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PROBLEM AREAS WITH ETHYLENE

OXIDE STERILIZATION
John E. Doyle, B.S., and Robert R. Emst, M.S.

The capability of ethylene oxide as a sterilant problems associated with ethylene oxide ster-
has been confirmed numerous times by inves- ilization.
tigators in the field. The principle stimulus to
its continued development is the increasing HISTORY
requirement for a reliable method to sterilize The killing ability of ethylene oxide was
heat-labile materials. first noted by Cotton and Roark in 1928 who
Since medical progress stimulates a steady used it as a fumigant against insects. The
increase in the numbers and types of equip- bactericidal action of the compound was es-
ment and materials to be sterilized, the use tablished in 1929 by Schrader and Bossert.'
of ethylene oxide will continue to be impor- Subsequently, there were several patents
tant. One wonders if the myriad of disposable granted in relation to ethylene oxide and
items would have developed without using sterilization of food * Ethylene
heat-labile materials; materials which could oxide received its greatest impetus from a
not have been used were it not for the capa- series of papers by Phillips and Kaye which
bility of being sterilized with ethylene oxide. defined the efficiency of this agent against
One is tempted to compare ethylene oxide bacterial spores and vegetative
sterilization with the classical processes such There are several reviews which have sum-
as dry heat or steam sterilization. Although marized many aspects of ethylene oxide pro-
the application of ethylene oxide is more cesses.'~
complex and more expensive, one should rec-
ognize that all sterilization processes have PHYSICAL, AND CHEMICAL
their limitations. There is no overall process PRO PERT1ES
that will sterilize all materials. Ethylene oxide is a cyclic ether or the sim-
Most previous authors of ethylene oxide plest epoxy compound, the structure of which
articles have emphasized the good attributes may be represented as follows:
of ethylene oxide sterilization. In order to
avoid the difficulties and pitfalls associated
with this method, the emphasis will be on the
It is an extremely reactive colorless gas,
~

with a boiling point of 10.8 degrees Centi-


John E. Doyle is micrnhiology manager at Castle Re-
search Laboratory and has been active for six years grade at atmospheric pressure. It is flammable
in research on the application of gaseous chemical with air, the limits being 3.6 to 100 per cent
and steam Sterilization and on the development of
by volume. However, there are nonflammable
sterility indicators. He holds a B.S. degree from
the University of Illinois. mixtures with carbon dioxide or chloro-fluoro-
Robert R. Ernst is manager of the Castle Research hydrocarbons.
Laboratory. He holds a B.S.M.E. degree from the
It is possible to sterilize with 100 per cent
L1. S. Merrhant Marine Academy; B.S. and M.S. de-
gress from Pennsylvania State University. He has ethylene oxide, but there are the disadvan-
been active for nine years as a consultant for stmil- tages of requiring expensive explosion-proof
ization, and in the development of various steriliza-
equipment, highly trained personnel, and
tion processes, and chemical analytical procedures for
determining ethylene oxide. higher insurance rates.'O

