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9781585280261

Principles of Sterile Product Preparation

by ; ; ;
  • ISBN13:

    9781585280261

  • ISBN10:

    1585280267

  • Edition: Revised
  • Format: Paperback
  • Copyright: 2001-09-01
  • Publisher: J a Majors Co
  • View Upgraded Edition
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List Price: $70.00

Summary

Textbook of fundamentals for pharmacists, pharmacy technicians, and students. Presents an understanding of the new, stricter, sterile compounding guidelines; supplements other educational materials published by the ASHP, and provides a reliable reference for compounding and dispensing sterile products. Softcover.

Table of Contents

Introduction v
Authors vii
Contributors viii
Reviewers ix
Concepts and Guidelines in Preparing Sterile Products
1(8)
E. Clyde Buchanan
Philip J. Schneider
Personnel Education, Training, and Evaluation
9(8)
Philip J. Schneider
E. Clyde Buchanan
Sterile Product Formulation and Compounding
17(8)
E. Clyde Buchanan
Sterile Compounding Facilities
25(12)
E. Clyde Buchanan
Equipment for Sterile Product Preparation
37(8)
Philip J. Schneider
Environmental Monitoring
45(4)
Philip J. Schneider
Use of Aseptic Technique
49(8)
Douglas J. Scheckelhoff
Personnel Behavior and Garb Use
57(6)
Barbara T. McKinnon
Handling, Preparation, and Disposal of Cytotoxic and Hazardous Agents
63(8)
Douglas J. Scheckelhoff
Preparation and Sterilization of Batch Compounds
71(8)
Barbara T. McKinnon
Batch Preparation Documentation
79(16)
Barbara T. McKinnon
Factors Influencing Expiration Dates
95(10)
Barbara T. McKinnon
Labeling of Sterile Products
105(6)
Douglas J. Scheckelhoff
Handling of Sterile Products Within the Pharmacy
111(6)
Barbara T. McKinnon
Handling of Sterile Products Outside the Pharmacy
117(4)
Douglas J. Scheckelhoff
Process Validation
121(4)
Philip J. Schneider
End-Product Evaluation
125(4)
Philip J. Schneider
Documentation of Sterile Product Preparation
129(4)
Barbara T. McKinnon
Policies and Procedures for Sterile Product Preparation
133(6)
E. Clyde Buchanan
Appendices
139(58)
1. FDA Compliance Policy Guide 7132.06 (Chapter 32---Drugs General)
139(3)
2. FDA Compliance Policy Guide 7132c.06 (Chapter 32c---Drugs---NDA/IND)
142(3)
3. National Association of Boards of Pharmacy Good Compounding Practices Applicable to State Licensed Pharmacies
145(4)
4. National Association of Boards of Pharmacy Model Rules for Sterile Pharmaceuticals
149(4)
5. ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products
153(21)
6. United States Pharmacopeial Convention, Inc., Chapter <1206>s Sterile Drug Products for Home Use
174(1)
7. ASPEN Safe Practices for Parenteral Nutrition Formulations
175(17)
8. ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures
192(5)
Glossary 197

Supplemental Materials

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