California Compressed Gases and Cryogenic Fluids Code -Storage, Handling, and Use of Ethylene Oxide for Sterilization and Fumigation

14.1 General
The storage, handling, and use of ethylene oxide for sterilization and fumigation shall be in accordance with the provisions of Chapters 1 through 7, as applicable.

14.2 Receiving and Unloading Ethylene Oxide Containers

14.2.1 Scope
This subsection shall apply to the handling of both full and empty ethylene oxide containers at a facility, including the following:
Handling of the containers between the truck and the dock
Inspecting containers at the dock
Handling of the containers within the facility

14.2.2 Procedures

14.2.2.1
Drums shall not be lifted by placing the forks under the chime rings on the drums.

14.2.2.2
Prior to the unloading of ethylene oxide containers, the vehicle engine shall be turned off, the brakes set, and the wheels chocked.

14.2.2.3
Smoking or open flames shall not be permitted within 25 ft (7.62 m) of any area where ethylene oxide containers are handled.

14.2.2.4
Ethylene oxide cylinders shall be secured to hand trucks or lift trucks during movement.

14.2.2.5
Ethylene oxide containers shall be kept upright at all times.

14.2.2.5.1
Containers shall not be stacked or rolled.

14.2.2.6
Immediately after offloading, ethylene oxide containers shall be inspected and the following checks performed:
An examination for evidence of damage to the container or valves
A confirmation that the valves are equipped with valve outlet plugs or caps
An inspection of the container labeling to confirm that each container is labeled as containing ethylene oxide
* A leak test of the container, including valves and fuse plugs

14.2.2.6.1
Ethylene oxide containers shall not be moved to storage until the inspection is complete.

14.2.2.7
In the event that any container fails incoming inspection, the ethylene oxide supplier shall be notified.

14.2.2.7.1
If a leaking container is found, the facility procedures for handling ethylene oxide leaks and spills shall be followed.

14.3 Storage of Ethylene Oxide

14.3.1 General

14.3.1.1
Ethylene oxide containers shall be kept upright at all times.

14.3.1.2
Ethylene oxide containers shall not be stacked.

14.3.2 Indoor Storage

14.3.2.1 Storage Within Sterilization Buildings

14.3.2.1.1*
The maximum quantity of ethylene oxide stored in a sterilization building shall be 10,000 lb (4536 kg).

14.3.2.1.2
The construction of all such sterilization buildings shall comply with Section 14.11.

14.3.2.1.3
Rooms within sterilization buildings shall be classified for purposes of ignition source control in accordance with 14.7.1.1.

14.3.2.1.4
Heated indoor storage areas shall be arranged so that stored cylinders or other containers cannot be spot heated or heated above 125°F (51.7°C).

14.3.3 Storage Outside of Buildings

14.3.3.1 Location of Storage Outside of Buildings
Storage outside of buildings shall be located in accordance with 7.10.2 and 7.10.3.

14.3.3.2 Outdoor Storage Areas

14.3.3.2.1
Outdoor storage areas shall have a minimum of 25 percent of the perimeter open to the atmosphere.

14.3.3.2.2
This open space shall be permitted to incorporate chain link fence, lattice construction, open block, or similar materials for the full height and width of the opening.

14.3.3.2.3
Storage areas shall be kept clear of dry vegetation and combustible materials for a minimum distance of 15 ft (4.6 m).

14.3.3.2.4
Cylinders stored outside shall not be placed on the ground (earth) or on surfaces where water can accumulate.

14.3.3.2.5
Storage areas shall be provided with physical protection from vehicle damage.

14.3.3.2.6*
Storage areas shall be permitted to be covered with canopies of noncombustible construction.

14.4 Piping Systems

14.4.1 Scope

14.4.1.1
This section shall apply to ethylene oxide piping systems, including pipe, tubing, flanges, gaskets, valves, fittings, flexible connectors, and to the pressure-containing parts of other components, such as expansion joints and strainers, and devices used to mix, separate, distribute, meter, and control the flow of ethylene oxide.

