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Health & Personal Care Logistics Conference

Written on November 6, 2012 at 7:46 pm, by

Just last month, members of the CSafe team attended the fall annual Health and Personal Care Logistics Conference and found a number of topics to share as this month’s Blog posting.  The conference website, at http://hpclcnet.org/, describes the conference organization as a group of logistic professionals, holding conferences designed to continually examine the logistics field and provide a forum to discuss, examine, and exchange ideas with its peers.  The conference programs keep its members current with the latest industry research and logistics trends, as a resource for pertinent case studies and technology updates.

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.

 [2] “CFO Magazine,” September 1, 2012, Freed from the Budget: Many companies see budgeting as a time-consuming exercise of limited value. Some are resorting to a radical fix: getting rid of the budget by Russ Banham.

 

HURRICANE SANDY CSAFE UPDATE

Written on October 31, 2012 at 8:42 pm, by

CSafe is ensuring that all affected East Coast United States airports will have access to the CSafe RKN.  This will include the movement of RKN’s from the service centers in Chicago, Memphis and from CSafe’s manufacturing facility in Ohio to partners in New Jersey and New York while the Newark and JFK service centers come back online.  We have continued to increase the size of our fleet and are confident that all incoming requests can be fulfilled.  We are committed to ensuring CSafe products are, and will continue to be, available during this time.  CSafe is also making available its passive and active cold chain packaging products to relief agencies and medical facilities impacted by the storm.  With up to five days hold time, CSafe products can prevent loss of temperature sensitive medical supplies.

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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Lane Mapping

Written on September 20, 2012 at 8:34 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
http://acutemp.com

Dayton, Ohio, USA, August 10, 2012

Last month’s AcuTemp blog posting gave some insight into the standards and guidelines offered by the International Safe Transit Associations (ISTA) used to ensure product safety during the transport of temperature sensitive materials. In keeping with the quarter’s discussion, this month’s blog posting will look at the process of lane mapping and its importance to validating temperature-sensitive product transport.

The FDA Guideline on General Principles of Process Validation, states that the purpose of validation is to “[Establish] documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” In other words, for the cold chain industry, process validation means that operators can have the confidence that shipping processes will consistently get the temperature-sensitive products they transport to their intended destinations intact. One way to ensure process validation is through lane mapping.

Lane mapping is a way to ensure industry compliance and/or identify necessary improvements in the transport process of temperature sensitive shipments in advance of regulator evaluations and in order to give companies a better understanding of their cold chain operations. Experts in this field believe that a regular program of temperature testing and lane mapping dramatically improves the effectiveness of a cold chain logistics program. There are a number of data collected during the lane mapping process:

• Distribution Maps are mapped layouts of the various transfer / transition points within the cold chain from the beginning of a product’s transport to its destination.
• Distribution Lanes are the paths followed throughout the transport process, taking into consideration season and weather conditions.
• Distribution Lane Frequency represents the number of shipments to be transported throughout the test period.
• Distribution Lane Volume is the number of packaged or palleted items transported.
• Distribution Lane Performance is a post-test data collection of the number of temperature sensitive excursions versus the number of successful deliveries.

The transfer of temperature sensitive materials is a complex process with numerous variables playing differing roles in its success or failure. Examples of these variables include temperature, humidity, airflow, transport shipper design, transport and facility layout, product storage locations, traffic patterns, HVAC performance, and seasonal extremes.

Of particular importance to the validation of a shipping operation is the broader consideration of time. Both time of day and time of year can have a tremendous impact on the temperature variation of temperature sensitive materials. Time of day is of importance for a number of reasons, including that exposure to the sun may show differing results from one transport vehicle to another, which is often dependent on the packing of that vehicle; and, that temperatures fluctuate throughout the day and evening. Collecting data points at varying times throughout the day reveals different results; a therefore equivalent data point is collected at a minimum of twice per year, and during the rest of the year lane tracking is performed with indicators that are set to capture unexpected or unprepared circumstances. Seasonal temperature changes can have an obvious impact on shipments; so, lane mapping must take into consideration seasonal weather changes when planning the validation process.

Thus, lane mapping allows those who work to safely and effectively transport temperature sensitive materials have an internally operated way to validate that their operations meet and maintain required industry standards. Next month’s blog posting will look at the value and use of another important validation process, the temperature profile.

