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Our 10th Year of Publication

Cover Story

Medical Devices

STERILIZATION OF MEDICAL DISPOSABLES

Mr. Pradeep Kumar KP
Marketing Manager
JUBILANT ORGANOSYS LTD
WHAT IS STERILIZATION? 

STERILIZATION IS A PROCESS BY WHICH THE PROBABILITY OF OCCURING OF MICRO-ORGANISMS IN A PRODUCT IS BROUGHT DOWN TO 10-6.

 

CONVENTIONAL METHODS
BOILING..BAKING..STEAMING..SOAKING…ETC
STEAM STERILIZATION

DISADVANTAGES

HEAT LABILE AND MOIST SENSITIVE 
MATERIALS COULD NOT BE STERILIZED. 
DIFFICULTY IN MAINTAINING THE TERILITY. 

CHEMICAL DISINFECTANTS

DISADVANTAGES
THEY ARE EFFECTIVE ONLY AS SURFACE DISINFECTANTS-THEY HAD LIMITATIONS OF PENETRATION.
DIFFICULTY IN MAINTAINING STERILITY. 

IDEAL STERILANT- 

  • SHOULD BEEASY TO STORE, HANDLE AND OBTAIN 

  • SHOULD BE ABLE TO STERILISE A WIDE RANGE OF PRODUCTS 

  • SHOULD NOT HAVE DETRIMENTAL EFFECTS TO THE PRODUCTS. 

  • EFFECTIVE AT LOW TEMP. 

  • PENETRATIVE 

  • EASILY REMOVABLE FROM THE STERILISED MATERIAL

ETHYLENE OXIDE HISTORY 

  • IT WAS JUST AFTER THE SECOND WORLD WAR THAT AMERICAN ARMY SCIENTISTS IDENTIFIED EO AS A POTENTIAL STERILIZING AGENT. 

  • IN INDIA ETHYLENE OXIDE STERILIZATION HAD BEEN INTRODUCED AROUND THREE DECADES BACK.

EO AS A STERILANT 

ADVANTAGES

  • EO CAN PENETRATE EVEN THROUGH PACKING MATERIALS. 

  • EO REMAINS IN GASEOUS FORM UNDER AMBIENT CONDITIONS. 

  • EASILY AVAILABLE 

  • CAN STERILISE ALMOST ALL MATERIALS EXCEPT LIQUID. 

DISADVANTAGES 

  • HIGH FLAMMABILITY AND EXPLOSIVITY OF EO DEMAND SPECIALISED CHAMBERS AND CONTROLS.

EO-PROPERTIES 

  • FORMULA-C2H4O 

  • MOLE.WT-44 

  • B.P-10.4-10.7 DEGREE CELCIUS 

  • FREEZING POINT- -111.3 DEG.CELCIUS 

  • FLASH POINT—17.8 DEG.CELCIUS 

  • DENSITY AT 4 DEG.CEL-890KG/C.MTS 

EO-PROPERTIES 

  • FLAMMABILITY LIMIT IN AIR-3% TO 100% 

  • MISCIBILITY – EASILY MISCIBLE WITH WATER 

  • AUTO-IGNITION TEMP .IN AIR-429 DEG.CELCIUS 

  • TLV-1PPM 

EO STERILIZATION

  • HOW STERILIZATION IS ACHIEVED?
    STERILIZATION IS ACHIEVED BY AN ALKYLATION REACTION OF EO WITH THE DNA MOLECULE OF THE LIVING CELLS. 

  • EO REPLACES LABILE HYDROGEN ATOMS OF AMINO, CARBOXYL,HYDROXYL,AND SULPH HYDRYL GROUPS OF THE LIVING CELLS, CAUSING A LETHAL EFFECT. 

CONDITIONS FOR EO GAS STERILIZATION 

IT IS ACHIEVED BY THE FOLLOWING CONTROLLED PARAMETERS- 

  • TEMPERATURE 

  • RELATIVE HUMIDITY 

  • EXPOSURE PERIOD 

  • GAS CONCENTRATION 

  • NATURE OF PACKING 

METHOD OF USAGE 

PURE FORM 

MIXTURES 

  • WITH C02 

  • WITH FREON12 

FREQUENTLY USED COMBINATIONS 

  • 90/10 

  • 80/20 

  • 70/30 

  • 20/80 

  • 10/90

APPLICATIONS 

  • MEDICAL DISPOSABLES MANUFACTURING INDUSTRY 

  • SPICE / FOOD PROCESSORS / EXPORTERS 

  • HOSPITALS / NURSING HOMES 

  • CHEMICAL INDUSTRY 

PRODUCTION OF EO 

  • OXIDATION OF ETHYLENE 

  • FROM CHLOROHYDRIN 

EO SOURCE / AVAILABILITY

SOURCE 

  • MAINLY PETROCHEMICAL INDUSTRY.SO IN INDIA , RELIANCE AND IPCL ARE THE MAIN SOURCES. 

AVAILABILITY 

  • USUALLY IN TANKERS. FOR COMMERCIAL USES THE SAME IS MADE AVAILABLE IN CYLINDERS AND CANISTERS. 

  
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