Autoclave Validation | Autoclave and Steam Sterilizer Solutions
Kaye Solutions for validating Steam Sterilization Processes
Application in a Glance
Steam Sterilization has been used for more than a century in the pharmaceutical and biotech industry to effectively sterilize products and materials withstanding moisture and higher temperatures.
Critical parameters such as Time, Temperature, Pressure, Direct Steam Contact, Air Removal have an impact on the sterilization results. Achieving Saturated Steam conditions is key and allows a proper temperature and pressure controlled process.
Depending on the product and packaging characteristics different sterilization temperatures are utilized.
Autoclave Validation is one of the most critical and widely studied processes for the sterilization of drug products, liquids in sealed containers, and hard goods used in the testing or manufacturing of Pharmaceutical, Biotech, and Medical Device products.
The purpose of the Autoclave Validation process is to ensure the destruction of all bacteria, viruses, and other viable microorganisms. The destruction of a microbial population subjected to a sterilization process follows a logarithmic progression based on the Thermal Death Curve.
In the pharmaceutical industry, in order to define a unit as sterile one must be able to certify that less than one unit in a million is exposed to the risk of not being sterile. The probability of finding a nonsterile unit (Probability of Non Sterile Unit, or Sterility Assurance Level SAL) must therefore be smaller (as mathematical value) than 10−6.
The critical parameters that affect a successful Autoclave Validation are:
- Temperature
- Pressure
- Time
- Saturated Steam
- Air Removal
- Steam Penetration
- Drying
Regulatory requirements worldwide require the Validation of all GMP Autoclaves to provide documented evidence that the sterilization process, developed in process design, can reliably and repeatedly deliver the prescribed sterilization process as well as the attainment of the required Sterility Assurance Level SAL of the products.
Autoclave /Steam Sterilizer Validation can be divided into two main phases: Process Design and Process Qualification.
Process Design is the most critical part of Autoclave Validation as it directly impacts the ability of the sterilization process to repeatably delivery the desired results and quality attributes. Process Design needs to consider many variables such as:
- Product Types (Porous/Hard Goods, Liquids, Finished Filled Parenterals)
- Heat sensitivity of Products (Bioburden / Overkill)
- Packaging
- Load Configuration
These variables have a direct impact on the selection of the appropriate sterilization process; Saturated Steam w/ Pre-vacuum, Gravity Displacement, Air Overpressure, Steam-Air Mixture or Superheated Water.
The final step to Process Design is the specification of critical measurements, calculations, and tolerances that will result in a product that is both sterile and functional after the sterilization process.
The second phase of Autoclave Validation is Process Qualification. The goal of the Process Qualification is to verify that the sterilization process meets all the critical design criteria thru Physical and Biological testing.
Physical testing includes:
- Distribution testing to verify chamber temperature uniformity and identify hot and cold spots
- Penetration tests to verify product temperature tolerances / CTQ’s and calculated product lethality to verify that defined min Lethality (F0) and SAL has been met.
- Equilibration CTQ has been met to verify steam penetration and the ability to condition the load thru air removal and load heating.
- Steam Saturation calculations to verify steam saturation conditions during exposure and assist in detecting any excess of air or non-condensable gases.
Physical testing should be conducted for the worse case load with sensors placed in the most difficult to sterilize positions. All sensors must be properly calibrated or verified to ensure adequate accuracy. Repeatability of measurements should be verified by 3 consecutive runs.
Biological testing involves the use of Biological Indicator placed throughout the load to verify proper steam penetration. BI’s are later incubated and checked for growth.
Only if both the Physical and Biologic testing meet expected results is the Autoclave Validation considered successful.
The Kaye AVS and ValProbe RT validation products are ideal for Autoclave Validation. They contain the accuracy, reliability and calculations necessary to access the performance of your Steam Sterilizer.
Kaye Announces Three New Distributors In the Middle East
Kaye has partnered with three new distributors in the Middle East, all of which are part of the Taawon Group in Jordan.
Al Taawon for Laboratory & Scientific Supplies Co. in Jordan is the parent company of Diamond Spectrum for Scientific & Laboratory Equipment in Saudi Arabia and Altayf Althahabi Scientific & Laboratory Equipment Trading L.L.C. in the United Arab Emirates.
Effective immediately these respected companies are authorized distributors of Kaye products and will serve customers in Jordan, Saudi Arabia, and the United Arab Emirates.
“Kaye has long awaited this partnership and we are excited to work with the Taawon group and its esteemed affiliates to provide the best equipment to customers in the Middle East,” says Davide Postacchini.
Taawon Group is a supplier of high-quality laboratory supplies and industrial equipment, disposables & chemical products in different market segments such as pharmaceuticals and bio-pharmaceuticals, food & beverage, chemicals & petrochemicals, oil & gas, academic institutions & research centers, IVF & genetics labs, hospitals & medical labs, environmental & testing labs and last but not least, forensics labs.
Kaye is proud to have its line of industry-standard validation and environmental monitoring equipment be among Taawon Group’s inventory of analytical solutions, testing instruments, microbiology lab solutions, environmental monitoring solutions, and more.
“We at Taawon Group believe that this new partnership with Kaye will generate new future business opportunities and will lead to achieving business goals as well as accomplishing more and attaining greater results and benefits,” says the general manager of the Taawon Group.
For professionals in the Middle East working in health sciences, technology and medical equipment, visit taawon.com to find what Kaye products are available to you.
ABOUT KAYE
For more than sixty years, Kaye has been at the forefront of high accuracy process measurement, for applications from thermal process validation and environmental and cold chain monitoring, to sensor calibration.
ABOUT TAAWON GROUP
Taawon Group was established in 2008 where the headquarter is based in Jordan and the group has expanded its activities internationally to reach Saudi Arabia (Diamond Spectrum), United Arab Emirates (Altayf Althahabi – TTSL) and Poland (Parameter EU). This was a result of the emerged need for a local supplier of laboratory supplies.
Taawon Group is specialized in the supplies of excellence level of high quality, compatible and best value laboratory and industrial equipment, disposables & chemical products in different market segments such as pharmaceuticals and bio-pharmaceuticals, food & beverage, chemicals & petrochemicals, oil & gas, academic institutions & research centers, IVF & genetics labs, hospitals & medical labs, environmental & testing labs and last but not least forensics labs.
