COO and CIO John Howe will participate in a panel discussion on the merits of employing reusable shippers for moving clinical trial material around the world, and leasing versus buying scenarios.

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Kingsville, TX (PRWEB) October 27, 2011

Intelligent Thermal Solutions, named 2011 Innovator of the Year by the Greener Package Awards, announces that its leadership team will attend the IQPC 3rd Clinical Trials Supply & Logistics Summit in San Diego Nov. 7-9, 2011. COO and CIO John Howe will participate in a panel discussion on the merits of employing reusable shippers for moving clinical trial material around the world, and leasing versus buying scenarios.

In addition, Dr. David W. Mueller of Clear Vascular, Inc. will review the challenges and solutions facing shipping radiopharmaceuticals worldwide, citing the results of shipping to and from Chile using Intelligent Thermal Solutions’ products.

The IQPC event will feature some of the top experts brought together to discuss major challenges and developments in the Clinical Trials market. Howe’s and Mueller’s presentations will be among more than 21 in-depth case studies and workshops highlighting best practices and innovative solutions addressing top industry concerns.

Intelligent Thermal Solutions makes EcoTherm™ containers – durable, reusable cold chain shipping containers that feature five-day temperature-assured durations for safely shipping pharmaceuticals and biologics worldwide. The company leverages depot-style logistics to offer a sustainable, inexpensive and eco-friendly alternative to typical shipping methods.

EcoTherm™ containers can be reused up to 100 times, versus once for typical one-use foam insulated containers and ice packs, dramatically reducing materials headed for landfills.

About Intelligent Thermal Solutions
Intelligent Thermal Solutions, LLC is a south Texas company headquartered in Kingsville, TX, previously known as Active CC Boxes LLC. ITS was recognized with the 2011 Greener Package Awards for Environmental Impact and Innovator of the Year, for its depot-style logistics system. The technology in EcoTherm™ containers was recognized with the 2002 DuPont Gold Award for packaging design innovation for cold chain, and the 2002 R&D 100 Awards recognizing the 100 most technologically-significant products of 2002. Info at http://www.intelligentthermalsolutions.com.

Kingsville, TX (PRWEB) October 04, 2011

Intelligent Thermal Solutions, U.S. maker of five-day temperature-assured and eco-friendly cold chain containers for safely shipping pharmaceuticals and biologics worldwide, announces a new website at http://www.intelligentthermalsolutions.com.

The site features comprehensive information about ITS products and services, including its award-winning EcoTherm™ containers. The environmentally-friendly containers allow pharmaceutical and biologics clients to ship for less cost worldwide with assurance of product efficacy in highly-variable ambient conditions.

“We’ve built a data-rich website full of information about our technology, products and testing results. By providing this large amount of data, we enable our customers to make informed purchasing decisions without bias,” said Richard Ellinger, ITS president and CEO. “Publishing proven results is what our customers deserve, not a subjective marketing message. We’re very proud of this new approach to the market with our website and literature.”

The debut of the site follows by two months a corporate name change and announcement of a new executive team. In addition to Ellinger, COO John Howe and Account Executive Steven Kaplan are leading the company, formerly known as Active CC Boxes.

The science behind EcoTherm™ containers is based on vacuum-insulated panels, an IntelliTherm™ temperature regulator, and a Thermal Shield™, unique in the industry, to ensure the integrity of temperature-critical payloads shipped globally. The container minimizes temperature stratification and maximizes payload volume. Rugged EcoTherm™ containers are reusable for years, so do not contribute profusely to landfills like typical corrugated boxes with polystyrene or urethane insulation.

In addition to purchasing programs, ITS offers customers a convenient rental program at less cost than purchasing competitive passive systems. The receiver of the shipment simply returns the rented containers to depots in New Jersey and Mainz, Germany. New containers arrive on-demand at the customer’s location, fully prepared for loading and shipping. Long term leasing programs are also available for the EcoTherm™ units.

About Intelligent Thermal Solutions

Intelligent Thermal Solutions, LLC is a south Texas company headquartered in Kingsville, TX, previously known as Active CC Boxes LLC. ITS was recognized with the 2011 Greener Package Awards for Environmental Impact and Innovator of the Year, for its depot-style logistics system. The technology in EcoTherm™ containers was recognized with the 2002 DuPont Gold Award for packaging design innovation for cold chain, and the 2002 R&D 100 Awards recognizing the 100 most technologically-significant products of 2002.

