An Introduction to the Classifications and Packing Guidelines
Packaging for Infectious Substances Category A & B must comprise of 3 packaging layers:
Primary/Inner Packaging (e.g. evacuated tubes; sample pouch; universal pots): Primary must be leak-proof and primary or secondary must withstand an internal pressure of 95kPa.
Absorbent (e.g. absorbent material, 4 bay pouch): For liquids, there must be absorbent sufficient to absorb entire contents contained in primary packaging. Multiple primaries must be individually wrapped or separated in order to prevent contact between them.
Secondary Packaging (e.g. pouch/bag, container): Secondary must be leak-proof and secondary or primary must withstand an internal pressure of 95kPa.
Outer Packaging (e.g outer box): Rigid 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. Also to contain suitable cushioning material and be clearly marked appropriately.
The combination of the 3 components must be submitted to various tests and certified to meet performance and technical criteria, such as internal pressure differential; temperature tolerance; strength; dimensions etc.
Infectious Substances: Those substances known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses rickettsia, parasites, fungi) and other agents such as prions, which can cause infectious disease in animals or humans.
Infectious substances are divided into two categories:
Category A: An infectious substance which is carried in form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals. Infectious substances meeting these criteria which cause disease in humans or both humans and animals shall be assigned to UN 2814. Infectious substances which cause disease only in animals shall be assigned to UN 2900. Infectious substances assigned to Category A when transported, must comply with the Packing Instructions 602 (IATA, air) or 620 (ADR, road).
Category B: An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B shall be assigned to UN 3373. Substances assigned to Category B when transported, must comply with Packing Instruction 650 (IATA or ADR).
Infectious substances are further subdivided by definition:
Biological Substances: Previously known as Diagnostic Specimens or Clinical Specimens, Biological Substances are any human or animal material including, but not limited to: excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being carried for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.
Diagnostic specimens are assigned to Category B when transported and must comply with Packing Instruction 650 (IATA or ADR).
Biological Products: Those products derived from living organisms, that are manufactured and distributed in accordance with the requirements of national governmental authorities which may have special licensing requirements, and are used for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposed related thereto. They include, but are not limited to, finished or unfinished products such as vaccines.
Biological products are divided into two groups:
a)Those which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and use for individuals. Substances in this group are not subject to these regulations.
b)Those which do not fall under paragraph a) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group must be assigned to UN 2814, UN 2900 or UN 3373 as appropriate.
Genetically Modified Micro-organisms and Organisms: Micro-organisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.
Genetically modified micro-organisms and organisms which meet the criteria for inclusion in Category A or Category B are assigned to UN 2814, UN 2900 or UN 3373 as appropriate.
Genetically modified micro-organisms and organisms not meeting the definition of infectious substance shall be classified as a miscellaneous dangerous substance and packed accordingly.
Clinical Waste: Wastes derived from the medical treatment of animals or humans from bio-research.
Medical or clinical wastes containing Category A infectious substances must be assigned to UN 2814 or UN 2900, as appropriate. Medical or clinical wastes containing infectious substances in Category B must be assigned to UN 3291.
Cultures: Cultures (laboratory stocks) are the result of a process by which pathogens are intentionally amplified or propagated in order to generate high concentrations, therefore increasing the risk of infection when exposure to them occurs. Please note, this definition does not include cultures intended for diagnostic and clinical purposes.
 Please click icon to download our A3 'Route to Compliance' chart.
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