Blogs

Regulation and Testing Help to Stabilize Cold Chain

November 28, 2011

By Rick Lenhard
Lead Engineer, Passive Systems
AcuTemp Thermal Systems

A successful cold chain industry depends upon temperatures within an insulated shipping container remaining stable throughout the entire storage and transportation process. Temperature assurance within the cold chain distribution cycle is especially critical when it comes to products such as blood, plasma, pharmaceuticals and vaccines.

To validate their capacities to protect temperature-sensitive products while in transit, a specially-designed insulated box undergoes an aggressive qualification process, and the shipping process itself is thoroughly evaluated under various stresses.

Good Manufacturing Practices and Enforcement

Industry standards ensure the safety and efficacy of pharmaceutical products and vaccines. In the U.S., Good Manufacturing Practices (GMP) provide for the proper manufacturing, testing, monitoring and control of these...

Less Dry Ice Means Lower Shipping Costs for AcuTemp Customers

November 03, 2011

By Dave Meyl
Vice President Packaging
AcuTemp Thermal Systems

The cold chain packaging industry has long relied on dry ice to ship temperature-sensitive materials. Dry ice expenses can take a heavy toll on a cold chain shipping firm's overhead costs, however.

Insulated shippers made with foam materials such as expanded polyurethane (EPS) and polyurethane (PUR) are a popular choice for cold chain shipping. Unfortunately, the costs of shipping with EPS and PUR can really stack up due to the amounts of dry ice these shippers require.

Shipments involving large amounts of dry ice can may also result in damage to the integrity of temperature-sensitive materials. This is especially true for air transport shipments, which can be grounded if they contain more than five pounds of dry ice.

The AcuTemp Solution

The high efficiency of AcuTemp insulated packaging solutions enables time- and temperature-...

Cold Chain Industry Adjusting to Demands of Growing Markets

October 19, 2011

By Brian Kohr
President and CEO

The process of effectively transporting temperature-sensitive items such as pharmaceuticals and biologics is a multifaceted endeavor, necessitating stable, reliable packaging capable of maintaining required temperatures for the duration of a journey, as well as coordinated communications between all parties along the cold chain transportation route.

Cold chain packaging and transportation logistics have become increasingly refined over time, in terms of both shipping container technology advances and communications improvements throughout the cold chain distribution cycle. The rapid growth of new cold chain markets in Asia present new challenges, however.

With the emergence of massive pharmaceutical and “life sciences” markets in China and India, adjustments in cold chain strategies and regulatory guidelines have been necessary in order to assimilate these markets on both infrastructural and...

Well-Managed Cold Chain Limits Wasted Vaccines

August 17, 2011

By Paul C. Kovarovic, Vice President Business Development

People all over the world rely on the protection that vaccines provide from diseases such as mumps, measles, polio and the flu. When vaccinated, we assume the product injected into our bodies is safe, effective and has been well-preserved during its storage and transportation. But this is not always the case.

Vaccines exposed to temperatures below or above their required storage range — usually 2 to 8 degrees Celsius — can lose their efficacy or diminish in strength. Millions of dollars in vaccines are lost each year due to spoilage or damage during shipping, according to the Centers for Disease Control and Prevention (CDC).

Refrigeration a Major Concern

One major cause of vaccine spoilage and potency loss is inadequate or inconsistent refrigeration. For example, unstable refrigeration units or cold chain packaging left either on hot tarmacs or sweltering staging...

Cold Chain Temperature Monitoring At Its Best With RFID Technology

May 23, 2011

By Jonathan Neeld

The cold chain industry plays a vitally important role in the delivery of vaccines, medicines, electronics and other vital temperature-sensitive goods.

Companies involved in the manufacturing and shipping of consumable goods that are susceptible to fluctuations are always looking for ways to reduce "shrinkage”. This term is often used in discussions concerning a company's financial losses from product theft or spoilage. But the word can also be applied to the spoilage of humanitarian-oriented products, such as blood and vaccines which in terms of dollars and volume, can be as high as 30%.

When it comes to tracking temperature and statistics of insulated containers in the cold chain, a wide range of Time-Temperature Indicator (TTI) monitoring and logging devices are used. In order to use most TTI equipment, the devices have to be mounted in the area in which they are operating. Once mounted, data from these devices can only be...

Making A Greener World With Cold Chain Solutions

May 16, 2011

By Dave Meyl

Cold chain specialists and their clients have been interested in implementing eco-friendly solutions for several years now. The advancement of dependable cold chain solutions has been significant in providing temperature assurance for temperature sensitive items throughout the entire distribution process. The performance quality of vaccines, pharmaceuticals and blood products is at great threat of being compromised if not kept refrigerated from point of origin to final destination.

After years of development, insulated storage containers known for reliability and dependableness and now more so, reusability, are now on the market. Designers of these temperature-controlled insulated containers have confronted many obstacles along the way, including transportation delays and exposure to unfavorable conditions. Coincidentally, the same ingenuity used to overcome these issues is now being applied in developing cold chain products and systems friendly to the...

Cold Chain Temperature Assurance Through RFID Tags

April 15, 2011

By Todd Flanagan

A crucial piece of the cold chain validation process is providing temperature assurance during the shipping and delivery of medicines and other temperature-sensitive products. To accomplish this task, it is vital a product's temperature is kept in a controlled state ranging between 2 to 8 degrees Celsius (for refrigerated cold chain products) during cold chain distribution.

Due to the importance of temperature assurance when delivering these goods, the insulated storage containers used during this process are subjected to meticulous testing. A number of qualifications must be met for insulated storage containers to be considered sufficient for cold chain use.

More rigorous validation testing methods help support claims that today's cold chain shippers are more effective than ever before. However, many medical professionals still lack confidence in the ability of the cold chain industry to deliver a superior product.
Just as...

The Military Approach to Cold Chain Distribution

April 11, 2011

The U.S. Department of Defense has specific rules and regulations for the storage, transport and delivery of temperature-sensitive vaccines and medicines. Whenever the military is involved in a humanitarian aid mission, it is asked to perform a variety of functions. This often includes the distribution of clothing, food, medicines and vaccines among other items of need.

The delivery and administering of medicines and vaccines is a highly-regulated function not only in the civilian world, but within the military as well. The Food and Drug Administration (FDA) is the main U.S. governing body responsible for regulating the standards of cold chain distribution, the process by which temperature-sensitive items travel from producer to end-user.

Equipment used in the cold chain process includes special insulated storage containers, which are monitored for temperature stability. Modernized insulated containers, both in active and passive form, feature the capacity of...

Cold Chain 101

July 02, 2010

By Brian Kohr, President COO

As I travel around the world and visit with people from different industries (non life sciences), I’m continually amazed by the general lack of understanding of truly what the cold chain is and how important it is to almost everyone’s life. People seem to understand the importance of keeping various products within certain temperature ranges, easy to create the analogy to keeping milk in the refrigerator. The gap seems to be understanding that many pharmaceutical products have much more restrictive requirements and if the cold chain is broken, the negative impact is much greater than sour milk.

Once I walk through and explain the importance of the cold chain and the then subsequent potential impact to the efficacy of the product if it is compromised, the light bulb seems to come on and the questions start to flow. Questions such as - How are companies ensuring that products arrive safely? What is...