ITS executive team to be available for consultation at Booth #23, featuring reusable cold chain containers with extended hold times and green benefits for the pharmaceutical and biologics sectors.

Kingsville, Texas (PRWEB) September 14, 2011

Intelligent Thermal Solutions, named Innovator of the Year by the 2011 Greener Package Awards, announces that its leadership team will attend the IQPC’s 9th Annual Cold Chain & Temperature Control Global Forum in Philadelphia, PA Sept. 26-30, 2011.

ITS President and Chief Executive Officer Richard Ellinger will be joined by COO and CIO John Howe. Both Ellinger and Howe will be available for consultation at IQPC Booth #23.

Intelligent Thermal Solutions makes EcoTherm™ containers – reusable cold chain shipping containers that feature five-day temperature-assured duration cold chain containers for safely shipping pharmaceuticals and biologics worldwide. The company leverages depot-style logistics to offer a durable and eco-friendly alternative to typical shipping methods.

EcoTherm™ containers can be reused up to 100 times, versus once for typical one-way corrugated boxes and packaging, dramatically reducing materials headed for landfills and overcoming the cost of return logistics.

“At first glance, our EcoTherm™ containers are obviously different than any temperature-assured containers anywhere,” said Mr. Ellinger. “EcoTherm™ containers offer remarkable improvement over typical corrugated boxes, with their extended hold times and green benefits.    We look forward to advancing cold chain logistics for the pharmaceutical and biologics sector.”

The IQPC conference will examine the modern cold chain – including all temperature range products and their regulatory requirements – as well as evolving sectors such as medical devices and diagnostics, generics, APIs, biologics and cell therapies.

About Intelligent Thermal Solutions

Intelligent Thermal Solutions, LLC is a south Texas company headquartered in Kingsville, TX, previously known as Active CC Boxes LLC. ITS was recognized with the 2011 Greener Package Awards for Environmental Impact and Innovator of the Year, for its depot-style logistics system. The technology in EcoTherm™ containers was recognized with the 2002 DuPont Gold Award for packaging design innovation for cold chain, and the 2002 R&D 100 Awards recognizing the 100 most technologically-significant products of 2002.

Info at http://www.intelligentthermalsolutions.com.

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John V. W. Howe, COO, CTO
Intelligent Thermal Solutions LLC

info@intelligentthermalsolutions.com

Intelligent Thermal Solutions nets Environmental Impact and Innovator of the Year honors

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Kingsville, TX (PRWEB) August 09, 2011

Technology and logistics that maximize reuse of cold chain shipping containers have earned two 2011 Greener Package Awards — for Environmental Impact and Innovator of the Year — for Intelligent Thermal Solutions, LLC (“ITS”), of Kingsville, TX. The Greener Package Awards are North America’s only independent, neutral, sustainable-packaging awards competition not affiliated with any supplier or company.

ITS, the U.S. maker of five-day temperature-assured cold chain containers for safely shipping pharmaceuticals and biologics worldwide, leverages depot-style logistics to offer an eco-friendly alternative to typical shipping methods. Its EcoTherm™ containers can be reused approximately 100 times, versus once for typical corrugated boxes and packaging, dramatically reducing materials headed for landfills.

ITS’ depot system overcomes the cost of return logistics, which has historically made container reuse unfeasible.

“We’re delighted to be recognized with these awards, since our products and systems offer an urgently-needed shift toward sustainability in this industry,” says Richard C. Ellinger, Intelligent Thermal Solutions president and chief executive officer.

Customers who rent or lease the containers return them to depots in Mainz, Germany or New Jersey, USA. The process is simple and the cost is competitive with a one-way disposable foam insulated container, which quickly winds up in a landfill.

A scenario of 10,000 cold chain shipments using typical disposable containers would require 10,000 containers, all of which would eventually inflate landfills. Intelligent Thermal Solutions’ EcoTherm™ reusable containers substantially lower that impact, with a mere 100 containers for 10,000 shipments. Once EcoTherm™ containers reach the end of their useful life, only 5% of the material goes to landfills, with 30% recycled and 65% reused.

