Dayton, Ohio, USA

Jeff Sitzlar, Director of Business Development – Americas

Jeff joined CSafe as Director of Business Development – Americas in January 2012. In this newly created position, Jeff is responsible for developing new business, with the primary focus being on the continued growth in the utilization of the CSafe RKN by life science companies for the shipment of their high value payloads. Jeff will work directly with our life science customers alongside CSafe’s global airline and forwarder partners.

As we have found in previous blog postings, the bi-annual Health and Personal Care Logistics Conferences (HPCLC) keep attendees up to date on the latest industry research and logistic trends. This year’s spring conference held in Philadelphia, Pennsylvania was entitled, Building Innovative Supply Chains through Data Analytics and IT Integration, had sessions on the following topics:

• Global Economic Issues and Trends: Why Innovative Data-Driven Supply Chain Operations are Relevant Now, More Than Ever
• Data Analytics: An Overview of the Issues, Risks, and Implications
• Making Data Analytics Work: Experiences with Converting Data to Information
• Best Practices in Data Management through Supplier Relationships
• The Value Proposition and Benefits of Data Analytics for Service Providers

The seminars discussed how one of the most important issues for today’s supply chain administrators is the ability to effectively use and apply data analytics. The attendees were provided an introductory overview of the fundamental risks involved with the leveraging of data and admonished that the ability to generate and access data is not enough for successful administration. Rather, they were told that it is in the application of the informed analysis that data manipulation manifests as effective decision-making.

Effective decision-making infrastructures must therefore, be built on solid data analytics, that, in turn, must be undergird by effective Information Technology integration and data management. Intensive research and extensive consideration must be given to the question of whether data resource management is to be managed from within the organization or outsourced to others. Both of these can be challenging and require an understanding and access to proper infrastructure, technologies, and skills that will, in turn, require expert management capabilities. Most of all, decision-makers must have a clear understanding of the overall value and possible performance benefits of introducing and supporting data analytics for their particular operations and those of their customers. These include return on investment, value implications, and experiential learnings.

For life science and healthcare sectors like the pharmaceutical industry, increased effectiveness in the use of data may reveal vast opportunities to improve operations. These industries have an abundance of data at their disposal that is growing exponentially with the continued introduction of mobile applications and web-based accessibility. The challenges lie in the ability to parallel this growth with processing capabilities. Transforming raw data into useful information is a valuable asset that brings with it an equally valuable competitive advantage for those who can generate, analyze, and interpret it. As for cold chain logistics, product integrity and patient safety are the ultimate goal. It is only through the careful generation, analysis, and interpretation of data that leading organizations are able to create and maintain optimized cold chain networks.
Data Generation

According to IBM, 90 per cent of the world’s data has been created in the last two years alone. Data is ubiquitous. From climate sensors to the postings on social media sites, the generation of data is constantly occurring. We see it in numerous forms such as digital pictures and videos, receipts for our purchases, and signals generated for GPS tracking.

In the life-sustaining industries that rely on cold chain logistics to transport their temperature-sensitive materials throughout the world, the generation of meaningful data is crucial. Monitoring times and temperatures throughout a product’s journey, from its point of origin to its final destination is critical to ensure the viability of these high-value shipments. Data is generated from a variety of sources throughout the intricate transport chain process. By accurately capturing this information at its various levels, the life science and healthcare organizations are able to make use of the data through the methods of analysis and interpretation.

Data Analysis

Analytics allows for those in operational roles to monitor and optimize processes on a regular basis, providing opportunities to make insightful changes to operations. Data becomes a powerful asset once it has been gathered, organized, and evaluated. Data analysis can be as simple as identifying temperature excursions or quantifying the frequency of shipments. Then again, it can be as intricate as validating Standard Operating Procedures performance while determining the effectiveness of risk mitigation. The analysis can consist of spreadsheets extracted from a number of formats, data extracted from multiple platforms, or can be completely unstructured.

Data analysts can evaluate hundreds of possible risk points that are likely to have an effect on temperature-sensitive products throughout the transport journey. These individuals have access to and are responsible for both real-time and historical analyses, allowing for the evaluation of trends and giving them an unprecedented level of control over operational conditions. When working effectively, data analysts are able to intervene in operations when necessary, ultimately mitigating risk.

What are companies doing with data analytics?

• 60% of executives say that they “believe in data analytics”
• Of the 60%, 40% of those executives are attempting to do something with the analytics
• Of the 40%, 20% have staff on hand that are working to analyze the data
• Of the 40%, 13% actually have data analytics initiatives

Today’s data analytics employs a rapidly growing number of technologies that allow for the collection, integration, and analysis of data in differing formats. It is important for administrators to have access to this data, in that it drives efficiencies and brings about cold chain excellence through continuous improvement and regulatory compliance. When looking at data from the perspective of innovation, it reveals numerous opportunities to add value to operations.

Data Interpretation

Technical capabilities allow for the manipulation of raw data and the bringing together of it into reviewable formats. The ultimate evaluation, however, is one of human interpretation. In the transportation of temperature-sensitive products, success comes with the combining of quantified operational processes; managed administrative transformations; and the extrapolation of deep, meaningful, and insightful information.

A typical cold chain operation has more than 10 parties involved in the transportation of a temperature-sensitive product. It is only through a detailed monitoring across all of these connections that a true interpretation of integrated data can be understood and utilized to improve operations. The goals of cold chain administration include patient safety, product integrity, regulatory compliance, process optimization and cost control. Data interpretation allows operators to explore some of the potential gaps within the logistics chain; and collaborative partnerships, open communication, and data awareness allow cold chain administrators to use information in powerful ways.

