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Monday, 27 April 2020

REQUIREMENTS FOR PACKAGING HAZARDOUS BIOLOGICAL MATERIALS

Patient specimens included in "Biological Substance, Category B" must be treated as UN3373, when they are transported for diagnostic or investigative purposes.

All specimens must be packaged to prevent damage and spills. The system used is to use three layers (Three Layer Packaging) in accordance with guidelines from WHO and the International Air Transport Association (IATA).

When a package of infectious material (containing harmful viruses or bacteria) is moved between the place of origin, the cargo transport unit, the warehouse and its destination, the package may encounter various challenges, including movement, vibration, changes in temperature, humidity, and pressure. Therefore it is important to use strong packaging to protect infectious material during transportation. The packaging must be of good quality and strong enough to withstand various challenges during shipping.

Therefore, materials containing infectious agents must follow a three-layer packaging system, in which the packaging layer is strong and the containment material is sufficient so that it can be used to anticipate leaks and ensure safety.

A three-layer packaging system with more specific and detailed requirements is needed for infectious materials classified as Category A, Category B, or medical or clinical waste according to UN 3291. These additional requirements ensure safe supervision in various modes of transportation, and help stakeholders the importance of being able to ensure that the packaging materials used have the appropriate strength and quality. Further specifications for a three-layer packaging system may also be needed if there are other dangerous goods (eg when dry ice is used as a cooler). The UN model regulations, as well as other capital agreements, provide information sheets outlining detailed packaging requirements for various classifications and sub-classifications of dangerous goods. These instruction sheets are generally referred to as "packing instructions", and three of them may apply to the transmission of infectious material.

BASIC THREE LAYER PACKAGING SYSTEMS
As the name suggests, a three-pack system used to contain infectious substances must consist of three layers:
• Main container;
• The second container must be waterproof and leak-proof and can wrap and protect the main container; and
• The third container is used to protect secondary packaging from physical damage while traveling.

FIRST CONTAINER
The first container or main container, which contains an infectious material, must be waterproof, and not penetrated by the material inside; that is, it must be leak-proof if the material is liquid or strong if the substance is solid. The main container must be labeled according to its contents. The main container should not be punctured, damaged, weakened or come into contact with infectious substances. For example, primary containers may not be corroded by preservative media used for patient specimen media. If the infectious material is liquid or semi-liquid, the main container must be wrapped with enough absorbent material to absorb all the liquid in the event of damage or leakage.

SECOND CONTAINER
The second container must be waterproof and leak-proof and strong, can be used to wrap and protect the main container, and its absorbent material. Multiple primary containers can be placed in a single secondary package, as long as they contain infectious material of the same class. If the primary container is fragile, each must be wrapped and placed in a secondary package separately, or in a way that prevents contact between the samples. Bearing material may be needed to secure the primary container in the secondary packaging.

THIRD CONTAINER
The third container, outer packaging is used to protect secondary packaging from physical damage while traveling. Therefore, this layer must have the appropriate strength for the weight, size and composition of the package inside, to ensure that the package is protected. The smallest external dimension must be at least 100 mm. Specimen data forms, letters, supplementary documentation and other types of information that identify or explain infectious material must be placed between the secondary packaging and the outer layer of the packaging. If necessary, these documents can be attached to the secondary pack

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