Best of Show: A Look at Breakthrough Technologies in Pharmaceutical Cold Chain for 2012

Last year at this time I enthusiastically predicted that 2011 would be looked back upon as a breakout year for innovation and technologies, related to storage, transport and logistics practices of time- and temperature-sensitive drugs. I came to this conclusion after walking the annual IQPC Cold Chain & Temperature Management Global Forum in Philadelphia – the perennial industry event where service providers roll out their latest and greatest. Early indications suggest my prediction was correct.

IQPC moved its annual September event to Chicago for 2012. And while the new location and venue were generally well received, there really wasn’t much that was new or innovative from the growing number of exhibitors. I scoured the cavernous exhibit hall at McCormick Place, with its fantastic panoramic views overlooking a placid Lake Michigan. (Overheard by one woman in attendance: "what a nice view of the ocean.") I was hoping to find a handful of new or innovative products or services as a follow-up to last year’s column, Changing the Face of Cold Chain Management: Five New Advances in Technology (Contract Pharma, Nov./Dec. 2011).
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I struggled to find four.

Moving the event to Chicago from Philadelphia drew a positive reaction from most people I spoke with. After nine years in Philly, most people thought the change of scenery was a good idea, and Chicago didn’t disappoint. It is a splendid city, centrally located and easy to get to, and the weather was spectacular (as is generally the case in September). I heard some complaints that the venue was too large and the eight-minute walk to the exhibit hall and conference space from the adjoining hotel was a bit inconvenient. Also, McCormick Place is located away from the city center and caused many exhibitors to choose hotels downtown for their stay and to host their receptions. Nevertheless, the event by all measures was a resounding success. There were 633 attendees (up 25% from 2011), delegates from 60 new companies and a record 76 exhibitors. The Cold Chain & Temperature Management Global Forum continues to be the world’s largest temperature management life sciences event, successfully bringing together hundreds of high-level stakeholders, industry leaders and key influencers, and provides an excellent platform to network, share valuable knowledge and tap into expertise. The event seems to be losing a degree of intimacy and represents more of a show and less of a conference. The three-day agenda in the Show Guide looked like a menu at a classic Chicago Greek diner, page after page of so many choices and a little something for everyone, bookended by breakfast briefings and cocktail receptions.

So what’s really new this year? Well, they were difficult to find, but here are four examples of temperature control innovation that I believe have the potential to move the entire industry forward. And I need to mention that review of these products does not constitute a personal endorsement by any means and I have not received any form of compensation from anyone for writing about them.

SAVSU Cryo Q Container

Savsu Cryo Q

With a bewildering amount of passive packaging companies touting minimally different solutions (there were 22 such manufacturers in the exhibit hall), it was refreshing to see SAVSU, the entrepreneurial company from Santa Fe, NM, expand its product line with several elegant and unique package offerings. As a follow-up to its debut launch of the Vaccine Transport/Long-term Storage System (reviewed in last year’s article), this company has rolled out a new and ingenious carrier for small payload dry ice shipments for use in such areas as the rapidly expanding bio-repository samples market and for laboratory/diagnostic specimen transport.

The age-old problem with shipping products in dry ice is keeping the product temperature stable and securely in place as the sublimating dry ice produces an ever-increasing void within the container. SAVSU has conquered this vexing problem in its typical elegant fashion. Shipments of various standard size specimen containers are locked in place within the container by means of an aluminum retainer that has four fins extending to the edges of the internal insulated container. Using aluminum instead of a traditional corrugated retainer allows for the contents of the package to remain at a constant -78°C regardless of orientation, even if 85% of the dry ice has sublimated. The dry ice pellets remain in contact with the aluminum fins that extend all the way to the bottom of the insulated container and surround the product on four sides. Conduction does the rest.

SAVSU’s proprietary patent pending technology delivers unparalleled insulating performance, without the risks associated with vacuum panel failures. The smallest of three sizes of Cryo Q containers holds one kilo of dry ice and will remain at -78°C for more than three days, under typical shipping conditions. This significantly reduces the risk or the need for costly replenishment of dry ice by a 3PL en route to its destination, which, depending on the size of the package, generally runs several hundred dollars to a few thousand dollars per package! For domestic shipments, shippers can safely ship over the weekend or opt for money-saving second-day delivery. This reusable system is ideal for well-controlled closed loop systems, such as between testing labs and sample collection sites.

MOOG Shipment Identification, Location and Condition Monitor
Engineers at Crossbow have developed the first multi-modal sensor information-sharing platform that is fully FAA compliant. This wallet-sized integrated monitoring device contains GSM/GPRS/GPS tracking capability with near-real-time communication for air cargo, truck & trailer fleets, and rail or ocean containers. The suite of sensors within the device allows for location tracking, recovery and environmental sensing of high-value assets, like drug shipments, over a web-based platform while in-transit. The MOOG device (Model ILC2000) monitors temperature and humidity and can send alerts between trusted parties. It also has full downloading reporting capabilities. The automatic radio frequency transmission contains an "aircraft mode," a suppression system that shuts the device off during air transit and turns it back on again automatically and begins transmitting all recorded and stored data during flight seconds after landing. It also contains a tri-axial recorder for shock/fall detection and a light sensor (for tampering). It is equipped with a barometer for recording pressure and contains a gyro for tilt and axis orientation. The device is made by MOOG, which purchased Crossbow about 18 months ago. MOOG is also behind the design and manufacture of a similar unit, SenseAware, branded specifically for FedEx.

Berlinger Q Tag CLm doc
This is not just another data logger. The Swiss company, Berlinger AG, refers to their device as an Electronic Data Integrator. Ever the country for greater precision and accuracy, Swiss engineers are clever fellows and the team behind the Q Tag CLm doc, took an entirely new approach to electronic data logging and monitoring, creating a powerful tool that adapts to the user rather than compelling the user to adapt to the device.

