Infectious Substances in Practice: Packing Instruction 620 and Packing Instruction 650
Key Takeaways
- Category A infectious substances (UN 2814, UN 2900, and UN 3549) are packed to Packing Instruction 620, which requires UN specification triple packaging tested to a 9 metre drop and a puncture test.
- Category B biological substances (UN 3373) are packed to Packing Instruction 650, which requires triple packaging and a 1.2 metre drop test but no UN specification marking and no Shipper's Declaration.
- Both instructions require a leakproof primary receptacle, a leakproof secondary packaging, absorbent material sufficient to take the entire liquid contents, and an itemised list of contents between the secondary and outer packagings.
- Every primary receptacle or secondary packaging holding liquid must withstand an internal pressure differential of at least 95 kPa across the range -40°C to +55°C, and the outer packaging must have a minimum dimension of 100 mm.
Infectious Substances in Practice: Packing Instruction 620 and Packing Instruction 650
Classifying an infectious substance as Category A or Category B decides which of two very different packing regimes applies. Packing Instruction 620 governs Category A and is one of the most demanding instructions in the manual. Packing Instruction 650 governs Category B and is deliberately accessible, because it is used daily by clinics and laboratories with no dangerous goods specialists on staff. Both are built on the same triple packaging principle.
1. The Triple Packaging Principle
Every infectious substance package, in either category, has three layers:
+-----------------------------------------------------------+
| OUTER PACKAGING (rigid, min. dimension 100 mm) |
| +---------------------------------------------------+ |
| | SECONDARY PACKAGING (leakproof, watertight) | |
| | +-------------------------------------------+ | |
| | | PRIMARY RECEPTACLE (leakproof, watertight)| | |
| | | The specimen itself | | |
| | +-------------------------------------------+ | |
| | Absorbent material: enough to absorb ALL liquid | |
| +---------------------------------------------------+ |
| Itemised list of contents between secondary and outer |
+-----------------------------------------------------------+
Three requirements are common to both instructions and are examined repeatedly:
- Absorbent material must sit between the primary receptacle and the secondary packaging, in a quantity sufficient to absorb the entire liquid contents of all primary receptacles.
- The primary receptacle or the secondary packaging must withstand an internal pressure differential of not less than 95 kPa, maintained across the temperature range -40°C to +55°C.
- The outer packaging must have a minimum external dimension of 100 mm, so that the marks and labels can be read.
- An itemised list of contents is enclosed between the secondary packaging and the outer packaging.
2. Packing Instruction 620 — Category A
Category A covers substances capable of causing permanent disability, or life-threatening or fatal disease, in otherwise healthy humans or animals: UN 2814 (affecting humans), UN 2900 (affecting animals only) and UN 3549 (Category A medical waste).
| Requirement | Packing Instruction 620 |
|---|---|
| Packaging standard | UN specification packaging, tested and marked, meeting the Packing Group I performance level |
| Drop test | 9 metres |
| Puncture test | Required |
| Pressure differential | Not less than 95 kPa |
| Quantity limits | Restricted per package, with lower limits on passenger aircraft than on cargo aircraft |
| Hazard label | Division 6.2 Infectious Substance label |
| Marking | UN number and Proper Shipping Name; the technical name of the pathogen where required |
| Shipper's Declaration | Required |
| Responsible person | Name and telephone number of a responsible person must accompany the consignment |
The 9 metre drop test is the figure to remember: it is far above the 1.8 m used for Packing Group I chemical packagings, because the consequence of release is biological rather than chemical.
3. Packing Instruction 650 — Category B
Category B is everything infectious that does not meet the Category A criteria — the routine diagnostic specimen. It is assigned to UN 3373, Biological Substance, Category B.
| Requirement | Packing Instruction 650 |
|---|---|
| Packaging standard | No UN specification packaging required |
| Drop test | 1.2 metres |
| Pressure differential | Not less than 95 kPa |
| Outer packaging | Rigid, minimum dimension 100 mm |
| Hazard label | None — the Division 6.2 hazard label is not used |
| Marking | The UN 3373 diamond-shaped mark with UN 3373 beside it, and the Proper Shipping Name Biological Substance, Category B adjacent to the mark |
| Shipper's Declaration | Not required when the consignment fully complies with PI 650 |
| Air Waybill | Should identify the consignment as UN 3373, Biological Substance, Category B |
A PI 650 consignment that fails any condition of the instruction is no longer a PI 650 consignment. It reverts to being fully regulated, which for a Category B substance means it can no longer be offered at all in that condition and must be repacked correctly.
4. Refrigerants and the Common Error
Diagnostic specimens are usually shipped cold, so an infectious substance package very often also contains a refrigerant:
- Dry ice (UN 1845) — the outer packaging must permit the release of carbon dioxide gas, and the dry ice must be placed outside the secondary packaging so that the secondary packaging is not crushed as the specimen contracts. The package is marked with the net mass of dry ice and the Class 9 label, and dry ice must be declared on the Air Waybill.
- Liquid nitrogen (UN 1977) — additional requirements apply, including the use of a receptacle designed for the temperature and the retention of any liquid.
The most common practical error is packing the coolant inside the secondary packaging. It must sit between the secondary and the outer packaging, with the secondary packaging supported so that it stays in position once the coolant has sublimated or evaporated away.
5. Deciding Between the Two
The decision is made on the classification, never on convenience or cost:
- Does the substance meet the Category A criteria — capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals? → Category A, UN 2814 / UN 2900 / UN 3549, Packing Instruction 620, full declaration.
- If not, is it still known or reasonably expected to contain pathogens? → Category B, UN 3373, Packing Instruction 650, no declaration.
- Is it a patient specimen with minimal likelihood of pathogens, or a substance that has been neutralised or is otherwise excluded? → It may fall outside Division 6.2 altogether; verify against the Section 3 exclusions before deciding.
A laboratory ships a cultured sample of a pathogen capable of causing fatal disease in otherwise healthy humans. Which packing instruction applies and what is its drop test height?
Which statement about a fully compliant UN 3373 consignment prepared under Packing Instruction 650 is correct?
Where must dry ice be placed in an infectious substance package, and why?