Introduction to Regulatory Products Packaging

Introduction to Regulatory Products Packaging

According to the most recent issue, U.S. Government and international air carrier regulations have undergone substantial changes regarding transport of infectious substances, diagnostic and clinical specimens, and biological products.

These materials are now assigned to one of two Categories (A or B).  For substances assigned to Category B, including diagnostic and clinical specimens, the proper shipping name is now called Biological Substance, Category B (UN3373). There have also been important changes in the requirements for use of dry ice and other refrigerants. As before, the classification determines the packaging requirements for the material; and it is the consignor’s responsibility to classify and provide proper packaging for all Division 6.2 materials.

* Because so many Division 6.2 materials are shipped by air, the products in this catalog are designed to meet the more stringent Dangerous Goods Regulations of the International Air Transport Association (IATA).  

For infectious substances assigned to Category A, we have certified packages that comply with 49 CFR, Part 173.196 and IATA Packing Instruction 602. According to IATA Packing Instruction 602, primary and secondary receptacles must be tested to withstand an internal pressure without leakage. 

For biological substances assigned to Category B, the products here are certified in compliance with 49 CFR, Part 173.199 and IATA Packing Instruction 650. IATA Packing Instruction 650 states the completed package must be capable of successfully passing the drop test described in 6.6.1.

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