Dossier: What s the difference between P 650 (ADR) and PI 650 (IATA)?

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1 DECEMBER 2015 Dossier: What s the difference between P 650 (ADR) and PI 650 (IATA)? Packing instruction 650 from both ADR and IATA imposes certain requirements on the packaging used for the transport of biological substances, cat B (UN 3373). ADR applies only for the transport by road, IATA for the transport by air. These regulations have some specific demands regarding the packaging and thus they need to be verified and tested. Both packing instructions show lots of similarities, but do have some unneglectable differences, which we will try to clarify further in this article: Composition of the packaging: The packaging needs to be composed out of at least these 3 different components: a) a primary receptacle; (f.i. a test tube) b) a secondary packaging, (a hermetically sealable bag, a drum or a box) c) and an outer packaging. (in most of the cases this is a cardboard or plastic box) For example: a tool/sample box to transport blood samples for home nursing use: Primary packaging: Test tubes. Those are put inside the secondary packaging accompanied of an absorbent material.

2 Secondary packaging This one is finally inserted into the outer packaging: ADR demands that either the outer packaging, either the secondary packaging is rigid, but IATA obliges that the outer packaging is always made in a rigid material. Here we see that in fact there is a slight but important difference for the structure of the complete packaging! Example of an IATA approved packaging: Example of on ONLY for ADR approved packaging:

3 In both cases the outer packaging must have at least one surface that measures 100 by 100 mm. This is needed to accommodate the specific UN 3373 logo in the right dimensions: For the transport of liquids both regulations require that breakable primary receptacles (f.i. glass or plastic test tubes or bottles) need to be separated by means of a shock and liquid absorbent material before they are placed inside of the secondary packaging. This to ensure that the primary receptacles do not come into contact with each other. In most cases we see that individual absorbing wipes or pouches or a combination of a foam holder and absorbent material is used. Moreover the secondary packaging has to be leak-proof in the worst case scenarios!!! Some differences regarding size and total content of the packaging also need to be taken in consideration. IATA has an upper limit which is not to be found back in the ADR. According to IATA PI 650 the primary packaging used for liquid biological substances of category B may not contain more than 1 liter and the complete packaging not more than 4 liter. For solid substances the upper limit for IATA is 4 kg (only the content!).

4 Testing of a complete packaging: The complete packaging needs to withstand all the required performance tests as foreseen by ADR and IATA and they are similar to the drop tests as described for cardboard boxes (4G), plastic boxes (4H1/2) or wooden boxes (4C/4D). This means a series of drop tests from a height of 1,2m effectuated on one and the same complete packaging: a) flat on the bottom b) flat on the top c) flat on the longest side d) flat on the shortest side e) on a corner The criteria to pass these tests are the same for ADR as for IATA: This means that there shall be no leakage from the primary receptacles. After the appropriate drop sequence, there must be no leakage from the primary receptacles, which are surrounded by absorbent material in the secondary packaging. If the primary receptacle contains a liquid, this receptacle or the secondary packaging needs to meet the supplementary requirement of withstanding a pressure test at 95 kpa. Here is also a difference between both regulations: ADR prescribes: The primary receptacle or the secondary packaging needs to be able to withstand an internal pressure of 95 kpa (0,95 bar) without any leakage. IATA prescribes: The primary receptacle or the secondary packaging needs to be able to withstand an internal pressure of 95 kpa (0,95 bar) without any leakage between the range of -40 C & +55 C. Internal hydraulic pressure test on a seal bag The major difference between ADR and IATA is thus the temperature. For ADR it is acceptable to execute this pressure test at ambient temperature.

5 The IATA requirements are more severe. It is needed to execute the test 2 times, once on samples that are conditioned at -40 C and once on samples conditioned at +55 C. It is also possible to execute this pressure test in different ways. ADR only accepts the internal hydraulic pressure test; for IATA there are more possibilities acceptable: an internal hydraulic pressure test; an internal air pressure test or even an external vacuum pressure test. Be aware that the latter test procedure is not accepted for flexible receptacles or flexible secondary packaging (better known as seal bags), so these ones can only be tested with internal pressure. Na het welslagen van al deze testen zal de verpakking door het BVI gecertifieerd worden, en mag deze gebruikt worden voor het transport! After passing all these tests with success, IBE-BVI will be issuing a certificate and so your package is ready for use in transport! Contact: Stefaan De Rijck Info and test requests: click through our website