To visualize the waste from disposables, Intelligent Thermal Solutions calculates that 10,000 typical corrugated containers with polystyrene or urethane packaging would cover a football field at a depth of 71.25 feet deep to 5.42 feet deep, respectively. Even without any salvage, 100 EcoTherm™ containers would cover a football field just 0.014 feet deep.

Besides their impressive environmental advantages, EcoTherm™ containers offer industry-leading safety advantages that ensure product efficacy in highly-variable ambient conditions.

Patented technology assures precise temperature maintenance over a five-day shipping period, the best in the industry. The science is based on vacuum-insulated panels, an IntelliTherm™ temperature regulator, and a ThermalShield™, to ensure the integrity of temperature-critical payloads shipped globally. The patented thermal regulating lid controls the payload temperature between 2 and 8 degrees Celsius for more than five days with no power or ice, at an average ambient temperature of 25 degrees Celsius.

Intelligent Thermal Solutions customer Gordon L. Johnson II, head of strategic innovation for LifeConEx, affirms the strategic value of reusable EcoTherm™ containers.

“We’ve used the EcoTherm ATA R36 for many shipments to all continents in all seasons without experiencing a temperature excursion,” he explains. “The ease of use of this particular thermal shipping system is impressive, as is the robustness of its design.”

For information about purchasing or leasing EcoTherm™ containers, call 1+ (888) 465-6342, or visit http://www.intelligentthermalsolutions.com.

About Intelligent Thermal Solutions

Intelligent Thermal Solutions, LLC is a south Texas company headquartered in Kingsville, TX, previously known as Active CC Boxes LLC. ITS manufactures reusable cold chain shipping containers with extended hold times, meeting the unique safety needs of pharmaceutical and biologics companies. EcoTherm™ containers overcome the cumbersome limitations of corrugated boxes lined with polystyrene or urethane insulation and filled with dry ice or frozen gel packs. ITS was recognized with the 2011 Greener Package Awards for Environmental Impact and Innovator of the Year, for its depot-style logistics system. The technology in EcoTherm™ containers was recognized with the 2002 DuPont Gold Award for packaging design innovation for cold chain, and the 2002 R&D 100 Awards recognizing the 100 most technologically-significant products of 2002. Info at http://www.intelligentthermalsolutions.com.

I hope that you will attend the 9th Cold Chain Distribution for Pharmaceuticals Global Forum in Philadelphia. PA USA September 26 – 30, 2011.

On September 27, Steven Maietta, Director of Sales Americas Envirotainer, Prakash Mahesh, VP Marketing and Business Development, ThermoSafe Brands, and I will be presenting a workshop  entitled “Leasing Programs: Evaluating Options for Temperature Sensitive Pharmaceuticals”.

Come and hear about the latest trends in our industry.  Rent or lease a container by the trip instead of paying for a one way shipper that ends up in the landfill.

Go the the IQPC workshop page for more information.

“This article was published in the March/April 2011 issue of PO, Vol. 12, Issue 2 on pgs. 52-55. Copyright rests with the publisher. To view more articles concerning this subject and others, please go to www.pharmoutsourcing.com.”

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By Rafik H. Bishara, Ph.D.

Substantial sums of budgets and resources are spent annually to design packages (containers) to ship temperature-controlled products. Most of the designs use expanded polystyrene foam (EPS) or polyurethane foam (PUR) insulation with gel packs as the cooling medium. Recently, some vacuum panel insulation has been used in package design and phase change material (PCM) has been implemented as a cooling medium in addition to the gel packs. The foam insulated shipper cooled by gel packs was invented in the late 1950’s and this technology is still the major design being employed in package design and development to produce small shippers for temperature – sensitive products instead of using some of the newer technologies.

Generally, the shipper of a cold chain product does not necessarily want to design a package. What the shipper really wants is a safe and successful shipment of the product. However, the shipper has not stopped to question if the old “tried and true” methods that have always been used are antiquated and need to be replaced. In addition, due to the increased regulatory requirements to ensure that the quality, integrity, potency, efficacy and safety of the temperature – controlled medicine are not compromised during handling, storing and shipping from the manufacturer to the end user, the capability of these small, “old technology”shippers is being pushed to the limit.