About AcuTemp

The AcuTemp mission is to enhance the efficiency and effectiveness of the temperature-controlled supply chain. The company’s product offerings make previously unachievable commercial and industrial applications possible. Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The bottom line: AcuTemp’s products offer a rugged, efficient, lower cost, lower risk solution for the quality oriented cold chain strategy. As a leading supplier of thermal management solutions, AcuTemp serves the need of industry and government to meet their cold chain needs. AcuTemp is a trusted partner with the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

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ISTA Regulations

Written on September 13, 2012 at 2:42 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277

http://acutemp.com

Dayton, Ohio, USA, July 2012

Each quarter the AcuTemp blog introduces a new topic, pertinent to the operations of those in the cold chain industry. The blog postings are an excellent way to stay informed about industry standards, procedures, and processes. AcuTemp’s third quarter blog topic will begin with a detailed look at the International Safe Transit Associations (ISTA) . ISTA is one of a number of organizations that provide programs, services, and activities significant to cold chain operators. The examination of ISTA will be followed over the following two months by postings on a number of important testing-related operations, including lane mapping and temperature profiles.

As mentioned above, ISTA is just one of a number of organizations that address cold chain standards and guidelines.

• The American Society for Testing and Materials (ASTM) are developers of international technical standards for materials, products, systems, and services.
• The Parenteral Drug Association (PDA) and its subgroup, the Pharmaceutical Cold Chain Discussion Group (PCCDG) is an informational exchange group that educates its members on global distribution and shipping of temperature-sensitive medicinal products through trade and regulatory organizations. This group also develops guidelines and proposes standards for validation of shipping and distribution of the products.
• The U.S. Pharmacopeia provides manufacturers, distributors, and transporters with assistance in handling pharmaceutical items.

That brings us to the focus of our posting, the International Safe Transit Association. ISTA develops and delivers standards, educational programs, and tools for the economic, social, and environmental optimization of packaging systems. ISTA members include shippers who manufacture and distribute products, carriers who provide the distribution means, organizations that supply packaging materials and services, and testing laboratories that perform packaged-product performance tests.

ISTA Testing
ISTA’s Performance Tests result in a Pass/Fail assessment that can be used to determine the viability of a packaged-product to endure ordinary shipment. Development Tests compare relative performance of two or more designs or the same design from different suppliers. Test protocols are grouped into what ISTA calls Series that move from non-simulation of transport environmental hazards through simulation in general or broad terms and finally to a test developed from a comprehensive collection of field data.

In an interview at the time of AcuTemp’s first testing facility certification by ISTA , its manager, Pam Jones underscored that “product testing and validation through our ISTA certified lab has been essential to supporting the needs of our customers for safe transport of their products. Because AcuTemp products are utilized to transport or store critical and often life-saving cargo, it is essential that our customers have peace of mind that their cargo will reach its destination without compromise.”

ISTA’s 7D and 7E Test Procedures
Most important to the cold chain industry are ISTA’s testing procedures for temperature transport. Its Test Procedure 7D is a development test to evaluate the effects of external temperature exposures of individually packaged-products. It is designed to measure the relative ability of a package to protect a product when exposed to test cycles of temperature conditions. The 7D procedure is supplemented by the 7E Test Procedure, the most current simulation of the thermal environment, including the thermal testing of insulated shipping containers in the parcel delivery system.

ISTA Education
ISTA regards Education and Networking crucial in an industry where up-to-date knowledge is more important than ever. ISTA offers numerous educational opportunities to keep current with relevant industry issues, advances in innovations, and best practices in transport packaging.

Over the next two months, our postings will take a look at efforts in developing prequalified shippers through lane-mapping studies and temperature profiles.

About AcuTemp

The AcuTemp mission is to enhance the efficiency and effectiveness of the temperature-controlled supply chain. The company’s product offerings make previously unachievable commercial and industrial applications possible. Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The bottom line: AcuTemp’s products offer a rugged, efficient, lower cost, lower risk solution for the quality oriented cold chain strategy. As a leading supplier of thermal management solutions, AcuTemp serves the need of industry and government to meet their cold chain needs. AcuTemp is a trusted partner with the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

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New Report Finds Program’s Improper Storage of Immunizations a Threat to Children

Written on August 6, 2012 at 12:56 pm, by

AcuTemp Thermal Systems

2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
http://acutemp.com

Dayton, Ohio, USA, June 11, 2012

The Vaccines for Children Program (VFC) provides immunizations to children whose families are unable to afford them.  The program ensures that children are better able to acquire necessary, often life-saving vaccinations protecting babies, young children, and adolescents from over a dozen diseases.  The VFC vaccinations are endorsed by the Advisory Committee on Immunization Practices (ACIP) administered by the Centers for Disease Control and Prevention (CDC) that purchases and distributes the vaccines to private and public healthcare members.  Because of the CDC’s work, approximately 80 million vaccines have been distributed to over 40 million children of low-income homes at a cost of approximately $3.6 billion.

