Packing Instruction 650

SIRANE'S Safe-Hold™ and absorbent pads will help you meet the requirements of Packing Instruction 650 for the safe transportation of diagnostic specimens. Current guidelines say that diagnostic specimens must be packed in good quality packagings, which must be strong enough to withstand the shocks and loadings normally encountered during transport, including trans-shipment between transport units and between transport units and warehouses as well as any removal from a pallet or overpack for subsequent manual or mechanical handling. Packagings must be constructed and closed so as to prevent any loss of contents when prepared for transport which might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure. 

Primary receptacles must be packed in secondary packagings in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into secondary packaging. Secondary packagings must be secured in outer packagings with suitable cushioning material. Any leakage of the contents must not substantially impair the protective properties of the cushioning material or of the outer packaging.

FOR LIQUIDS

* The primary receptacle(s) must be leakproof and must not contain more than 500ml

* There must be absorbent material placed between the primary receptacle and the secondary packaging; if several fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated so as to prevent contact between them. The absorbent material must be in sufficient quantity to absorb the entire contents of the primary receptacles and there must be a secondary packaging which must be leakproof

* The primary receptacle or the secondary packaging must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa in the range of -40OC to + 55OC (-40OF to 130OF)

* The outer packaging must not contain more than 4 L. 

SUMMARY

Transportation of biological, diagnostic and clinical samples, infectious and hazardous materials, chemicals, pharmaceuticals and environmental samples is subject to stringent regulatory controls. These controls dictate the packaging, labelling and shipping requirements to ensure that such materials are transported safely and without danger of leakage, contamination or infection. 

The legislation is enshrined in a number of UN regulations and associated ADR, RID and IATA Packaging Instructions. The legislation can be summarised as follows:

Infectious substances –

For the purpose of this legislation, these are divided into two categories, A and B. 

Category A materials include those which are capable of causing permanent disability, life-threatening disease or fatal disease to humans or animals. These are assigned to UN 2814 and UN2900 and their associated Packaging Instructions 602 (IATA, air) and 620 (ADR, road).

Category B materials are those infectious substances not included in category A. These are assigned to UN3373 and associated Packaging Instruction 650 (IATA or ADR)

Infectious substances are further divided as follows:

Biological Substances – These include diagnostic and clinical specimens and covers any human or animal material including body fluids, tissues, body parts and others. These are assigned to UN3373 and associated Packaging Instruction 650 (IATA or ADR)

Biological Products – These are products derived from living organisms, possibly used for disease prevention or treatment or for research or experimental purposes. They include vaccines and similar products. Biological products are assigned to UN2814, UN2900 or UN3373 and associated Packaging Instructions 602, 620 or 650.

Genetically Modified Organisms and microorganisms

– These are organisms or microorganisms in which genetic material has been purposefully altered in a way that does not occur naturally. These materials are categorised as A or B according to their level of infectiousness and assigned to UN2814, UN2900 or UN3373 and associated Packaging Instructions 602, 620 or 650 as appropriate.

Clinical waste 

– These are wastes derived from medical treatment of humans or animals. They are

categorised as A or B depending upon whether they contain infectious substances and assigned to UN2814, UN2900 or UN3373 and associated Packaging Instructions 602, 620 or 650 as appropriate.

Chemicals – Phosphoric acid is covered by UN1805. Corrosive liquids and other chemicals are covered by UN1760 and associated packaging instructions.

Packaging Instructions for the transportation of clinical materials all define a three-tier package structure consisting of a leak-proof primary receptacle, protective secondary packaging and a rigid outer pack. Most of these packaging instructions, including 602, 620 and 650, also specify that the secondary packaging includes absorbent material in sufficient quantity to absorb all the liquid that would be released should the primary packaging leak or break. 

This is a critical requirement. It must be met in full to ensure safe, secure and compliant packaging.

Traditional solutions—

It is common to use cellulose wadding, cotton wool, super-absorbent granules or vermiculite to provide this absorbency. All these materials are absorbent... to some extent. 

However, their absorbent properties are limited to particular liquids and their absorbent capacity is highly variable. Many packages containing these materials may be non-compliant with the legislation and potentially dangerous.

For example, super-absorbent granules are effective for absorbing pure water. They are not effective for absorbing water containing dissolved salts (urine, blood and other body fluids for example). As a result, packages which have been approved for compliance based on the absorbency of water may not be compliant for the transport of other liquids.

Another important factor is the position of the absorbent material inside the package. The material will only be effective if it is located so that leakage or breakage of the primary container releases the liquid directly onto the absorbent material. Liquid may not be absorbed if the liquid is released at the bottom of the pack and the absorbent pad is positioned at the top. 

This is often the case in a ‘bubble pouch’ wrapped tightly around a primary pack. The absorbent pad ist rapped in one position and leakage may occur elsewhere.

Absorbent capacity is just one important property required for the absorbent material to provide safe, secure and compliant packaging.

Ideally, the material should not lint or contaminate the package or contents. Cotton wool, vermiculite and cellulose wadding are particularly unsuitable in this respect. 

Furthermore, the material should not only absorb liquid, it should retain it under pressure. It should also provide as much additional protection and containment as possible.

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