Overlapping, Imprecise Regulations Cause a Hiccup In Temperature-Sensitive Pharma Shipping

An awkward restriction on temperature monitors for cold-chain shipping was averted in the past month by some fast memo-writing by Sensitech (Beverly, MA), a leading manufacturer of such monitors. But overall, while the immediate problem has been alleviated, the situation points to the complex regulatory systems that affect such shipping.

The hitch developed when Delta Air Cargo issued a letter prohibiting the presence of lithium batteries in cargo it handles—specifically, data loggers—saying that “the use of such devices containing any amount of lithium must be approved before being carried aboard passenger flights” and citing regulations from the Dept. of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA). Those regulations (CFR Parts 172, 173 and 175) were issued in August 2007, and came about because of the real concern over the fire hazards represented by lithium technology in, for example, computer batteries. Nested within the PHMSA guidance is reference to Special Provision (SP) 188 of a UN expert committee. The PHMSA guidance (itself years in the making) is clear on bulk shipments of such batteries, but less so on cases where the batteries are a small component of an electronic device. Delta took a very conservative interpretation in imposing its ban.

In-transit monitoring

Temperature monitors themselves are not a required GMP component of shipping temperature-sensitive pharmaceuticals, but many manufacturers do such monitoring as a quality assurance step. If the Delta ban were to be broadly imposed, manufacturers would need to look to alternative technology, or forgo temperature monitoring altogether. Henry Ames, director of strategic marketing at Sensitech, obtained an opinion from PHMSA that “these devices qualify for the exceptions provided for small lithium batteries under SP 188.” After this information was communicated to Delta, the company issued a letter allowing Sensitech monitors to be used. Delta says that its “engineering department has worked closely with Sensitech and the FAA to ensure the monitors meet all requirements and can be safely utilized in flight.”

There are still questions regarding electromagnetic interference to be resolved with the temperature monitors, for which testing results are due to DOT by next autumn. And DOT and the UN are not the only agencies involved with safe delivery of temperature-sensitive pharmaceuticals; over the past year, a Time and Temperature Task Force has been organized by the International Air Transport Assn. to update its Perishable Cargo Regulations (Chap. 17) guidelines. FDA looks to US Pharmacopeia (USP) for its General Guidance Chapter 1079, and to the Parenteral Drug Assn. for its Technical Report No. 39. All of which points to the need for competent service providers in shipping services as well as packaging components. PC