J u n e 1968 47
TOXICITY Wesley, Rourke, and Darbishire l’ reported
Ethylene oxide gas diffuses rapidly through that fumigation of foods with ethylene oxide
a i d into materials. This property is advan- produced toxic chlorohydrins. This was later
tageous for sterilkation. However, some ma- confirmed by Ragelis, Fisher and Klimeck.lx
terials may take up the gas so readily that That toxic chemicals could be produced in
long aeration times are necessary to elute the plastic or rubber items is a distinct possibility.
gas. Materials should be chosen b y the manu- The formulations of these materials and their
facturer of ethylene oxide sterilized items additives (accelerators, additives, plasticizers,
with this problem in mind. Some items such etc.) should be evaluated with the possibility
as polyethylene bags elute ethylene oxide in a of forming compounds with the highly re-
few hours, whereas an item such as a silicone active ethylene oxide. Some additives can even
rubber prothesis required over 50 days for retard the sterilizing activity of ethylene ox-
the ethylene oxide to become undetectable.ll ide.l9 In the same vein, the ethylene oxide or
A possible problem area in ethylene oxide freon compounds, under certain conditions,
sterilization could be the possibility of the could leach additives which could be toxic to
formation of toxic compounds. Ethylene ox- humans.
ide is readily soluble in water and tends to Another type of toxicity possible with the
hydrolyze to toxic ethylene glycol. use of ethylene oxide is skin reaction. The
Allen, Meier, and Hoag reported on the pure liquid, if applied to the skin, evaporates
toxicity of wood shavings to mice which had too rapidly to cause burns. However, if ar-
been treated with ethylene oxide.I2 Reyniers, ticles such as rubber gloves, which contain
Sacksteder and Ashburn reported on the for- dissolved ethylene oxide, are confined against
mation of tumors in mice exposed to ethylene the skin, burns can occur. Aeration for up to
oxide treated bedding.13 Hirose, Goldstein and one day is recommended for such materials.
Baily 14 demonstrated hemolysis of the blood The inhalation toxicity of ethylene oxide is
from plastic tubing exposed to ethylene oxide. about that of ammonia. With proper room
However, the blood was in a static condition air exchange, there is little problem. How-
and no circulation was attempted. They con- ever, situations should not be allowed where
cluded that aeration times of three to five
the gas could be vented in a confined area.
days were necessary before using ethylene
oxide sterilized tubing for clinical extracor- HUMIDITY
poreal bypass.
The importance of optimum humidity (30
O’Leary and Guess l6 also recently reported per cent to 40 per cent) at room temperature
on hemolysis of blood and death of cells in
was discovered by Kaye and Phillips 2O and
culture from materials exposed to ethylene
confirmed by Ernst and ShullZ1 for higher
oxide. However, they performed their tests
temperatures. Because of diffusion it is desir-
immediately after ethylene oxide exposure,
able to humidify the sterilizer chamber to levels
allowing no gas elution time other than dur-
ing the vacuum phase of the sterilization above the recommended optimum. This is
cycle. They concluded that polypropylene was especially important at higher sterilizing tem-
the best material for making a medical prod- peratures. At 130 degrees F., 45 to 50 per
uct which would require ethylene oxide steril- cent RH is all that can be tolerated short of
ization. actually wetting materials. There have been
Recently, Adler reported on the presence some reports, however, of sterilization with
of residual ethylene glycol and ethylene oxide no humidity provision. This is because the
in drugs.10 environment and the materials themselves can

48 AORN Journal
sometimes provide sufficient (but usually not relatively cool door, and 2) as a straw colored
optimum) humidity for sterilization to occur. oily liquid which appears in piping associated
However, this available humidity is highly with steam under heat and pressure. This oily
uncoiltrollable and call result in sterilization liquid eventually continues to polymerize to
skips if the material or environment is ex- form a resin-like solid. The polymer is usually
cessively dry. Consequently, for reliable steril- water soluble and can be periodically flushed
ization, it is necessary to have a humidity con- away. Good maintenance will keep accumula-
trol. tions to a minimum. Plastic covers on mate-
The gas must be heated before admission rials that are being sterilized will adequately
to the sterilizer or the cold influx of gas can protect them from damaging p o l ~ m e r s . ~
condense the moisture thereby reducing the
humidity below sterilizing levels.D TESTING FOR STERILITY
There are two general methods of testing
PERMEATION for sterility; one is the use of sterility indi-
The permeation characteristic of materials cators, the other is testing a certain number
to moisture and to ethylene oxide are impor- of the items which have been sterilized (ac-
tant considerations. The polymers such as cording to the methods in the U. S. Pharma-
polyethylene, polyvinyl chloride, and poly- copeia) .
propylene are readily permeated by ethylene The indicators of sterilization are usually
oxide, but not by moisture. On the other chemical or biological. The chemical indica-
hand, nylon, mylar and cellophane are highly tors usually change in color after a certain
permeable to moisture but less to ethylene ethylene oxide exposure time. Their major
oxide. The choice of packaging materials can limitation is that they do not indicate the
be an important consideration. The permea- complex relationship of ethylene oxide ex-
tion of laminates by moisture and gas can be posure-temperature-humidity required to ster-
severely limited. Laminates of more than one ilize. Their advantage is immediate indication
plastic (i.e. a polyethylene-cellophane lam- of ethylene oxide exposure, but not necessar-
inate) are very difficult to permeate. ily sterilization.
The only true and acceptable indication of
POLYMERIZATION EFFECTS sterility is performed with a biological indi-
Polymerization can also be a problem area cator. The biological indicator is usually de-
with ethylene oxide. There are many poIy- signed to provide a safety factor for the ster-
merization catalysts such as steel, stainless ilization process. Bacillus subtilis var. niger
steel, glass, lead, hydrochloride of tin, iron, spores are usually chosen. These spores have
aluminum, carbonic acid and alkalies. Poly- a greater resistance than most microorga-
merization rates also increase under increased nisms which would be present by natural con-
pressure, increased temperature, and in the tamination such as pathogens. Bacillus stearo-
presence of water vapor. Thus, gas trans- thermophilus spores should not be used since
mission lines can become clogged and valves they are easily killed by ethylene oxide. By
may cease to function by the accumulation of adjusting the contamination level of the test
polymer. organism, a safety factor is provided which
Polymer can also cause severe damage to will assure sterility of the product to be steril-
unprotected materials. Ethylene oxide poly- ized if prescribed sterilization parameters are
merization is noted in many forms: 1) as a followed. To further guarantee sterility, indi-
white powder where water has a tendency to cators are placed in strategically difficult-to-
accumulate by condensation such as near the sterilize locations within the sterilizer.