About CSafe

CSafe and AcuTemp merged to become the world’s largest producer of actively controlled mobile refrigeration units for life sciences, healthcare, military and international disaster relief agencies. The company is now called CSafe Global and includes the AcuTemp brand passive packaging and hand held mobile carriers and the CSafe brand of active containers.
The active solution product assortment includes the CSafe RKN, the only compressor-driven air cargo container of its kind with approvals from both the US Federal Aviation Administration (FAA) and European Aviation Safety Agency (EASA). The RKN utilizes heating and compressor-driven cooling technology to eliminate the cost and the environmental challenges associated with dry ice transportation, refrigerated trucking and internal packaging and to allow the flexibility of uninterrupted routing of shipments without the need for special staging or dry ice handling. CSafe Global’s AcuTemp brand has provided more than 10 thousand hand-held mobile management solutions since its founding more than 25 years ago. CSafe Global is now proud to introduce a series of AcuTemp brand hand-held
CSafe Global offers a highly efficient and precisely engineered product range that delivers door to door and ‘last mile’ temperature controlled solutions to the pharmaceutical, life sciences, medical, military, and disaster relief organizations around the world. CSafe’s active solutions, and their passive line of AcuTemp solutions, are designed to protect the integrity of temperature-sensitive goods during transportation.

Company President and CEO, Brian Kohr explains, “AcuTemp and CSafe are grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.” Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A. To find out more about the company and its product and service offerings, visit CSafeGlobal.com

References:

Cold Chain View on WordPress.com (2013): What’s the business case for real-time temperature monitoring and analytics? Available online at http://dyzle.wordpress.com/, checked on 6/05/2013.

Cold Chainers (2013): Innovative Data. Cold Chainers News. Available online at http://www.coldchainers.com/latestnews.11.html#LatestNews, checked on 6/05/2013.

Health and Personal Care Logistics Conference Inc. (2013): Health & Personal Care Logistics Conference | Just another WordPress site. Available online at http://hpclcnet.org/, checked on 6/05/2013.

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Pete Chesna, CSafe Business Development Manager, has been in the cold chain solutions industry for over 10 years and has experience working with Global Pharmaceutical Strategic Customers. Throughout this time he has successfully lead key projects for the design and development of both domestic parcel and international bulk passive packaging solutions.

Peter Hall and Markus Hesse write in their 2012 work entitled, Cities, Regions, and Flow , that “the ‘last mile’ remains one of the more extensively studied yet still unsolved issues in logistics management.” This inability to pin down a definition may stem from the great diversity of labor and resources that it requires, the fact that this final link in the cold chain might be thousands of miles or merely a few feet to the point of delivery, or that it is often identified as the most expensive aspect of temperature-sensitive transport while being the least efficient.

The last or final mile is the end stage in the logistics chain, where a shipment meets its ultimate destination. It is here that temperature-sensitive materials may be at their most vulnerable point. Transporting a shipment across the supply chain without issue or temperature anomalies requires the formation of a comprehensive logistical process that preserves a shipment’s integrity from product preparation to the final verification of a shipment’s integrity at the delivery point.

“Last Mile” Challenges

The challenges faced by those transporting temperature-sensitive materials are numerous. Industry expert Bédard emphasizes that the efforts made thus far by the pharmaceutical industry to address these challenges are not enough, especially in the final stage of the transport process. In his 2009 article entitled “Going the Extra Mile,” the author writes that “while a great emphasis is put on the control and monitoring for storage and transport conditions from the manufacturers to the wholesalers, a lot of work has still to be done for the very ‘last mile’ distribution steps.” One must only look at the related problems experienced within the healthcare industry in 2008, when, between 17 and 37 percent of the industry’s vaccine suppliers were found to have exposed their shipments to unacceptable storage conditions through a logistical breach that occurred during the ‘last mile’ of transport.

As the world’s largest manufacturers of vaccines and biologics extend their reach into emerging markets, gaps in cold chain infrastructures are being exposed. Manufacturers entering country regions such as Sub-Saharan Africa must often struggle to complete the distribution of medical products to combat infectious diseases. In their 2011 work, Distribution and Administration in Public Health, Government, and Developing World Markets, Harjivan and Guyton identify three primary challenges facing those distributing temperature-sensitive products in emerging markets; one of which is dedicated solely to managing transport in the ‘last mile.’

Distribution in emerging markets presents three particular challenges:

• Improving forecast accuracy and data reliability for estimating vaccine or drug demand
• Maintaining product stability throughout the distribution chain, including requirements       for cold- chain continuity
• Managing the dispensing of medical products to patients in the “last mile” of the distribution chain (i.e., the stage where products are delivered from the wholesaler or pharmacy to the consumer).

Another ‘last mile’ challenge has to do with the growing economies in countries such as India that have increased their demand for vaccines and biologics. This expanded demand necessitates a competition for the existing cold-chain capacity that is also needed by other industries that transport temperature-sensitive products, including food and other consumable goods.

Earthquakes, tsunamis, floods, hurricanes, droughts, terrorist attack, famine, etc. are a few examples of (natural and manufactured) disasters that affect cold chain transport, especially that of the ‘last mile.’ Following these high impact disasters, the people affected require emergency relief in the form of food, water, medicine, shelters, etc. In the case of a disaster, a quick and efficient response, accompanied by access to a complete line of transport carriers is crucial.

CSafe’s Courier Line Solution

These challenges represent only a portion of those that affect the final link in the cold chain. When viewed broadly, the cold chain is a bringing together of disparate operations and resources. CSafe offers a full range of active and passive transport containers to meet the needs of all phases of temperature-sensitive transport, including the ‘last mile.’

