Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Component Selection for Sterile Compounding

Author(s):  Dilzer Richard H

Issue:  Jul/Aug 2017 - Volume 21, Number 4
View All Articles in Issue

Page(s):  277-280

Component Selection for Sterile Compounding Page 1
Component Selection for Sterile Compounding Page 2
Component Selection for Sterile Compounding Page 3
Component Selection for Sterile Compounding Page 4

Download in electronic PDF format for $75

Abstract:  This article describes the factors to consider, as well as the process of proper component selection, for use in preparing compounded sterile preparations. Special emphasis is placed on individual chemical factors that may impact a preparation’s accuracy and potency. Values reported in a typical certificate of analysis are discussed, including methods of identifying any required adjustments to a master formulation or compounding record during the compounding of sterile preparations. Proper screening of the certificate of analysis, the Safety Data Sheet, procedural documentation, and the filing of all certificates of conformance are crucial to the operation of a sterile compounding facility.

Related Keywords: Richard H. Dilzer, RPh, FACA, FIACP, compounded sterile preparations, certificate of analysis, documentation, standard operating procedures, vendor, package integrity, good manufacturing practice, safety data sheet, United States Pharmacopeia Chapter <797>, United States Pharmacopeia Chapter <1160, USP, Compounding Compendium, potency, purity, quality control, loss on drying


Printer-Friendly Version

Related Articles from IJPC
(Click for Abstract / Details / Purchase)
Component Selection for Sterile Compounding
Dilzer Richard H
Jul/Aug 2017
Pg. 277-280

Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists
Rahe Hank
Mar/Apr 2004
Pg. 89-94

Root Cause Analysis, Part 2: Sterile Compounding
Cabaleiro Joe
, Jackson Kathleen
Mar/Apr 2016
Pg. 99-104

Standard Operating Procedure: Certificates of Analysis of Materials Used for Pharmaceutical Compounding
Mar/Apr 2001
Pg. 147

Healthful Living: Good Practices for Good Health
Jackson Kathy
May/Jun 2002
Pg. 164-166

Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
Kastango Eric S
, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura
Jul/Aug 2015
Pg. 268-278

Safety Standards in Pharmaceutical Compounding, Part 3: Fire Safety
Allen W Chris
, Greeson Nicole MH, Mixon William
Nov/Dec 2020
Pg. 451-458

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations
Allen Loyd V Jr
May/Jun 2013
Pg. 210-219

Compounding Enclosures: Ensuring Safety During the Preparation of Sterile and Nonsterile Formulations
Ashe Krystina
, Baskett Dustin
Sep/Oct 2018
Pg. 387-398

Basics of Sterile Compounding: Intravenous Admixture Preparation Considerations, Part 10: Packaging and Container-closure Issues
Allen Loyd V Jr
Jul/Aug 2021
Pg. 311-317

Standard Operating Procedure: Basic Compounding Documentation--the Master Formula Form
Allen Loyd V Jr
May/Jun 2007
Pg. 240-241

Prevention Is the Best Medicine: Don J. Bottoni, RPh, FACA, FIACP
Bottoni Don J
Jan/Feb 2004
Pg. 22-27

Microbiologic Testing for 503A Sterile-Compounding Pharmacies
Mixon William
, Roth Abby
May/Jun 2017
Pg. 193-203

The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013
Lutz Eugene
, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc
Jan/Feb 2014
Pg. 6-12

Basics of Sterile Compounding: Personnel Requirements for Sterile Compounding
Akers Michael J
Jul/Aug 2016
Pg. 307-314

Standard Operating Procedure: Incubator Temperature Monitoring
Allen Loyd V Jr
May/Jun 2003
Pg. 228-229

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Standard Operating Procedure: Determining and Documenting the Commercial Unavailability of a Manufactured Drug Product
Allen Loyd V Jr
Jul/Aug 2004
Pg. 292-293

Sterile Basics of Compounding: Intravenous Admixture Compounding, Part 3: Preparation Procedures
Allen Loyd V Jr
Jul/Aug 2023
Pg. 305-313

Adventures in the Environmental World and Environmental Microbiology Sampling of Air for Pharmaceutical Sterile Compounding
Ligugnana Roberto
May/Jun 2017
Pg. 182-190

Return to Top