A hazard and operability (HAZOP) study was conducted on a sterilizer supplied by compressed gas cylinders of ethylene-oxide (75218) (EtO). The sterilizer installation, equipment, and operational procedures were reviewed, and recommendations were developed both specifically for the studied installation and for the generic installation. The sterilizer consisted of a jacketed chamber and associated pumps, pipes, filters, valves and other equipment. Sterilizer facility design, sterilizer equipment design, leak monitoring, system utilities, equipment maintenance, and operational procedures were discussed. These recommendations should provide guidance to hospitals installing EtO sterilizers. The study also showed how the HAZOP study procedures which are typically used in large chemical facilities can be used on a small scale setting. The HAZOP study involved evaluating the facility as a series of systems. Log sheets of information gathered were included in this report. A process diagram of an EtO sterilizer was included along with a schematic of EtO piping from tanks to sterilizer, a schematic of EtO sample line, calibration gas line, and carrier gas line, and schematics of the air inlet line to chamber and the piping from EtO tank to supply valve.
Technica Inc., Consultants in Engineering and Science, Report No. CT-146-20b, NIOSH Purchase Order Report 937003, 82 pages