| Description | 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 Sec. 173.4a of
this subchapter, irrespective of the restriction of Sec. 173.4a(b) and
the indication of ``forbidden'' in columns (9A) and (9B) of the Sec.
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
[deg]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 Sec. 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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