14.4.1.2
This section shall not apply to scrubber and vent systems.

14.4.1.3 Cleaning and Purging of Gas Piping Systems
Cleaning and purging of piping systems shall be in accordance with 7.1.18.

14.4.2 Materials for Piping, Valves, and Fittings

14.4.2.1 Materials

14.4.2.1.1
All metallic materials used shall be as specified in ASME B31.3, Process Piping.

14.4.2.1.2
The requirements of the hazardous materials section shall apply.

14.4.2.1.3
The following restrictions shall also apply:
All metallic materials used shall have a minimum melting point greater than 1500°F (815.6°C).
No furnace butt-welded steel product shall be used.

14.4.2.2* Joining Methods

14.4.2.2.1
Joints shall be made gastight and shall be welded, flanged, brazed, or threaded.

14.4.2.2.2
Joints shall be welded where located in concealed spaces within buildings.

14.4.2.2.3
The requirements in 14.4.2.2.3.1 through 14.4.2.2.3.4 shall apply.

14.4.2.2.3.1 Welding

(A)
All welding processes and procedures shall be in conformance with ASME B31.3, Process Piping.

(B)
The Oxy-Fuel Gas Welding (OFW) procedure shall not be used on any component or system fabricated to this code.

14.4.2.2.3.2 Brazing

(A)
All brazing processes and procedures shall be in strict conformance with ASME B31.3, Process Piping.

(B)
All braze alloys shall have a minimum melting point of 1000°F (537.8°C).

(C)
The failure of the braze joint in the event of a fire exposure shall not in any way result in the release of additional fuel that can accelerate or spread the existing fire.

14.4.2.2.3.3 Soldering

(A)
Soldering shall not be used for pressure containment or structural purposes.

(B)
Soldering for hermetic or environmental sealing purposes as part of a mechanical sealing system shall be permitted.

(C)
The failure of any soldering application in the event of a fire shall not allow a release of fuel that can accelerate or spread the existing fire.

14.4.2.2.3.4 Threading
Threaded joints shall be made with a thread sealant or lubricant compatible with ethylene oxide.

14.4.3* Preparation for Dismantling of Piping

14.4.3.1
Piping and valves that have been used to transport ethylene oxide to or from a sterilizer to the emission control or release point shall be drained and purged in accordance with 7.1.18 prior to dismantling.

14.4.3.2
The piping shall be purged free of flammable concentrations of ethylene oxide prior to cutting or welding on the lines.

14.4.3.3
The piping shall be inspected for evidence of polymers prior to cutting or welding.

14.4.3.4
If found, all polymers shall be removed prior to cutting or welding.

14.4.4 Valves

14.4.4.1
Valves shall be designed for a minimum operating gauge pressure of 150 psi (1030 kPa).

14.4.4.2
All materials used, including valve seat discs, packing, seals, and diaphragms, shall be in accordance with 14.4.2.

14.4.5 Testing
Pressure piping systems shall be tested in accordance with ASME B31.3, Process Piping, prior to use.

14.4.6* Identification
Ethylene oxide lines shall be identified.

14.5 Gas Dispensing Areas

14.5.1 General
In addition to the requirements in Section 14.3, the requirements in 14.5.1.1 through 14.5.1.3 shall apply to areas where ethylene oxide is dispensed from containers.

14.5.1.1
Ethylene oxide storage shall be permitted in dispensing areas.

14.5.1.2*
Indoor dispensing areas shall be equipped with a continuous gas detection system that provides an alarm when ethylene oxide levels exceed 25 percent of the LFL (7500 ppm).

14.5.1.3*
Exhaust ventilation shall be installed in all indoor dispensing areas used for ethylene oxide.

14.5.1.4
Exhaust ventilation shall comply with the following:
Mechanical ventilation shall be operated continuously at a rate of not less than 1 scf/min•ft2 (0.3 Nm3/min•m2) of floor area of dispensing area.
Exhaust ventilation shall not be recirculated within a room or building unless under the following conditions:
Where the air is treated to reduce the ethylene oxide concentration to below that which represents a hazard, recirculation shall be permitted.
Controls shall be provided to ensure the performance of the treatment and recirculation system.
The ventilation system shall be designed to prevent accumulation of ethylene oxide anywhere in the dispensing area.