Recently, an investigation by the Department of Health and Human Services’ Office of the Inspector General (HHS OIG) has brought great scrutiny and concern to the program’s operations after its report found that many of the program’s doctors are improperly storing vaccines, putting their efficacy in question.  The new government report obtained exclusively by ABC News found that many of the approximately 44,000 offices and clinics participating in the program do not store their vaccines at suitable temperatures and that their improper storage represents a major breakdown in the program’s management process.  During the investigation, the VFC visited the offices of 45 providers in five states that offer free immunizations as part of the program to verify that their operations meet the HHS OIG’s requirements for delivery and storage.  Over three-quarters of the immunization providers were storing vaccines at a temperature either higher or lower than specifications.  More broadly, it was found that not one of the providers properly managed the vaccines according to all of the VFC program requirements, falling short with both on-site storage and the delivery of vaccines to and between individual clinics and their satellite sites.

In response to the report, the HHS OIG recommended that the CDC take the necessary steps to ensure that those taking part in the VFC program “do their jobs.”  Dwayne Grant, the regional inspector general for the Office of Inspector General in Atlanta, stressed the importance of the CDC working closely with the grantees and providers to ensure that vaccines are properly stored during transport and at on-site environments.  While there has been a consensus that the VFC program has helped protect many children from preventable diseases, those involved also acknowledge there are issues with the transport logistics and storage management processes that are designed to ensure the safety of these temperature-sensitive products.  A root cause analysis of the investigation’s findings has identified equipment changes and selection at the end stages of the cold chain process as the key factors in the development of the current problems.  Increased quantities and variations in prescribed vaccines have placed a heavier burden on storage requirements during the delivery to and storage within provider locations.

Those taking part in the investigation emphasize how important it is that these issues have come to light, and point out that everyone involved must take part in the solution.  First and foremost, they stress that parents must continue to get their children immunized.  In addition to this, they feel it is the parent’s responsibility to question their doctors as to where vaccines are stored and how they are transported and handled.  Doctors also have an extremely important role to play in addressing these issues.  Not only must they take greater responsibility for the monitoring and maintenance of vaccine storage temperatures while on-site, they must also insist that those transporting temperature-sensitive vaccines are doing their part to ensure proper temperature ranges during transport.  According to Dr. William Schaffner, chair of preventive medicine at Vanderbilt University Medical Center:

 We want every dose given to every child to provide the optimum protection as it’s intended,[to accomplish this] the temperature has to be monitored throughout the entire time, from the time it leaves the manufacturer to the time it spends in transit to the time it’s delivered to the clinic and it’s used in the clinic.

It is in the design and delivery of solutions for the transport stage of the logistical cold chain process that AcuTemp has become a global leader.  AcuTemp offers both active and passive transport solutions that meet HHS OIG’s requirements by replacing what some pediatricians describe as the “large Styrofoam containers” that are used throughout the program’s current operations.

AcuTemp AX27L mobile refrigeration units are energy efficient, precisely controlled, and transportable.  Designed to safely store or transport critical vaccines, drugs, specimens, and other bio-medical materials to the point of use, the units are capable of running up to five days on battery power only and are certified for in-flight operation.  The AcuTemp AX27L has become an essential component in vaccine and drug distribution around the world.  Furthermore, the AcuTemp AX27L can be used in conjunction with the AcuTemp PX1L portable carrying case and AcuTemp PXC coolant packs for a complete distribution system.  These units are built with AcuTemp’s ThermoCor high performance insulation technology that has an R Value up to 45 per inch thickness (0.00312 W/mK) – the highest in the industry, and can maintain crucial vaccines, drugs and other bio-medical payloads at required temperatures for up to 60 hours in refrigeration mode with no power while ensuring integrity at point of use.  The AcuTemp PXC Coolant Packs are made of a phase change material that enables the packs to maintain specified temperatures for long periods.  These AcuTemp solutions are an extremely reliable, cost-effective way to ensure the safety of temperature-sensitive materials.

