N.Y.C. Admin. Code § FC 5806: Section FC 5806: Ethylene Oxide

5806.1 Scope.

This section shall govern the storage, handling and use of flammable gas containing ethylene oxide used for sterilization purposes.

5806.2 General.

Flammable gases containing ethylene oxide used for sterilization purposes shall be stored, handled and used in compliance with the requirements of this chapter and FC Chapter 53. Ethylene oxide shall additionally be stored, handled and used in compliance with the requirements of NFPA 55.

5806.3 Design and installation requirements.

The design and installation of sterilization systems shall comply with the requirements of FC 5806.3.1 through 5806.3.7.

5806.3.1 Sterilizer design.

The sterilization equipment shall be of a type listed by an approved testing laboratory, and approved by the department, and having a chamber volume of not more than 10 cubic feet (0.2832 m

3

).

5806.3.2 Sprinkler protection.

Sterilization systems shall be located in a room or other area protected by a sprinkler system.

5806.3.3 Proximity to hazard.

Sterilization systems shall be installed away from sources of heat and ignition, means of egress and areas of activity, and shall not be installed in any room or other area in which flammable liquids or flammable gases, other than sterilizer gases, are stored, handled or used.

5806.3.4 Sterilization system room and local area ventilation.

Room ventilation and local area ventilation shall comply with the requirements of FC 5806.3.4.1 and 5806.3.4.2.

5806.3.4.1 Room ventilation.

Rooms in which sterilization systems are installed shall be equipped with ventilation systems that provide not less than 10 air changes per hour.

5806.3.4.2 Local area ventilation.

When a local ventilation system is required by the regulations of the United States Department of Labor, such ventilation system shall comply with the following requirements:

1. The discharge point of the ventilation system shall be at least 25 feet (7620 mm) from pedestrian traffic, building openings or sources of ignition. Prevailing wind direction and location of adjacent buildings shall be considered in selecting the discharge point.

2. At each discharge location there shall be a durable sign, conspicuously posted, that reads "DANGER – FLAMMABLE GAS".

3. Signage shall appear on the duct at intervals of not more than 20 feet (6090 mm) and at least once in each room and each story traversed by the duct. Such signage shall be by means of metal tags, stenciling, stamping or adhesive markers, which shall be attached or imprinted in a manner that is not readily removable.

4. A sparkproof centrifugal fan with backward curved blades designed for continuous operation shall be used, and the impeller and the ring around the impeller drive shaft shall be nonferrous.

5806.3.5 Vent lines.

Sterilization system vent lines shall be designed and installed in accordance with the following requirements:

1. The discharge point of vent lines shall be at least 25 feet (7620 mm) from pedestrian traffic, building openings and sources of ignition. Prevailing wind direction and location of adjacent buildings shall be considered in selecting the discharge point.

2. At each discharge location there shall be a durable sign, conspicuously posted, that reads "Danger – Flammable Gas".

3. Signage shall appear on the vent line at intervals of not more than 20 feet (6096 mm) and shall be present in at least one place in each room and in each story traversed by the duct.

4. A sparkproof centrifugal fan with backward curved blades designed for continuous operation shall be used, and the impeller and the ring around the impeller drive shaft shall be nonferrous.

5. Vent terminals shall be provided with a flash arrester, provided that the manufacturer of the sterilizer or the testing laboratory does not prohibit same. The flash arrester, when used, shall be constructed of material compatible with ethylene oxide and installed in such a manner as not to restrict gas flow.

5806.3.6 Storage.

Flammable gases containing ethylene oxide shall be stored in compliance with the following requirements:

1. Only containers of the type, composition and size approved by the manufacturer for the particular model of sterilization system shall be stored or used.

2. A one-day supply of flammable gases that contains ethylene oxide, but not more than 12 containers, may be stored in its original packaging in the room or other area in which the sterilizer is installed, provided that:

2.1. Such room or other area is above grade.

2.2. The containers are stored at room temperature, away from sources of heat and ignition.

2.3. The containers are stored not less than 5 feet (1524 mm) from the sterilizer, on open shelving protected by a sprinkler system or in an approved flammable liquid storage cabinet.

2.4. In addition to the amounts specified in FC 5806.3.6(2), a maximum of 3 gallons (11.4 L) liquid volume (9908 grams, or 21.8 pounds) of flammable gases that contain ethylene oxide may be stored in their original packaging in a flammable gas storage room, provided that such storage room meets the requirements of the construction codes, including the Building Code, is located above grade, is away from sources of heat and ignition, and is protected by a sprinkler system. Storage of flammable gases that contain ethylene oxide, in excess of 3 gallons (11.4 L) liquid volume, shall be in a detached above grade building designed for the storage of flammable gas in accordance with this chapter and the construction codes. For purposes of complying with the foregoing, 3-gallon (11.4 L) storage limitation, FC Table 5806.3.6 shall be used to determine the quantity of ethylene oxide being stored.

FC Table 5806.3.6 Maximum Number of Ethylene Oxide Containers Not Exceeding 3 Gallon Limit

Quantity of gas per container (grams)

Maximum number of containers not exceeding 3 gallon limit

100

99

134

73

150

66

170

58

200

49

For SI: 1 gallon = 3.785 L.

5806.3.7 Certification of installation.

The owner of the facility in which the sterilization system is installed shall maintain on the premises and make available for inspection by any representative of the department a written certification from the manufacturer of the sterilizer, the certificate of fitness holder responsible for the supervision of the sterilization system and/or a New York State licensed professional engineer, that the installation conforms to the requirements of the manufacturer, the approved testing laboratory that listed the sterilizer and this section.

5806.4 Operation and maintenance.

Sterilization systems shall be operated and maintained in compliance with the following requirements:

1. The quantity of flammable gases that contain ethylene oxide connected to the sterilizer at any one time shall be no more than required for a single sterilization cycle and in no circumstance more than 200 grams (7 ounces) net weight. Containers shall be opened only while connected to the sterilizer in the manner specified by the manufacturer of the sterilizer.

2. Empty or underweight containers, containers with past expiration dates, and containers which fail to open in the sterilizer shall be kept separate from other containers and promptly removed from the premises and lawfully disposed of. Containers shall not be incinerated.

5806.5 Portable fire extinguishers.

At least one portable fire extinguisher having a minimum 40 B:C rating shall be provided in the area where flammable gases containing ethylene oxide are stored or used. The maximum travel distance to such extinguisher shall not exceed 30 feet (9144 mm).