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The refrigerating packaging market in the United States is continuing its sustained growth. The Food and Drugs Administration, the American controlling body, has strengthened its efforts in terms of regulations. The result is the expansion of highly technical heat insulated packaging solutions!
The US FDA, the American agency for food and drugs, is a US government agency.
Below are a few of its responsibilities:
The FDA publishes over 100 draft texts and guides every year. Level 1 guides explain the new significant requirements, describe major changes in FDA interpretation, and cover complex issues. Level 2 guides cover existing practises or minor changes to regulations.
Recently, the new accent put on room temperature packaging requirements created interest in new forms of drug protection for drugs that previously did not require these types of measure.
Under FDA regulations, the use of temperature controlled packaging has become unavoidable when transporting heat sensitive products. According to the Code of Federal Regulations (CFR) Title 21, Section 211.94 (b): "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product."
For diagnosis samples and infectious materials: "Special packaging (a triple packaging consisting of a primary receptacle, a secondary packaging, and an outer packaging) is required to transport diagnosis samples" (Section 49 CFR part 173.199 and 173.196)
Thanks to its tool-free manufacturing
process, Sofrigam is able to provide solutions compliant with the regulations
applicable anywhere in the world. It is an extremely flexible manufacturing
method. Further, insulated polyurethane
packaging has excellent insulation properties.
Thus, Sofrigam meets the most complex specifications and designs to-measure solutions depending on the pharmaceutical products to transport. All Sofrigam packaging is tested, qualified, and validated by its partner the Ater Métrologie laboratory.