PI650 Packing Instructions

Types of specimens that meet the criteria of UN 3373:

“Diagnostic” or “clinical specimens”, or “Biological substance, Category B” are substances which could contain pathogens and which are shipped for diagnostic or investigational purposes. Pathogens which can cause disease in humans or animals are divided in two categories –Category A infectious substances are capable of causing permanent disability, life-threatening or fatal disease to humans or animals. Human or animal specimens which do not contain pathogens  in Category A fall into Category B and must be assigned to UN 3373 “Biological substance, Category B.” All UN 3373 substances must be transported in compliance with 49 CFR, Part 173.199 or IATA Packing Instruction 650. The KelvinBox T900 series is specifically developed for shipping UN3373 Biological substance, Category B type samples on dry ice.

Transport Packaging for UN 3373 Substances

Any packaging for biological substances must include three components:

  1. a primary receptacle
  2. a secondary packaging
  3. a rigid outer packing
1.   A watertight primary receptacle: the tube, vial or other container typically made of glass, metal or rigid plastic that is in direct contact with the specimen.

Under normal conditions of transport, primary receptacles must not break or leak their contents into secondary packagings. Please make sure your sample tubes are qualified to meet the requirements. For liquid specimens, the primary receptacle must be leak-proof and must not contain more than 1 L. In addition, Multiple primary receptacles in the same secondary packaging must be separated to prevent contact between them. Please inquire about the available sample tube pouches and sample boxes available.

2. A watertight secondary packaging (including cushioning and other materials) that fully encapsulates the primary  receptacle.

The performance of cushioning materials and the outer packaging must not be compromised due to any leakage from primary receptacles. For liquids, absorbent material sufficient to absorb the entire contents of all primary receptacles must be placed between the primary receptacles and the secondary packaging.

The primary and secondary receptacles must maintain their integrity and performance at the temperatures of the refrigerant used as well as being able to withstand, without leakage, an internal pressure of not less than 95 kPa in the range of -40 °C to 55 °C (-40 F to 130 F). When dry ice is used as cooling agent,  the packaging should be able to withstand -79 °C.  Dry ice must be placed outside the secondary packaging, inside the outer packaging, and the secondary packaging must be supported internally so that it maintains its original position while the dry ice sublimates. The Transposafe AirSealbag® is the first in his kind that guarantees leakproof shipments at temperatures of -79°C (dry ice conditions). The AirSealbag is designed for shipping and storing any biological materials, is suitable for road and air transport and certified for IATA/ADR regulations. The KelvinBox T900 packaging systems all include the Transposafe AirSealbag® as secondary packaging,  a fixation system as well as absorbent material.

3. A sturdy outer packaging for shipping or transit.

The KelvinBox consists of high quality EPS, Expandable PolyStyrene, inside a sturdy, corrugated box, qualified and meeting set requirements. The external surface of the outer box clearly shows all required information: each UN3373 shipment must show the text “Biological Substance Category B” adjacent to the UN3373 label. Also the name and address of the shipper and the consignee must be marked on the packages. For the dry ice shipments, the EPS packaging allows for escape of carbon dioxide gas and the outer box is marked with the text “Dry Ice”, “UN 1845” and the net quantity, in kilograms, of dry ice.*

The KelvinBox T900 series is THE packaging solution for all your  UN3373 dry ice shipments.

 

*Please review IATA Packing Instructions 650 for the complete guide of packaging requirements