Don Pagel, President and CEO, Kodiak Thermal Technologies, Inc.
The needs of the transportation sector of the cold chain are changing rapidly. The explosion of the number of biotech companies and the globalization of clinical trials, manufacturing, and distribution in recent years are demanding new technology for the transport of ever-increasing numbers of temperature sensitive payloads. With these new realities of global pharmaceutical transportation also comes the need to update current testing standards.
Thermal packaging standards, testing, and recommended procedures are discussed by a number of recognized associations and organizations such as the Institute of Packaging Professionals (IOPP), the International Air Transport Association (IATA), and the Pharmaceutical Cold Chain Interest Group (PCCIG), which is part of the Parenteral Drug Association (PDA). However, primary testing protocols and standards for testing thermal packag ing have always been the purview of the International Safe Transit Association (ISTA). There are two primary thermal packaging testing protocols from ISTA that most companies focus on: Series 5B and Series 7D.
Series 5B, Focused Simulation Guide for Thermal Performance Testing of Temperature Controlled Transport Packaging, is “designed to provide a laboratory simulation based on actual field measured and observed hazards and levels. Measured hazards will typically include complex-shaped random vibration, multi tiered drop height distribution, temperature and humidity extremes and/or cycling, and dynamic or static compressive loads. Series 5 are not performance tests per se, but guides to the creation of focused simulation user-defined tests,” ISTA writes. As noted, Series 5 outlines a testing and data gathering methodology that allows various testing laboratories and companies to create their own protocols based on real field data. This procedure is by far the most widely used in the industry.
Series 7D, Thermal Controlled Transport Packaging for Parcel Delivery System Shipment, is described as covering only “basic requirements: atmospheric conditioning, vibration and shock testing,” writes ISTA. In the preface of the procedure, ISTA notes that “it can be used for individual or comparative performance analysis of standard or insulated transport packages against normally encountered conditions.” Series 7D not only outlines testing procedures, but also specifies 12 thermal profiles ranging from 24 to 72 hours for both summer and winter. These profiles can be used to determine the efficacy of proposed packaging as well as offering the ability to compare one package to another. ISTA describes 7D profiles as general simulations that are “not intended to represent the worst-case thermal exposure in the small-parcel shipment environment.”
As pharmaceutical and biotech companies begin to outsource more and more of their transportation processes, it is imperative that these comparative profiles more closely meet the needs of today’s and tomorrow’s global transportation realities so that vendor packaging can effectively be evaluated and qualified.
THE REALITIES OF A GLOBAL INDUSTRY
With the completion of the first rough draft of the Human Genome Project (HGP) in 2000, the development of genetic and biologically based products is increasing every year. According to the annual report on the global top 100 biotechnology companies by Euromoney Institutional Investor PLC, the biotech industry grew by more than 23% from 2005 to 2006 (Euromoney Institutional Investor PLC, 2007, p. 26) up from 17% in the prior year. Given the very nature of the biotech industry, many of the products generated by these companies are temperature sensitive. Consequently, the next 5 to 10 years will also show dramatic increases in demand for all forms of temperature-sensitive transportation throughout the world.
International transport for finished goods, clinical trials, active pharmaceutical ingredients, and raw materials will increase correspondingly, creating greater potential failure points in customs delays, missed or canceled flights, and simple human error.
With the combination of increased demand and a more global need, enhancements to current testing standards for packaging qualifications are needed in order to meet the new realities of the temperature-sensitive product packaging industry. The 72-hour test (the upper-limit on the ISTA tests) is no longer long enough, nor are the existing Series 7D profiles based on reality to allow for effective packaging comparisons.
Recommendations for increasing the difficulty of testing standards for disposable and reusable parcel packaging must be considered. All international profiles should be extended to 120 hours, allowing for better time-failure control as well as modifying the cycle limits (specifically in time) to represent more common transportation realities. The following are a series of five tests that would give a much closer comparative capability. Each test should be run with both minimum and maximum loads.
120-Hour Summer Profile. This profile would represent warehouse storage at 25°C, a truck pick up time of 8 hours at 40°C, an international flight time of 12 hours at 0°C, and another truck delivery time of 8 hours at 40°C.
120-Hour Winter Profile. This profile would represent warehouse storage at 18°C, a truck pick up time of 8 hours at -10°C, an international flight time of 12 hours at 0°C, and another truck delivery time of 8 hours at -10°C.
40°C Test-to-Failure Profile. This test would show the impact on the payload over extended periods of time at the upper temperature control. It is designed to show how long the package can protect the product without intervention.
Minus 10°C Test to Failure Profile. This test would show the impact on the payload over extended periods of time at the lower temperature control. It is designed to show how long the package can protect the product without intervention.
120-Hour 25°C Constant Profile. This test would determine the true longevity of the packaging for a term that would meet most needs.
These recommended testing profiles are not intended to meet all extremes. However, they should represent a much more realistic pattern for chamber testing packaging products. Additionally, the data derived from these tests can, with robust packaging, allow for the creation of mathematical models that can be used for more-specific profiles to determine packaging modifications as required by extreme lane conditions.
Determining the future needs of the cold-chain transportation industry should be a high priority for all life science companies. With the increase in biotech products expected to be approved and the increase in global sourcing, production, and trials, we must plan now for what projects to be an explosive growth rate over the next 5 to 10 years.
Euromoney Institutional Investor PLC. (2007, June 6). Global top 100 biotechnology companies ranked by revenue. Med Ad News, p. 26.