Course: Mass Transfer Processes 2020

A plan to accelerate the sterilization of PPE’s by EO using

Microwave Radiations

王力
Muhammad Ajmal
Student ID: 6119000061
Ajmal@tju.edu.cn

Signature: ________

Date: 15-06-2020

The School of Chemical Engineering, TJU

Table of Contents
1 Introduction...................................................................................................................................1

1.1 Ethylene oxide as sterilizing agent.........................................................................................1

1.2 Factors affecting the sterilizing action of Ethylene Oxide.....................................................1

1.2.1 Humidity..........................................................................................................................1

1.2.2 Temperature and Time....................................................................................................1

1.2.3 Concentration of Ethylene oxide.....................................................................................2

2 Description of Process..................................................................................................................2

2.1 Preconditioning......................................................................................................................2

2.2 Sterilization............................................................................................................................2

2.3 Aeration..................................................................................................................................2

2.3.1 Nature of material............................................................................................................3

2.3.2 Temperature.....................................................................................................................3

2.3.3 Air pressure.....................................................................................................................4

3 Aeration of ethylene oxide by using microwave radiation...........................................................4

3.1 Process Description................................................................................................................4

3.2 Desorption of ethylene oxide from polymers........................................................................5

3.3 Effect of Microwave radiation on polymeric materials.........................................................6

3.4 Effect of microwaves on Diffusion coefficient......................................................................7

3.5 Comparison between simple aeration and microwave aeration.............................................8

3.6 Conclusion.............................................................................................................................9

References......................................................................................................................................10
 List of Figures
Figure 1: Chemical structure of ethylene oxide[2].........................................................................1
Figure 2: (a) Plot showing time at 23 °C for the level of residual ethylene oxide in sterilized
polymers (1 5 mm thick) (b) Effect of polymer thickness on aeration time(where name are of
same order as shown in (a))[8]........................................................................................................4
Figure 3:Simplified Process description using Microwave............................................................5
Figure 4:(a) Aeration vs temperature (b) Aeration vs Turnover[7]................................................6
Figure 5: Diffusion coefficient vs Inverse of temperature[10].......................................................7
 List of Tables
Table 1:Pros and cons of Ethylene oxide as Sterilizing agent[6]...................................................3
Table 2: Comparison of Microwave desorption and conventional desorption[9]..........................8
1 Introduction
Ethylene oxide also known as diethylene oxide is a colourless, highly reactive and flammable
gas with characteristic ethereal smell at room temperature and atmospheric pressure. Ethylene
oxide has a molecular formula of H2C-O-CH2. It contains a ring of two carbon atoms and one
oxygen atom as shown in Figure 1. Boiling point of ethylene oxide is 10.4°C and density is
0.8821g/cm-3 [1].

Figure 1: Chemical structure of ethylene oxide[2]

1.1 Ethylene oxide as sterilizing agent

Ethylene oxide has ability to kill microorganisms that’s why it is being used as sterilizing agent
to sterilize disposable medical personal protection equipment. It is specially used for those
materials which are temperature sensitive and moisture sensitive. Ethylene oxide works as
alkylation agents, reacts with DNA, RNA and proteins and changes their chemical composition
and disrupts normal cell metabolism and replication. Using ethylene oxide as sterilizing agent is
simple and easy to operate. It has many advantages and disadvantages which are shown in Table
1[3].

1.2 Factors affecting the sterilizing action of Ethylene Oxide

There are few factors which affects the sterilizing action of ethylene oxide are discussed below:

1.2.1 Humidity
In order to kill the microorganism ethylene oxide must enter into the cell for this ethylene oxide
is dissolved in water and in solution form it can enter into the cell. For this purpose, moisture is
provided and range of optimum relative humidity must be in between 30%-50%.[4]

1.2.2 Temperature and Time

Temperature of the material being sterilized, time for sterilization and concentration of the
ethylene oxide all of them affect sterilizing process. The temperature of the materials being

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sterilized is very importance to the efficiency of the sterilizing operation, not only with respect to
time required for sterilization, but also with respect to the concentration of ethylene oxide
required for maximal killing rates. At room temperature or slightly above, the time for
sterilization with ethylene oxide is 80 minutes or longer, depending on the ethylene oxide
concentration employed[4].

