Ethylene Oxide Gas Sterilization Process

Mekanisme Reaksi Ethylene Oxide + H2O  Ethylene Glikol

Alkylation reaction with amino acid in protein and enzymes
Alkylation reaction with DNA or RNA
Items should be calibrated :
1. Thermo sensor
Temperature range between 30ᴼC to 60 ᴼC every Celsius degree should has an
actual value and précised value compare to temperature standard
2. Vacuum and pressure Gauge
Negative pressure (vacuum) from -0.7 kgf/cm2 to(+) 1.5 kgf /cm2 should be
calibrated and compare to vacuum or pressure standard
3. % Relative Humidity (RH)
- Preparation of Relative Humidity Standard
a. Saturated solution LiCl
Weight accurately 70.0 gram of LiCl and distilled water 30 gram and mixed into
Iodine Flask 250 mL ,stirring slowly and outside equipped by cooling water,
and solution covered by rubber in tight condition and allow to stand for 24 hours
b. Saturated solution of NaCl
Weight accurately 120 gram of NaCl and distilled water 15 gram. Perform a
same manner of saturated solution LiCl
c. Humidity Sensor
Humidity sensor which will be calibrated was placed into the saturated solution
of LiCl and NaCl at 25ᴼC in the Iodine flask alternately and keep for 10 minutes
(constant value) for both measurement
 Thermosensor & Humidity Sensor

Thermosensor

Humidity sensor
Notes :
The unit and the solution should be at the
same uniform , stable temperature before
starting calibration

New solution should be prepared at least

12 hours prior the first time use
 Chart of Ethylene Oxide Gas Sterilization

+ H2O

Humidity up
2-4 hrs 9 times
Explanation of EOG sterilization Chart
After entering product in the Sterilization chamber , perform the heating process
until around 50ᴼC , vacuum until -0.7 kgf/ cm2 and inserting distilled water around
250 mL into the hole of chamber for achieving % RH target and pressing by EOG until
positive pressure suddently around 0.7 kgf/cm2 . When the condition was achieved the
sterilization period is starting . Keep the condition for 2 hrs and perform aeration
process (evacuation and air flush) until 9 times for extraction of EOG from the chamber
purposes. When aeration process has been finished the chamber could be opened and
product that has been wrapped by HDPE container can be performed to another next
Process. HDPE container has been sealed before sterilization is done
Product (Infusion Set) will be sterilized

Wrapped by HDPE and permeable materials

as primary container
DISADVANTAGES OF EOG STERILIZATION

- the costly
- the lengthy cycle,
- risks of handling a flammable and explosive gas
- its complexity, hazardous and toxic potential

It’s requires a properly designed area (promoting an efficient

work), sophisticated technology and equipment
References :
Frederick J. Carlton , James P Agalloco , Validation of Aseptic Pharmaceutical
Process, copyright 1986 by Marcel Dekker , Marcel Dekker Inc, 270 Madison
Avenue , New York 10016