Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s

Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s
by Michael J. Groves (Editor), Ram Murty (Editor)
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"The exact origins of parenteral therapy are lost in antiquity, but we do know that devices recognizable today as syringes, made from pewter or brass,..." (more)
SIPs: sterilize phase, spore challenge concentration, air shower off, air shower operating, pressure within the freeze dryer
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Edition: Hardcover
Editorial Reviews
From Book News, Inc.
Explores the technology, developments, and applications of aseptic processing for terminal sterilization, offering how-to information in areas including processing of biopharmaceuticals, lyophilization, manufacture of radiopharmaceuticals, controlled environments, regulatory requirements, and quality systems. Highlights include discussion of hydrogen peroxide vapor sterilization, form-fill-and- seal technology, and international regulatory bodies. Includes b&w photos, and glossaries. For professionals in the development, quality assurance, engineering, and production of pharmaceuticals. Annotation c. by Book News, Inc., Portland, Or.
Book Description
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
Product Details
Hardcover: 520 pages
Publisher: CRC Press (May 1, 1995)
Language: English
ISBN: 0935184775
Product Dimensions: 9.4 x 6.0 x 1.6 inches
Shipping Weight: 2.1 pounds. (View shipping rates and policies)
Amazon.com Sales Rank: #1,463,579 in Books
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Inside This Book (learn more)
First Sentence:
The exact origins of parenteral therapy are lost in antiquity, but we do know that devices recognizable today as syringes, made from pewter or brass, were found recently in the wreck of the Mary Rose, a ship of the line that sank under the eyes of an embarrassed King Henry VIII during a battle with a French fleet in 1545. Read the first page
Statistically Improbable Phrases (SIPs): (learn more)
sterilize phase, spore challenge concentration, air shower off, air shower operating, pressure within the freeze dryer, air dispersed spores, parenteral radiopharmaceuticals, air shower operation, sterilant vapors, continuous aerosolization, vacuum set point, constant level loading, mold carriage, advanced aseptic processing, steam hydrogen peroxide, filling mandrels, contaminated ampoules, lyophilization run, sterilization phase, sterilant concentration, aerosolized suspension, aeration phase, freeze dryer chamber, requirements for controlled environments, barrier isolators