For 11 years running, IQPC has successfully presented the most comprehensive and largest networking conference related to temperature management in the Life Science industry. It hosts similar conferences throughout the world but the U.S. conference has always been the signature event. This year’s mega-conference — by cold chain standards — was held the first week of October at Chicago’s massive McCormick Place Convention Center.

Owing considerably to IQPC’s expertise in marketing the event and to Chicago’s favorable reputation, weather and amenities, attendance was up 15% over the previous year, with 726 delegates converging from 24 countries, along with 75 exhibitors plying their wares and flexing their marketing muscles. To see and be seen has long been a significant part of this show — especially for product and service providers. Their development cycles have collectively aligned, marking September’s rollout a priority to meet the needs, demands and project budgets of customers for the upcoming year. With tongue firmly planted in cheek, I’d say the U.S. Global Forum has become to temperature management what Cannes is to film, and the Detroit Auto Show is to the car industry.

A few years ago, I began visiting with each of the exhibitors in search of the most innovative solutions and technologies related to storage, transport and logistics practices of time- and temperature-sensitive drugs, to report on them for Contract Pharma. In keeping with that “tradition,” here are four examples of temperature-control innovation that I believe have the potential to move the entire industry forward.

And I need to insert my usual disclaimer here: that review of these products does not constitute a personal endorsement by any means, and I have not received any compensation from these companies for writing about them.

# 4: Stratta™ Composite Shipper
Company: ThermoSafe Brands
Since ThermoSafe Brands was sold to the global packaging giant Sonoco around two years ago, it has been able to pour more time and resources into new product development. Above and beyond its many new offerings that can be categorized as “variations on a theme,” comes the first truly composite insulated molded container — two separate technologies, vacuum-insulated panels and expanded polystyrene, fused together to form one piece. Others have integrated the two by separately placing VIP liners inside EPS-molded tubs or cut panel boxes, but ThermoSafe Brands has developed a unique, patented process for embedding ½” VIP into the 2” molded EPS walls, lid and base, resulting in a super-high-performance container with an astounding R value of approximately 30. The benefits of this are that it combines the high R value of VIP with the durability and lightweight of the EPS by using less of both materials than traditional packages, and yielding smaller overall dimensions, increased interior product capacity because less refrigerant is required, and an overall DIM weight comparable to actual weight — a critical cost consideration when shipping — and the holy grail in insulated package design.

The EPS provides puncture protection to the VIPs and the 2” composite provides for a higher insulating value (and lighter weight) than a comparably thick PUR or 1” VIP panels used alone. The cost is relative to a PUR container of comparable size.

#3: CRYO-Q Vial Rack
Company: SAVSU Technologies
For the third year in a row, SAVSU, the esoteric little company out of Santa Fe, NM, has made my list for ingeniously and elegantly solving an elusive problem associated with frozen transport packaging. At first blush, one might just bury the product one wants to keep frozen in dry ice. And to a certain extent, that would work. But while most packaging companies focus on bigger and bigger designs to meet increases in shipping volumes, SAVSU thinks small.

In the rapidly expanding world of nanotechnology, scientists have come to discover that exposure to a stable frozen temperature profile is not only essential to cryo preservation but to cell viability and colony yield. Depending on the biotechnology cell types, strict freezing and thawing protocols must be adhered to in order to minimize crystallization and to keep the cells suspended — but alive. In many instances, simply burying the cells in dry ice during transit is no longer acceptable and often causes damage or death to the suspended cells due to uncontrolled cycles of freezing temperatures ranging anywhere from zero to -78° C, depending on the product’s proximity to the dry ice.

Another problem is finding and uncovering these small samples inside the package and not damaging them during removal. The primary containers for these rarified biological drug components are often specimen vials containing only a few milliliters of cutting-edge science. As mentioned last year, an age-old nuisance with shipping products in dry ice has been keeping the product temperature stable and securely in place as the sublimating dry ice produces an ever-increasing void within the container. SAVSU has expanded its engineered designs to this vexing problem in its typically elegant fashion. On display this year were standard-sized vial racks that are inserted and locked into place within the container by means of a copper-anodized aluminum retainer that has two fins extending to the internal corners of the insulated container. Aluminum is a great conductor allowing for the contents of the package to remain at a constant -78°C, even if 85% of the dry ice has sublimated. With as little as one kilo of dry ice pellets, the specimens will remain at a controlled -78° C for as long as three days of transport under typical environmental conditions. The dry ice pellets remain in constant contact with the aluminum fins regardless of package orientation, in that they extend the length and depth of the insulated container and envelop the inserted vial rack containing the product on all six sides. Conduction does the rest and there is never a transition or change in frozen temperature. The reusable vial rack can be retrieved instantly upon opening the patented container design.