14.5.2 Ethylene Oxide Containers

14.5.2.1
No more than two ethylene oxide containers shall be connected to each sterilizer.

14.5.2.2
Before connections are made, containers shall be grounded.

14.5.2.3
The ethylene oxide supply line shall have a reverse flow prevention device to prevent contamination of the supply container where automatic switchover of containers is used.

14.5.2.4
Each ethylene oxide piping system from the containers to the process chamber shall have two remotely operated shutoff valves in the flow stream.

14.5.2.4.1
The valve required in 14.5.2.4 closest to the container shall be located 5 ft (1.5 m) or less from the container.

14.5.2.4.2
The valves shall be operable from the sterilizer control room or other location outside the dispensing area.

14.5.2.5
Any supply piping containing liquid ethylene oxide that can be isolated shall be equipped with a pressure relief device.

14.5.3 Nitrogen System

14.5.3.1
Nitrogen used for head space pressurization shall be no less than 99.0 percent nitrogen and shall contain no impurities that are chemically incompatible with ethylene oxide.

14.5.3.2
A reverse flow prevention device shall be provided to prevent ethylene oxide from entering the nitrogen supply system.

14.5.3.3
A particulate filter shall be provided to prevent rust from being introduced into an ethylene oxide container.

14.5.3.4
Refillable containers shall be pressurized with nitrogen to a gauge pressure of 50 psi (345 kPa) prior to disconnection and shipment to the supplier.

14.5.4 Vaporizer

14.5.4.1 Liquid Flow Control Valve

14.5.4.1.1
A valve shall be provided to control liquid flow to the vaporizer.

14.5.4.1.2
This valve shall be permitted to be one of the valves required in 14.5.2.4.

14.5.4.2* Temperature Recording Device

14.5.4.2.1
An indicating or recording device shall be provided at the control panel to demonstrate that the ethylene oxide temperature is within the range of 60°F (16°C) to 200°F (93.3°C).

14.5.4.2.2
An alarm shall be provided for out-of-range conditions.

14.5.5 Liquid Ethylene Oxide Piping
Ethylene oxide shall not be piped outside the confines of the process area.

14.6 Operations

14.6.1 Operating Procedures Manual

14.6.1.1
Each facility shall prepare and maintain an operating procedures manual covering facility start-up, operation, and shutdown.

14.6.1.2
Operating procedures manuals shall include procedures for the safe operation of the facility under normal and nonroutine operation conditions.

14.6.1.3
Operating procedures manuals shall be accessible to facility operators at all times.

14.6.1.4
Operating procedures manuals shall include operator actions to be taken if toxic or flammable concentrations of ethylene oxide are detected in the facility.

14.6.1.5
Operating procedures manuals shall include procedures for purging and inerting equipment and piping.

14.6.1.6
Operating procedures manuals shall include procedures for addressing leakage and spills of ethylene oxide.

14.6.2* Sterilizer Operation

14.6.2.1* Purging
The vessel shall be purged to reduce the ethylene oxide concentration to less than 25 percent of the LFL prior to opening the chamber door.

14.6.2.2* Postcycle Ventilation
A nonrecirculating ventilation system or equivalent means shall be provided to prevent ethylene oxide accumulation due to product outgassing prior to and during unloading of the sterilizer.

14.6.2.3 Cycle Abort

14.6.2.3.1
Ethylene oxide sterilizers shall be equipped with a manually initiated cycle abort feature accessible to the operator.

14.6.2.3.2
This cycle abort feature also shall be operable from outside the sterilizer area.

14.6.2.3.3
A key-locked device shall not be permitted.

14.6.2.3.4
The cycle abort operation shall allow for the controlled removal of flammable concentrations of ethylene oxide from the sterilizer.

14.6.3 Area Monitoring for Ethylene Oxide
Ethylene oxide sterilizer areas shall be monitored continuously for ethylene oxide concentrations.

