The annual IQPC Cold Chain Temperature Management Global Forum has become the Detroit Auto Show of the Pharmaceutical Cold Chain industry. This past September, a record 611 delegates attended and 73 exhibitors filled 21,480 sq. ft. of the Pennsylvania Convention Center in downtown Philadelphia to roll out their latest and greatest, with everything from containers to consultative services, to a clamoring and curious pharmaceutical industry. The variety of products and services has never been greater. The level of competition has also never been tougher, as the needs of both the industry and the solution providers have grown exponentially in recent years.    

I enthusiastically believe that 2011 will be looked back upon as a breakout year for technologies, benchmarks and trends specific to the storage, transport and logistics practices of time and temperature-sensitive drugs. In this column, I’ll offer five examples to support that belief.

Before we get on with it, I have to mention the following: Throughout my career I have carefully avoided promoting or endorsing the many fine products and services employed for maintaining drug product quality from manufacturer to the end user. Instead, I have worked diligently to promote good practices throughout the supply chain – holding fast to the adage that a rising tide raises all boats. So, in the interest of full disclosure, let me state that the mention of the products and services and the companies who provide them, does not constitute a personal endorsement by any means, and I have not received any form of compensation from anyone for writing about them. When taken in the proper context, I believe each of these new technologies and solutions — all of which had their debut at the IQPC Cold Chain Management Global Forum — has the potential to propel the entire industry forward.

American Thermal Instruments – LOG-IC NFC Mobile Data Logger

Just a few years ago the data-logging industry was transformed by incorporating USB technology into electronic data-monitoring devices, providing greater accessibility and making proprietary “read” software unnecessary and virtually obsolete. American Thermal Instruments (ATI) has gone a step further: taking the traditional temperature data logger and combining it with the power of today’s smartphones. This is currently done by following a Near Field Communication (NFC) protocol — similar to the phone apps that are beginning to supplant credit cards — that allows data to be transferred securely over a short distance (max. six inches) without the need for direct contact – such as USB plug-in, cable interface, magnetic strips or infrared transmission. This specific application allows anyone within a network to read, upload, transfer and analyze temperature data and produce 21CFR-compliant reports using a common smartphone. This ability only exists on the NFC platform. And while many of the new smartphones already have this capability built-in, some (like the iPhone and Blackberry) do not yet. Others can be converted. Beginning in January 2012, ATI plans on incorporating Bluetooth technology, opening up accessibility to nearly all phone manufacturers and extending the reading range to 300 feet line-of-site, which ATI claims will have the capability of reading single or multiple boxes, an entire pallet, a truckload or a warehouse.

This technology carries with it the promise of countless advantages for data logging, including realtime temperature monitoring allowing for the mobilization of data throughout a workforce. It acts as an all-in-one scanner, reader and decision support tool. No other hardware or additional infrastructure is needed. The data can be transmitted via cell signal to just about anywhere in the world. The open platform of the data allows users immediate information and access from numerous points in the supply chain without opening the package or compromising the integrity of a temperature-controlled shipment. Some or all of that data can be shared with appropriate parties with no extra steps and intervening actions can be taken if necessary. The single- or multiple-use programmable data loggers are comparatively low-cost, small (about the size of a matchbook), resilient (encased in clear, pliable, Nema 6 waterproof food grade barrier film) and also contain red/green LCD status and alarm visual cues. One drawback: they cannot scan through metal. To address this, ATI has developed the Ribbon Probe version of their LOG-IC tag whereby a probe sits inside the payload while the device sits outside. No doubt more elegant solutions will evolve.

NFC technology is only in its infancy. It will soon forever change our daily lives and along with it, the industry’s approach to data logging and monitoring.

American Airlines – Expedite TC

Five years ago there were only a handful of air carriers offering specialized product and logistics services specifically for the pharmaceutical industry. Today there are more than 30. They are not all are created equal. In the three years since aggressively marketing its Expedite Temperature Control product, American Airlines (AA) has been consistent in making its presence known to the pharma industry. AA continuously staffs its splashy exhibits at cold chain conferences with members of senior management from the cargo division and eagerly accepts offers to present or sit on open track discussion panels – often before a somewhat hostile audience.

On September 1, AA expanded its Expedite TC offering. Along with the Expedite TC Active service — which has earned Envirotainer’s Qualified Envirotainer Provider (QEP) accredidation at more than 59 locations worldwide — AA announced it is pursuing additional active container solutions and simultaneously launched its Expedite TC Passive for single, small parcel and pallet-sized passive shipments.

These dedicated services are intended to de-mystify the “black hole” in visibility that the pharmaceutical industry often has of airlines. To that end, American Airlines premiered a 10-minute video at the conference of how temperature-sensitive healthcare cargo moves through its system. Presented as two case studies — one an active shipment, the other passive — the video, with its “in a perfect world” scenario, clearly demonstrates AA’s commitment to processes, procedures and training with high-visibility logistics, validated controlled room temperature storage facilities and extensive training to employees. AA has made a considerable financial investment to beef-up its facilities at five major U.S. hubs, has installed 10 mapped and validated climate controlled (CRT) rooms with more on the way, expanded its training and communications network, offers a 100% flown-as-booked guarantee, and to date has rolled-out Expedite TC at more than 100 world-wide locations. While other airlines talk about their abilities, American Airlines walks the talk.

