Guidance

Packaging and transport requirements for patient samples – UN3373

Published 26 March 2020

Purpose of guidance

Guidance to assist testing laboratories, or others involved in healthcare, in the transport of patient specimens suspected of containing Coronavirus (COVID-19), which has been classified as UN 3373 Biological Substance Category B.

It is not intended as a guide to classification of patient samples, which remains the responsibility of the consignor.

Interpretation of Packing Instruction 650

The requirements for the road transport of UN 3373 are specified in Packing Instruction 650 of ADR (The European Agreement concerning the International Carriage of Dangerous Goods by Road).

This guidance provides the UK government’s interpretation of the requirements of Packing Instruction 650.

If you transport UN 3373 Biological Substance, Category B, in accordance with this packing instruction, no other requirements of ADR will apply to your consignment.

The numbered paragraphs below are text from the packing instruction. Where necessary these are followed by the Department for Transport’s interpretation of the requirement.

Packing instruction P650

This packing instruction applies to UN No. 3373.

(1) The packaging shall be of good quality, strong enough to withstand the shocks and loadings normally encountered during carriage, including transhipment between cargo transport units and between cargo transport units and warehouses as well as any removal from a pallet or overpack for subsequent manual or mechanical handling.

Packagings shall be constructed and closed to prevent any loss of contents that might be caused under normal conditions of carriage by vibration or by changes in temperature, humidity or pressure.

DfT interpretation

Since neither this packing instruction nor the above paragraph in particular references ADR 4.1.1.3 (the requirement for using successfully tested UN design type packagings), packaging mentioned here does not require design type approval.

(2) The packaging shall consist of at least 3 components:

(a) a primary receptacle;
(b) a secondary packaging; and
(c) an outer packaging

of which either the secondary or the outer packaging shall be rigid.

DfT interpretation

Paragraph 2 states that the packaging shall consist of 3 layers. It does not specify which type of packaging is required for each level, only that either the secondary or outer is rigid. It is acceptable therefore to have the following packaging:

• primary packaging – sealed plastic bag
• secondary packaging – sealed plastic bag
• outer packaging – cardboard box suitably closed (paragraph 5 below specifies that at least one of the surfaces of the outer packaging must have a minimum dimension of 100mm x 100mm)

(3) Primary receptacles shall be packed in secondary packagings in such a way that, under normal conditions of carriage, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packagings shall be secured in outer packagings with suitable cushioning material. Any leakage of the contents shall not compromise the integrity of the cushioning material or of the outer packaging.

DfT interpretation

Paragraph 3 relates the primary packaging with the secondary by indicating the protective capabilities imparted by the secondary packaging to the primary. For instance, glass vials individually located in a plastics box would be provided a high level of protection but the same vials in a plastics bag would only be acceptable if each vial had its own cushioning in the bag.

(4) For carriage, the mark illustrated below shall be displayed on the external surface of the outer packaging on a background of a contrasting colour and shall be clearly visible and legible. The mark shall be in the form of a square set at an angle of 45° (diamond-shaped) with minimum dimensions of 50 mm by 50 mm; the width of the line shall be at least 2 mm and the letters and numbers shall be at least 6 mm high. The proper shipping name “BIOLOGICAL SUBSTANCE, CATEGORY B” in letters at least 6 mm high shall be marked on the outer packaging adjacent to the diamond-shaped mark.

DfT interpretation

The requirements of paragraph 4 relate to the identification mark required to be placed onto the outer packaging. It does not require the mark to be preprinted onto the outer packaging. The mark, together with the proper shipping name could be applied using the following methods:

• handwritten / drawn directly onto the outer packaging (as long as the specified dimensions are adhered to) e.g. thick black pen used onto the background of a brown cardboard box
• pre-printed marks on a sticky label - these can be sourced from many suppliers internationally - the mark must be applied as a diamond and not square
• the mark(s) can be preprinted onto the outer packaging

(5) At least one surface of the outer packaging shall have a minimum dimension of 100 mm x 100 mm.

(6) The completed package shall be capable of successfully passing the drop test in 6.3.5.3 as specified in 6.3.5.2 at a height of 1.2 m. Following the appropriate drop sequence, there shall be no leakage from the primary receptacle(s) which shall remain protected by absorbent material, when required, in the secondary packaging.

