Glass inner packagings (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 transported in accordance with §173.4a, irrespective of the restriction of §173.4a and the indication of “forbidden” in columns (9A) and (9B) of the §172.101 table provided that:
a. After filling, each glass inner packaging must be determined to be leak-tight by placing the glass inner packaging in a hot water bath at a temperature and for a period of time sufficient to ensure that an internal pressure equal to the vapor pressure of ethylene oxide at 55 °C is achieved. Any glass inner packaging showing evidence of leakage, distortion or other defect under this test must not be transported under the terms of this special provision;
b. In addition to the packaging required in §173.4a, each glass inner packaging must be placed in a sealed plastic bag compatible with ethylene oxide and capable of containing the contents in the event of breakage or leakage of the glass inner packaging; and
c. Each glass inner packaging is protected by a means of preventing puncture of the plastic bag (
e.g., sleeves or cushioning) in the event of damage to the packaging (
e.g., by crushing).
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