Overview:
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme thermophile organisms have their optimal growth temperature at 110°C, whereas most vegetative cells are killed at 60°C. Some species (not necessarily spore formers) are highly radiation resistant.
The chemical environment causes significant variance in the death rate of a microorganism. Very dense cell walls, spore coats, or slime layers outside the cell can severely limit the ingress of what is being used to sterilize the product.
General principals used to kill microorganisms such as Steam and Dry Heat which causes denaturization of macromolecules, dissociation of tertiary and secondary structures, and protein agglutination along with destruction of molecular arrangements in the cells caused by radiation. The generation of free radicals causes destruction and re-arrangement of chemical bonds in macromolecules. Chemical disinfection or sterilization causes modifications of macromolecules depending on the agent used.
General Sterilization Terms
D value calculator – all types of sterilization
Z value calcuator – thermal sterilization processes
F-value – thermal sterilization processes that originated from 250oF
FBIO - thermal sterilization for specific organisms
Fo(F sub zero) – moist heat sterilization
FH(F sub H) – dry heat sterilization &depyrogenation
L – Lethality (aka F value) used in various processes
How do we calculate and monitor these different variables in order to generate the required SAL and PNSU based on the bio burden that may be contaminating the product from an API or the process?
Areas Covered in the Session:
From the topics listed above the areas covered provide the mathematical means of developing and proving the sterilization process is effective and does not generate a problem for heat liable products.
1. Survivor Curves to determine D-values and Z-values
2. Linear Regression used to calculate the edge of failure
3. Fraction Negative studies
4. Correction factors associated with heating and cooling
5. Cold spot determination - product and chamber - TD and HP
6. Calculation of process lethality
7. Biological Indicators to be used and how to make the selection
8. Laboratory Studies needed to support Sterilizer Studies
9. Identification of elements in the process that can affect D-value
Who Will Benefit:
• Manufacturing Operations Professionals
• Formulation Professionals
• Engineering Professionals
• QA/QC Professionals
• Product and Process Development Professionals
• Regulatory Affairs Professionals
• Research and Development Professionals
• Sterility Assurance Professionals
• Technical Operations Professionals
• Validation Professionals
• Inspectors
• Auditors
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme thermophile organisms have their optimal growth temperature at 110°C, whereas most vegetative cells are killed at 60°C. Some species (not necessarily spore formers) are highly radiation resistant.
The chemical environment causes significant variance in the death rate of a microorganism. Very dense cell walls, spore coats, or slime layers outside the cell can severely limit the ingress of what is being used to sterilize the product.
General principals used to kill microorganisms such as Steam and Dry Heat which causes denaturization of macromolecules, dissociation of tertiary and secondary structures, and protein agglutination along with destruction of molecular arrangements in the cells caused by radiation. The generation of free radicals causes destruction and re-arrangement of chemical bonds in macromolecules. Chemical disinfection or sterilization causes modifications of macromolecules depending on the agent used.
General Sterilization Terms
D value calculator – all types of sterilization
Z value calcuator – thermal sterilization processes
F-value – thermal sterilization processes that originated from 250oF
FBIO - thermal sterilization for specific organisms
Fo(F sub zero) – moist heat sterilization
FH(F sub H) – dry heat sterilization &depyrogenation
L – Lethality (aka F value) used in various processes
How do we calculate and monitor these different variables in order to generate the required SAL and PNSU based on the bio burden that may be contaminating the product from an API or the process?
Areas Covered in the Session:
From the topics listed above the areas covered provide the mathematical means of developing and proving the sterilization process is effective and does not generate a problem for heat liable products.
1. Survivor Curves to determine D-values and Z-values
2. Linear Regression used to calculate the edge of failure
3. Fraction Negative studies
4. Correction factors associated with heating and cooling
5. Cold spot determination - product and chamber - TD and HP
6. Calculation of process lethality
7. Biological Indicators to be used and how to make the selection
8. Laboratory Studies needed to support Sterilizer Studies
9. Identification of elements in the process that can affect D-value
Who Will Benefit:
• Manufacturing Operations Professionals
• Formulation Professionals
• Engineering Professionals
• QA/QC Professionals
• Product and Process Development Professionals
• Regulatory Affairs Professionals
• Research and Development Professionals
• Sterility Assurance Professionals
• Technical Operations Professionals
• Validation Professionals
• Inspectors
• Auditors