1.2.3 Concentration of Ethylene oxide

Commercially, the concentration of ethylene oxide is in between 440mg to 880mg per liter. In a
system employing 440 mg of ethylene oxide per liter, we must maintain the temperature
somewhat above 100°F. to insure that the concentration of ethylene oxide provided will produce
the maximal killing rate[4].

2 Description of Process
The EO sterilization process is a batch process and typically consists of three phases:

2.1 Preconditioning

This is the first step of sterilization. In this step air from sterilized object is removed and air from
sterilization chamber is also removed by creating vaccum. Sample is placed in sterilization
chamber, nitrogen gas and steam is provided in the chamber till the relative humidity reached to
40-80% and temperature is maintained at 86-122°F for almost 12-24 hours[5].

2.2 Sterilization

Sterilization chamber is made up of stainless steel. With air or water heated jacket to maintain
the temperature at optimum level. The sterilization load is transferred to a sterilization chamber;
100% pure ethylene oxide is used as sterilant because it gives maximum efficiency. Sterilization
process takes 8-16hrs at a temperature of 40-60°C[5].

2.3 Aeration

This is last step of the process and very time consuming. There are other methods as six
successive vacuum cycles which is used to reduce the aeration time However, repeated vacuum
cycles have been shown to be ineffective as a means of accelerating the elution of residual
EO[6]. Heated aerator method is also used to shorten the aeration time this method air is

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continuously circulating and vents off at 50-60°C. This procedure reduces aeration time to
between 8 and 12 h dependent upon the type of material and its geometry.

The process of aeration depends upon various parameter such as temperature ,nature of material
being sterilized, thickness of material and air pressure [5].

Table 1:Pros and cons of Ethylene oxide as Sterilizing agent[7]

Advantages Disadvantages
Used for heat sensitive materials Excessively Long cycle
Highly efficient, destroys microorganisms Relatively high annual costs for maintenance,
including resistant spores servicing and consumables
Large sterilizing volume Carcinogenic to humans
Non corrosive to: plastic, metal and rubber Requires special room conditions, safety
materials equipment and separate ventilation system

2.3.1 Nature of material

Time of aeration mainly depends upon the type of material being sterilized because different
material has different sorption capacity of ethylene oxide gas. Those materials which has high
sorption capacity will take long time for desorption of gas and those who has very low sorption
capacity will take less time for desorption of ethylene oxide gas. Figure 2 (a) represent a graph
of diffusion co-efficient vs aeration time of different materials and (b) represents the effect of
material thickness on aeration time. Diffusion coefficient of different materials can be calculated
by the following formula[8].

2
h ln ⁡(0.5)
D=
π2t 1
2

D=diffusion coefficient (cm2/sec)

h=thickness of polymer sheet (cm)
t1/2= half-life (sec)

2.3.2 Temperature
Temperature of aeration chamber also affects the aeration speed. If we increase the temperature
the aeration speed also increases as shown in Figure 4

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2.3.3 Air pressure
In order to remove the ethylene oxide from the samples being sterilized, pressurized nitrogen gas
is used which will help ethylene oxide to desorb actively. Similarly, vaccum is also created to
remove the ethylene oxide gas Figure 4 shows that increasing air turnover will reduce the
aeration time[2].

(a) (b)

Figure 2: (a) Plot showing time at 23 °C for the level of residual ethylene oxide in sterilized polymers (1 5 mm
thick) (b) Effect of polymer thickness on aeration time(where name are of same order as shown in (a))[8]

3 Aeration of ethylene oxide by using microwave radiation

Aeration speed of ethylene oxide can be successfully increased by using microwave
electromagnetic radiation. Microwaves actually reduces the activation energy of diffusion which
helps in increased desorption rate. (i.e., a time saving of up to 400%). Efficiency of this process
is maximum at lower temperature. We will use PVC as our sterilized material in this method.