About AcuTemp

The AcuTemp mission is to enhance the efficiency and effectiveness of the temperature-controlled supply chain.  The company’s product offerings make previously unachievable commercial and industrial applications possible.  Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The Cold Chain Industry’s Support of Disaster Stricken Communities

Written on June 2, 2012 at 2:08 pm, by

AcuTemp Thermal Systems

2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
http://acutemp.com

Dayton, Ohio, USA, May 20, 2012

acutempbldgWith a number of manmade and natural disasters striking both at home and abroad over the past decade, the focus on the safe and reliable transport of temperature-sensitive, lifesaving supplies has become a more pressing priority than ever before.  Hurricanes, tornadoes, earthquakes, tsunamis, and wars have resulted in electrical outages, floods, and droughts effecting millions.  Besides the human cost that these natural and manmade tragedies produce, the financial and business losses are often exorbitant.  Millions of dollars are lost when medicines, medical supplies, and perishable food products are exposed to conditions beyond specified temperature ranges.  Dealing with the aftermath of these catastrophes requires an emergency response that is immediate and effective.  To mitigate these losses, many in the cold chain transport industry have bolstered their emergency response offerings, making available the necessary products and services to transfer mission-critical and life-saving biologics, pharmaceuticals, and medical supplies.

An example of these efforts can be found in AcuTemp Thermal Systems’ reaction to the tragic events in Haiti after its recent disaster.  The earthquake of January 12, 2010 brought widespread death and destruction to the already impoverished Caribbean nation.  In its immediate aftermath, a number of companies, foundations, and organizations stepped forward to offer assistance.  One of the most crucial needs was the ability to transport temperature-sensitive, life-saving supplies through often rough terrain to those in need.  Echoing the thoughts of all of its employees, Brian Kohr, President of AcuTemp stated,

 ”We are deeply saddened by the tragic earthquake in Haiti … Because of the desperate need; we are offering our solutions to relief agencies that are administering medical aid to the victims.  We know the importance of keeping life-saving blood, medicines, and other medical supplies at the right temperature to ensure they are usable, so offering our products for this cause is the best way for us to help the victims of this disaster that are suffering so greatly.”

AcuTemp made available a number of products to relief agencies that included their passive insulated shipping boxes and active mobile containers such as the company’s AX27L and AX56L mobile refrigerator / freezers and the AX2100LG refrigerated pallet sized container that runs on either AC or battery power with the former also running on solar power.  Because of their rugged, time-tested construction, the AcuTemp active mobile containers have been an exceptional solution to the rigors experienced in disaster stricken areas.  In addition to this, the company’s contributions to these communities, has led to expanded partnerships with regional providers in Asia, the Middle East and South America.  AcuTemp’s expansion into these areas has been unique in that its cold chain product offerings represent both active and passive technologies.  The pairing of these industry-leading technological advances and the company’s client-centered business practices has resulted in the establishment of a worldwide network of regional transportation service providers.

From the point of view of the manufacturer, the transport of pallet-sized loads of temperature-sensitive products into diverse countries may not in itself be particularly challenging.  It is the next step, the delivery from the airfields of major cities to a community’s remote localities that heightens concerns.  AcuTemp’s extensive experience in supplying containers for blood collection, delivery and vaccines, which occurs “in-country,” has given the company unique insights into these challenges and the capability to create successful solutions to address them.  Along with the more traditional passive containers, the AcuTemp product line includes battery-powered and solar powered, active transport containers that are extremely adaptable to local conditions.  Because these active containers can be reused, local agents typically acquire a stock of active containers to address their needs over periods of years.

About AcuTemp

The AcuTemp mission is to provide solutions to the cold chain to ensure successful shipment of life saving and life-enhancing products.  The company’s revolutionary product offerings make previously unachievable commercial and industrial applications possible.  Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The bottom line: AcuTemp’s products offer a rugged, efficient, lower cost, lower risk solution for the quality oriented cold chain strategy.  As a leading supplier of thermal management solutions, AcuTemp serves the need of industry and government to meet their cold chain needs.  AcuTemp is a trusted partner with the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care.  Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry.  When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

 Sources

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

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.  (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

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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The Cold Chain Community Response to the Expanding Needs of Emerging Markets

Written on June 2, 2012 at 1:20 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277

http://acutemp.com

Dayton, Ohio, USA, May 20, 2012

UNICEF leads the world in the distribution of vaccines to the developing world. As a globally recognizable representative, Ewan McGregor, recently highlighted the organization’s work when he hosted a two-part BBC series on the difficulties of making available immunizations to protect vulnerable children from preventable diseases in the most difficult to reach areas of the world. The fragile vaccines he was helping to deliver require specific methods of transportation that have been unavailable on a consistent basis until recent years.

