Working toward Cold-Chain Standards, Certification
Published: March 9th, 2010
At the upcoming International Transport Packaging Forum,
attendees will become familiar with emerging best practices in
temperature control.
ISTA’s International Transport Packaging Forum will be held March 29–April 1, 2010, at Disney World in Orlando Florida. During the forum, ISTA will be presenting important new ISTA Standards relating to the qualification of temperature-sensitive-products packaging solutions. The results of two major projects that took place over the past couple of years will be presented, along with a certification program:
1. ISTA’s Heat and Cold Profile Study of the 2nd Day parcel shipping environment within the United States.
2. The development of ISTA Manual 20: A Thermal Qualification Process for cold-chain packaging.
3. Thermal Laboratory ISTA Certification Program.
The presentation on the temperature profile development will cover the results and analysis of the two-part case study that was conducted to collect a large set of ‘real-lane’ data on the environmental conditions encountered during two-day parcel shipments throughout the United States. One series of tests was conducted in the summer and the other was conducted in the winter to cover the extreme range of the conditions to which a shipment may be exposed. All data was then used to statistically build generic temperature profiles representative of ‘typical’ summer and winter conditions.
The presentation on the development of ISTA Manual 20 will be a case study detailed by Amgen focusing on the processes and methodology it followed to design and qualify an insulated shipping container (ISC). The ISTA Manual 20 project took Amgen’s process and methodology and formalized it into an industry standard process for transport validation of temperature-sensitive products. The presentation highlights the benefits to both industry and suppliers when following the process of ISTA Manual 20.
The ISTA Thermal Laboratory Certification Program presentation will outline the process by which thermal transport testing laboratories, such as both independent and internal pharmaceutical industry laboratories, can become certified by ISTA. This portion of the session will cover the application process, preparing for audit/assessment for certification, ISTA’s process and requirements, training, and reporting.
EnviroCooler LLC, as a founding commercial sponsor of these projects, will be hosting pre- and post-presentation Q&A sessions and materials at its exhibition booth during the forum.
More information on the forum is available online at www.transportpackagingforum.com. ■
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An operational qualification
An operational qualification that demonstrates the process performs at the operational extremes. The final piece is the performance qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the operational qualification limits. Thanks a lot.
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The cold chain is a
The cold chain is a temperature controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of products such as fresh agricultural produce, seafood, frozen food, photographic film, chemicals and pharmaceutical drugs. Thanks.
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The distribution process one
The distribution process one should monitor that process until one builds a sufficient data set that clearly demonstrates the process is in compliance and in a state of control. Each time the process does not conform to the process, the event should be properly documented, investigated and corrected so that the temperature excursion do not occur on future shipments. Thanks.
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The process can evolve into
The process can evolve into periodic monitoring once sufficient data demonstrates that the process is in a state of control. Any anomaly that occurs once a process is in a state of control will result in the process being invalidated and not in control and result in product withdraw from the market to ensure patient safety. Thanks.
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Thermocouple probes and
Thermocouple probes and separate temperature data loggers measure temperatures within the product load to determine the response of the package to the test conditions. Replicate testing based on a qualification protocols is used to create a final qualification report that can be used to defend the configuration when audited by regulators. Thanks.
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