N.Y.C. Admin. Code § FC 5308: Section FC 5308: Ethylene Oxide

5308.1 Scope.

This section shall govern the storage, handling and use of gases containing ethylene oxide used for sterilization purposes. The storage, handling and use of gases containing ethylene oxide for purposes other than sterilization shall comply with the other applicable requirements of this chapter. The storage, handling and use of flammable gases containing ethylene oxide shall additionally comply with the requirements of FC Chapter 58.

5308.2 General.

The storage, handling and use of gases containing ethylene oxide used for sterilization purposes shall comply with the other requirements of this chapter, as applicable, and shall additionally be in accordance with this section.

5308.3 Prohibitions.

It shall be unlawful to sterilize pressurized oxygen equipment with gases containing ethylene oxide.

5308.4 Application.

Prior to storing or using gases containing ethylene oxide, or modifying an existing installation or system, the owner shall file with the department an application for the approval of the design and installation of the sterilization system which contains such information and documentation as the commissioner may prescribe.

5308.5 Design and installation requirements.

The design and installation of sterilization systems shall comply with the requirements of FC 5308.5.1 through 5308.5.3.

5308.5.1 Compliance with other codes and standards.

The design and installation of sterilization systems and the storage of gases containing ethylene oxide shall be in accordance with the construction codes, including the Building Code, the Electrical Code, the manufacturer's specifications and the approved testing laboratory that listed the sterilizer.

5308.5.2 Sterilization system room and local area ventilation.

Sterilization systems shall be installed in rooms that are ventilated as follows:

5308.5.2.1 Room ventilation.

Sterilizers shall be installed in a well-ventilated room or other area provided with an independent, nonrecirculating mechanical ventilation system that discharges outdoors. Ventilation supply and exhaust registers shall be located such that there are no stagnant air spaces in the immediate area of the sterilizer and that the direction of air movement is away from the operator.

5308.5.2.2 Local area ventilation.

Where a local ventilation system is required by the regulations of the United States Department of Labor, such ventilation system shall be an independent, dedicated and nonrecirculating system that discharges directly outdoors or to an emission control system and only metallic ductwork impervious to ethylene oxide shall be used. The amount of flexible ducting and the number of elbows in the duct shall be kept to a minimum.

5308.5.3 Vent lines.

Sterilizer vent lines shall be designed and installed in compliance with the following requirements:

1. Each sterilizer shall be equipped with an independent, dedicated and gas-tight vent line for the discharge of gases containing ethylene oxide.

2. Vent lines shall discharge directly outdoors or to an emission control system. Such vent lines shall not discharge into any other ventilation or exhaust system.

3. The piping and the point of discharge for all vent lines discharging outdoors shall be designed and installed to prevent moisture from entering the vent line.

4. Vent lines, including piping, fittings and other components, shall be in accordance with the specifications of the sterilizer manufacturer. Pipe lengths shall not exceed the maximum lengths specified by the manufacturer. Vertical travel distances, elbows, sharp bends and any reduction in vent line size shall be kept to a minimum.

5308.6 Operation and maintenance.

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

1. Sterilization systems shall be operated and maintained in compliance with the manufacturer's specifications and the approved testing laboratory listing requirements.

2. Air compressors and their air intakes shall be located such that any gas that may leak from the sterilization system or stored containers will not enter the compressor.

3. Sterilizers shall not be operated if the room ventilation system, local area ventilation system or vent pipe is not operational.

5308.7 Emergency plan.

Where required by the regulations of the United States Department of Labor, a written emergency plan to be implemented in the event of an ethylene oxide spill or leak shall be prepared, shall be maintained on the premises and made available for inspection by any representative of the department.

5308.8 Recordkeeping.

A copy of the manufacturer's instructions for the installation, operation and maintenance of the sterilizer shall be maintained in the room or other area in which the sterilization system is located.