CSafe’s active solutions, and their passive line of AcuTemp solutions, are designed to protect the integrity of vaccines, biologics and other temperature-sensitive goods during transportation. From pharmaceutical delivery and biotech research, to the front lines of global conflicts and catastrophes, CSafe’s customers rely on a complete line of thermal managed shipping solutions.
As discussed in our previous posting, CSafe answers the challenges of the ‘last mile’ with its Courier container line, the AcuTemp PX1L Vaxipac®, and the introduction of its PX3L, PX6L and PX12L Couriers. The AcuTemp brand courier solutions are unique in that they require no ‘bench’ (post conditioning) time for phase change materials. This makes them quick and easy to use, with effortlessly customizable versions for payloads of 2-8°C and 2-25°C, and frozen that can be packed in just seconds. The new soft sided Courier design has options and features that make the mobile solution convenient including an adjustable and detachable shoulder strap, padded handles on the top, front and side, and belts to secure a rolling cart. These solutions have also been tested in extreme ambients ranging from -30 to +65 Celsius.

About CSafe

On October 8, 2012, CSafe LLC and AcuTemp Thermal Systems merged their industry leading operations, creating CSafe Global, the only company to provide a full line of cold chain solutions. CSafe offers a highly efficient and precisely engineered product range that delivers door to door and ‘last mile’ temperature controlled solutions to the pharmaceutical, life sciences, medical, military, and disaster relief organizations around the world. CSafe’s active solutions, and their passive line of AcuTemp brand solutions, are designed to protect the integrity of vaccines, biologics and other temperature-sensitive goods during transportation.

Company President and CEO, Brian Kohr explains, “AcuTemp and CSafe were grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.” Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A. To find out more about the company and its product and service offerings, visit www.CSafeGlobal.com.

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References
Bédard, J. (2009). Going the Extra Mile – Business Strategies & IT – NG Pharmaceutical US | GDS Publishing. Retrieved from http://www.ngpharma.com/article/Going-the-Extra-Mile/
Hall, P. V., & Hesse, M. (2012). Cities, Regions and Flows: Routledge Studies in Human Geography: Routledge. Retrieved from http://books.google.com/books?id=PdJR9DXQqaMC&dq=%22last+mile%22+%22cold+chain%22+challenges&lr=&source=gbs_navlinks_s
Harjivan, C., & Guyton, J. (2011). Distribution and Administration in Public Health, Government, and Developing World Markets. Pharmaceutical Technology Sourcing and Technology, 7(5). Retrieved from http://www.pharmtech.com/pharmtech/Distribution-and-Administration-in-Public-Health-G/ArticleStandard/Article/detail/718610?ref=25
Magennis, T., Cook, S., Villa, J., & Cotugno, M. (2010). Pharmaceutical Cold Chain: A Gap In The Last Mile. Pharmaceutical & Medical Packaging News, September. Retrieved from http://www.thermalpackagingsolutions.com/blog_images/LastMileGap.pdf
Robinson, K. CSafe Launches Larger Acutemp PX Courier. Retrieved from http://www.scemagazine.com/csafe-launches-larger-acutemp-px-courier/
Rodrigue, J.-P., Comtois, C., & Slack, B. The geography of transport systems ([Third edition].).
Roy, P., Albores, P., & Brewster, C. Logistical Framework for Last Mile Relief Distribution in Humanitarian Supply Chains: Considerations from the Field. Retrieved from http://windermere.aston.ac.uk/~kiffer/papers/Roy_ICMR12.pdf

A Global Chain

The cold chain is a complex connection of diverse and often seemingly incompatible environments. Yet, global cold chain providers bring them together; from manufacturer, to ground transport, to handler, to origination airport, to airline, to destination airport, to forwarding terminal, to distributor’s warehouse, to consumer outlet, and ultimately to the consumer and all the intermediate stops and transfer along the way!!  Cold chain logistics providers must make certain that temperature sensitive materials are kept safe throughout the cold chain process.

In a recent article by Brian Kohr, President & CEO of CSafe Global, , the author stresses the importance of all links in the process as being crucial to bringing unadulterated products to their final users.  Kohr provides an example of how the clinical trial process exemplifies the concept that a chain is only as strong as its weakest link when he explains that:

Delays in any stage of the clinical trial process can often result in costly delays to eventual commercial product launch. Imagine though if these clinical products had survived the airport and passed through customs, but there were no onward temperature-controlled containers available to take the shipment to a warehouse and then on to the lab, hospital or clinic? The end result would be the same – a lost shipment and a lost opportunity.

In this example, Kohr points out the need for packaging that is consistent with each environment encountered throughout the transport chain. Drawing the attention to the complexities of the cold chain operation, the author exhorts his readers to consider embracing a global cold chain vendor. According to Kohr,

What cold chain managers crave is a globally available supplier of a range of qualified thermal solutions who can provide reliable, consistent and measureable performance, along with cost savings.

The Last Links in the Chain – CSafe’s Solution

There are three types of packaging (or containers), primary, secondary, and tertiary. As a rule, manufacturers design their own primary and secondary packaging. Bottles and vials that contain the manufactured pharmaceutical tablets or liquids make up the primary packaging. The secondary packaging is typically made up of a paperboard carton that holds the bottles and vials along with any pertinent medical information sheets. Manufacturers rely on their packaging vendors and logistics providers like CSafe to design and provide the tertiary packaging that will ensure successful temperature controlled shipments. Tertiary packagings are designed to protect the manufacturer’s products during their travels from the distributor’s warehouse, to the consumer outlet, and consumer. Tertiary packaging vendors consider the most effective technologies, material, features, and design options to meet each unique transport condition.

