Non-heat terminal sterilization of controlled released material
Presentation overview
- A balance must be achieved between the need to maintain a safe, stable and efficacious product while providing sufficient lethality to attain a minimum level of sterility assurance
- No sterilization method should be considered exempt
Material perspective
- Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of microorganisms
- A sterilization process that destroys all microorganisms, but renders the item being sterilized unfit for use is of no value
- The sterilization process and the specific product, formulation and container must all be suited to each other
- There are few universal answers, and some of those that appear to be broadly applicable may be wrong.
Sterilization Methods (ranked by estimated material effect)
• Sterilization by Filtration
• Chemical Sterilization
• Includes aldehydes, oxidizers, halides, acids, bases
•Gas Sterilization
• Includes ETO, Chlorine Dioxide, Ozone
•Vapor Sterilization
• Includes H2O2, and Peracetic acid Radiation Sterilization
• Steam Sterilization
•Dry Heat Sterilization
Sterilization Methods (effect & issue)
• Sterilization by Filtration Must be a solution, likely requires aseptic processing to manufacture a dosage form.
• Chemical (Liquid phase) Sterilization-Strong acids / bases, post Process neutralization required, won’t penetrate solids
• Chemical (Gas Phase) Sterilization Potent chemicals, won’t penetrate solids
• Vapor (BiPhasic) Sterilization Poorly suited – prefer liquid or gas systems for ease of use / validation
• Radiation Sterilization Method of choice?, penetration varies with method, new methods and ideas possible
• Steam Sterilization Heat effects can be extreme, new ideas possible
• Dry Heat Sterilization Heat effects are always extreme, few real opportunities
• (Emerging Methods) Effective, but may require extensive support for implementation, material effects are largely unstudied.
Sterilization & Penetration
• Little or no penetration
• Chemical Sterilization
• Vapor Sterilization
• Some penetration
• Gas Sterilization
• Steam Sterilization
• Good Penetration
• Dry Heat Sterilization
• Radiation Sterilization
- author: Agalloco James
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