In the cold supply chain, the package shipper and carrier are the means to accomplish the task of shipping a temperature – controlled product from one point to another while ensuring that its temperature does not experience excursions below or above the specified minimum or maximum temperatures and the product arrives at the destination without physical damage. The shipper typically chooses the packaging and duration of shipment (e.g. overnight, 2 day) while the carrier choose the mode of transportation (e.g. truck, air) and the route.

Most of the above mentioned shipping containers are designed to be used once and then be discarded. This has not been environmentally friendly. The impact of the packaging insulating components and the refrigerants on the environment should be investigated in regard to toxicity, energy used, created pollution, emission, biodegradability, recyclability and reusability. A non exhaustive overview of various global directives and waste stream for packaging components used to distribute temperature – sensitive products in the last mile is discussed in Section 6.3 of the PDA Technical Report No. 46, “Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User” (1). Proposed requirements and directives from the Chinese (2), Japanese (3) and EU (4) authorities include the responsibility of the brand owner to “take-back” post-consumer packaging and packaging producers to be fiscally and physically responsible for their products at the post consumer stage of their life cycle. Currently, there are no legislated requirements in the USA except for nickel-cadmium batteries.

Most shipments of pharmaceuticals to consumers such as physicians, pharmacies, hospitals, and patients, particularly most injectables and biologicals, utilize EPS packaging, which usually become landfill items. The Alliance of Foam Packaging Recyclers has posted a resource document on its website listing available recycling / reclamation sites in the United States for EPS packaging (5). Solutions using biodegradable, reusable, and sustainable materials in the construction of the small shipper packages would address the previously discussed environmental challenges.

This article presents a model for a program for the renting or leasing of small reusable package shippers for temperature – controlled products where the customer could rent a container on a per trip basis to ship its product from its location to the destination. The high tech container guarantees transporting the goods successfully. In addition, the cost of the rental of the reusable small container is less than the cost of purchasing a container that is used once and is then discarded.A turnkey, all inclusive service could be provided by logistics integrators that would include the container rental, the freight cost, customs clearance, and the handling fee in one set price.

Reusable containers have been proposed for many years, but unless a company has a closed loop system, they are not usually economically feasible. The two main reasons that reusable containers have not been feasible are the containers change from an expense to an asset which then must be managed and the cost of returning the containers for inspection, cleaning, and repair negates the advantages.

Sustainable Reusable Pallet Shipper Model

Currently, a successful model for reusable actively cooled pallet sized containers is operated by some companies.  The two main reasons this pallet shipper model is successful are the customer does not own the container and only pays for the shipment and the container does not have to be returned to the origin. It is sent to the nearest depot, thus reducing the return cost.

Sustainable Reusable Small Package Shippers

A similar system is needed for shipments of small packages since many more of them flow through the cold supply chain than pallet sized bulk container shipments. Currently, the majority of these small package shippers end their life cycle as landfill.

The small reusable package shipper industry needs to implement a set of standardized specifications for reusable containers for shipping through the cold chain. These high tech reusable containers would be qualified for all types of shipping configurations and for different temperature extremes for the lanes over which they move. If a central industry data base is established, then, each shipment of these containers would add to the qualification data base and strengthen the qualification model thus eliminating the need for extensive testing for every new product entering the market.

The specification of the small reusable package shippers should include:

• The container must be well built to withstand the harsh handling in commercial shipping systems and must be capable of numerous shipping cycles.
• Loading of the container is simple without a complicated pack out procedure.
• The container must have an active temperature control so it automatically adjusts to the ambient temperature.
• The container must automatically handle winter or summer shipping profiles, and ship hot – arrive cold, or ship cold – arrive hot profiles.
• The container must tolerate extended durations at hot or cold temperatures without allowing temperature excursion of the product.
• The container must have a high payload volume to tare weight ratio.
• The container must have a dual channel logger to measure the ambient (environment) and internal temperatures of the product.
• The logger must quickly download the data via an on-board global Internet system. Thus, within minutes, the product would be approved for use.