CSafe answers the challenges of final mile delivery of tertiary packaging with its AcuTemp PX1L Vaxipac^® and the introduction of its PX3L, PX6L and PX12L Couriers. The PX1L Vaxipac^® has been proven to be a qualified, reliable, consistent, and cost saving thermal solution. Kohr explains,

It has been 20 years since we launched the first hand held AcuTemp device and there are now over 10,000 of our PX 1 liter units currently out in the field so it was a natural, organic step for us to extend the product range with larger containers with optional mobility enhancing features and extended temperature and duration options.

At the12th annual Cool Chain Europe Exhibition in Basel, Switzerland in January 2013, CSafe Global launched these new products into their AcuTemp brand temperature management shipping solutions. Like the Vaxipac^®, the Couriers are designed to be transportable by hand and are extremely easy to use with a patent pending belt system that takes less than a minute to pack out with coolants that require no ‘bench time’.  The Couriers ensure that temperature sensitive products reach the healthcare provider, pharmacy, doctor, research lab, or clinic in optimum condition; completing the final link in the cold chain process.

About CSafe

On October 8, 2012, CSafe LLC and AcuTemp Thermal Systems merged their industry leading operations, creating CSafe, the only company to provide a full line of cold chain solutions. CSafe Global offers a highly efficient and precisely engineered product range that delivers door to door and last mile temperature controlled solutions to pharmaceutical, life sciences, medical, military and disaster relief organizations around the world. CSafe’s active solutions, and their passive line of AcuTemp solutions, are designed to protect the integrity of vaccinesand high value temperature-sensitive goods during transportation.

Company President and CEO, Brian Kohr explains, “AcuTemp and CSafe are grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.”  Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A.  To find out more about the company and its product and service offerings, visit www.CSafeLLC.com and www.AcuTemp.com.

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Dayton, Ohio, USA

Ensuring the safe transport of healthcare products is a tremendous responsibility, one with challenges that far outweigh those experienced within a typical supply chain environment.  Crucial life science products like vaccines and insulin are two of the many temperature-sensitive pharmaceuticals that need to be stored and transported within precise temperature ranges in order to retain their efficacy.  The cost to manufacturers, pharmacies, and patients to replace even a single shipment of these important products is immense.  This is especially true for those companies expanding their product reach across the globe.  It is for this reason that specific cold chain procedures have been established to deal with the unique requirements of temperature-sensitive life science and healthcare cargo, and why many pharmaceutical manufacturers are looking outside of their own companies to add the necessary flexibility, expertise, and efficiencies for global cold chain transport.

3PLs

There has been a dramatic change over the past decade in the way that life science and healthcare companies have managed their distribution operations.  No longer is it the norm for manufacturers to establish expansive warehouse facilities dedicated to the storage of their products.  No longer do pharmaceutical companies necessarily oversee their own packaging and shipping of products to their clients.  With the added complexity of cold chain operations due to global expansion, a majority of these companies, today, have turned over at least a portion of their distribution operations to third-party logistics (3PL) partners.  Because of the risks and challenges inherent in global, regional, and local transport, more and more operators are outsourcing a greater and greater number of distribution processes to add flexibility, expertise, and efficiencies to their operations.

Added flexibility

The globalization of life science and healthcare industries has added a heretofore-unseen need for operational flexibility within logistical cold chain processes.  Larger pharmaceutical manufacturers have merged and acquired regional and local operators, expanding their reach into growing markets.  Today, the top 10 pharmaceutical manufacturers are responsible for servicing over 60 percent of global markets.  With this expansion and integration has come the need for flexibility to ensure operational consistency, while these companies work to meet the demographic challenges of fulfilling cultural, language, and regulatory complexities.  By relying on 3PL partners, expanding companies are able to add flexibility to their operations, adding resources attuned to regional and local parameters and aware of current supply chain modeling.

Added expertise

It is because of the unique expertise of their 3PL partners that companies are able to address the complexities inherent in each aspect of the supply chain.  We have written in earlier postings about the difficulties cold chain suppliers are confronted with when having to address varied regulatory requirements at global, regional, and local levels.  Regulatory compliance is a key area of expertise brought to bear by3PL partners.  This collaboration allows expanding companies to fill gaps in their knowledge and capabilities, and to stay up-to-date with an ever-changing collection of regulatory requirements.

Added efficiencies

It should not have to be said, but life science and healthcare operators must operate profitably, and global expansion is a costly endeavor.  Contemporary cold chain manufacturing and delivery operates using different revenue enhancement and profit making strategies than traditional manufacturing and delivery.  Public and private payers increasingly resist pricing increases, with margin pressures mandating cost reduction.  With this increased scrutiny, supply chain managers must bring to light operational inefficiencies and identify opportunities to improve bottom lines.  3PL partners are often used to assist in this process by identifying ways to operationalize underutilized facilities; reduce labor costs through automation, retraining, and outsourcing; and unburdening companies of expensive fixed assets.

About CSafe

On October 8, 2012, CSafe LLC and AcuTemp Thermal Systems merged their industry leading operations, creating CSafe, the only company to provide a full line of cold chain solutions.  As the world’s largest producer of actively controlled mobile refrigeration units with a comprehensive line of packaging, passive systems, and active systems, CSafe has fulfilled the rigorous approval process in service of airline and non-airline customers in the life sciences, healthcare, military, and international disaster relief.

Company President since 2008, Brian Kohr explains, “AcuTemp and CSafe are grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.”  Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A.  To find out more about the company and its product and service offerings, visit www.CSafeLLC.com and www.AcuTemp.com.

