ETHYLENE OXIDE

SP 342

Glass inner receptacles (such as ampoules or capsules) intended only for use in sterilization devices, when containing less than 30 ml of ethylene oxide per inner packaging with not more than 300 ml per outer packaging, may be carried in accordance with the provisions in Chapter 3.5, irrespective of the indication of "E0" in column (7b) of Table A of Chapter 3.2 provided that: (a) After filling, each glass inner receptacle has been determined to be leaktight by placing the glass inner receptacle in a hot water bath at a temperature, and for a period of time, sufficient to ensure that an internal pressure equal to the vapour pressure of ethylene oxide at 55 °C is achieved. Any glass inner receptacle showing evidence of leakage, distortion or other defect under this test shall not be carried under the terms of this special provision; (b) In addition to the packaging required by 3.5.2, each glass inner receptacle is placed in a sealed plastics bag compatible with ethylene oxide and capable of containing the contents in the event of breakage or leakage of the glass inner receptacle; and (c) Each glass inner receptacle is protected by a means of preventing puncture of the plastics bag (e.g. sleeves or cushioning) in the event of damage to the packaging (e.g. by crushing).