Current industry best practices, as per PDA Technical Report No. 39 (6), is to perform
Design / Component Qualification (DQ /CQ), Operational Qualification (OQ) and Performance Qualification (PQ) for the development of a package shipper and the qualification of a specific shipping lane. However, in the future, using this standardized container and the industry qualification database system model described above, all a company must do to get a product to market is design its primary and secondary packages to maximize the cube in one of the standard container sizes and the job is finished. The need for extensive thermal testing is eliminated since the qualification data base created from thousands of live shipments can be used to qualify the use of the standard container in the required lane.

The success of the shipping system for small reusable package shippers requires the establishment ofdepots at various geographical locations to accept containers so they do not have to be shipped back to the originating location. The receiving customer of the small reusable package shipper would unload the material and then route the shipper to the nearest depot in the shipping system where it would be cleaned and prepared for its next use. In contrast, a use-once–and-discard shipper would become landfill. In some European countries such as Germany, it would have to be shipped out of the country or the shipperwould have to pay special disposal fees since disposal of EPS or PUR is not permitted in landfills (7).

Shipping models

Two different shipping models should be considered. The first will be the pay per trip model where the container will be ordered from the depot conditioned and ready to accept the customer product. The container will be brought to the customer location by the driver. The material will be loaded while the driver waits. The driver will take the container to the airport where it will depart on the designated flight. At the destination airport, the container will be picked up and taken to the destination. On arrival at the consignee’s location, the driver activates the logger to transmit the temperature data over the cellular network so the material can be deemed fit for use. The container will be opened and the material will be unloaded. The driver will take the container away and route it to the nearest depot. This shipping model is currently in operation in the United States and Europe. It is also offered by logistics integrators as a turnkey solution. For example, Company A in cooperation with Company B , will deliver a fully-charged dry LN2 shipper (used to ship cells, tissue and other cryogenic substances) to a customer. After loading the product into the shipper, the customer notifies Company B who picks up the shipper, and delivers it to the customer-chosen destination. When the customer is finished unloading the LN2 shipper, Company B picks it up and returns it to Company A for refurbishing and recharging with liquid nitrogen and the cycle is repeated.

The second is the leasing model. It consists of a customer leasing a quantity of containers that are maintained at the customer’s site. The customer is responsible for conditioning the containers and preparing them for shipment. The customer can contract an integrator for the shipping service or it can handle the logistics itself. At the end of the trip, the consignee is responsible for activating the logger to transmit the temperature data, unpacking the product, and then routing the container to the destination depot. As soon as the container is received by the destination depot, a replacement container is shipped to the customer from a depot near the originating location. The container lease could be paid monthly for a term of 36 months as an example. The lease payments include annual inspections and annual recalibrations of the logger. A depot handling fee will be charged by the destination depot.

In a recent article, the author indicated that “There is a developing trend among packaging providers of insulated packaging systems to issue to its customers pay-per-use, high-performance insulated packaging” (8).He addressed the implementation of the leasing or renting system for healthcare products as it relates to total cost of ownership for insulated packaging systems. His conclusion was that when the total cost of ownership is considered, the pay-per-use system is competitive.

Conclusion

With a strategically located depot system where the customer can rent or lease small reusable package shippers for temperature-controlled products, the reusable container program becomes economically feasible and environmentally friendly. In addition, the customer benefits from the elimination of the high cost of cold chain package development. The reusable container is much more sophisticated than the standard one-way foam and gel pack container which virtually guarantees a successful shipment thus reducing product scrap due to temperature excursions. All these benefits are realized without the customer having to invest in a large inventory of its own reusable shipping containers. Finally, at the end of its useful life, the reusable container would be returned to the manufacturer who would recycle all possible content and properly dispose of the remainder.

Acknowledgement

The author would like to acknowledge the cooperation of Mr. John Howe, Active CC Boxes, LLC, and Edward J. Smith, Ph.D. PACKAGING SCIENCE RESOURCES, Pharmaceutical Packaging Training and Consulting,in preparing this article.

References

(1) PDA Technical Report No. 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User; Parenteral Drug Association: Bethesda, MD, 2009.
(2) China: http://www.researchandmarkets.com/categories.asp?cat_id=329.
(3) Japan: JIS Q 0064:1998: Guide for the inclusion of environmental aspects in product standards
(4) EU: http://www.greendotcompliance.eu
(5) USA: www.epspackaging.org
(6) PDA Technical Report No. 39 (Revised 2007): Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment; Parenteral Drug Association: Bethesda, MD, 2007.
(7) The Recycling and Waste Act – Federal Republic of Germany 7 October 1996
(8) Kevin O’Donnell, “No Deposit, No Return?- Considering Total Cost of Ownership for Insulated Packaging Systems”, Contract Pharma,November/December, 2010, 32-34.

