Autoclaves for the Sterilization of Compounded Parenteral Products
Download in electronic PDF format for $75
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
Related Articles from IJPC |
Title/Author
(Click for Abstract / Details / Purchase) |
Issue/Page
View/Buy |
Autoclaves for the Sterilization of Compounded Parenteral Products
Rahe Hank
|
Mar/Apr 2003
Pg. 114-116
|
Sterilization of Compounded Parenteral Products: Verification of Autoclaves
Rahe Hank
|
Mar/Apr 2013
Pg. 94-98
|
Sterile Basics of Compounding: Methods of Sterilization and Depyrogenation
Allen Loyd V Jr
|
Mar/Apr 2022
Pg. 129-136
|
Sterilization and Depyrogenation Principles and Methods
Akers Michael J
|
Jul/Aug 1999
Pg. 263-269
|
Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing
Akers Michael J
|
Mar/Apr 2015
Pg. 127-138
|
Dry Heat Sterilization of Parenteral Oil Vehicles
Kupiec Thomas C, Matthews Parrish, Ahmad Riaz
|
May/Jun 2000
Pg. 223-224
|
Sterile Basics: Intravenous Admixture Compounding, Part 2: Parenteral Vehicle Considerations
Allen Loyd V Jr
|
May/Jun 2023
Pg. 223-229
|
Quality Assurance for Sterile Products
Kastango Eric S, Douglass Kate
|
Jul/Aug 2001
Pg. 246-253
|
Autoclave Efficiency Validation
Allen Loyd V Jr
|
Mar/Apr 2003
Pg. 126-127
|
Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing
Akers Michael J
|
May/Jun 2024
Pg. 229-240
|
Compounding with Biotechnology Products, Part 2: Product-specific Considerations
Allen Loyd V Jr
|
Nov/Dec 2022
Pg. 446-466
|
A Review of Parenteral Admixtures Requiring Select Containers and Administration Sets
Rice Stephen P
|
Mar/Apr 2002
Pg. 120-122
|
How to Handle a Product Recall
Allen Loyd V Jr
|
Jul/Aug 2003
Pg. 292-293
|
Improving the Management, Operations and Cost Effectiveness of Sterile-Product Compounding
Kastango Eric S, Douglass Kate
|
Jul/Aug 1999
Pg. 253-258
|
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 5: Verification of Accuracy, Sterility, and Sterilization of Compounded Preparations
Allen Loyd V Jr, Okeke Claudia C
|
Jan/Feb 2008
Pg. 54-60
|
Standard Operating Procedure for Quality Assessment of Parenteral Nutrition Products
Allen Loyd V Jr
|
Sep/Oct 1998
Pg. 380-381
|
Product Containment in the Compounding Laboratory
Vidrine Eric
|
May/Jun 2003
Pg. 213-214
|
Nonsterile Basics of Compounding: Using U.S. Food and Drug Administration-approved Commercial Products as Ingredients
Allen Loyd V Jr
|
Nov/Dec 2023
Pg. 474-481
|
Sterile-Product Preparations: Mix or Buy?
Kastango Eric S
|
Jan/Feb 2001
Pg. 59-63
|
Intravenous Admixture Preparation Considerations, Part 7: Stability Issues
Allen Loyd V Jr
|
Nov/Dec 2020
Pg. 473-478
|
Return to Top |