While the internationally recognized modal regulations had for many years required the use of specification packagings trhat met rigourous design and/or performance criteria, in the U.S,. the domestic requirement to physically mark the certification on the packaging was implemented on January 1st, 1995 for calss 6.2 (infectious) substances. The medical research community was not prepared, and shipments of research sopecimens ceased. At issue was the U.S. requirement for a secondary packaging having the capability to maintain a 95 kPa internal pressure. A new commercially-produced calss 6.2 packagings were on the market, but none of the packagings could be used for the 81-cell freezer box. The foundation of medical research studies is the arrangement of speciments in a very specific order in the boxes. Face cell in the box defines meaningful research data. The order cannot be tampered with. The vials should not be removed from the oxces. Therefore, it was necessary to start at the beginning and design a 6.2 certified packaging for use with the 81-cell freezer box.
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