Perspective
Put Temperature
to the Test
Temperature-sensitive parcel packaging needs new testing standards.
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
packaging 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, multitiered 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.