3.1Process Description

In this method a prototype device can be used to aerate the ppe’s in the presence of microwave
radiations as shown in Figure 3. This apparatus consists of four microwave generator (750-W
magnetrons) provided at the bottom of the chamber. For gas inlet and outlet pipes are provided.
Nitrogen gas at 25°C is circulated and the temperature of sterilized material is 55°C. Lower the
temperature better is aeration speed. In order to control the temperature of the chamber an
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infrared thermometer is install at the lid of the chamber which is tightly sealed to prevent any
leakage of ethylene oxide gas.

To maintain the temperature of the test item within preselected limits during the process, the real
time output signal from the infrared thermometer is amplified and filtered using custom built
electronic circuitry and subsequently fed into one of the analogue to digital converters of a BBC
microcomputer. The microcomputer is programmed to interpret the temperature reading and then
to control the magnetron on/off times accordingly via an output port. The IR thermometer was
calibrated coincidentally by contact thermometry using a thermocouple[9].

Figure 3:Simplified Process description using Microwave

3.2 Desorption of ethylene oxide from polymers

EO aeration of plastics is a diffusion-controlled process. When diffusion takes place some

amount of ethylene oxide gets absorbs into the material. After sometime under suitable
conditions this absorbed gas will desorb from the material. The concentration of the desorbed
ethylene oxide can be calculated by using following equation[9]:

8C o π
2
−π
2
c (t )= 2
exp− 2
Dd (t−t 1 )×(1−exp ⁡[ 2 D s t 1 ])
π l l

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Co=initial concentration of gas
l=thickness of material
DS=diffusion coefficient during sorption
Dd=Diffusion coefficient during desorption
Diffusion coefficient can also be calculated by using Arrhenius relationship.

D=D o exp ⁡ ( )
−Ed
RT

D=Diffusion coefficient at absolute temperature T,

DO=Constant of proportionality
Ed=Energy of activation of diffusion
R= Universal gas constant

(a) (b)

Figure 4:(a) Aeration vs temperature (b) Aeration vs Turnover[7]

3.3 Effect of Microwave radiation on polymeric materials

Microwave heating of polymeric materials involves the interaction of permanent or induced

molecular electric dipoles with an externally applied electric field. Application of a low-
frequency sinusoidal electromotive force (e.m.f.) to a polar material causes the electric dipoles to
reorient themselves with the electric field. This reorientation of the dipoles is the molecular
process transmitting the electromagnetic energy through the medium and it results in a
"displacement current" in the dielectric material. If there is no lag between the orientation of the

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molecules and the variations of the applied alternating voltage then the displacement current will
be exactly ninety degrees out of phase with the e.m.f, the former being ahead of the latter[10].

This follows from the fact that rotation of the dipoles will be most rapid when the e.m.f. changes
most rapidly, i.e., when the latter possesses an instantaneous value of zero the displacement
current will be at a maximum. Since the current is not in phase with the e.m.f. there is no "Joule"
heating in the material. However, if the frequency of the applied field is increased up to
microwave values the rotation of the molecular dipoles lags behind the voltage oscillations as the
dipoles are unable to follow such rapid variations in synchrony. The consequence of this lag is
that the current acquires a component in phase with the voltage, and as a result there is a
dissipation of energy in the medium through "Joule" heating[10].

Figure 5: Diffusion coefficient vs Inverse of temperature[10]

3.4 Effect of microwaves on Diffusion coefficient

Normally when ethylene oxide sorption takes place over PVC material, a hydrogen bonding
develops between highly electropositive hydrogen of ethylene oxide O-H and highly
electronegative chlorine Cl-H of polyvinyl chloride. When microwaves are applied it disrupts the

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active bonding between EO/PVC as the Cl-H and O-H dipoles attempt to align themselves with
the applied e.m.f., in this way the activation energy is reduced and diffusion coefficient is
increased. For example, the activation energy of PVC under normal aeration is 13.7±1.8 kcal
mol-1and under microwave the activation energy is 7.3±0.6kcal mol-1[11].