June 1968 49
If one wishes to make his own biological transfer the samples without contamination
sterility indicators he should be very careful occurring, giving a false indication of non-
to wash the suspension several times to elim- sterility. The items that are sterilized with
inate the residual culture niedia. The micro- ethylene oxide are usually plastic materials.
organism could become severely resistant to These materials can easily pick u p an electro-
ethylene oxide as reported by Doyle and static charge. Microorganisms which have the
Ernst.22 Ethylene oxide is primarily used to opposite charge can become attracted to them
sterilize clean materials. It is unrealistic to readily. Baribo, Avens, and O’Neill, 24 de-
monitor sterility with excessively protected scribed how bacterial spores can become at-
microorganisms. tracted to plastic food containers by an elec-
The use of flamed alcohol dipped forceps trostatic charge. Consequently, sterile plastic
for transferring biological sterility indicators isolators are recommended for sterility trans-
to culture media should be discouraged. Vi- fers of product samples.
able spores sometimes accumulate by one
means or another in the alcohol and remain CONCLUSION
viable. These spores, picked up by the transfer The use of ethylene oxide as a sterilant
forceps will also survive the flaming proce- has been confirmed numerous times by pre-
dure and cause contamination of the sterility vious investigators. The use of this agent
indicators.28 The recommendation is to use in- will undoubtedly increase as the influx of
dividually sterilized forceps for each transfer. heat labile items proliferate. The problems
Sterility testing by taking a statistical sam- associated with flammability (100 per cent
pling of the material processed and placing ethylene oxide), toxicity, humidity, permea-
the samples in culture media is rarely per- tion, polymerization and sterility test proce-
formed in hospitals, but continually done in dures should be considered so that they may
industry. The major problem area here is to be avoided.

REFERENCES
1. Cotton, R. T., and Aoark, R. C., “Ethylene-oxide 10. Alquire, D. E., “Sterilization with 100 per cent
gas as a fumigant,” Ind. Eng. Chem., Vol. 20, 1928, ethylene oxide,” Bull. Parent. Drug Assor., Vol. 17.
pp. 805-806. 1963, pp. 1-8.
2. Schrader, H., and Bossert, E., “Fumigant com- 11. Ernst, R. K., Unpublished data.
position,” U. S. Patent 2,037,439, 1936. 12. Allen, R. C., Meier, H., and Hoag, W. G.,
3. Gross, P. M., and Dixon, L. F., “Method of “Ethylene glycol produced by ethylene oxide steril-
sterilizing,” U. S. Patent 2,075,845, 1937. ization and its effect on blood-clotting factors in an
4. Griffith, C. L., and Hall, L. A., “Sterilizing food- inbred strain of mice,” Nature, Vol. 193, 1962, pp.
stuff,” U. S. Patent 2,107,697, 1938. 387-388.
5. Phillips, C. R., “The sterilizing action of gaseous 13. Reyniers, J. A., Sackstetler, M. R., and Ashburn,
ethylene oxide. 11. Sterilization of contaminated ob- L. L., “Multiple tumors in female germfree inbred
jects with ethylene oxide and related compounds: albino mice exposed to bedding treated with rthylenc
time, concentration and temperature relationship,” oxide,” Nut. Cancer Inst., Vol. 32, 1%4, pp. 1045-
Ant. J. Hyg., Vol. 50, 1949, pp. 280-288. 1057.
6. Kaye, S., and Phillips, C. R., “The sterilizing 14. Hirose, T., Goldstein, R., and Bailey, C. P.,
action of gaseous ethylene oxide. IV. The effect of “Hemolysis of blood due to exposure to different
moisture,” Am. J . Hyg., Vol. 50, 1949, pp. 296-306. types of plastic tubing and the influence of ethylene
7. Phillips, C. R., and Kaye, S., “Sterilizing action oxide sterilization,” J . of Thoracic and Cardiouascu-
of gaseous ethylene oxide. I. Review,” Am. J. Hyg., lar Surgery, Vol. 45, 1963, pp. 245-251.
Vol. 50, 1949, pp. 270-279. 15. O’Leary, R. K., and Guess, W. L., “Toxicological
8. Bruch, C. W., “Gaseous sterilization,” Ann. Rev. studies on certain medical grade plastics sterilized
Microbiol., Vol. 15, 1961, pp. 245-262. by ethylene oxide,” J. Phnrm. Sci., Vol. 57, 1968,
9. Ernst, R. R., and Doyle, J. E., “Sterilization with pp. 12-17.
gaseous elhylene oxide: A review of chemical and 16. Alder, N., “Residual ethylene oxide and ethylent
physical factors,” Biotech. and Bioeng., Vol. 10, glycol in ethylene oxide sterilized pharmaceuticals,”
1968, pp. 1-31. J. Pharm. Sci., 1965, Vol. 54, pp. 735-742.