The process of effectively transporting temperature-sensitive pharmaceuticals and biologics is a multidimensional endeavor, which is made even more challenging when occurring in developing countries where the logistical infrastructure does not exist. To be successful, the process requires stable and reliable packaging that is capable of maintaining specified temperatures throughout the duration of transport and a clear and concise set of communications between all of those involved. While these cold chain packaging and transportation logistics have become increasingly sophisticated over time with both shipping container technology advances and communications enhancements throughout the cold chain distribution cycle, the rapid growth of new cold chain markets throughout Asia, Africa, Latin America, and other emerging markets presents new challenges.

The greatest example of the effects of developing immense pharmaceutical and biologics markets can be found in Asia, where China and India have become key drivers of the advancements made in cold chain strategies and the industry’s approach to changing regulatory requirements. This assimilation of diverse, developing markets taxes the cold chain industry on both infrastructural and logistical levels. The growth rate of Asia’s cold chain market alone is projected to be almost double that of the rest of the world over the next few years. This booming demand has added urgency to the ongoing efforts to streamline cold chain distribution processes and increase the efficiency of cold-chain-related infrastructures. The challenges of delivering critical, temperature-sensitive cargo to remote locations that have little, if any, infrastructure to support the already complex cold chain processes are enormous. In the expanses of large countries like China and India, products must be transported across numerous, disperse cold chain transport points. It is at these crucial transfer points that temperature-sensitive products might be exposed to extended waiting periods and extreme temperatures that result in irreparable damage, or complete elimination of viability, to lifesaving cargo.

To address these concerns, the international cold chain community continues to make great strides in the coordination, consolidation, and standardization of distribution systems by nurturing emerging markets toward becoming active contributors in the global cold chain effort. AcuTemp has played a key role as part of this community by going beyond simply developing cold transport shipping containers, to designing technological innovations and creative processes that ensure the maintenance of specified temperature ranges under varied scenarios. The company’s efforts have had an exceptional impact in the following areas:
• Overseas transit
• Extreme ambient temperature environments
• Large ambient temperature swings
• Remote point-of-use destinations
• Extended periods without available grid power
• Military and relief missions
One key to AcuTemp’s success lies in its sophisticated testing equipment and experienced technical staff who test and qualify existing packaging and develop and validate new insulated containers and thermal management solutions. This testing/qualification and development/validation can be performed to a variety of industry standards or protocols. Using numerous environmental test chambers, advanced data acquisition systems and a selection of sophisticated control and analysis software, AcuTemp has the ability to confirm internal payload temperatures under wide-ranging ambient conditions. And, through the use of portable acquisition systems, the company can validate the performance of insulated shippers under actual field conditions. When it comes to addressing the global changes occurring in emerging markets, these capabilities and others make AcuTemp an important member of the international cold chain community.

About AcuTemp

The AcuTemp mission is to deliver cold chain solutions that improve the quality of human life. The company’s revolutionary product offerings make previously unachievable commercial and industrial applications possible. Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a great increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The bottom line: AcuTemp’s products offer a rugged, efficient, lower cost, lower risk solution for the quality oriented cold chain strategy. As a leading supplier of thermal management solutions, AcuTemp serves the need of industry and government to meet their cold chain needs. AcuTemp is a trusted partner with the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

Sources

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

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. (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

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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PHARMACEUTICAL COLD CHAIN LOGISTICS: COMPLIANCE AND CERTIFICATION

Written on April 24, 2012 at 2:10 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439 Map
Phone: +1.937.312.0114
Fax: +1.937.312.1277
www.AcuTemp.com

Dayton, Ohio, USA, April 15, 2012
The Special Needs of a Pharmaceutical Cold Chain
A recent criminal case in the state of California highlighted the complexities of transporting temperature sensitive pharmaceuticals. In a plea agreement with the United States Attorney’s Office, an individual admitted to the illegal transfer of foreign drugs to the U.S. The illicit operations were discovered when a nurse receiving the medicines noticed what they described as “a gooey mess.” The substance they had noticed came from a number of leaking cold packs. Because of the leakage, the drugs were found to be “adulterated” in that the methods of their storage and shipment were not appropriate and did not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of prescription drugs. (Town and Country, 2012, para. 11)
Storage methods and external protections are critical components of a well-operating pharmaceutical cold chain, as is the ability to maintain specific temperatures over extended periods. The medications confiscated from the criminal activities included the critical cancer chemotherapy drugs Neupogen® by Amgen Inc, a prescription drug typically intravenously infused into cancer patients; and Herceptin®; and Rituxan® by Genentech Inc.. All of these medications must be maintained in an environment with a temperature between 2° to 8°C (36° to 46°F) and cannot be left at room temperature for a period longer than 24 hours, or frozen.