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Dayton, Ohio, USA

Previous postings have stressed the necessity and challenge of abiding by the various global, regional, and local rules, regulations, customs, and environmental conditions encountered throughout the cold chain transport process.  These writings point to the paralleled expansion of geography-specific operational requirements to contemporary global economic growth.  Globalized operations mean that facilities, staff, and administration are often situated in diverse locations, where a cohesive structure is crucial if operational and administrative responsibilities are to continue to be met in the areas of security, contingency planning, regulation compliance, quality assurance, and process tracking/traceability.

In July of last year, Pharma IQ introduced a study entitled, Seven Unique Challenges in Maintaining Cold Chain Continuity in Study Sites in Emerging Markets across the Globe.  In it, participants listed compliance with required documentation and regulations as two of the top five most significant operational challenges[i] today’s global cold chain operators must overcome:

Required documentation

Documentation is becoming an increasingly pertinent part of regulatory compliance even in emerging markets.  Pharmaceutical Commerce’s Bio/Pharma Cold Chain Sourcebook noted Canada, Saudi Arabia, Singapore, Malaysia, and Argentina all now demand documentation of individual shipments as a requirement of entry.  Under World Health Organization Guidelines, time and temperature controlled shipments must have monitoring systems providing documentation that can be both stored and accessed.  However, standardization of even the labeling of cold chain shipments is something that has been lacking until recently and required documentation varies between markets.

Regulatory compliance

With eight of the top ten pharmaceutical products expected to require cold chain storage in 2016, regulators are stepping up their requirements.  Yet, ensuring regulatory compliance across a global network of facilities, particularly in emerging markets, remains a challenge.  Better information is being seen as the key to ensuring regulatory compliance, using data logging technology to ensure they meet the tightened shipping requirements being introduced by not just the European Union and the United States, but also emerging markets.

Our September, 2012 posting, entitled ISTA Regulations[ii], gives an example of merely one of the many operational resources available to international cold chain providers.  The posting discusses how the International Safe Transit Association (ISTA) establishes necessary standards, educational programs, and resources specifically designed to meet the needs of global operators.  As CSafe continues its expansion into global markets, ISTA certification has become an essential component of its product testing and validation practices.  Utilization of the association’s capabilities and resources are vital to ensure that the temperature-sensitive products that CSafe transports arrive at their destinations without compromise.

Like ISTA, all of the global and regional agencies hold to their own unique set of regulatory practices, documentation, and approval processes.  In an article written exclusively for ColdChainInfo.com[iii], the author describes the environment contemporary cold chain operators find themselves.

Negotiating the many facets of storage and distribution of temperature controlled or cold chain products can be a difficult task.  When dealing with products that not only hold significant monetary value but also are critical components to the quality of human life, the stakes are high.  Companies that manufacture and deliver healthcare products such as those in biotech, pharmaceutical, diagnostic, and blood and tissue industries are aware of this and so are the regulatory bodies who govern their activities.  There has been a growing awareness and therefore a growth in regulatory documents and industry guidance documents around the world, which can be difficult to navigate for those who are tasked with the distribution of a cold chain product.

Nothing, however, emphasizes the prominence of regulatory compliance in global cold chain operations more than the decision made at this year’s 10th Annual Cold Chain & Temperature Control Global Forum[iv] to list as its primary topic:

-          Global Compliance: Regulator, Industry ,and Supporting Agencies’ Perspectives

Every phase of CSafe’s global expansion has been accompanied by an increased investment in time and resources as it goes through the necessary regulatory approval processes.  These commitments have resulted in the approval of the AcuTemp RKN as the industry’s first and only active controlled air container to be certified by the Federal Aviation Administration (FAA), European Aviation Safety Administration (EASA), Transport Canada, Hong Kong Civil Aviation Department (CAD), Irish Aviation Authority (IAA), and Israel Civil Aviation Authority (Israel CAA).

About CSafe

On October 8, 2012, CSafe LLC and AcuTemp Thermal Systems merged their industry leading operations, creating CSafe, the only company to provide a full line of cold chain solutions.  As the world’s largest producer of actively controlled mobile refrigeration units with a comprehensive line of packaging, passive systems, and active systems, CSafe has fulfilled the rigorous approval process in service of airline and non-airline customers in the life sciences, healthcare, military, and international disaster relief.

Company President since 2008, Brian Kohr explains, “AcuTemp and CSafe are grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.”  Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A.  To find out more about the company and its product and service offerings, visit www.CSafeLLC.com and www.AcuTemp.com.

http://acutemp.com

www.CSafeLLC.com

Dayton, Ohio, USA, November 28, 2012 (Thomas, 2012)

Further economic globalization has continued to bring together the regions of the world, creating an ever-expanding need for effective and efficient cold chain logistical systems to transport a diverse collection of temperature-sensitive materials. These conditions have also made necessary a growing reliance on specialization in cold chain transport as companies turn to industry experts to cope with transport complexities.

The global cold chain logistics expert must ensure abidance to global, regional, and local rules, regulations, customs, and environmental conditions all while maintaining the safety and the temperature-sensitive requirements of their customers’ shipments. From manufacturing, to a product’s ultimate use, the complexities encountered during transport are uniquely expressed based on the breath of geographic boundaries. Global, regional, and local transport each has its own, unique requirements and challenges.

