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STERILIZATION The complete destruction of all living organisms and their spores or their complete removal from the formulation. All parenterals, as well as otic, nasal, ophthalmic solutions, must be sterile, includes packaging materials methods steam dry-heat filtration gas ionizing radiation B. Amsden CHEE 440
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Viruses B. Amsden CHEE 440
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Bacteria B. Amsden CHEE 440
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Bacterial Endospores B. Amsden CHEE 440
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Yeast and Mould aspergillus penicillium B. Amsden CHEE 440
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Sterilization Methods
steam sterilization conducted in an autoclave method of choice 121 C, 20 minutes dry heat less effective than moist heat 170 C, > 2 hours used to sterilize equipment B. Amsden CHEE 440
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Heat Resistances method determined by nature of micro-organism and formulation ingredients protocols are developed based on reference organisms of known sterilization resistance micro-organisms possess different resistances to heat B. Amsden CHEE 440
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Steam Sterilization Determination of steam sterilization protocol
first select a reference organism determine its D value under defined conditions establish initial bioburden calculate time of exposure at 121 ºC B. Amsden CHEE 440
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Sterilization Methods
Filtration used for heat sensitive solutions pore sizes range from 14 to mm Gas sterilization used in hospitals and industry for thermolabile materials ethylene oxide, propylene oxide used mg/L, hours at 55 ºC, %RH need to remove absorbed gas after sterilization Ionization use of gamma rays limited application B. Amsden CHEE 440
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Kinetics of Cell Inactivation
death rate follows first order kinetics B. Amsden CHEE 440
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D value decimal reduction time
time required for 90% reduction in cell count B. Amsden CHEE 440
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Z value degrees of temperature/dose change required to achieve a tenfold decrease in D B. Amsden CHEE 440
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Example Using G. stearothermophilus as a reference organism (D121 = 1.5 min), and an initial bioburden of 1000 spores, determine the sterilization time required to achieve a 1 in 1,000,000 chance of a spore surviving using a steam autoclave. B. Amsden CHEE 440
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De-pyrogenation Emphasis is placed on prevention of introduction of pyrogens Removal glassware, metals 250 ºC for 45 minutes water oxidation to nonvolatile solvents using potassium permanganate, then distill reverse osmosis plastics protect against contamination B. Amsden CHEE 440
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