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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

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sterilization
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

CHEE 440

viruses
Viruses

CHEE 440

bacteria
Bacteria

CHEE 440

yeast and mould
Yeast and Mould

aspergillus

penicillium

CHEE 440

sterilization methods
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

CHEE 440

heat resistances
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

CHEE 440

steam sterilization
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

CHEE 440

sterilization methods9
Sterilization Methods
  • Filtration
    • used for heat sensitive solutions
    • pore sizes range from 14 to 0.025 mm
  • Gas sterilization
    • used in hospitals and industry for thermolabile materials
    • ethylene oxide, propylene oxide used
    • 500-1000 mg/L, 4 - 16 hours at 55 ºC, 50-60 %RH
    • need to remove absorbed gas after sterilization
  • Ionization
    • use of gamma rays
    • limited application

CHEE 440

kinetics of cell inactivation
Kinetics of Cell Inactivation
  • death rate follows first order kinetics

CHEE 440

d value
D value
  • decimal reduction time
  • time required for 90% reduction in cell count

CHEE 440

z value
Z value
  • degrees of temperature/dose change required to achieve a tenfold decrease in D

CHEE 440

example
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.

CHEE 440

de pyrogenation
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

CHEE 440