Current through Reg. 49, No. 52; December 27, 2024
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 cycle;
(ii) the total pounds of EO purchased and
used per calendar year listed as monthly totals;
(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 following conditions.
(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.
