Validation of Pharmaceutical Processes: Sterile Products

Validation of Pharmaceutical Processes: Sterile Products
By by Frederick J. Carleton (Editor), James P. Agalloco, Editor
Amazon.com
"The prime objective of anyone working in a pharmaceutical plant, whether in production or quality control, is to manufacture consistently products of the requisite quality..." (more)
SIPs: minimum sterilization dose, automatic ice bath, dry heat processes used, control system validation, finished product attributes (more)
CAPs: Validation of Pharmaceutical Water Systems, Parenteral Drug Association, United States Pharmacopeia, Validation of Environmental Control Systems, Parenter Sci Technol (more)
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Edition: Hardcover
Editorial Reviews
From Book News, Inc.
Revised and expanded from the 1986 . Provides a detailed, single-source reference for designing, qualifying, calibrating, certifying, and validating systems required to prepare aseptic and non-aseptic pharmaceutical products. Compiles compliance and regulatory principles, documentation practices, scientific approaches, and engineering concepts that can be used independently or in combination to validate products, processes, and equipment. Among the topics are facility design, monitoring non-viable particles, validating utilities, steam sterilization-in-place technology, sterilizing-grade filters, preparing components, packaging operations, and process control and quality systems. Book News, Inc.?, Portland, OR
Product Details
* Hardcover: 864 pages
* Publisher: Marcel Dekker; 2nd Illus edition (November 1, 1998)
* Language: English
* ISBN: 0824793846
* Product Dimensions: 10.3 x 7.1 x 1.8 inches
* Shipping Weight: 3.3 pounds. (View shipping rates and policies)
* Average Customer Review: based on 1 review. (Write a review)
* Amazon.com Sales Rank: #402,968 in Books