. Meltzer, R. C. Livingston, R. E. Madsen, M. W. Jornitz, R. M. Johnson, M. W. Mittelman
PDA Journal of Pharmaceutical Science and Technology Jan 2009, 63 (1) 1-7;
Jump to section
- Article
- Introduction
- Sterility of WFI
- Regarding the EMEA Summary
- Identical Microbiological and Chemical Quality
- Differences in Means of Preparation
- Distillation Concerns
- Distillation and Endotoxin Carryover
- Metallic Impurities
- Metallics and Pharmaceuticals
- The Purification System
- Microbial Recontamination
- Organism Limits of Purified Water
- Biofilm
- EMEA References to Biofilms
- RO Mechanical Properties
- Towards Harmonization
- Footnotes
- Reference
- Ancillary Sources Regarding Biofilms
- References
- Info & Metrics
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