14.6.3.1
The gas detection system shall provide an audible and visual warning signal to indicate when concentrations of ethylene oxide reach a level of 25 percent of the LFL of ethylene oxide.

14.6.3.2*
The gas detection system shall automatically shut off the supply at the ethylene oxide containers when the concentration of ethylene oxide exceeds 25 percent of the lower limit of flammability.

14.6.4 Emergency Stop

14.6.4.1
An emergency stop device shall be provided to halt all operating equipment, including valves, rotating equipment, and heating apparatus on the sterilizer and gas dispensing equipment.

14.6.4.2
The emergency stop shall be activated by a manually initiated feature accessible in the control room or at the control panel.

14.7 Electrical Installation

14.7.1 Area Electrical Classification

14.7.1.1
The sterilizer room, gas dispensing room, ethylene oxide container storage area, aeration rooms, and emission control area shall be classified as a Class I, Division 2, Group B area in accordance with NFPA 70, unless under the conditions of 14.7.1.1.1.

14.7.1.1.1
Aeration rooms shall be permitted to be unclassified electrically where it is demonstrated that flammable concentrations of ethylene oxide cannot occur during all normal and nonroutine operating conditions, including power failure.

14.7.1.2
The interior of the sterilization vessel shall be classified Class I, Division 1, Group B.

14.7.2* Static Electricity Control
All piping shall be bonded to an earth ground.

14.7.3 Grounding Requirements
All equipment shall be grounded in accordance with NFPA 70, Article 250.

14.8 Sterilizer Construction

14.8.1* Vessel
Sterilizers operating at gauge pressure of 15 psi (100 kPa) or higher shall be designed, built, and stamped in accordance with the ASME Boiler and Pressure Vessel Code, Section VIII.

14.8.2 Rotating Equipment
Rotating equipment exposed to flammable concentrations of ethylene oxide shall be designed to prevent sparking and localized overheating of surfaces during normal and nonroutine operation.

14.8.3 Pressure Relief Device
A pressure relief device, set to open at the sterilizer's design pressure, shall be installed on each sterilizer.

14.8.3.1
Pressure relief devices shall be inspected annually for corrosion or accumulation of material (such as polymer buildup) that could prevent operation.

14.8.3.2
The point of discharge of the pressure relief device shall not be located in an area where potential ignition sources exist or where ethylene oxide vapors could re-enter the building.

14.8.3.3
Shutoff valves shall not be installed in relief device discharge piping.

14.9 Disposal and Emissions

14.9.1* Scope
This section shall apply to the disposal and emission of ethylene oxide from sterilization buildings.

14.9.2 Wet Scrubbers
Where a wet scrubber is used, the following requirements shall apply:
Wet scrubbing systems shall be designed so that scrubber solution cannot enter ethylene oxide vent or process lines.
Sources of pure ethylene oxide liquid shall be prevented from being fed directly to scrubber systems designed only for ethylene oxide gas treatment.

14.9.3 Flare Stacks
Where a flare stack is used, the following requirements shall apply:
Flame arresters shall be installed to prevent flame flashback into the sterilizer.
Flare stack failure shall initiate a shutdown of the flare stack feed and an audible alarm.

14.9.4 Catalytic Converter
Where a catalytic converter is used, it shall be designed to shut down or be bypassed if the temperature exceeds the maximum temperature determined by the catalyst supplier.

14.9.5* Oxidizing Emission Control Devices

14.9.5.1 General

14.9.5.1.1
All interlocks and safeguards shall be in place before sterilization begins.

14.9.5.1.2
Sterilization products that sit idle in the sterilization or aeration room shall be periodically washed or vented.

14.9.5.1.3
Confined spaces shall be vented to the outside after power loss.

14.9.5.1.4
Regular preventive maintenance shall be performed.

14.9.5.2 Sterilizers Equipped With Back-Vent Systems Connected to Emission Control Devices

14.9.5.2.1
Sterilizers equipped with a back-vent system connected to an oxidizing emission control device shall be in accordance with 14.9.5.2.1.

