Ethylene oxide (EO) sterilizing chambers/operations located on the
same or contiguous property and under common ownership that use 1,000 pounds
or less of EO per year are permitted by rule provided that the following conditions
of this section are satisfied.
(1) Any sterilizer usage that is less than 0.04 pounds of EO
(20 milliliters liquid EO) per charge and the annual usage is 4.0 pounds or
less of EO for the entire facility, is exempted from all requirements.
(2) All sterilizers must meet the following conditions.
(A) EO shall only be handled by medical professionals or appropriately
trained personnel in medical and industrial use areas.
(B) Written records shall be maintained for a minimum of two
years and shall be made available to representatives of the commission upon
request. Records shall include:
(i) documentation of the date and time of each sterilizer operation
(ii) the total pounds of EO purchased and used per calendar
year listed as monthly totals;
(iii) leak test results.
(C) Leak tests of each sterilizer system shall be performed
at least every six months. Results of the tests shall be made available to
the commission upon request.
(D) EO shall only be used alone or in combination with carbon
dioxide, nitrogen, chlorofluorocarbon, hydrochlorofluorocarbon diluent gases,
or other mixtures as approved by the executive director.
(E) The sterilizer vent system exhaust stack shall meet the
(i) The stack shall be uncapped and exhaust vertically upward.
(ii) The stack height shall be extended to at least 15 feet
above the roof line of the building; and the stack tip shall be located at
least 25 feet from any opening to the building interior, such as fresh air
intake, unsealed windows, or pedestrian traffic areas. Stacks on multi-level
roofs must only extend 15 feet above the roof upon which the stack is located.
(iii) Stack exit velocity shall be at least 50 feet per second.
(3) The following conditions apply only to sterilizers
that use more than four pounds, but less than 100 pounds of EO per year.
(A) Sterilizer systems which vent entirely to atmosphere shall
not exceed 0.5 pounds of EO used per cycle. Sterilizer systems which use nonrecirculating,
water sealed vacuum systems shall not exceed two pounds of EO charged per
cycle. For facilities with multiple sterilizers, the usage rate is based on
total EO usage at any given time.
(B) Any combination of sterilizers located on the same or contiguous
property under common ownership shall not exceed a total EO usage of less
than 100 pounds per year.
(4) The following conditions apply only to sterilizers
that use between 100 and 1,000 pounds of EO per year.
(A) Before construction begins, the facility shall be registered
with the commission using Form PI-7.
(B) The sterilizer chamber exhaust shall vent through an emission
control device that will continuously achieve a minimum EO removal efficiency
of 99%. Thermal incineration shall not be used to control sterilizer exhaust
emissions if chlorofluorocarbons are used as a diluent.
(C) There shall be no discharge of water containing dissolved
EO through a sanitary sewer system.
(D) Any combination of sterilizers located on the same or contiguous
property under common ownership shall be limited to a total EO usage of 1,000
pounds per year.