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Packaging

It is a legal requirement that all diagnostic samples carried on the public road must be packaged and transported in compliance with The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2011.

These regulations set into UK Law the directives of the European ADR ("Accord européen relatif au transport international des marchandises dangereuses par route") agreement concerning the carriage of dangerous goods by road. Under these regulations, it is the sender's responsibility to ensure that they are complied with.

Paragraph 2.2.62.1.5.8 of the ADR (2015) states that: "Human or animal specimens for which there is a minimal likelihood that pathogens are present are not subject to ADR if the specimen is carried in a packaging which will prevent any leakage and which is marked with the words "Exempt human specimen" or "Exempt animal specimen."

The CMFT Cellular Pathology EM Service holds the position that this paragraph applies to all EM samples sent to it on condition that phosphate buffer is the transport medium (since phosphate buffer is a non-hazardous substance) and that all samples have been fixed in glutaraldehyde (as this will cause any pathogens present in the sample to be inactivated), as specified in Tissue sampling.

Therefore, if these two conditions are met, all packages containing samples sent to the CMFT Cellular Pathology EM Service should be clearly labelled with the words: EXEMPT HUMAN SPECIMEN.

Paragraph 2.2.62.1.5.8 continues to clarify that the packaging is deemed to comply with the requirement of "preventing any leakage" only if it meets the following conditions:

a) The packaging consists of three components:

i. a leak-proof primary receptacle(s)
ii. a leak-proof secondary packaging; and
iii. an outer packaging of adequate strength for its capacity, mass and intended use and with at least one surface having minimum dimensions of 100mm x 100mm;

b) For liquids, absorbent material in sufficient quantity to absorb the entire contents is placed between the primary receptacle(s) and the secondary packaging so that, during carriage, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material;

c) When multiple fragile primary receptacles are placed in a single secondary packaging, they are either individually wrapped or separated to prevent contact between them.

Therefore, in addition to the "Exempt human specimen" labelling, Service Users must ensure these 'leakage prevention' requirements are met.

 

(Last updated April 7th 2016)