14.9.5.2.1.1*
Engineering controls shall be provided to ensure that residual ethylene oxide concentration at the entrance to the oxidizing emission control device does not exceed 25 percent of the LFL (0.75 percent by volume).

(A)
The sterilization chamber shall be equipped with gas detection to monitor the concentration of ethylene oxide within the sterilization chamber.

(B)
A safety interlock shall be provided to prevent the backvent system from opening if the concentration of ethylene oxide in the sterilization chamber exceeds the predetermined limits required by the operating procedures specified in 14.6.1.1.

(C)*
Exhaust duct systems used to convey ethylene oxide vapors shall be in accordance with the mechanical code.

14.9.5.3
Piping used to convey ethylene oxide to the sterilization process shall not be purged to an oxidizing emission control device.

14.10 Maintenance

14.10.1 General Requirements
A written program shall be developed for the following maintenance activities:
Confined space entry
Purging of equipment and piping
Welding (hot work) permit system
Lockout/tagout
Preventive maintenance for key equipment

14.10.2 Maintenance Manuals
Manuals shall be accessible to facility operators and maintenance personnel at all times.

14.11 Construction

14.11.1 Scope

14.11.1.1
This section covers the construction, ventilation, and heating of structures that house ethylene oxide storage, dispensing, and use.

14.11.1.2
These structures shall be used exclusively for ethylene oxide storage, dispensing, and use and for the housing of other materials having similar hazards, or they shall be permitted to be rooms attached to or located within buildings used for other purposes.

14.11.2 Separate Structures or Buildings

14.11.2.1 Construction of Structures or Buildings
Separate structures or buildings shall be one story in height and shall have walls, floors, ceilings, and roofs constructed of noncombustible or limited-combustible materials.

14.11.2.1.1
Exterior walls, ceilings, and roofs shall be constructed in one of the following ways:
Of lightweight material designed for explosion venting
* Of heavy construction, such as solid brick masonry, concrete block, or reinforced concrete construction, provided there are explosion venting windows or panels in the walls or roofs

14.11.2.1.2
The floor of such structures or buildings shall not be located below ground level.

14.11.2.1.3
Any space beneath the floor shall be of solid fill, or the perimeter of the space shall be entirely unenclosed.

14.11.2.2* Structure or Building Ventilation
The structure or building shall be provided with general ventilation through the use of air supply inlets and exhaust outlets.

14.11.2.2.1
These inlets and outlets shall be arranged to provide movement of well-mixed air throughout the space.

14.11.2.2.2
Air circulation shall be at least 1 scf/ft2 (0.3 Nm3/m2) of floor area and shall be permitted to be provided by natural or mechanical means.

14.11.2.3 Structure or Building Heating
Heating shall be by electrical appliances listed for Class I, Group B, Division 2 locations in accordance with NFPA 70 or shall be by means of steam or hot water radiation or other heating transfer medium with the heat source located in one of the following locations:
Outside the building
In a separate room with a 2-hour fire resistance rating pressurized relative to the remainder of the building

14.11.2.4 Sterilization Rooms
The sterilization room shall be provided with Protection Level 2 and Protection Level 4 controls as specified by the building code.

14.11.2.4.1
Sterilizing rooms with quantities of hazardous materials, including ethylene oxide, in quantities less than the MAQ per control area as established by the building code shall not be required to have Protection Level 2 and Protection Level 4 controls.

14.11.2.5* Explosion Control
Explosion control shall be provided in accordance with Section 6.10.

14.11.2.5.1
When explosion venting is provided, interior walls and other walls of the sterilization room not designed as explosion venting shall be designed to withstand an overpressure of at least 100 psf (4.8 kPa).

14.12 Fire Protection

14.12.1 Sprinklers
Facilities using ethylene oxide shall be protected by an automatic sprinkler system in accordance with Section 6.11.

14.12.1.1 Ethylene Oxide Storage Areas
Ethylene oxide storage areas shall be equipped with a deluge system in accordance with NFPA 16.

Storage, Handling, And Use Of Ethylene Oxide For Sterilization And Fumigation

Publish Time：2024-06-19