Global transport requires unique capabilities to distribute temperature-sensitive materials like pharmaceuticals, biologics, and vaccines from individual, large facilities, to regional and local destinations throughout the world. These deliveries require provisions for long-distance transport and a clear understanding of the demands of numerous regulatory agencies.1

Regional transport is unique in that it involves economies of scale as area markets service the production and distribution of temperature-sensitive materials from large cold storage facilities to localized distribution points

Local transport focuses on the safe and timely distribution of temperature-sensitive products to their ultimate destinations

The global cold chain logistics expert’s most important responsibility is to safeguard their clients’ cargo as it encounters these variations in geographic boundaries. With the added complexities of global transport, there is a greater likelihood that shipments may be exposed to potentially damaging conditions. These conditions fall into three categories: Physical, damaging vibrations and shocks; Temperature, external heat and cold variations and extremes; and Time, sensitivity to degradation. To ensure cargo safety, today’s companies are increasingly relying on specialized cold chain logistics and technology.

A study, completed in November of 2012 entitled Research and Markets: Global Healthcare Cold Chain Logistics Market Report & Forecast (2012-2017) points out the explosive growth of cold chain operations in the healthcare industry due to globalization:

IMARC Group, one of the world’s leading research and advisory firms, finds that the total size of the healthcare cold chain logistic services market is expected to expand from its current US$ 6.7 billion to nearly US$ 10.7 billion by 2017.

CSafe is representative of the cold chain logistical and technology specialists that continue to grow in demand. The CSafe brands, AcuTemp and CSafe, represent the full range of cold chain packaging solutions. CSafe is the only global provider of both passive and active solutions, and is the world’s largest producer of active controlled mobile refrigeration units. The following represents the companies’ global service partner locations to be in place by Q1 2013 and 2014, and are an example of CSafe’s expanding global reach.

Current Locations
United States – Chicago, Cincinnati, Cleveland, Dayton, Detroit, Indianapolis, Los Angeles, Louisville, Memphis, Miami, Newark, New York, San Francisco, San Juan
Canada – Montreal, Toronto
EMEA – Amsterdam, Basel, Cologne, Dubai, Dublin, Frankfurt, Leipzig, London, London Gatwick, Manchester, Paris, Rome, Tel Aviv
Asia – Hong Kong, Incheon, Singapore,

Future
Atlanta, Bangalore, Beijing, Brussels, Dallas, Jeddah, Melbourne, Mumbai, Shanghai, Tokyo, Vienna, Zurich

About CSafe

On October 8, 2012, CSafe LLC and AcuTemp Thermal Systems merged their industry leading operations, creating CSafe, the only company to provide a full line of cold chain solutions. As the world’s largest producer of actively controlled mobile refrigeration units with a comprehensive line of packaging, passive systems, and active systems, CSafe has fulfilled the rigorous approval process in service of airline and non-airline customers in the life sciences, healthcare, military, and international disaster relief.

Company President since 2008, Brian Kohr explains, “AcuTemp and CSafe are grounded by the same guiding principles: to offer quality products and services centered on sincerity and business integrity that ensure successful shipments of our customer’s products.” Kohr adds, ‘‘By combining resources, CSafe now leads the industry as the global total cold chain solution provider.”

CSafe’s corporate headquarters are located in Dayton, Ohio, U.S.A. To find out more about the company and its product and service offerings, visit www.CSafeLLC.com and www.AcuTemp.com.

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The fall conference, entitled Changing Global Health and Personal Care Networks, focused on the major restructuring of global health and professional care (HPC) supply chains that is taking place as firms evolve their business models following the devastating recession.  The meeting centered on key decision areas wherein HPC supply chain managers must excel, including:

• Regulations
• Compliance
• Network design
• Sourcing and total cost management
• Shipper-service provider governance

The CSafe team expressed their pleasure at attending the conference in Longboat Key, Florida as a great venue for new thoughts, vibrant discussion, and learning; CSafe’s President, Brian Kohr describes the visit in the following way:

Attendees were shippers (mainly life sciences and personal health product companies) and service providers (mainly freight forwarders and trucking operators).  One of the presentations was on the RFP process[1], describing not only the items that work well in the process but also highlighting those that do not.  The relatively short time required for service providers to respond to RFP’s received some attention.  A participant from a major global freight forwarder stated that they see an average of sixteen days provided for the response.  Within sixteen days, respondents must review the RFP, ascertain how best to respond and gather all of the relevant information.  Typically this would include soliciting quotes from many airlines, ocean carriers, truckers, as well as other logistics providers.

This was of great interest to me in my role at CSafe.  I observed a firm sense from both shippers and service providers that the fast turnaround required for responses may not provide adequate time for service providers to perform ‘out of the box thinking and analysis.’ So the typical process does not promote the development of innovative ideas that could result in new solutions, services or products for shippers.  Lost are possible opportunities to improve performance and/or reduce cost.  Options that may not receive full consideration include modal shifts and review of the costs savings from the application of active packaging solutions where passive pallet shippers or dry ice containers are utilized.

I learned a lot from this individual session and the related break out session as to why the process is the way it is, with one of the reasons being the timing of the corporate budgeting process.  A recent article in a financial officer magazine[2] discussed this very subject; how there are downsides to the formal budgeting process that are often unforeseen and how some large companies are now looking at more dynamic and timely budgeting processes.  There were many other takeaways from the conference presentations and roundtable discussions.  I would recommend others to consider attending a HPCLC conference in the future.

[1] [1] HPCLC 2012 Fall Conference, Session 10. RFP Creating a Win-Win Solution Through Effective Collaboration.

Our company was founded on providing solutions that ensure the successful delivery of our customer’s temperature sensitive products.  We are reaching out to disaster relief agencies to offer our active and passive products to assist in the delivery of needed perishable medical supplies as a result of the devastation caused by Hurricane Sandy.