This exemplifies the complex requirements of temperature sensitive medications, and shows why many of those requiring the safe transfer of their pharmaceuticals rely on experienced partners like AcuTemp to ensure their products’ safety.

Learning More about the Transfer of Temperature Sensitive Pharmaceutics
There are a number of resources available for those who wish to get a clearer picture of the necessary legal requirements and best practices for developing a quality pharmaceutical cold chain. These include:
The Food and Drug Administration (FDA)
The United States Pharmacopeial Convention (USP)
The International Safe Transit Association (ISTA)

The Food and Drug Administration (FDA)
The FDA regulates pharmaceuticals in the United States, and has codified regulations regarding the storage and handling of pharmaceuticals. In the Code of Federal Regulations, Title 21, Sub-chapter C, Part 205 Sec. 205.50(c), the FDA has established guidelines that address a review of facilities, security, and storage. In addition, the FDA has provided guidelines on the examination of materials, proper record keeping, establishing written policies and procedures, and identifying the chain of responsibility (U.S. Food and Drug Administration, 1992). An example of the critical nature of effective cold chain management in pharmaceuticals is in PET (Positron Emission Tomography) drugs. The FAA has specifically listed PET drugs for special shipping concerns due to their unique nature. Often, PET drugs must be administered within hours of their manufacture (U.S. Food and Drug Administration, 2009).

The United States Pharmacopeial Convention (USP)
The United States Pharmacopeial Convention provides general guidance concerning the storage, distribution, and shipping of Pharmacopeial preparations. It describes the procedures necessary to maintain proper storage environments for individual articles and to ensure the medication’s integrity and appearance, until it reaches its intended destination (U.S. Pharmacopeia, n.d.).

The International Safe Transit Association (ISTA)
The ISTA has established guidelines for manufacturers’ evaluation of their own shipping and storage environments. The association assists manufacturers in the selection of test protocols and assessment processes to evaluate their operations from point of manufacture to end user. Their guidelines are available at http://www.ista.org/forms/ISTAGuidelines.pdf (International Safe Transit Association, 2012).
Pharmaceutical Cold Chain Compliance in Practice
There are a number of questions an organization must ask when considering their pharmaceutical cold chain compliance:
What are the risks of various forms of transport?
Are employees trained to handle temperature sensitive or delicate cargo?
Which storage and equipment products will protect medications while monitoring temperature and environment?
What temperature range is needed: Frozen … varied temperatures … controlled room temperature?
To answer these questions an organization must implement a management system to control and track cold chain shipments. They must create best practices, find vendors with a long term and experienced record of successful engineering and manufacturing of cold chain shipping containers; and seek out vendors with certifications.

AcuTemp is a leader in the development and manufacture of passive thermal systems for temperature-controlled management. The company’s proprietary ThermoCor technology allows for a significant reduction in the amount of dry ice necessary for the shipment of temperature sensitive materials. These capabilities allow savings of up to 30% over PUR and EPS passive solutions, making AcuTemp the perfect partner for pharmaceutical cold chain management.

About AcuTemp
AcuTemp Thermal Systems is a leading supplier of thermal management solutions for the pharmaceutical, biotechnology, medical device, and public health industries. AcuTemp is also a trusted partner for the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

Sources:

International Safe Transit Association. (2012). Guidelines for Selecting and Using ISTA® Test Procedures and Projects. Retrieved from http://www.ista.org/forms/ISTAGuidelines.pdf .

Town and Country (2012): Woman Pleads Guilty To Supplying Town And Country Doctor With Altered Cancer Drugs. Manchester, MO. Available online at http://townandcountry-manchester.patch.com/articles/woman-pleads-guilty-to-supplying-town-and-country-doctor-with-altered-cancer-drugs-to, checked on 9/04/2012.

