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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 leak-tight 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).