Kaye has multiple solutions for Autoclave Validation. Steam Sterilization has been used for more than a century in the pharmaceutical and biotech industry.
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:
- Saturated Steam
- Air Removal
- Steam Penetration
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.
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