U.S. Food and Drug Administration. (1992). Compliance Policy Guides: CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act – Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b). Retrieved from http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074367.htm

U.S. Food and Drug Administration. (2009). Guidance: PET Drugs – Current Good Manufacturing Practice (CGMP). Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070306.pdf

 

ACUTEMP DRY ICE FROZEN SHIPPING: LESS DRY ICE, LOWER WEIGHT, LOWER COSTS

Written on March 29, 2012 at 10:26 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
http://acutemp.com

Dayton, Ohio, USA, April 15, 2012

AcuTemp Thermal Systems is one of the leading suppliers of cold chain packaging for the pharmaceutical, biotechnology, medical device, public health, and defense industries. AcuTemp has exhibited an ongoing dedication to providing innovative, life-saving solutions as a leader in the cold chain industry. With the announcement of another addition to its line of Frozen Packaging Solutions, AcuTemp has once again enhanced its offerings to meet the ever-changing needs of those shipping temperature sensitive materials. AcuTemps’ ThermoCor Vacuum Insulation (VIP) has been integrated into a revolutionary, cost-saving, cold chain packaging system designed to replace current dry ice solutions.

Advantage of the AcuTemp ThermoCor VIP

The AcuTemp ThermoCor VIP is a state-of-the-art thermal management system designed to help companies, organizations, and institutions improve their cold change effectiveness and efficiency. Because of the ThermoCor VIP’s increased R-Value, it has a significant advantage over polystyrene (EPS) and polyurethane (PUR) solutions, and its rugged and long lasting construction ensures the security and protection of temperature-sensitive shipments.

R-Value Advantage

While EPS and PUR containers have long been considered the workhorse of the cold chain industry, these passive cold chain packaging solutions are shown to have a major disadvantage when compared to AcuTemp’s new offering. When it comes to R-Value, the ThermoCor VIP is a dramatic improvement over its predecessors. The EPS and PUR R-values measure at a mere 3-6 per inch of thickness, respectively, which cannot compare to the ThermoCor VIPs’ impressive R-value measurement of 45 per inch of thickness. This tremendous difference in R-Value results in a significant reduction in the amount of dry ice needed for a given payload, given duration providing a more streamlined packaging, and improved operational efficiency, all of which are a significant source of cost savings and reduced risk to cold chain shipments.

Integrity and Stability Advantage

AcuTemp’s ThermoCor VIP solution addresses the damaging effects on product integrity and stability caused when using traditional EPS and PUR products, like when temperature-sensitive materials are over exposed to extensive quantities of dry ice. Integrity and stability are also apparent in AcuTemp’s focus on quality. The company has been producing panels for more than ten years and the company’s stringent life test protocols are designed to ensure the longest product life, making its’ 27 different payload sizes ranging with durations from 24 to 192 hours one of the best choices for frozen packaging solutions.

ThermoCor VIP and the Bottom Line

By reducing the amount of dry ice required for temperature sensitive materials, shippers can decrease the overall weight of their shipment, meaning a direct savings on freight costs. In fact, ThermoCor VIP users can have a significant impact on their operational expenditures, reducing their dry ice purchases to up to 88% over EPS and PUR passive solutions.

As an example of the cost savings that can be found when using the AcuTemp frozen packaging solution, consider the following scenario of a temperature sensitive payload with a volume of 8 liters that requires a -20 controlled temperature duration of 72 hours:

  • As to weight, standard EPS and PUR containers would require 63 lbs. of dry ice and 23.5 lbs. of dry ice, respectively, while the AcuTemp solution requires only 7.5 lbs. of dry ice. 
  • As to shipping costs, a comparison of transporting temperature sensitive products from New York to Los Angeles using AcuTemp’s ThermoCor VIP as opposed to traditional EPS and PUR shippers saves $239 and $53, respectively; the AcuTemp total shipper cost of $86 is a great deal less than the EPS shipper at $325 and the PUR shipper at $139.

These examples show the tremendous cost savings that can be achieved using AcuTemp shippers because of their lower requirements for dry ice. Less dry ice means lower overall weight and lower overall shipping costs.

About AcuTemp Thermal Systems

AcuTemp’s revolutionary product offerings make previously unachievable commercial and industrial applications possible. Its users benefit from reductions in power consumption, the additional available transporting space of a decreased footprint, a greater increase in achievable hold times, and an overall reduction in operating costs through higher thermal efficiency.