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Dayton, Ohio, USA, August, 2012

In less than a month, representatives of the world’s most prominent cold chain industry companies and organizations will meet in Chicago for the 10^th Anniversary Cold Chain & Temperature Management Global Forum[1].  CSafe will once again contribute as a sponsor for this important event.  Each year the forum focuses on contemporary challenges that affect all aspects of the cold chain industry.  This year it will take special interest in the risks and challenges of cold chain operations in Central and Latin America with presentations from two of the forum’s prominent speakers, Humberto Laserna Zubiaga, Pfizer’s Quality Coordinator in Peru, and Jair Calixto, Good Practices and Pharmaceutical Audits Manager for Sindusfarma.

The spotlight on markets south of the United States border is not surprising.  In fact, ColdChainIQ’s “Temperature Controlled Biopharmaceutical Logistics in Central America” survey[2] points out that over 90% of the biopharmaceutical industry currently operates south of the border with over 50% planning an increase of their presence over the next three years.  However, while the opportunities for growth seem abundant, the survey also shows that an expansion into this region is not without risks, nor challenges:

• ✓ 37% of the respondents consider transportation and infrastructure throughout the extent of the operations to be the greatest risk in establishing a temperature controlled pharmaceutical supply chain in this area
• ✓ 18% point to collaborating with affiliates and ‘sister companies’ for expertise and best solutions for domestic distribution within the various countries
• ✓ 18% identified the diverse regulatory compliance requirements encountered when working within and between individual countries
• ✓  9% specified the need for an available infrastructure and roads within countries
• ✓  9% required assistance in the selection of an optimal transportation model
• ✓  9% emphasized supply chain security issues

This emphasis on Central and Latin America is just one example of the expansion taking place throughout the world in developing countries.  Pharma IQ has generalized this information, establishing seven categories of challenges faced by those implementing and maintaining cold chain operations in emerging markets like those in Latin America[3]:

1. Security

Securing the cold chain plays an essential role in developing markets, presenting a greater challenge to manufacturers and distributors

2. Maintenance of cold chain conditions in the air and on the ground

The same underdeveloped infrastructure that presents security concerns for the industry also challenges the maintenance of cold chain conditions, as does the unstable power supply that is not a factor in developed markets

3. Planning, adaptability and contingency plans

The potential political instability in emerging markets adds a new dimension to the creation of continuity plans in emerging markets

4. Required documentation and deciding on the value of the material

Documentation is becoming an increasingly pertinent part of regulatory compliance with language and cultural differences becoming a particular challenge in emerging markets

5. Regulatory compliance

Ensuring regulatory compliance across a global network of facilities, particularly in emerging markets, remains a challenge

6. Improvements in kit design

Cold chain packing must cut environmental impact, meet regulatory requirements, and ensure the security of the supply chain

7. Technology enabling tracking of temperature and location

Biopharmaceutical companies are increasingly turning to track and trace technologies

While the survey revealed an unquestionable consensus as to challenges, its respondents agreed that these challenges could be overcome.  When asked to identify the barriers to overcoming these challenges, 60% identified a lack of knowledge and training; 20% budgetary constraints; and 10% a lack of time, maturity of technologies, or production constraints.  Knowledge and communication are the overwhelming keys.

CSafe is proud to have been able to overcome these barriers and successfully expand its offerings throughout much of the world and into numerous markets where these challenges exist.  In a recent article touting the continued expansion of the company’s fleet and corresponding growth in the number of MLA’s, CSafe’s President, Brian Kohr, proves the respondents of the survey correct, explaining that as to the success of its AcuTemp offerings:

“Communication is key, by continuing close communications with our partners and customers, we are able to anticipate and adapt to quickly changing short and long term requirements.”[4]

This month’s posting expands on the discussion about compliance and certification requirements in cold chain logistics begun in our earlier blog writings that will continue next month with a discussion of the various approval agencies and their requirements.

About CSafe, LLC

CSafe, LLC has a full range of proven products and a worldwide network of logistics partners ready to address the stringent requirements of the temperature sensitive air cargo market.  Making use of AcuTemp’s active and passive transport containers for delivering temperature-sensitive drugs and biological shipments, the company is making aggressive moves to expand its reach throughout the world.  Headquartered near Dayton, Ohio, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with service centers and partners worldwide.  For more information, visit www.csafellc.com.

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Dayton, Ohio, USA, May 20, 2012

As the world’s largest distributor of vaccines to the developing world, UNICEF supplies inoculations for more than half of the world’s children.  When emergencies occur, such as conflict or a natural disaster, the organization still must deliver the necessary medicines to protect vulnerable children from preventable diseases when health services are inoperable.  A recent BBC series documents the efforts of actor Ewan McGregor as he works to fulfill the UNICEF mission by immunizing some of the hardest-to-reach children in the world.  The documentary highlights the fragile nature of the vaccines that must be kept constantly cold as they are passed along the supply chain.  These cold chain routes exist across the globe and McGregor’s represent some of the world’s most difficult to operate.

Efforts like those of McGregor and UNICEF are pushing the boundaries of cold chain air distribution to geographic areas heretofore untouched by the lifesaving capabilities of these much-needed vaccinations.  Add this to the fact that almost all of the world’s fastest growing cities are expected to be in developing countries, and that over 70% of all pharmaceuticals in clinical trials are temperature-sensitive, it is easy to see why the fastest growing air cargo market segment is the cold chain pharmaceutical sector.  And, it is thanks to this growing global market for pharmaceuticals that cold chain initiatives are underway at almost all the major global airlines.

