Oftentimes, many days and miles lie between the time patient specimens are collected and subsequently analyzed. That’s also why the proper packaging is crucial to ensure pristine and - above all - securely sealed clinical specimens. However, different types of samples also require special packaging and labeling for transport.
Whether it applies to diagnosing diseases or the latest scientific findings – medical science depends on the analysis of patient samples. Inevitably, the packaging of said clinical materials plays an important role in this context. It not only ensures the integrity, preservation, and sterility of the sample, it also prevents the spread of bacteria and viruses. After all, patient specimens often contain pathogens.
Different types of substances are analyzed in laboratory settings for research, diagnostic, examination, treatment or preventive purposes. All human materials collected directly from humans are defined as patient specimens.
For transport, medical examination material is classified into the dangerous goods regulation's categories A or B or sent as exempted human specimens.
Classification: How infectious is my sample?
Basically, the packaging for the transport of specimens depends on the degree of risk for infection. The applicable legal safety precautions are based on the European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR). This document is reviewed and amended every two years in accordance with globally applicable UN recommendations.
"First, there is Category A, which pertains to certain infectious substances in a form capable of causing permanent disability or life-threatening fatal disease in otherwise healthy humans," explains Dieter Manz, Director of Sales & Marketing at Süsse Labortechnik GmbH. These include numerous pathogens of the WHO Risk Group 3 with a high risk of infections such as the Herpes B virus or hand-foot-and-mouth virus and also all infective microorganism of Risk Group 4, meaning dangerous microorganisms likely to cause human disease such as the Ebola virus or Smallpox (variola) virus.
Category B pertains to all hazardous substances that are not included in Category A and are shipped for diagnostic or clinical purposes. For example, patient specimens with suspected influenza should be assigned to this Category. Many organisms of the WHO Risk Group 3 are also part of this Category.
Patient specimens that most likely don’t contain any or merely a minimal amount of pathogens are not subject to the applicable requirements of hazardous materials in Categories A and B. For example, this includes blood and urine samples to test cholesterol, blood sugar or hormone levels and samples collected for insurance or employment medical exams to detect drug or alcohol use. Samples for pregnancy testing are also unlikely to contain pathogens and are therefore classified as non-infectious and non-hazardous.
The packaging for the shipment of a medical sample depends on the level of infection risk.
The right packaging, the right identification
Each of the three categories of patient specimens is subject to different regulations with regard to packaging, identification, and shipment. The more hazardous the sample, the stricter the guidelines.
Specimens included in Category A are assigned to the corresponding UN numbers UN 2814 ("Infectious Substance Affecting Humans") or UN 2900 ("Infectious Substances, Affecting Animals Only") for transport purposes. It is not permitted to send these substances through regular mail. Instead, a specialized hazardous materials carrier must be commissioned to handle the shipment. The P620 Packaging Instruction applies. Normally, laboratories provide the proper packaging materials.
All other samples may be sent in the mail without reservation. Samples included in Category B are subject to the P650 Packaging Instruction. The packaging should consist of three parts. The primary receptacles, sterile and watertight receptacles contain the actual samples. These are inside the secondary packaging, which contains cushioning materials, preventing the primary receptacles from crashing into each other during transport. "This also includes outer packaging that ensures the sample is safely secured to where it won't be damaged," Manz clarifies. The UN number UN 3373 in the shape of a diamond must be displayed on the packaging. In addition, the text "BIOLOGICAL SUBSTANCE, CATEGORY B" should also be clearly noticeable.
If the sample likely does not contain pathogens, a UN number is not required because it is exempt from the hazardous materials regulations. The P650 light Packaging Instruction applies in this case, according to which the transport packaging must also consist of three parts. The outer packaging should specify the content as an "EXEMPT HUMAN SPECIMEN".
If the specimen has to be refrigerated for transport, the required ice or dry ice has to be packed between the secondary and the outer packaging and the latter must have an additional label stating "UN 1845 CARBON DIOXIDE, SOLID, USED AS COOLING AGENT" or "UN 1845 DRY ICE, USED AS COOLING AGENT". To prevent a buildup of pressure, the packaging must also permit the release of carbon dioxide gas.
All persons involved in sample transport should always be informed about the type, size and quantity of the sample as well as the time of the shipment.
Three steps to safety
"The packaging technologies that are available on the market are already excellent. That being said, we see a chance for improvement in educating and instructing the senders," Dieter Manz sums up. It is important that all parties involved in the transport process are educated about the type, size, and quantity of the sample as well as the time of shipment.
Manz also sees challenges for manufacturers. "As a packaging and laboratory equipment manufacturer, we also have to keep an eye on changes in the logistics infrastructure. Some time ago, Amazon has introduced delivery drones for example. If there are drastic changes in logistics, we must respond by adapting and redesigning our shipping receptacles accordingly."
If stakeholders follow the three steps of proper classification, packaging, and identification, nothing will get in the way of the shipment and subsequent analysis of clinical samples.
The article was written by Elena Blume and translated from German by Elena O'Meara. COMPAMED-tradefair.com