Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Quality Assurance for Sterile Products

Author(s):  Kastango Eric S, Douglass Kate

Issue:  Jul/Aug 2001 - Sterile Product Compounding
View All Articles in Issue

Abstract:  The focus on developing, implementing and using quality systems during pharmacy preparation of sterile products has never been important than it is today. United States Pharmacopeia (USP) Chapter <1206> (“Sterile Drug Products for Home Use”) can be used as the standard for compounding sterile preparations. The focus of this article is to emphasize that the operating standards described in the American Society of Health-System Pharmacists Guidelines on Quality Assurance for Pharmacy-Prepared Products and/or USP Chapter <1206> should be reviewed and followed by responsible pharmacy personnel who prepare sterile products and to identify operating metrics that can be used to design a quality system for the preparation of sterile products in a pharmacy. The authors discuss process simulation testing, development of a dynamic environmental monitoring program, routine cleaning and sanitizing procedures, validation of aseptic technique, validation of compounding equipment and end-product testing. Figures provide information about types of activities validated by process simulation testing, pharmacy cleanroom environmental sampling locations and sample environmental monitoring scheduling. Tables cover baseline alert and action-limit values for pharmacy cleanroom environmental sampling, characteristics of cleaning and sanitizing agents and a sample cleaning plan for controlled work areas. A sample validation plan is also provided.

Related Keywords: Aseptic technique, validation of, End-product testing, sterile products, Equipment, compounding, validation of, Quality assurance, sterile products, Sterile products, quality assurance


Printer-Friendly Version

Download in electronic PDF format for $65

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Quality Assurance for Sterile Products Kastango Eric S, Douglass Kate Jul/Aug 2001 246-253 Buy
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations McElhiney Linda F Jul/Aug 2013 307-311 Buy
Improving the Management, Operations and Cost Effectiveness of Sterile-Product Compounding Kastango Eric S, Douglass Kate Jul/Aug 1999 253-258 Buy
Accuracy Considerations in Sterile Compounding Akers Michael J Mar/Apr 2017 133-142 Buy
Compounding with Biotechnology Products, Part 2: Product-specific Considerations Allen Loyd V Jr Nov/Dec 2022 446-466 Buy
Microbiologic Testing for 503A Sterile-Compounding Pharmacies Mixon William, Roth Abby May/Jun 2017 193-203 Buy
Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon Jul/Aug 2020 322-326 Buy
Quality Assurance and Quality Control, Part 2 Akers Michael J May/Jun 2015 215-221 Buy
Autoclaves for the Sterilization of Compounded Parenteral Products Rahe Hank Mar/Apr 2003 114-116 Buy
How to Handle a Product Recall Allen Loyd V Jr Jul/Aug 2003 292-293 Buy
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions