Global Supply Chain Insights
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3D-Printed Pharmaceuticals & their impact on the Cold Chain:
Imagine, a doctor sends a prescription to a pharmacy that uses a 3D printer to create a custom formulation based on the special needs of a patient or perhaps a patient is able to print his own medications from home with raw materials purchased at a pharmacy or who knows, delivered via drone or by an autonomous delivery truck. This futuristic outlook involving cost shifting to the patient is not likely to occur soon. The requirement of purchasing a printer and raw materials could be prohibitive for many. It also would raise numerous quality control and regulatory questions.Read more
July 27, 2016 by Cathy Roberson

Logical Logistics
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Mark Edwards
Seafreight Container Weight Regulations– Update:
Back in November 2015, I highlighted the new regulations regarding container weight declarations (Verification of Gross Mass or VGM) which came under the International Convention for the Safety of Life at Sea, more commonly known as SOLAS. These were adopted in November 2014 and came into force from 1st July 2016.Read more
July 13, 2016 by Mark Edwards

Global Cold Chain Connections
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Gary Hutchinson
Case Study: Meeting Cold Chain Logistics Challenges In Global Clinical Trials :
Clinical trial material (CTM) or investigational medicinal products (IMP) are an important part of the early stages of the life science supply chain. As trials are being run on a global scale, in markets with less than ideal infrastructure, there is a dire need for companies to work with specialized cold chain experts to engineer and design innovative distribution processes. Cold chain failure may lead to: the patient being administered an unsafe product; liability based on compliance infractions; inconsistent data results; or an entire shipment’s product integrity could be rejected by the quality department, resulting in costly delays.Read more
June 29, 2016 by Gary Hutchinson

Making Tomorrow's Medicines
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Tony Hitchcock
A More Balanced Understanding Of “Risk”:
Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue.Read more
May 16, 2016 by Tony Hitchcock

Stay Cool with Jim Bacon
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Jim Bacon
The Human Side of Lane Qualification – The Mock Shipment Call:
Wouldn’t it be great if roles and responsibilities by all parties involved in a shipment were completely understood and agreed to? All too often, an excursion can be attributed to some form of human error and more often than not this occurs during a transfer or hand-off from one service provider to another. I have addressed this issue in many presentations over the past many years, referring to it as "the weakest link". Shippers that improve these hand-offs through robust and disciplined process steps and improved agreements with providers have mitigated their risk by securing "stock throughput coverage" insurance which provides continuity coverage for shipments. This however does not eliminate the risk, so extra steps and a continuous loop of review is required.Read more
January 5, 2016 by Jim Bacon

Biologistic Insights
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Eugenio Filippi
Selecting high quality suppliers:
A couple of interesting quotes I have recently seen in cyberspace made me muse.Although not new, they are certainly evergreens, such as the famous "the bitterness of poor quality remains long after the sweetness of low price is forgotten" by Benjamin Franklin (1706 – 1790) which hits the nail on the head as far as supplier selection in the pharmaceutical industry goes.Read more
June 1, 2015 by Eugenio Filippi

Cold Chain Corner
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Kevin Kohleriter
The Standards Myth: Why Temperature Controlled Packaging Fails And What You Can Do About It:
What if I told you that not all standards are created equal. Some are just flat out confusing and some are just unfinished at best. In an ongoing effort to create a global standard, the reality is that those standards have created a baseline, not a target. So how do we get from a baseline to a target? Let’s start with that baseline and work our way through its flaws, how to remediate those flaws, and the steps to take to get past that baseline and closer to a cost effective, protective, and green friendly solution.Read more
April 14, 2015 by Kevin Kohleriter

Manufacturing and Distribution practices in Eurasian Economic Union
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Mikhail Khazanchuk
GDP Implementation in Russia, Belarus and Kazakhstan:
For long years pharmaceutical industry in Russia has been awaiting implementation of GxP-practices as a legally binding requirement. Start was given at the end of 2013 when GMP was officially put in force in the country based on EU adopted guides.Read more
March 17, 2015 by Mikhail Khazanchuk

Insulated & Cooling Packaging Insights
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Sofrigam Editorial
An Insulated Shipping Packaging Solution Perfectly Stable for 240 Hours:
The most commonly used insulations in manufacturing insulated shipping packaging solutions are polyurethane, expanded or extruded polystyrene and polyethylene. With thermal conductivity at 20 and 25mW/m.K, PU produces the best thermal performance in traditional insulation. Combined with eutectic gel panels at 0°C, PU boxes provide up to 5 days autonomy between +2 and +8°C, compared to only 3 days for others.Read more
June 24, 2014 by Sofrigam Editorial

American Airlines Cargo Business Insights
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Tom Grubb
Rigorous Realities – Enhanced Expectations in the Air Cargo Cold Chain:
Advancements in pharmaceuticals are changing the face of 21st century medicine, giving patients around the world access to new life-saving drugs and vaccines. Because many of these innovative pharma and biopharma products are temperature-sensitive, the growing global pharmaceutical market is driving demand for cold chain logistics.Read more
March 6, 2014 by Tom Grubb

Dr. Nicola Spiggelkötter on Qualification
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Dr. Nicola Spiggelkötter
Food meets Pharma: What are the 6 Must Haves to become a Carrier Specialized at Pharma Logistics?:
Pharma logistics has become a box-office hit, widely discussed and attracting many people, among them many carriers and service logistic providers, especially those who wants to become a carrier specialized at pharma logistics. What are the must haves to become such a specialist?Read more
November 17, 2013 by Dr. Nicola Spiggelkötter

Carlos Castro on Cold Chain Supply
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Carlos Castro
Ambient Profiles – The building blocks (Part 2):
In my last article, I mentioned that ambient profiles must be a true representation of the temperature a shipping container experiences during transit from origin to destination sites. Failure to capture realistic temperature conditions in the supply chain will create inefficiencies and increase the risk. In this second article I will describe how ambient profiles should be built and what practices should be avoided.Read more
May 20, 2013 by Carlos Castro

Laurent Foetisch
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Laurent Foetisch
New GDP Guidelines Spell Substantial and Drastic Change for the Entire Pharma Industry:
As per the GDP the main change will be related to ambient (15° to 25°C) shipment which will impact all the entire temperature controlled transportation and qualification processes.Read more
April 4, 2013 by Laurent Foetisch

Richard Ellinger
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Richard Ellinger
A Muted Outlook in 2013:
Every one of us in the temperature assurance market would like to know if this will be a strong year for our collective businesses or not. It is very difficult to tell these days considering the ‘fiscal cliff’ discussions produced by our daily media outlets.Read more
January 22, 2013 by Richard Ellinger

Quality in the Cold Chain
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Humberto Laserna
Importance of Cold Chain in Latin America:
To assure the cold chain, we should have robust processes, suitable qualifications, effective training programs, risk assessments and back-up plans, challenged periodically.Read more
August 19, 2012 by Humberto Laserna

Energize The Chain
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Dr. Harvey Rubin & Alice Conant
Rerouting Power. Reshaping Health:
Rapid progress was made in implementing this innovative cold chain strategy after Energize the Chain presented its strategy to a receptive audience of cell tower operators and suppliers at the GSMA Green Power for Mobile Conference in Mombasa, Kenya in March 2011. We developed a very close working relationship with Econet Wireless, the major cell tower operator in Zimbabwe.Read more
August 14, 2012 by Dr. Harvey Rubin & Alice Conant