§178.609. Test requirements for packagings for infectious substances. — Inbound Citations

(ii) Forensic material known or suspected to contain a Category A infectious substance or an infectious substance listed as a select agent in 42 CFR part 73 must be transported in packaging capable of meeting the test standards in § 178.609 of this subchapter. The secondary packaging must be marked with a BIOHAZARD symbol conforming to specifications in 29 CFR 1910.1030(g)(1)(i). An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.

(a) A packaging for a Division 6.2 material that is a Category A infectious substance must meet the test standards of § 178.609 of this subchapter and must be marked in conformance with § 178.503(f) of this subchapter. A packaging for a Category A infectious substance is a triple packaging consisting of the following components:

(2) If multiple fragile primary receptacles are placed in a single secondary packaging, they must be either wrapped individually or separated to prevent contact between them.

(3) A rigid outer packaging of adequate strength for its capacity, mass and intended use; including, drums (1A1, 1A2, 1B1, 1B2, 1N1, 1N2, 1H1, 1H2, 1D, 1G); boxes (4A, 4B, 4N, 4C1, 4C2, 4D, 4F, 4G, 4H1, 4H2); or jerricans (3A1, 3A2, 3B1, 3B2, 3H1, 3H2). The outer packaging must measure not less than 100 mm (3.9 inches) at its smallest overall external dimension.

(4) For a liquid infectious substance, an absorbent material placed between the primary receptacle and the secondary packaging. The absorbent material must be sufficient to absorb the entire contents of all primary receptacles.

(6) The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi).

(7) The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding without leakage temperatures in the range of −40 °C to + 55 °C (−40 °F to + 131 °F).

(f) A manufacturer must mark every UN specification package represented as manufactured to meet the requirements of § 178.609 for packaging of infectious substances with the marks specified in this section. The markings must be durable, legible, and must be readily visible, as specified in § 178.3(a). An infectious substance packaging that successfully passes the tests conforming to the UN standard must be marked as follows:

(2) The code designating the type of packaging and material of construction according to the identification codes for packagings specified in § 178.502.

(3) The text “CLASS 6.2”.

(5) The letters “USA” indicate the packaging is manufactured and marked in the United States in compliance with the provisions of this subchapter.

(6) The name and address or symbol of the manufacturer or the approval agency certifying compliance with subparts L and M of this part. Symbols, if used, must be registered with the Associate Administrator for Hazardous Materials Safety.

(7) For packagings meeting the requirements of § 178.609(i)(3), the letter “U” must be inserted immediately following the marking designating the type of packaging and material required in paragraph (f)(2) of this section.

(1) is the performance of the tests prescribed in § 178.603, § 178.604, § 178.605, § 178.606, § 178.607, § 178.608, or § 178.609, as applicable, for each new or different packaging, at the start of production of that packaging.

(i) The secondary and outer packaging combination must be successfully tested in accordance with paragraphs (a) through (h) of this section with fragile (e.g., glass) inner receptacles.

(i) The secondary and outer packaging combination must be successfully tested in accordance with paragraphs (a) through (h) of this section with fragile (e.g., glass) inner receptacles.

(i) The secondary and outer packaging combination must be successfully tested in accordance with paragraphs (a) through (h) of this section with fragile (e.g., glass) inner receptacles.

(4) The completed package must be designed, constructed, maintained, filled, its contents limited, and closed so that under conditions normally encountered in transportation, including removal from a pallet or overpack for subsequent handling, there will be no release of hazardous material into the environment. Package effectiveness must not be substantially reduced for minimum and maximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations normally encountered during transportation. The packaging must be capable of successfully passing the drop test in § 178.609(d) of this subchapter at a drop height of at least 1.2 meters (3.9 feet). Following the drop test, there must be no leakage from the primary receptacle, which must remain protected by absorbent material, when required, in the secondary packaging. At least one surface of the outer packaging must have a minimum dimension of 100 mm by 100 mm (3.9 inches).

(a) Samples of each packaging must be prepared for testing as described in paragraph (b) of this section and then subjected to the tests in paragraphs (d) through (i) of this section.

(a) Samples of each packaging must be prepared for testing as described in paragraph (b) of this section and then subjected to the tests in paragraphs (d) through (i) of this section.

(a) Samples of each packaging must be prepared for testing as described in paragraph (b) of this section and then subjected to the tests in paragraphs (d) through (i) of this section.

(a) Samples of each packaging must be prepared for testing as described in paragraph (b) of this section and then subjected to the tests in paragraphs (d) through (i) of this section.

(a) Samples of each packaging must be prepared for testing as described in paragraph (b) of this section and then subjected to the tests in paragraphs (d) through (i) of this section.

(7) For packagings meeting the requirements of § 178.609(i)(3), the letter “U” must be inserted immediately following the marking designating the type of packaging and material required in paragraph (f)(2) of this section.