One limitation of nearly all electronic data-logging monitors (EDLMs) is the pre-programmed time interval between temperature observations. This time interval — or the device’s ability to capture data, is dependent on two things: the size of the memory and duration of the observation time. Nearly all EDLMs used within the pharmaceutical industry today contain a 2K memory chip capable of storing 1,920 data points. Larger memory chips are available, but costly and not widely used. To overcome the limits of memory, the industry acquiesces to longer time intervals between temperature observations. Typically, EDLM’s used in the pharmaceutical industry are pre-programmed to record data at intervals every 10 to 15 minutes (four to six readings per hour). The Q Tag CLm doc records temperature every minute.

The fickle pharmaceutical market demands that monitoring devices do more, for less cost. Berlinger appears to have answered that challenge.

The Q Tag CLm doc uses a silicon-based thermal sensor rather than a thermistor for quicker response time. Silicon-based temperature sensors are decidedly more stable over a wider range of temperatures and for a longer period of time then standard NTC sensors widely used in the industry today. Combined with the solid-state construction, it allows for greater accuracy: ±0.5°C over the entire thermal range, attaining the highest level of precision with the added advantage of producing a digital output.

The device has five time-temperature alarm settings — standard; these are pre-programmed per user parameters and can be interchangeable as single event or cumulative events.

Utilizing a wide range of alarm settings, users can incorporate both known drug stability profiles and incorporate Time out of Refrigeration (ToR) or Time out of Temperature (ToT) calculations into the alarm functions, thereby significantly reducing or even eliminating "false alarms" or having to justify "allowable excursions." Alarms focused on time above or below specific temperature ranges can allow a firm to leverage their product intelligence to knowingly avoid alarms. Many firms currently compensate for this by developing secondary calculations (or internal scoring methods) that speed the analysis of the scourge and plethora of temperature excursion data. For example, a firm may assign a higher degree of volatility for temperatures that are further away from the target temperatures. In such cases, the temperature itself can be multiplied against the time exposed to that temperature to generate a score. If the total score is above a firms predefined range, then the alarm would trigger. Currently, these complex formulas, which are calculated manually off-line, are time-consuming and expensive processes that are completed after the temperature data has been downloaded. And more often than not, such minor excursions are almost always accepted and the product is eventually released.

But the real difference of the Q Tag CLm doc is in how it collects data. Berlinger has developed a unique data compression method as part of the graphing functionality. This "exception management" method used in its electronic data integrator acts like a motion detector for temperature, allowing for greater storage capacity. It compensates for the limitations of time interval employed by EDLMs by reducing the amount of data stored on the device, while capturing the maximum amount of relevant data possible. Selecting only the relevant data stored allows as many as 16,000 data points to be accurately represented in a graph depicted by 1,500 relevant points. Since the device is making a temperature observation every minute instead of every 10-15 minutes, its sensitivity to temperature change is dramatically enhanced, leading to a more accurate MKT and average temperature value.

Finally, Berlinger has developed an easily integrated raw data file for flexibility with user-based ERP/SAP systems, Excel file, or Berlinger’s own cloud-based data storage and data analysis network. Data from the device are extracted via a built-in USB onto a PC or Mac, without the need for additional hardware, software or program downloads. Com-bined, this makes for a significant move forward in making monitoring easier und better documented.

ThermoPod ThermoKeeper

ThermoPod, a Division of MP Global Products located in Norfolk, NE, actually launched its entry into our industry two years ago during the IQPC Cold Chain & Temperature Management Global Forum in Philadelphia back in 2010. But hardly anyone noticed, and few took the company seriously. Why? Its product is a soft-sided insulated liner material made from shredded blue jeans and other recycled fabrics. The biodegradable ThermoKeeper is marketed as a sustainable alternative to EPS, PUR foam and VIP. Not only is it environmentally and user-friendly, it is socially responsible and cost effective.

The proprietary, purified flocked material, made from an array of recycled textiles, is the key to its insulating properties. It has an R value (resistance to heat flow) comparable to 1" of 1.5 ft.3 density EPS. After a biodegradable stiffener is added, the stiffened flocked material is then "molded" into a six-sided flat panel that is placed into a corrugated box. In manufacture, once the flat panel is mitered, so as to enable folding, it is laminated to a perforated biodegradable polysheet. The end-result is a complete, biodegradable, insulated shipping system that ships flat, for less expensive in-bound freight and storage, yet easily folds together as a snug, stand-up container with a full flap-over lid. The cost is about 10-15% higher than a comparable EPS system but as the technology catches on, so should the savings. Passive systems manufacturers ThermoSafe Brands, TCP Reliable and Cold Chain Technologies all displayed their versions of the ThermoPod ThermoKeeper system at the Cold Chain & Temperature Management Global Forum as part of their new product lines.

First published on ClutchCargo.us
Promoting Good Practices for Temperature-Sensitive Healthcare Products

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About Kevin O'Donnell

Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management Consultancy US, an international provider of consultative, research and training services to manufacturers, airlines, forwarders and other stakeholders in the life science logistics sector. Mr. O’Donnell’s prior positions include: Director & Chief Technical Advisor at ThermoSafe Brands, and Principle Packaging Engineer at Abbott Laboratories Global Pharmaceutical Division, from where he retired in 2005 after a 26-year career. He is widely considered a principal architect of the modern-day cold-chain movement and is internationally respected throughout industry as an advocate, author, blogger, educator, training developer, and champion of good distribution and logistics practices for temperature-sensitive drugs. www.exelsius.co.uk