Category: ISC University – Cold Chain Education

Introducing the Industry’s First Academic Offering to Train and Certify Cold Chain Packaging Professionals

Certification Program for Design, Development and Distribution of Temperature Controlled Packaging

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Sonoco ThermoSafe, a unit of Sonoco (NYSE:SON) and a leading global provider of temperature assurance packaging, has launched the industry’s first academic offering to train and certify cold chain packaging professionals globally. The certification program was developed by Sonoco ThermoSafe’s ISCLabs in partnership with The Packaging School; Dr. R. Andrew Hurley, assistant professor of packaging science at Clemson University; and an advisory panel of pharmaceutical manufacturers, wholesalers, logistics providers and industry experts.

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Biobased phase change material and expanded polystyrene

Expanded polystyrene, commonly used in coffee cups, coolers and packaging, will dissolve if it comes in contact with most vegetable oils, including biobased phase change material. The phenomenon is proving effective as a “green” solution to reducing EPS waste. But it demonstrates that care must be taken in both the containment and shipment of organic phase change material.

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Thermal Cycling 101

A thermal cycling study is designed to determine the cycling stability of a phase change material. During the study, a PCM goes through 10,000 or more cycles as quickly as possible to see if any thermal or chemical degradation is observed. The results help determine the useful lifetime of a PCM and its suitability for various applications.

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The Results are In!

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During the spring and summer of 2014, Sonoco ThermoSafe
sponsored and managed a 26-question survey aimed at gaining
a deeper understanding of the rapidly evolving packaging
and logistics markets for the transport of temperaturesensitive
products over the next 2 to 3 years. The survey was
co-developed by an eight-member advisory panel of leading
industry experts from pharmaceutical manufacturing, logistics
companies, media partners, independent consultants and IQPC
event managers.  After months of collecting data, we’re proud to present our results to the industry.

Click here to access the results!

Media Partners Offer a First Look at Cold Chain Industry Survey Results

ThermoSafe recently conducted a forward looking cold chain industry survey.   Three of our media partners published a preview of the results prior to the full release at the 2014 Cold Chain Global Forum Conference in Boston on October 2nd.

Click the links below to view the articles.

IQPC

Healthcare Packaging

Pharmaceutical Commerce

Stages of New Drug Development

Many people do not realize the amount of time and money it takes to take a commercial drug to market.  Here are some key things to remember:

  • Drug development is a very long process, the costs are extremely high, and the chance of success is very low
  • If a drug becomes commercialized, a lot is then riding on its success.
  • Our customers invest all of that time and money into getting the drug to market so cutting corners on a temperature controlled shipper can prove risky and in the end, costly.

Here is a very helpful graph from FDAReview.org that maps out the process:

PRECLINICAL
CLINICAL
APPROVAL
MARKET
Toxicology
Investigational New Drug Application
Phase I
Phase II
Phase III
New Drug Application
Phase IV / Postmarket surveillance
Safety
Safety dosing efficacy

Safety efficacy side effects

Expenses
$15.2 million
$23.4 million
$86.5 million
Time
21.6 months
25.7 months
30.5 months
1 to 6 years
6 to 11 years
0.6 to 2 years
11 to 14 years
Overall probability of success
30%
14%
9%
8%
Conditional probability of success
40%
75%
48%
64%
90%
Sources: Dimasi, Hansen, and Grabowski (2003).
Notes: The line marked “Overall probability of success” is the unconditional probability of reaching a
given stage. For example, 30 percent of drugs make it to phase I testing. The line marked
“Conditional probability of success” shows the probability of advancing to the next stage of the
process conditional on reaching a given stage. For example, the probability of advancing to Phase III
testing conditional on starting Phase II testing is 48 percent.

Temperature Controlled Packaging: Considerations You Might Not Know

Discussion Points

  • Temperature spread based on refrigerant coverage
  • Conditioning – Cold Shock and Refrigerant Bench Times
  • Product Mass and Temperature
  • Opening up Product Temperature Range
  • Ambient Profile and Cost
  • Universal vs Seasonal Solutions
  • Shipping a Box on its Side
  • Cost versus Insulation Choice
  • Cost Versus PCM Choice

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Defining: ISCgold® and ISCsilver® Ambient Temperature Profiles

ISC Ambient Temperature Profiles

ThermoSafe understands the importance of shipping temperature-sensitive products with confidence.   Reliable packaging systems that effectively control the temperature of products during transport and distribution are vital to maintaining the integrity of those products. The ability to accurately predict and adapt to temperature fluctuations encountered during shipping has a direct impact on the quality of the temperature assurance packaging solution.

The selection of an ambient temperature profile is a critical starting point.   Currently, there are no industry standards for the development of ambient temperature profiles. The International Safe Transit Association (ISTA) has published several profiles over the years (5B, 7D, 7E). However, these profiles are only representative of specific distribution practices, modes, and lanes, and are not generally accepted among global regulatory authorities. Choosing the right ambient profile requires detailed knowledge and a thorough understanding of the distribution environment through which the package must travel.

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