DfT interpretation

Paragraph 6 does not require the completed package to be drop tested. It merely requires the completed package to be ‘capable’ of passing the drop test. VCA guidance on this is to either perform an in-house test keeping a record of what was done or to compile an evidence folder. This could include records of previous shipments, comparisons with other similar packagings used without problems. Due consideration should be given to the nature of the content (solids/liquids) and the mass of the packaging.

(7) For liquid substances:

• (a) The primary receptacle(s) shall be leakproof;
• (b) The secondary packaging shall be leakproof;
• (c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated to prevent contact between them;
• (d) Absorbent material shall be placed between the primary receptacle(s) and the secondary packaging. The absorbent material shall be in quantity sufficient to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging;
• (e) The primary receptacle or the secondary packaging shall be capable of withstanding, without leakage, an internal pressure of 95 kPa (0.95 bar).

DfT interpretation

Paragraph 7 only relates to liquid substances. If there is no free liquid present in the packaging then it is not considered to be a liquid substance e.g. a sample contained in a solution completely absorbed into cotton wool would not be considered to contain any free liquid.

(8) For solid substances:

• (a) The primary receptacle(s) shall be siftproof;
• (b) The secondary packaging shall be siftproof;
• (c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated to prevent contact between them;
• (d) If there is any doubt as to whether or not residual liquid may be present in the primary receptacle during carriage then a packaging suitable for liquids, including absorbent materials, shall be used.

(9) Refrigerated or frozen specimens: Ice, dry ice and liquid nitrogen:

• (a) When dry ice or liquid nitrogen is used as a coolant, the requirements of 5.5.3 shall apply. When used, ice shall be placed outside the secondary packagings or in the outer packaging or an overpack. Interior supports shall be provided to secure the secondary packagings in the original position. If ice is used, the outside packaging or overpack shall be leakproof.
• (b) The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the refrigerant used as well as the temperatures and the pressures which could result if refrigeration were lost.

(10) When packages are placed in an overpack, the package marks required by this packing instruction shall either be clearly visible or be reproduced on the outside of the overpack.

DfT interpretation

Paragraph 10 relates to complete packagings (the 3 layers) which are marked and ready to be transported but are then placed into a (closed) box for ease of handling. There are no restrictions on the number of complete packagings that are placed into the overpack.

(11) Infectious substances assigned to UN No. 3373 which are packed and packages which are marked in accordance with this packing instruction are not subject to any other requirement in ADR. This means that if the packagings are in accordance with the above and marked accordingly, requirements such as requiring a ADR qualified driver or a placarded vehicle et al., do not apply.

(12) Clear instructions on filling and closing such packages shall be provided by packaging manufacturers and subsequent distributors to the consignor or to the person who prepares the package (e.g. patient) to enable the package to be correctly prepared for carriage.

DfT interpretation

The requirements of paragraph 12 should be fulfilled by the packaging supplier/manufacturer when all packaging components come from the same supplier or can be an in-house instruction where packaging is supplied as individual components.

(13) Other dangerous goods shall not be packed in the same packaging as Class 6.2 infectious substances unless they are necessary for maintaining the viability, stabilizing or preventing degradation or neutralizing the hazards of the infectious substances. A quantity of 30 ml or less of dangerous goods included in Classes 3, 8 or 9 may be packed in each primary receptacle containing infectious substances. When these small quantities of dangerous goods are packed with infectious substances in accordance with this packing instruction no other requirements of ADR need be met.

DfT interpretation

Paragraph 13 specifies that a maximum quantity of 30ml of a flammable, corrosive or environmentally hazardous liquid could be included within the primary packaging without the need for the separate identification of that substance.

(14) If any substance has leaked and has been spilled in a cargo transport unit, it may not be reused until after it has been thoroughly cleaned and, if necessary, disinfected or decontaminated. Any other goods and articles carried in the same cargo transport unit shall be examined for possible contamination.

Additional requirement

Alternative packagings for the carriage of animal material may be authorized by the competent authority of the country of origin in accordance with the provisions of 4.1.8.7.

If the country of origin is not a contracting party to ADR, the competent authority of the first contracting party to the ADR reached by the consignment.