178.604—Leakproofness test.
(a) General.
The leakproofness test must be performed with compressed air or other suitable gases on all packagings intended to contain liquids, except that:
(1)
The inner receptacle of a composite packaging may be tested without the outer packaging provided the test results are not affected; and
(b) Number of packagings to be tested—
(1) Production testing.
All packagings subject to the provisions of this section must be tested and must pass the leakproofness test:
(2) Design qualification and periodic testing.
Three samples of each different packaging must be tested and must pass the leakproofness test. Exceptions for the number of samples used in conducting the leakproofness test are subject to the approval of the Associate Administrator.
(c) Special preparation—
(1)
For design qualification and periodic testing, packagings must be tested with closures in place. For production testing, packagings need not have their closures in place. Removable heads need not be installed during production testing.
(2)
For testing with closures in place, vented closures must either be replaced by similar non-vented closures or the vent must be sealed.
(d) Test method.
The packaging must be restrained under water while an internal air pressure is applied; the method of restraint must not affect the results of the test. The test must be conducted, for other than production testing, for a minimum time of five minutes. Other methods, at least equally effective, may be used in accordance with appendix B of this part.
(e) Pressure applied.
An internal air pressure (gauge) must be applied to the packaging as indicated for the following packing groups:
(f) Criteria for passing the test.
A packaging passes the test if there is no leakage of air from the packaging.
[Amdt. 178-97, 55 FR 52723, Dec. 21, 1990, as amended at 56 FR 66286, Dec. 20, 1991; Amdt. 178-106, 59 FR 67522, Dec. 29, 1994; 66 FR 45386, Aug. 28, 2001]