This document discusses ethylene oxide (EO) sterilization, which is a common method used to sterilize disposable healthcare products. It describes the EO sterilization process, which involves exposing products to EO gas at specific concentrations, temperatures, and durations. EO is effective because it is an alkylating agent that disrupts DNA and prevents microorganism reproduction. The document lists several Pakistani pharmaceutical companies that use EO sterilization and provides details on the three phases of the EO sterilization cycle - pre-conditioning, sterilization, and aeration.

1. Submitted to: Sir Qazi Adnan Sb
By: Ahsan SAQI

2. Ethylene oxide (also known as EO or EtO) is a
simple chemical compound that is commonly
used for gaseous sterilization of disposable
healthcare products. A wide variety of
materials and components commonly used in
the manufacture of these products
may undergo ethylene oxide sterilization in
their final breathable packaging configuration.
Ethylene Oxide:-

3. Ethylene oxide sterilization is a chemical process
consisting of four primary variables: gas
concentration, humidity, temperature and time.
Ethylene oxide is an alkylating agent that disrupts
the DNA of microorganisms, which prevents them
from reproducing. EO sterilization assures that a
safe and sterile product will be delivered to the
market each and every time.
How Does Ethylene Oxide Sterilization
Work?

4. 1. Ferozsons Laboratories
2. Getz Pharma
3. Horizon Pharmaceuticals/Wilshire Labs.
4. Searle Pakistan Limited
5. Herbion
6. Remington Pharmaceuticals
7. Barrett Hodgson Pakistan
8. Nucleus Pharmaceuticals (Pvt) Limited
9. Sami Pharma
10.Macter International Limited
11. AGP Pharmaceuticals
Pharmaceutical industry in Pakistan
which are using the Ethylene oxide as
sterilizing agent

5. The ethylene oxide sterilization process may take place within
a traditional ethylene oxide (EO or EtO) sterilization cycle or
through our exclusive EO Express® expedited processing cycle.
Both options consist of three processing phases.
• Pre-conditioning: Used to preheat and humidify product
loads to predefined conditions. This will assure a repeatable
EO sterilization process regardless of pre-processing load
storage conditions
• Sterilization: Performed using process phases specifically
designed to provide the required level of ethylene oxide
exposure to assure sterility for a device or family of devices
• Aeration: Used to accelerate out gassing of exposed
product loads and to contain and eliminate residual
ethylene oxide emissions
The Ethylene Oxide Sterilization
Process

7. • Temperature:-
Ethylene oxide treatment is generally carried out
between 30 °C and 60 °C.
• Humidity:-
With temperature its humidity is above 30%.
• Gas concentration:-
Gas concentration between 200 and 800 mg/l.

8. This gas, mixed with air at a ratio of at least 3%
EtO gas, forms an explosive mixture. Pure EtO
gas boiling point is 10.73 ºC at atmospheric
pressure. Most of the time, it is mixed with
Nitrogen or CO2. This explosive condition
requires Intrinsic Safe material (ATEX) zoning, for
security of people as well as security of the
process itself.
Measuring's:-