The bottom line: AcuTemp’s products offer a rugged, efficient, lower cost, lower risk solution for the quality oriented cold chain strategy.

As a leading supplier of thermal management solutions, AcuTemp serves the needs of industry and government customers to meet their cold chain needs. AcuTemp is a trusted partner of The United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. AcuTemp also boasts life science customers both small and large on every continent. Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts, trust AcuTemp.

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ACUTEMP TEMPERATURE CONTROLLED SOLUTIONS: EXPERIENCE AND TRUST

Written on March 27, 2012 at 8:01 pm, by

AcuTemp Thermal Systems
2900 Dryden Road
Dayton, OH USA 45439
Phone: +1.937.312.0114
Fax: +1.937.312.1277
www.AcuTemp.com

AcuTemp, www.acutemp.com, is a leader in developing and manufacturing active and passive thermal systems for temperature controlled management. AcuTemp’s active system technology utilizes ThermoCor insulation, power management, electronics, and control systems to ensure that sensitive materials are stored or transported at their required temperature. In addition to active cold chain solutions, AcuTemp offers passive solutions with hold times up to 120 hours. Custom shipping solutions can also be manufactured in order to address specific requirements in the storage and transportation of temperature sensitive materials.

AcuTemp designed the first and only compressor driven pallet sized air cargo container certified by the Federal Aviation Administration (FAA) and the European Aviation Safety Agency (EASA). To receive FAA certification, an extensive evaluation is completed, and certified containers, Unit Load Devices (ULD’s), must meet stringent requirements and be in compliance with RTCA / DO-160 Environmental Conditions and Test Procedures for Airborne Equipment. This compliance adheres to standards of electromagnetic interference, Hazmat, container airflow characteristics, battery safety, and decompression testing. The FAA certification, for AcuTemp, adheres to laws under Title 14 of the Code of Federal Regulations (14 CFR) part 21, § 21.8(d), formerly §21.305(d).

With a decade of experience in active thermal management, AcuTemp continues to provide a great degree of cold chain logistical products. In addition, AcuTemp is the world’s largest volume producer of active mobile refrigerated systems for the shipment of temperature sensitive materials. AcuTemp has extensive expertise serving the pharmaceutical, defense, biotechnology, logistics and transportation industries. Many companies and organizations rely on AcuTemp’s products and technologies in their cold chain.

AcuTemp’s active and passive cold chain solutions have been used by the US Military, including the US Army Medical Materials Agency which transports vaccines throughout the world. The Center for Disease Control has also trusted AcuTemp’s cold chain solutions for storage and transport of small pox and anthrax vaccines. AcuTemp’s flagship product, the AcuTemp RKN, is the first active controlled air container with FAA, EASA, Transport Canada, Hong Kong CAD, Irish Aviation Authority, IAA and Israel CAA approvals. AcuTemp’s first active thermal system for temperature controlled management was used by the military to transport vaccines in 2002.

One example of the rugged versatility is the AX56L. Meeting the “Department of Defense Test Method Standard for Environmental Engineering Considerations and Laboratory Tests” (MIL-STD-810), durability and performance, the AX56L is a mobile active thermal management system that is used to store and transport pharmaceuticals, vaccines, blood, and plasma. Features of the AX56L include multiple operating modes, a large payload area, and the ability to operate it anywhere in the world from any power source.

On the passive side, AcuTemp has further solidified its industry leading position with the recent announcement of its expansion in frozen packaging solutions that uses its proprietary ThermoCor technology to significantly (up to 88%) reduce the amount of dry ice required for transit. This provides for a significant savings in the supply chain spend and does not require reuse to achieve 30% savings over PUR and EPS passive solutions.

AcuTemp also offers design and qualification services for custom thermal managed shipping solutions. After designing and developing a custom container, AcuTemp’s ISTA® Laboratory Certification, is used for testing to ensure that the custom solution meets specified requirements. Custom solutions can reduce shipping costs, maintain greater hold times and improve payload capacity.

About AcuTemp Thermal Systems

AcuTemp Thermal Systems is a leading supplier of thermal management solutions for the pharmaceutical, biotechnology, medical device and public health industries. AcuTemp is also a trusted partner for the United States Department of Defense, having been engaged numerous times to develop products that help meet the critical challenges of battlefield medical care. Through the years, AcuTemp’s continuous dedication to offering live-saving, innovative solutions has further solidified its position as a leader in the cold chain industry. When shipping temperature sensitive materials, trust the experts. Trust AcuTemp.

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