FEATURE
The primary or secondary packaging must withstand the 95kPa pressure test, and the entire package, with its three layers, must withstand a 1.2m drop test without any damage to the primary container. In addition, there must also be sufficient absorbent material included in the package to absorb all of the sample volume (special absorbent sheet, blue roll, foam, cotton wool etc.). Samples being sent under UN3373 Category B, Biological Substance should also display the appropriate symbol. This is a diamond with each side at least 50mm in size in a colour which contrasts clearly with the package background. The diamond should contain ‘UN3373’ in letters at least 6mm high. There are additional stipulations and requirements particularly relating to air transport (IATA).
Trying to meet these requirements using standard materials around the laboratory can be a daunting task and lead to variability within the packaging processes. For example, the use of various absorbent materials could mean insufficient absorbency is provided, or excess padding is added which makes the package unnecessarily bulky and more expensive to mail. Ideally, DIY solutions should be avoided as there are specific tests regarding robustness, absorbency etc. which elements of the packaging must comply with to be considered suitable.
To help provide some packaging consistency there are a range of ‘off the shelf’ materials readily available to assist with compliance, but the choice can be overwhelming and some are overly large, which can become costly in terms of transport. It’s important to shop around to find the most appropriate and cost effective solution for your particular requirements.
The SpeciSafe range of secondary packaging from Alpha Laboratories is one example that provides a consistent, convenient and cost effective means of compliance. The robust, blister type, leak-proof pack combines an ultra- absorbent gel-based material within the rigid container. It simply encloses the sample container and protects it in the sealed casing.
When transporting by road, you then only need to add a padded envelope or bag as your outer packaging and your sample is ready for transportation according to UN3373 regulations (also suitable for air transport when combined with a rigid outer). The slim design of SpeciSafe also minimises postal costs. SpeciSafe packs are available in a wide range of design options covering the most commonly used 95 kPa sample vessels. These include packs for: blood/serum vials, Vacutainer type tubes, 30ml Universal tubes for urine or faecal samples, Bijou containers, up to 90ml sample containers and swabs. Custom designed solutions can also be prepared such as sample packs for logistics solutions in clinical trials and contract research projects in the pharmaceutical, healthcare and laboratory industries. A wide
UN3373 label
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range of other sample transport packaging materials are also available including absorbent sheets, 95kPa pouches, rigid boxes, envelopes and labels. Find out more here.
Staff need to be fully trained in their responsibilities for compliance to transport regulations and how to correctly package samples. To help support this Alpha Laboratories now offers a Sample Transport Seminar. This training is provided by a technical expert who is certified in the Carriage of Diagnostic and Infectious Substances by Air, through a CAA approved course. To find out more and request a seminar for your laboratory please contact
marketing@alphalabs.co.uk.
ASSESS YOUR SAMPLE Under the Dangerous Goods Regulations, there are nine classes of goods segregated according to the particular risks they pose.
Human or Animal Specimens fall into Class 6 – Toxic and Infectious Substances.
6.1 Toxic Substances
6.2 Infectious Substances, where these types of samples are assigned
CATEGORY A Pathogens vary greatly in their ability to cause disease and how dangerous those diseases can be. Those which are capable of causing permanent disability, life threatening or fatal disease in humans or animals are categorised as Category A Infectious Substance and a complete list of these organisms is contained within the regulations. Transport of Category A Infectious substances is very strictly regulated and must only be done in UN approved packaging.
CATEGORY B Most pathogens fall into Category B Biological Substances as they may cause disease or illness but it is not usually too serious.
Category B has less stringent requirements but the packaging instruction detailed in the regulations must be adhered to. The majority of samples transported in the UK fall under UN3373 Biological Samples, Category B.
EXEMPT SAMPLES Under Class 6.2, there is a third sub division which causes a great deal of misunderstanding and these are Exempt Samples. Many people think that ‘exempt’ means you don’t require any special packaging, but this is not the case. Exempt samples are described as those which have ‘minimal likelihood that pathogens are present’. However, the UK authorities believe that unless you are able to categorically say that the sample does not contain pathogens, it should be treated as any other sample containing pathogens. Even when a sample is categorised as ‘exempt’, it still requires a triple layer packaging system to be compliant with the Dangerous Goods Act for Transport.
www.alphalabs.co.uk
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