SO ,4OKN .I mi rnril
17. Wesley, F., Rourke, B., and Darbishire, O., “The moisture,” Am. J . Hyg., Vol. 50, 1949, pp. 296-306.
formation of persistent chlorohydrins in foodstuffs 21. Emst, R. R., and Shull, J. J., “Ethylene oxide
tiy fumigation with ethylene oxide and with pro- gaseous sterilization. I. Concentration and tempera-
pylene oxide,” J. Food Sci., Vol. 30, 1965, pp. 1037- ture effects,” Appl. Microbiul., Vol. 10, 1962, pp.
1042. 337-341.
18. Ragelis, E. P., Fisher, B. S., and Klimeck, B. A., 22. Doyle, J. E., and Ernst, R. R., “The influence
“Note on the determination of chlorohydrins in of various pretreatments (carriers, desiccation and
funds fumigated with ethylene oxide and with relative cleanliness) on the destruction of Bacillus
propylene oxide,” I . of the A.O.A.C., Vol. 49, 1966, subtilis var. niger spores with gaseous ethylene
pp. 963.965. oxide,” I. Pharm. Sci., 1968 (to be published).
19. Ernst, R. R., and Doyle, J. E., “Limiting factors 23. Doyle, J. E., Unpublished data.
in ethylene oxide gaseous sterilization,” Develop. 24. Baribo, L. E., Avens, J. S., and O’Neill, R. D.,
Ind. Microbiol., Vol. 9 (to be published in 1968). “Effect of electrostatic charge on the contamination
20. Kaye, S., and Phillips, C. R., “The sterilizing of plastic food containers by airborne bacterial
action of gaseous ethylene oxide. IV. The effect of spores,” Vol. 14, 1966, pp. 905-913.

A N A GUIDELINES FOR AN ACTION PROGRAM FOR STATE


AND DISTRICT COMMITTEES ON EMERGENCY HEALTH
PREPAREDNESS
Emergency-disaster health preparedness is defined broadly as the
mobilization of all health resources to administer immediate and
preventative health care to both the injured and well population
affected by upheaval of natural phenomena, civil strife, or war.
The Association has prepared guidelines to assist nurses to make a
contribution to maximum population survival following disasters.
Essential to this purpose is the preparation and utilization of nurses
who will function effectively during disasters.
The health personn,el employed by public and private health fa-
cilities andlor orgnnizations are a potential health personnel reser-
voir for utilization in emergencies. Health facilities and organizations
have an obligation to plan and develop medical care programs which
operate as integral units of an overall state plan incorporating all
allied medical professions.
It is essential thnt state and district nurses’ associations assume
responsibility for leadership in the preparation, utilization and
allocation of all available nurse manpower capable of functioning in
natural, civil, or war-caused disasters.
This document (available from A N A Order Department, 10
Columbus Circle, New York, New York 10019) is a suggested
framework to assist state and district organizations to assume posi-
tions of leadership in state and local communities as spokesmen,
planners, educators and evaluators of nursing preparedness in dis-
aster and national defense.

June 1968 51

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