#2: Real-time Remote Monitoring System For Stationary and Mobile Assets
Company: Infitrak
This may sound like a familiar practice, but actually it’s not. There are several companies that offer piecemeal or partial solutions but Infitrak’s new realtime monitoring is sold as the only comprehensive turnkey monitoring and data collection solution validated to ISPE GAMP 5 and 21 CRF Part 11-compliant. Its tracking systems and intelligent sensors utilize handshake protocols for two-way communication via multiple wifi frequencies (including a proprietary frequency) and 900 and 1400 MHz, or through any number of cellular frequencies, all seamlessly integrated onto one backbone. Customers do not have to deal with purchasing software or integrating separate systems. All data is centrally located and maintained by Infitrak. Hardware (the intelligent sensors) is also fully calibrated and maintained by the company.

In addition to monitoring and logging temperature data, the system is capable of monitoring for humidity, light, CO2, pressure, air flow, shock, vibration, motion, load (weight), liquid level (for nitrogen tanks), power consumption, and flood sensing. Their fully scalable systems are capable of mapping and monitoring stationary assets i.e., rooms, refrigerators, freezers, and warehouses. In real-time. Wirelessly, or hardwired. Mobile assets, such as fleet trucks, vans or other vehicles (and soon sea containers) contain realtime geolocation tracking via GPS and have the same realtime data-logging and other appropriate monitoring capabilities as the stationary assets but in addition include reefer unit runtime information, payload door status, complete route history for 24 months (plus unlimited archived routing) and — coming in 2014 — geofencing.

I went along on a test drive of the web-based system for a test drive during the conference and found it remarkably intuitive, flexible and fun! Alarm notifications are easily customizable for tiered alerts and responses, and the system can monitor multiple sites, facilities or fleets — all from one login. Reports and analytics are also customizable and can be printed on demand or automated to taste and provided by Infitrak in encrypted PDF.

#1: Thermostable 770C Air Transport Container
Company: SkyCell AG
As in previous years, there was a plethora of passive packaging companies exhibiting at the conference, offering solutions with minimal differentiation. So it was refreshing to see a new Swiss entrant into this segment with some new concepts beyond that of a poser or just another pretty face.

SkyCell’s air-worthy “thermostable” pallet container was designed not simply to improve on today’s existing solutions, but to create a new generation of container and services that redefine temperature stability, reliability and sustainability. This Swiss-chic container is built exclusively for the pharma supply chain. It will accommodate a pre-assembled europallet of goods (800mm x 1200 mm). Its reinforced 16mm outer shell panels are made of robust and lightweight recyclable PET and the geometric relief of the surface reflects up to 96% of radiant heat. The unit maintains a uniform temperature by combining non-hazardous PCM (phasing at 6° C) integrated into the walls, lid and floor with virtually no temperature stratification internally, and a dense, proprietary honeycomb-structured thermal isolation material incorporating nanotechnology and laminated metals. The 2mm inner shell helps to reciprocate the heat exchange within the container. It’s beefy with a tare weight of 270 kg (about that of an active RKN container but with a smaller footprint) and an astounding product-to-packaging ratio of 44%.

The SkyCell 770C is a rented passive unit intended for use in challenging destinations such as the BRIC countries, the Middle East, and Africa. The manufacturer handles all the logistics for use of the container, delivering it to the shipper pre-conditioned by storing it for two days at -20° C. The PCM allows for recharging during use without risk of freezing. So if the unit is placed inside a refrigerator at 5° C during transit, or in a refrigerated truck, greater longevity can be attained. The network of containers is currently 200 but the company states that there will be more than 1,000 units by the end of 2013, and 2,000 by the end of 2014. It has been nominated for the GS-1 Swiss Logistics Award for 2013.

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Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy – U.S. He is the former chair for the International Air Transport Association (IATA) Time & Temperature Task Force, a member of the USP Expert Committee on Packaging, Storage and Distribution, a temporary advisor and certified mentor to the World Health Organization (WHO), co-author of PDA Technical Report No. 39, and a member of the International Safe Transit Association (ISTA) Thermal Council. He blogs at www.clutchcargo.us. He can be reached at kevin.odonnell@exelsius.us.