This General Information Chapter (USP< 1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP< 55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
Parametric release becomes possible when the mode of sterilization is 1) very well understood, 2) the physical parameters of processing are well defined, predictable, and measurable, 3) and the lethality of the cycle has been microbiologically validated through the use of appropriate biological indicators or, in the case of ionizing radiation, the appropriate microbiological and dosimetric tests.
The use of parametric release for sterilization processes requires prior FDA approval. It should be expected that the regulatory agencies evaluating submissions including the use of parametric product release would insist upon a well-supported scientific rationale for the sterilization process and well documented validation data.
The agencies would need assurance that any marketed sample of product will be sterile and, if tested after release, would pass the requirements for sterility as found in the General Chapter USP< 71> Sterility Tests.
It is important to consider the limitations of the USP< 71> Sterility Tests in the evaluation of terminally sterilized products. The sterility test described in General Chapter USP< 71> is limited in its sensitivity and is statistically ill-suited to the evaluation of terminally sterilized products given the exceedingly low probability of finding contaminated units.
Therefore, once a sterilization process is fully validated and operates consistently, a combination of physical sterilization data such as accumulated lethality or dosimetry in combination with other methods, such as load monitors (e.g., biological indicators, thermochemical indicators, or physicochemical integrators), can provide more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
There are four modes of sterilization that theoretically and practically could qualify for parametric release: moist heat, dry heat, ethylene oxide, and ionizing radiation sterilization.
Why It Provides More Accurate Information than the USP< 71> Sterility Tests.
Learn about the Interrelationship between USP< 1222> and the EU “Guideline on the Sterilization of Medicinal Products…” (March 2019).
Learn about the four modes of ParametricRelease.
Issues and Answers of the Manufacture of Biological Indicators.
Why Should You Attend:
Parametric release is defined as the release of terminally sterilized batches or lots of sterile products based upon compliance with the defined critical parameters of sterilization without having to perform the testing requirements under USP< 71> Sterility Tests.Parametric release becomes possible when the mode of sterilization is 1) very well understood, 2) the physical parameters of processing are well defined, predictable, and measurable, 3) and the lethality of the cycle has been microbiologically validated through the use of appropriate biological indicators or, in the case of ionizing radiation, the appropriate microbiological and dosimetric tests.
The use of parametric release for sterilization processes requires prior FDA approval. It should be expected that the regulatory agencies evaluating submissions including the use of parametric product release would insist upon a well-supported scientific rationale for the sterilization process and well documented validation data.
The agencies would need assurance that any marketed sample of product will be sterile and, if tested after release, would pass the requirements for sterility as found in the General Chapter USP< 71> Sterility Tests.
It is important to consider the limitations of the USP< 71> Sterility Tests in the evaluation of terminally sterilized products. The sterility test described in General Chapter USP< 71> is limited in its sensitivity and is statistically ill-suited to the evaluation of terminally sterilized products given the exceedingly low probability of finding contaminated units.
Therefore, once a sterilization process is fully validated and operates consistently, a combination of physical sterilization data such as accumulated lethality or dosimetry in combination with other methods, such as load monitors (e.g., biological indicators, thermochemical indicators, or physicochemical integrators), can provide more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
There are four modes of sterilization that theoretically and practically could qualify for parametric release: moist heat, dry heat, ethylene oxide, and ionizing radiation sterilization.
Areas Covered in the Webinar:
An Overview of “Terminally Sterilized pharmaceutical Products - Parametric Release”.Why It Provides More Accurate Information than the USP< 71> Sterility Tests.
Learn about the Interrelationship between USP< 1222> and the EU “Guideline on the Sterilization of Medicinal Products…” (March 2019).
Learn about the four modes of ParametricRelease.
Issues and Answers of the Manufacture of Biological Indicators.
Who Will Benefit:
- Microbiology
- Quality Control
- Quality Assurance
- Regulatory Compliance
- Facilities
- Manufacturing
- Validation
- Metrology
- Research and Development
Course Provider
Barry A Friedman,
