Front Matter
Preliminary Material
PART I: Sterile Preparation
1 Imperative for Change: Adverse Sterile Compounding Events
2 Standards for Compounded Sterile Preparations
3 Immediate-Use Compounding
4 Sterile Preparation Formulation
5 Parenteral Nutrition Compounding
6 Special Considerations in Pediatric Compounding
7 Special Considerations in Compounding Biologicals
8 Ancillary Equipment and Supplies
9 Primary Engineering Controls
10 Personnel Cleansing and Garbing
11 Aseptic Technique
12 Hazardous Drugs as Compounded Sterile Preparations
13 Radiopharmaceuticals as Compounded Sterile Preparations
14 Storage and Beyond-Use Dating
15 Labeling Sterile Preparations
16 Documentation of Compounded Sterile Preparations
18 Finished Preparation Release Checks and Tests
19 Microbiological Issues in Compounding Sterile Preparations
20 Handling Sterile Commercial Products and Compounded Sterile Preparations Within the Pharmacy
21 Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs
22 Batch Compounding
PART II: Quality Management
23 Pharmacist Education
24 Pharmacy Technician Education, Certification, Training, Evaluation, and Regulation
25 Secondary Engineering Controls
26 Sterile Compounding Technology
27 Cleaning and Disinfecting
28 Environmental Quality and Control
29 Dealing with Latex Allergies
30 Personnel Training and Competency Evaluation
31 Policies, Procedures, and Quality Assurance Programs
32 Outsourcing the Compounding of Sterile Preparations
Back Matter
Appendix A: ASHP Guidelines on Compounding Sterile Preparations
Appendix B: ASHP Guidelines on Handling Hazardous Drugs
Appendix C: Selected ASHP Guidelines Pertaining to Sterile Compounding
Appendix D: Selected Websites Pertaining to Compounding Sterile Preparations
Glossary
Index

17 Sterility Assurance of Compounded Sterile Preparations

in Compounding Sterile Preparations
Author:
Angela W. Yaniv
DOI:
https://doi.org/10.37573/9781585284856.017
Restricted access