Cool Containers / UPS

To call the PharmaPort 360 pallet-sized container an “active system” would be a misnomer. It’s more of a portable 5°C storage container. An incarnation of this container designed and built by Cool Containers and distributed by ULD Logistics has been around for a few years. But at the IQPC show, UPS unveiled its exclusive use version of the container designed and tested to meet its specifications and to fit into the UPS integrated transportation fleet. Unlike a traditional active container that uses dry ice and operates on AC and/or DC power to heat or cool the internal payload area, the UPS PharmaPort 360 uses AC only, which “charges” the heating/cooling system while at rest (such as in a warehouse or between transits on a dock). Once charged, the system maintains autonomy for as long as 100 hours (depending on ambient conditions) during transportation events by truck or air, using no external power until it is recharged or delivered to the consignee. (This made FAA approval far less of an issue than other active systems containing compressors and heating elements).

Its rectangular design offers some advantages over trapezoidal-shaped ULDs as well. It can fit into UPS’ entire fleet of aircraft and all narrow-bodied commercial aircraft. Two containers fill a wide-body “cookie sheet.” Since there is no active cooling or heating during flight, it does not emit heat, noise or vapors and can be stored on main deck as well as lower deck, opening up more flight and lane options. The units also fit nicely into UPS’ fleet of trucks for last mile delivery to the consignee. They have a sophisticated array of monitoring including FAA-approved global GPS, battery status levels (used to power the internal circulating fans), mobile monitoring, temperature data logging with reserve temperature conditioning capacity, and deviation from set-point temperature.

One potential drawback: the only temperature set-point available on the unit is 5°C — but I’ve seen the test data and it holds temperature reliably well against ISTA 7D profiles and surpasses the minimal time requirement for the World Health Organization’s Performance Quality System test for autonomous hold temperature. This unit, in conjunction with UPS’ global logistics network, may be just what each other needs to make headway in this competitive market space.

Panther Life Science Logistics – Good Distribution Practices Guidebook

Panther Life Science Logistics has taken aim at addressing client concerns over the consistently changing regulations surrounding the transport of pharmaceutical, biotechnology and medical device shipments. As we know, company-specific good distribution practices can provide excellent support to those with the intent to ship healthcare material, by helping to streamline the exchange of information needed to build the valued partnership required for a secure and successful supply chain.

While many companies claim to offer the sophistication and expertise necessary to manage these important shipments, Panther Life Science Logistics has backed it up with a 31-page guidebook called Life Sciences – Good Distribution Practices. The book is available to anyone. While the competition might view this as a “pulling back the curtain” marketing ploy, it provides shippers of time-critical and temperature-sensitive cargo much-needed transparency in an otherwise complex, rapidly changing and often convoluted industry.

The publication is essentially an overview of Panther’s Validation Master Plan and provides a detailed look at how the company ensures the integrity of the product from the time it takes custody until delivery. It leans heavily on USP General Chapter Good Storage and Shipping Practices and PDA Technical Report #39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, for the coverage of the content — and that’s a good thing. While the book does not contain any groundbreaking processes and procedures, it is clearly and concisely written as a quality manual and as guidance for current and prospective clients. And the handbook serves a dual purpose, as a training tool for both operators and supply chain partners. To the critics who claim that this process is already standard or routine practice within their own organizations, all I can say is — show me your guidebook.

SAVSU – Vaccine Transport/Long-term Storage System

This little entrepreneurial company located in Santa Fe, NM sought to challenge a single, elusive problem: design a reusable passive 2-8°C combination transport/long-term storage system to improve global immunization programs by eliminating loss of vaccines due to thermal damage. It unveiled its solution 28 months later: an entirely new concept in insulated packaging. The elegant container reflects SAVSU’s corporate mission — “technology for delivering global health” — and it is a magnificent marriage of rugged construction, simplicity in design, ease of use and unprecedented thermal performance.

The first thing that caught my attention of the model I saw at the conference (Model 14/6, one of six configurations the company markets) was its geometry. All models have the same basic architecture, just different sizes. The molded polyethylene container has an octagonal exterior with a round, cylindrical interior. The benefit: it’s more efficient in both performance and payload capacity than a square or rectangular design. The design team also took a fresh look at the use of insulation material. The 2.5” walls contain a Nano porous material (like that used in vacuum panel insulation) but it is not vacuum encapsulated like traditional panels. This provides excellent resistance to heat flow and ensures reliability. Vacuum encapsulated materials lose their insulation capability if punctured, breached or damaged. The container has all recessed external hardware and integrated, state-of-the-art electronic monitoring equipment that records temperature, shock, vibration, tilt, and security (opening).

The entire system consists of just four pieces: the outer transport/storage container, two 5-liter refrigerant canisters and one payload canister. The entire unit assembles in 30 seconds.

But for all of its features, the most remarkable is its thermal performance. This passive system delivers 10 days of continuous 2-8°C storage against a constant 32°C ambient temperature — even longer under “more normal” conditions.

This exceptional thermal performance is attained by use of two polyethylene cylindrical “drums” with screw-top lids that are each filled with 5 liters of water (any source of fresh water will do) and frozen in a standard freezer (-10° C to – 20° C) for 48 hours. The 6-liter payload container, which is red in color and labeled to distinguish it from the ice drums, also has an integrated thermal buffer built into the top and bottom virtually eliminating accidental or inadvertent freezing from conduction. The Payload to Packaging Ratio (PPR) is about 19%, which is super-efficient for a water-based passive system.

One-quarter of the world’s population has no access at all to electricity. Think of the advantages a container such as this can have on developing nations, underserved regions and remote locations of the world.

Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.coolerheadsblog.com. He can be reached at kevin.odonnell@exelsius.us.