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.

Autoclaves for the Sterilization of Compounded Parenteral Products

Author(s):  Rahe Hank

Issue:  Mar/Apr 2003 - Terrorism
View All Articles in Issue

Abstract:  This article documents the results of recent testing conducted to determine whether the performance of an autoclave (Model AS12P 58939-950, Barnstead/Thermolyne, Dubuque, Iowa) matched the preset cycles, provided heating to a temperature of 121 degrees C (required for sterilization) and maintained that temperature for the required 15 minutes. When the autoclave was tested without a load, results indicated that its performance matched the respective printout data. When a load was added, measurements showed a variation between the actual temperature of the water and the temperature indicated on the printout. According to the printout, the water in the beaker did not reach 121 degrees C until the sterilization cycle was more than half complete, which indicated that the required temperature was not maintained for the 15 minutes necessary for sterilization. Previous experience with several autoclaves indicated that individual units perform differently and that a single unit cannot be used to determine sterilization cycles for other brands or types of unit. Each unit should be tested to determine the correct sterilization cycle for a specific load. Testing must be based on the characteristics of the load because different loads require different cycles. All autoclaves used for preparing sterile injectable products that are not sterile-filtered through a double 0.22-micrometer filter should be subjected to this type of testing.

Related Keywords: Autoclaves, for sterilization of parenteral products, Parenteral products, sterilization of by autoclave, Sterilization, of parenteral products, by autoclave


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Autoclaves for the Sterilization of Compounded Parenteral Products Rahe Hank Mar/Apr 2003 114-116 Buy
Sterilization of Compounded Parenteral Products: Verification of Autoclaves Rahe Hank Mar/Apr 2013 94-98 Buy
Sterile Basics of Compounding: Methods of Sterilization and Depyrogenation Allen Loyd V Jr Mar/Apr 2022 129-136 Buy
Sterilization and Depyrogenation Principles and Methods Akers Michael J Jul/Aug 1999 263-269 Buy
Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing Akers Michael J Mar/Apr 2015 127-138 Buy
Dry Heat Sterilization of Parenteral Oil Vehicles Kupiec Thomas C, Matthews Parrish, Ahmad Riaz May/Jun 2000 223-224 Buy
Autoclave Efficiency Validation Allen Loyd V Jr Mar/Apr 2003 126-127 Buy
A Review of Parenteral Admixtures Requiring Select Containers and Administration Sets Rice Stephen P Mar/Apr 2002 120-122 Buy
Quality Assurance for Sterile Products Kastango Eric S, Douglass Kate Jul/Aug 2001 246-253 Buy
Compounding with Biotechnology Products, Part 2: Product-specific Considerations Allen Loyd V Jr Nov/Dec 2022 446-466 Buy