To meet the expanding needs of this temperature sensitive air cargo transport, CSafe has pioneered the development of active mobile refrigeration solutions that make use of the industry’s leading thermal management technologies.  The company’s flagship product, the AcuTemp RKN thermal pallet shipper addresses the challenges of providing the required temperature management, by ensuring precise temperature control and comprehensive data tracking.  The AcuTemp RKN air cargo container has been designed to eliminate the challenges that are associated with maintaining cold chain operations for the shipment of temperature sensitive pharmaceuticals and biotechnology products even in extreme conditions.  These products are highly susceptible to damage or compromise due to deficient temperature management as a result of insufficient packaging when encountering extreme ambient temperature conditions, the irregularities that come along with dry ice use, and delays in transit and the customs process.  CSafe addresses all of these issues with its AcuTemp RKN.  Their cargo containers provide superior thermal efficiency through efficient designs that are able to operate for extended periods.

The CSafe RKN active pallet shipper is the first and only compressor-driven refrigeration unit of its kind that is approved by the European Aviation Safety Administration and Federal Aviation Administration.  The RKN is the ultimate solution for transporting pharmaceuticals, while maintaining a tight internal temperature of its payload compartment, even in extreme or fluctuating ambient environments.  CSafe’s shippers utilize ThermoCor^® high-performance insulation along with high-efficiency refrigeration and heating systems and a proprietary air movement system to ensure the precise control of temperature-sensitive shipments.  Their extended battery operation and temperature control system guarantee precise temperatures during the transportation of sensitive cargo.  Onboard data-tracking devices within the RKN provide a complex data logging system with real-time shipment recording of all relevant temperature and control information, along with the tracking of door openings, all to verify that cargo has been safely maintained at the required temperature during all phases of its transport.

The AcuTemp RKN is now being utilized by most major global pharmaceutical companies.  Many of them have performed extensive and independent testing of the container at a wide range of temperature requirements across multiple shipping lanes, ambient conditions, varying payload sizes, and shipment durations.  The consistent and successful results of this testing, and actual use, has identified the AcuTemp RKN as a qualified and reliable solution for transporting temperature sensitive healthcare products, especially where extreme ambient temperatures are encountered.  Since beginning its service in early 2008, the AcuTemp RKN has been used by over 80 life science companies and has consistently demonstrated an ability to maintain customer-desired payload set points and the elimination of recorded product loss.  The container’s heating and compressor driven cooling systems have eliminated the cost and challenges associated with the use of traditional dry ice, refrigerated trucking, and internal packaging.  CSafe continues to expand their business to meet the needs of their customers.  The company has added new partnerships with global airlines, forwarders, and specialty couriers and continues to make additions to their global service network.  CSafe continues its commitment to design aviation products that meet all global safety standards and provide products that deliver the performance needed to mitigate risks in cold chain transportation process and that provide overall cost savings.

About CSafe, LLC

CSafe, LLC has a full range of proven products and a worldwide network of logistics partners ready to address the stringent requirements of this temperature sensitive air cargo market.  Making use of AcuTemp’s active and passive transport containers for delivering temperature-sensitive drugs and biological products, the company is making aggressive moves to expand its reach throughout the world.  Headquartered in the United States, CSafe, LLC is a joint venture between AmSafe, Inc. and AcuTemp Thermal Systems, with service centers and partners worldwide.  For more information, visit www.csafellc.com.

Sources

BBC.  (2012).  Ewan McGregor: Cold Chain Mission.  Retrieved from http://www.bbc.co.uk/programmes/b01gw5vj

Cold Chain IQ.  (2012). CSAFE Continues to build FAA approved RKN fleet.  Retrieved from http://www.coldchainiq.com/transportation-logistics/articles/csafe-contines-to-build-faa-approved-rkn-fleet/

GMP Coach.  (2010).  Airlines Court Pharma Industry with Cold Chain Services.

Logistics Asia.  (2012).  CSafe Introduces New Product – Temperature Management Solutions. Retrieved from http://www.logisticsasia.asia/articles/csafe-introduces-new-product—temperature-management-solutions

On The Box.  (2012).  Ewan McGregor: Cold Chain Mission Review.  Retrieved from http://channelhopping.onthebox.com/2012/04/22/ewan-mcgregor-cold-chain-mission-review/

PR Newswire.  (2009).  CSafe Announces Its AcuTemp Air Cargo Container Receives EASA Approval.  Retrieved from http://en.prnasia.com/story/19952-0.shtml

PR Newswire.  (2010).  AcuTemp Thermal Systems and CSafe, LLC to Offer Temperature Controlled Containers to Aid in Relief Efforts in Haiti.  Retrieved from http://www.prnewswire.com/news-releases/acutemp-thermal-systems-and-csafe-llc-to-offer-temperature-controlled-containers-to-aid-in-relief-efforts-in-haiti-81968277.html

PR Newswire.  (2012).  CSafe Confirms Operational Qualification of the AcuTemp RKN Air Cargo Container by Major Pharmaceutical Companies.  Retrieved from http://www.prnewswire.com/news-releases/csafe-confirms-operational-qualification-of-the-acutemp-rkn-air-cargo-container-by-major-pharmaceutical-companies-80823732.html

Samedan Ltd Pharmaceutical Publishers.  (2011).  Pharmaceutical Industry Directory. Retrieved from http://www.samedanltd.com/directory/detailed/473

The International ONE.  (2012).  Ewan McGregor’s Cold Chain Mission. Retrieved from http://one.org/international/blog/ewan-mcgregors-cold-chain-mission/

UNICEF.  (2011).  UNICEF’s Global Work on Immunizations. Retrieved from http://www.unicef.org.uk/Latest/Photo-stories/vaccinations-immunisations-vaccines-photos-gavi/

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