About the Author:

Rafik H. Bishara, Ph.D., Is a Technical Advisor, and the Chair of Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA).

To learn about cold chain shipping containers, let’s start with definitions taken from the World Health Organization (WHO) publication “Model requirements for the storage and transport of time and temperature sensitive pharmaceutical products”.

Active systems: Actively powered systems using electricity or other fuel source to maintain a temperature-controlled environment inside an insulated enclosure under thermostatic regulation (e.g. cold rooms, refrigerators, temperature-controlled trucks, refrigerated ocean and air containers).

Passive systems: Systems which maintain a temperature-controlled environment inside an insulated enclosure, with or without thermostatic regulation, using a finite amount of pre-conditioned coolant in the form of chilled or frozen gel packs, phase change materials, dry ice or others.

Both of these definitions refer to “thermostatic regulation” which is active temperature control. The thermostat provides the intelligence in the container to make the decision to activate cooling when the temperature inside the insulated enclosure rises and deactivate cooling when the internal temperature drops.

In the cold chain shipping industry, the normal tendency has been to think that a system must be an active system to have active temperature control, but such is not the case. I applaud the WHO for including the phrase “with or without thermostatic control” in its definition of a passive system. A thermostat can be designed into a passive system and the resulting system does not require any external power or fuel source, but can regulate the temperature just like an active system that requires power to operate.

Utilizing this new technology, a passive cold chain shipping container will make the decision when to cool and when to stop cooling, while actively controlling the internal temperature,. This eliminates the need for various packing protocols used to create passive packages that do not have active temperature control.

Without the need for different packing protocols such as “ship hot, arrive cold” or “ship cold, arrive hot”, a company can ship from the northern hemisphere in the dead of winter to the southern hemisphere where it is the middle of the summer without having to take any special precautions. The active control in the passive container compensates for the wide swings in ambient temperature.

How does it work?

The passive cold chain shipping container with active thermal control uses a thermostat that senses the internal temperature in the container. When the internal temperature rises above approximately 5°C, the thermostat connects a conduction path to allow the heat in the container to flow to the “heat sink” of frozen phase change material (PCM). When the internal temperature drops below approximately 5°C, the thermostat disconnects the conduction path to stop the cooling.

In order to prevent the flow of heat from the payload area of the container to the frozen PCM except when the thermostat permits it, the PCM must be separated from the payload area. This is accomplished by vacuum panel insulation that separates the PCM from the payload area. The thermostat and the conduction path are installed through a penetration in this insulation so heat can flow through the conduction path to the PCM when the thermostat turns on the cooling.

As you can appreciate, a passive cold chain shipping container with active control has a distinct advantage over a completely passive container. The active thermal control compensates for unpredicted ambient temperature events during transit, and it eliminates the need for the various packing protocols required by passive packages that do not have active temperature control. In cold weather, active thermal control stops cooling where a passive package without temperature control continues to cool which potentially freezes the payload.

Most active systems are pallet sized shipping containers which are great for large, bulk shipments. However, there is more volume of small package shipments and this is where the passive system with active thermal control will primarily be used. It is much smaller and lighter than the smallest active system.

In conclusion, a passive cold chain shipping container with active temperature control will revolutionize the cold chain small package shipping industry.

John V. W. Howe is CEO of Active CC Boxes, LLC. His company develops, manufactures, sells, rents, and leases high tech cold chain shipping containers for the pharmaceutical and biotech industries. For more information visit the Active CC Boxes website at http://www.activeccboxes.com.

Article Source: http://EzineArticles.com/?expert=John_V._W._Howe

I presented a case study at the most recent IQPC Cold Chain & Temperature Management Summit in Toronto.  I appreciate and thank those who attended the session.  There were some great questions raised about the merits of renting/leasing versus other options.

If you did not attend, I have attached the Power Point presentation for your viewing.

A Case Study of Rental and Leasing Systems Final 2-23-11

John Howe