Shipping Temperature Sensitive Biological and Infectious Substances
General Guide
Packaging for Temperature Sensitive Biological Specimens
To maintain their integrity, many specimens in route to clinical laboratories require transport within defined temperature ranges: -25 to -10°C (frozen), 2 to 8°C (refrigerated), or 8 to 15°C (cool). Engineering temperature control within transport packaging can be a challenge, especially if the desired temperature range is narrow; if the ambient temperatures of the shipping environment differ greatly from the desired specimen temperature; or if ambient temperatures vary significantly both below and above the desired temperature range. Thermal packaging designs are also affected by the volume, type of specimens and the duration of the shipment.
Decisions about the appropriate temperature range and level of temperature control usually involve an assessment of the sensitivity and value of the specimens. Some may be packaged in relatively inexpensive foam containers with an accompanying refrigerant gel pack or two. Such packaging will not guarantee tight temperature control; but it may be adequate depending on the specimens and the intended diagnostic procedures. More critical or vulnerable specimens may warrant packaging where the design has been tested against expected ambient temperature profiles. Specimens which are part of an FDA-mandated clinical trial may require fully-validated testing of minimum and maximum package loads against more extreme ambient temperatures. Finally, some specimens may be nearly irreplaceable, justifying the considerable expense of durable, frequently reusable, fully-validated packaging against the known costs of spoiled specimens.
Temperature-Controlled Overpacks
If the DOT/IATA certified package already is complete, only the design for temperature control needs to be considered. The regulations specifically exempt well-constructed overpacks from additional testing, including those with dry ice (carbon dioxide, solid), wet ice, and most refrigerant gel packs. In some cases, temperature-controlled overpacks already have been engineered. if the DOT/IATA certified specimen package fits properly into the overpack, almost no additional design work is necessary.
All-in-One, Temperature-Controlled, DOT/IATA Certified Packaging
An “all-in-one” design is usually custom-designed to the particular requirements of the specimens and the client. The finished product typically is more compact, having avoided the over-packaging inherent in overpack designs, and may be less costly in terms of materials and end-use. However, the process of identifying and engineering an appropriate design, suitable components, and packaging procedures to accommodate both the hazardous materials regulations and the temperature requirements of the specimens is lengthier than relying on an overpack. Design testing and/or thermal validation further extend the process. All-in-one packaging will involve third-party testing and certification – and its associated costs – to establish compliance with DOT and IATA regulations.
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