TY  - BOOK
AU  - Akers,Michael J.
AU  - Larrimore,Daniel S.
AU  - Guazzo,Dana Morton
TI  - Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing 
SN  - 0824708857 (alk. paper)
AV  - RS201.P37 A54 2003
U1  - 615.19 
PY  - 2003///
CY  - New York
PB  - Marcel Dekker
KW  - Parenteral solutions
KW  - Analysis
KW  - Standards
KW  - Pharmaceutical industry
KW  - Quality control
N1  - Includes bibliographical references and index; TOC; 1. Sterility testing --
2. Pyrogen testing --
3. Particulate matter testing --
4. Package integrity testing --
Appendixes: --
I. Example of standard operating procedure for sterility testing by direct inoculation --
II. Example of standard operating procedure for sterility testing by membrane filtration --
III. Aseptic procedures at the laminar flow workbench; Pharmacy
N2  - Summary:
Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities
UR  - http://www.loc.gov/catdir/enhancements/fy0647/2002035194-d.html
UR  - http://www.worldcat.org/title/parenteral-quality-control-sterility-pyrogen-particulate-and-package-integrity-testing/oclc/50851952&referer=brief_results
UR  - http://lib.ewubd.edu/ebook/3824
ER  -