Magazine
New Label for Times &Temps
Can a symbol curb temperature risk in the distribution supply chain?
By Kevin O'Donnell
“Sixty percent of the total time a package spends in distribution is spent at an airport.” This, according to studies performed by Jean Pierre Emond, Ph.D., and Director for Food Distribution and Retailing at the University of Florida Institute of Food and Agricultural Sciences. Temperature data loggers accompanying shipments of time- and temperature-sensitive healthcare products repeatedly indicate that a package is most vulnerable to exposure to temperature extremes when that package is static. Many temperature studies of the distribution environment conducted by drug manufacturers show that temperature extremes at airports result in 40-55% of all recorded incidents. The airline industry recognizes this gap and has implemented new regulations to improve the process and reduce the risk.
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Beginning July 1st, the International Air Transport Association (IATA) newly revised regulations: Logistics for Time- and Temperature-Sensitive Healthcare Products, otherwise known as IATA Chapter 17 of the Perishable Cargo Regulations, will take effect. The extensive revisions offer a holistic approach to handling and the distribution supply chain, with more practical, more relevant, and clearer requirements than previous editions. The chapter includes the following new sections:
- Quality Management Systems requirements (including exception management)
- Shipper, forwarder, ground handlers/transportation service provider, consignee, and air carrier processes and responsibilities
- Regulatory expectations driving specific handling requirements
- Product storage/handling temperature ranges
- Emphasis on critical control points
- Storage and warehousing requirements (including temperature mapping)
- Training expectations and development
- Introduction of a new Time & Temperature Sensitive Handling Label usage requirement (agreed upon by process stakeholders) to become mandatory after an introductory period of 12 months
The revised Chapter 17 represents the airlines’ proactive effort to improve healthcare product quality through efficient air transport logistics. The Live Animals & Perishables Board (LAPB) within the Cargo Services Committee of IATA is the group responsible for establishing airline regulations pertaining to perishable cargo. The LAPB recognized that healthcare products were at serious risk to potential exposure extremes during this segment of the supply chain after concerns were raised at the World Cargo Symposium in Rome, Italy in March of 2008. As a result, the board established a Time & Temperature Task Force (TTTF), a 12-member cross-industry team of volunteers in May, 2008, mandating that the task force “develop minimum standards for transport and handling of healthcare products,” in an effort to “close the gap” between the rigid requirements of the healthcare industry driven by regulation, while meeting the operational capabilities of IATA’s 230 airline members. The TTTF concluded that the best approach to achieve this goal was to involve as many industry partners in the process as possible: shippers, freight-forwarders, specialty service providers, ground handlers, and air carriers.
“It was the Time & Temperature Sensitive Handling Label issue that was the most contentious aspect and the most difficult to get consensus on during the Chapter 17 revision process,” said Eric Raemdonck, manager of Special Cargo for IATA and secretary of the LAPB. “There was no shortage of spirited debate among the airline carriers and within the healthcare industry in terms of what the label should look like and what, specifically, it should communicate,” he added. “It was determined by all involved that a label alone was not the answer to improved handling of this sensitive, high value freight. It had to be part of a bigger program and it was felt that it should be part of an overall Quality Management System, which is now an extensive part of the new Chapter 17.”
Indeed, there have been countless versions of handling labels used by various drug manufacturers and transportation service providers over the years, but few have ever extended beyond their segment of the distribution process and none bridged across the entire supply chain. There is no consistency in size, shape, color, or verbiage. Some are too detailed, and in many cases multiple labels become confusing — if not contradictory — and are simply ignored. By the time the package reaches its final destination, there might be a dozen or more separate handling labels on the outside.
The first task the TTTF Label Workgroup (lead by Tony Wright, managing director of Exelsius Consultancy in the UK) was faced with was agreement across the supply chain on a single, common label. Once that was achieved, the group had to reach consensus on what the label should communicate and what the requirements should be. For this members of the PDA-PCCIG Label Committee and the USP Shipping Label Workgroup were called in and consulted as were other process stakeholders (freight forwarders, ground handlers, air carriers, and shippers). It was agreed to follow a similar format that dangerous goods (DG) labeling currently uses because it is well understood and recognized within the transportation industry. In addition, the final label recommendation had to meet the following design criteria:
- Must meet a multitude of ground handling and air operational requirements
- Must meet multiple shippers’ needs (drug manufacturers, 3PL’s, wholesalers, etc.)
- Must classify contents as a “perishable” other than flora / fauna
- Must be unique to healthcare products but not allude to contents
- Must be unique in shape and color
- Must contain a simple, universally understood pictorial
- Must be approved by the IATA LAPB
After months of deliberation, feedback and compromise, the TTTF felt confident in presenting the Time & Temperature Sensitive Handling Label to the Live Animals & Perishables Board for review. It was unanimously ratified by the board in March, 2009.
- The final label contains blue printing on a white or contrasting background. It’s overall dimensions are 4”x 4” (10 cm x 10 cm, the same size as DG labels). The pictorial consists of a red triangle (the universal sign of caution) superimposed with a stopwatch and thermometer. “Time & Temperature Sensitive” is printed in English (the official language of IATA) in a contrasting color on a blue bar with arrows on either end to alert the handler.
- A minimum of one label is to be applied on point (similar to DG labels) on the side panel of outermost package.
- The blue hash-marks are also reminiscent of dangerous goods red bordered form Air Way Bills (AWB), conveying a sense of urgency.
- The label indicates handling temperatures, external to the package, not product temperatures, and is applicable to active and passive packaging systems.
- The range of allowable temperatures external to the package must be agreed upon in a Quality Service Agreement (also called a Technical Agreement) between stakeholders.
- The lower half of the label contains an area for applying a specific temperature range by the shipper, provided an agreement between parties and specific instructions are included on the AWB. If no temperature range is added in this space, it is assumed every effort will be made along the supply chain to keep the package between 15° and 30° C.
- The lower half of the label may also be used by any transportation service provider along the supply chain to enter markings to communicate handling procedures unique to their operations.
- Shippers may begin applying the label to the outermost package of any time- and temperature-sensitive healthcare product, human or veterinary, beginning July 1st, 2009.
- The label will become mandatory after July 1st, 2010.
IATA is in the process of developing certified training specific to Chapter 17 of the PCR for the handling of time- and temperature-sensitive healthcare products, which it will offer to any interested parties in the supply chain.
Shippers may opt out and not enter Quality Service Agreements with their service providers or carriers and not use the handling label. But this is in direct opposition to current best practices where regulatory authorities around the globe encourage, and in some cases insist, that quality agreements between parties are in place. This includes the FDA, MHRA, EMEA, Health Canada, and several guidance organizations such as USP, PDA Technical Report #39, and France’s Guide Practique. Additionally, failure to identify shipments as time- and temperature-sensitive healthcare products will put them at unnecessary additional risk to temperature extremes as it will likely be mixed with common freight and any liability claims against transportation service providers as a result of “mishandling” will be difficult to justify.
It is important to keep in mind this is an airline industry initiative; they are subject to their own regulations, capabilities, and limitations, which may not, in all cases, meet certain expectations of the healthcare industry. The goal is to improve the logistics process and deliver the highest quality drug product to patients around the world who rely on them. The airline industry has certainly done its part to help bolster that outcome. Time will tell if the process and the handling label are utilized properly and successfully.