Thus leading to a significant reduction in the proportion of immobilized to mobilized diffusant

molecules and reduces the activation energy hence, a substantial increase in the value of the
diffusion coefficient. It can also be seen from Figure 5 that at same temperature diffusion of
enhanced microwave diffusion is higher than normal diffusion. Diffusion coefficient can be
calculated by the Arrhenius equation. Activation energy is calculated by getting the slope of
Arrhenius equation graph[11].

Table 2: Comparison of Microwave desorption and conventional desorption[9]

3.5 Comparison between simple aeration and microwave aeration

From literature it is found that different polymeric materials such as PVC, BS 2775, Black
neoprene, Brown rubber and silicon rubber are tested against simple aeration and microwave
aeration process and time of aeration was calculated for each material and each technique.
Results given in Table 2 shows that microwave aeration successfully increased the aeration rate
and hence it took less time for the removal of ethylene oxide as compare to the normal aeration
process. To facilitate a comparison between the two processes, the diffusion coefficient for
normal aeration may be defined as
−Ed
D=N exp
RT

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where N is the normalizing constant. Similarly, during the microwave enhanced process, the
diffusion coefficient may be defined as where Eu, represents an effective reduction in activation
energy due to applied e.m.f.[12].
(E d−E u)
D=N exp−
RT

3.6 Conclusion

The diffusion of EO in PVC is an active process. The efficiency of this methods relies on the fact
that microwave electromagnetic radiation results in decreasing of activation energy for diffusion.
The mechanism of action is due to the reduction in immobilized fraction of ethylene oxide in
polymer. The relative efficiency of microwave desorption increases with decreasing temperature.
The optimum operating temperature will therefore depend upon considerations in microwave
energy input rate and practically realizable cooling methods. The relative efficiency (i.e., a time
saving of up to 400%) of microwave desorption compared to conventional aeration offers
considerable gains in the cost effectiveness of gas sterilization. It will permit a much greater
throughput of material thereby removing the need for excessively large inventories of equipment.

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References
1. Concise International Chemical Assessment Document 54 Ethylene Oxide.pdf.
2. SHINTANI, H., Ethylene Oxide Gas Sterilization of Medical Devices. Biocontrol Science, 2017.
22(1): p. 1-16.
3. Guideline for Disinfection and Sterilization in Healthcare Facilities (2008).pdf.
4. Shull, J.J., Principles and Application of Ethylene Oxide Gas Sterilization. AORN Journal, 1963.
1(6): p. 43-51.
5. 2017-Comparison-Gamma-Eb-Xray-and-EO-for-Sterilisation.pdf.
6. R.B Roberts, L.R.-B., Aeration after ethylene oxide sterilisation. Anaesthesia, 1972. 27(3).
7. Association for the Advancement of Medical Instrumentation., Process development and
performance qualification for ethylene oxide sterilization--microbiological aspects : approved 13
March 2000 by Association for the Advancement of Medical Instrumentation. AAMI technical
information report. 2000, Arlington, VA: Association for the Advancement of Medical
Instrumentation. 18 p.
8. White, J.D., Standard aeration for gas-sterilized plastics. Great Brttain, 1977. 79(225): p. 225-
232.
9. I. P. Matthews, C.G., and A. H. Samuel, Enhancement of the kinetics of the aeration of ethylene
oxide sterilized polymers using microwave radiation. Journal of Biomedical Materials Research,
1989. 23: p. 143-156.
10. M.Davies, Some Electrical and Optical Aspects of Molecular Behaviour. 1965, New York:
Pergamon Press.
11. Sykes, P., A Guidebook to Mechanism in Organic Chemistry. 1961, London: Longsman.
12. Crank, J., Mathematics of Diffusion. 1975, Oxford: Clarendon Press.

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