Industry Feeds a Fever Over Cold Chain Regulation

The heightened concern over delivering flu vaccines, especially for the H1N1 virus created a dramatic backdrop to this year’s IQPC Cold Chain Distribution for Pharmaceuticals meeting (Philadelphia, Sept. 21-24). Vaccines—one of the larger-volume temperature-sensitive products of biopharma—will be headline news during this year’s flu season. And, given the host of new issues arising from new transportation regulations, and industry’s redoubling of its efforts to get a better handle on managing the cold chain, it can fairly be said that the cold chain fever has yet to break.

One of the more far-reaching regulatory actions is the issuance of draft guidelines from the US Transportation Security Agency for how air cargo carriers are going to meet the requirement of 100% inspection of all cargo (not just pharmaceuticals) being conveyed on passenger aircraft by August 2010. TSA rules specify that unless a method of pre-qualifying cargo is established, it will be required to open packages before they can be loaded. For the carefully engineered and prepared packaging of temperature-sensitive products, the results could be disastrous. A potentially attractive (and potentially essential) alternative: participating in TSA’s Certified Cargo Screening Facility (CCSP) program, which would allow for cargo to be certified before it arrives at the airport.

TSA rules aren’t the only ones to worry about: Health Canada, the regulatory agency of that country, has issued draft updates to its shipping standard (GUI-0069); a public comment period will be open until early November. Among the rules under consideration are one of the first governmental guidelines to ensure the safe shipping of “ambient” (room temperature) products.

Meanwhile, Rafik Bishara, chairman of the Pharmaceutical Cold Chain Interest Group (PCCIG; operating under the aegis of the Parenteral Drug Assn.) reported that the group approved, in late August, a set of proposed revisions to the the PDA Technical Report No. 39, defining “good distribution practices” (GDPs), and setting the table for a next round of revisions and updates, including rules for powered (“active”) aircraft shipping containers.

Cold chain equipment and service vendors, ranging from the international air carriers to producers of pre-qualified shipping containers, data loggers, insulation materials and the like, are responding to the heightened industry interest with a growing array of offerings. American Air Cargo has joined FedEx Custom Critical, UPS and other carriers with dedicated healthcare cargo management; Delta is working on the same thing and will attempt to include members of its SkyTeam alliance (which brings together Delta Cargo together with a dozen or so international carriers). Continental Air Cargo has solidified its Puerto Rico-to-US carrier lane with contractual arrangements for shipping and storage. UPS, which formally opened a new facility in Puerto Rico earlier this year, included cold chain storage in the layout of the facility.

Tighter temperature ranges

As related by Dave Ulrich, QA director at Abbott Laboratories, last year Mexican health authorities rejected shipments from the US because there was a difference between the stated acceptable temperature range of the product, and the conditions under which it was shipped. Allowing for temporary excursions has normally been a part of cold-chain shipping; now, the Mexican authorities were challenging the industry to either tighten their shipping procedures, or to validate acceptable levels of excursions.

FIG. 2. IATA'S PROPOSED 'BLUE LABEL'

Based on presentations at the Cold Chain meeting, pharma companies and their logistics providers are taking several courses of action. One is simply to perform more in-transit temperature monitoring (and there is talk of making all shipments have monitoring). In a presentation by Eli Lilly, a process of performing a risk-based “distribution temperature profile” was detailed; by scoring various levels of risk, the shipper can determine an acceptable level of excursion from a product’s specified temperature range. In a similar vein, Johnson & Johnson has used FMEA (failure modes evaluation and analysis) techniques to evaluate the reliability of using active shipping containers (which contain powered heating/cooling equipment, as opposed to “passive” combinations of insulation and dry ice or other chilling agent).

More ULD choices

The J&J testing was to validate use of the aircraft-ready containers of Envirotainer (Lagga Marma, Sweden), which was the first on the market with such a “unit load device” (ULD) several years ago. Envirotainer has developed a certification program, called QEP, for air carriers and 3PLs using its equipment; Continental and American Airlines are among the US carriers that have won this certification. Envirotainer is now competing with AcuTemp, which came out with its ULD last year, and a new entrant, a combination of two Ohio companies, Farrar Scientific (Marietta) and ULD Logistics (Delta), which have designed a ULD called the PharmaPort 360.

Similar rigor is being applied to the design of shipping containers, whether ULDs or simply cardboard boxes with insulation and coolant. Working with Cold Chain Technologies (Holliston, MA), which has thermal testing laboratories for qualifying shipping containers, Wyeth has developed a method of modeling container performance based on the physical composition and dimensions of both the container and its contents; this testing can be used to narrow the range of testing conditions for ultimate shipment validation.

Suppliers of containers and insulation materials are butting heads with each other over the environmental consequences of their material choices. On the one hand, vendors like Entropy (Minneapolis) tout the low environmental impact of their nonorganic phase-change cooling materials and recycled-plastic content. On the other, Tegrant’s Thermocare business unit (Arlington Heights, IL) emphasizes the recyclability of its expanded polystyrene (EPS) insulation. Meanwhile, AcuTemp, which uses high-R-value vacuum insulation, promotes the retesting and reuse of its containers for multiple shipments.

Dealing with the related issue of electronics disposal, temperature-sensor maker Sensitech (Beverly, MA) now offers to recycle its disposable sensors; other vendors, such as American Thermal Instruments (Dayton) tout the reusability of their RFID-based temperature tags. At the very least, it can be said that the packaging materials vendors are offering a growing range of options to industry.