Planning is the key to successful and efficient Cold Chain Distribu-

About the Author tion. Yet even with careful planning, many companies still miss out
on opportunities to save money, streamline processes and increase
overall efficiency. This could be related to packaging, staying cur-
rent with the latest technology for monitoring temperature or choos-
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ing an experienced transportation provider -- all of which can have

a significant impact on efficiency.
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The answer, of course, is taking more time to research and gain

 
      
 
          
the knowledge necessary to determine just the right systems and
protocols. Easier said than done for smaller operations. While large

  

      
       

 

pharmaceutical organizations are more likely to have staff dedicat-

  

     
     

ed to investigating the safest and most cost effective packaging con-

         
             

figurations, leaner businesses, where employees have a myriad of

responsibilities simply may not have the resources. However, there


              

 

 
          

  
  
are some basic guidelines that companies of all types and sizes can
 

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follow when considering their best Cold Chain Distribution pack-
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aging options. Plus, an experienced transportation partner can also
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help simplify processes greatly by sharing their best practices on

packaging and temperature monitoring devices, as well as establish-
ing standard operating procedures to minimize any risk of loss due
to delays.
 Unproven Packaging Systems
When dealing with Cold Chain shipments, companies should al-
ways use packaging that has been properly tested or qualified for
maintaining the required temperature range. As an example, it may
not be appropriate to use a packaging system qualified for trans-
porting shipments under dry ice conditions for a commodity that
needs to be kept at refrigerated temperatures. We have come across
situations where shippers added cold packs to an insulated design
assuming that it will keep the shipment cold, but it’s a gamble if the
system has not been tested under these conditions. The system sim-
ply may not be designed to hold at this temperature. The bottom
line is: if the package hasn’t been tested to perform under very
specific conditions – the shipper is open to a great deal of risk.

CHECKLIST: Cost Versus Value

Conversely, some shippers may be using packaging configurations
that are too sophisticated and usually too costly for their needs.
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It’s not cost effective, for instance, to use a packaging system that
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will maintain temperature for 72 or 96 hours for shipments that are

likely to be delivered within 24 hours. Likewise, using a large ac-
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tive shipping configuration when a passive system is sufficient can

also result in unnecessary costs, including paying for a lot of empty
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payload space if the unit’s capacity is not maximized. While some

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businesses have determined that it’s simpler to have a single pack-
aging configuration for all their global shipments, many would ben-
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efit from conducting a thorough cost/value analysis.

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Monitoring Temperature
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Regardless of the packaging system chosen, companies should also
always employ some sort of temperature monitoring device. Ad-
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vancements in device monitoring technology have given shippers a

variety of options that range in cost.
 Even with the best systems and monitoring technology in place,
an unplanned delay or rerouting could potentially jeopardize the
stability of a shipment. That’s why it’s critical for shippers to work
with their transportation partners to develop contingency plans that
clearly map out what is to be done in the event of a delay. This
includes whether to keep packaging cold or frozen in refrigerated
rooms or freezers, or replenishing the pack out as needed. These
contingencies must also include the recipients of the shipment, de-
termining if after hours delivery is an option and if proper personnel
are on site to accept an after hours delivery. Keeping the lines of
communication open will ultimately help avoid losses.

As a first step in selecting the most appropriate packaging, it’s im-

PASSIVE SYSTEM portant to identify whether a passive or active shipping system is
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needed.

Passive Shipping Configurations

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PROS

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Passive shipping configurations are manufactured systems that are
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typically insulated with polystyrene, polyurethane or vacuum in-
sulated panels. Many have been pre-qualified to hold a particular
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temperature for a certain amount of payload capacity for a speci-

fied period of time: 24, 72 or 96 hours, and more. With these types
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of configurations, the shipper must create the environment based

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on the manufacturer’s exact specifications using gel packs or other

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types of phase change materials in order to maintain the desired

CONS

temperature.
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If an off-the-shelf pre-qualified design doesn’t work, many manu-

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facturers can customize a solution for a company’s specific needs.

 inexpensive polystyrene coolers to more complex configurations
using phase change materials and vacuum insulated panels costing
hundreds of dollars.

Active Shipping Configurations

Active shipping configurations are usually leased containers with
advanced temperature controls that are often powered by electric-
ity and/or battery. Some may have a heating and/or cooling system
built in, or may work using dry ice as a coolant and system to push
cool air into the payload area to maintain a specific set temperature.
These types of configurations are generally designed to hold one or
ACTIVE SYSTEM more pallets and, as such, are ideal for large shipments, although
smaller units are also available.
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Active shipping configurations are considered to be more secure

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than passive systems, where units lock and are never opened during
transport. If the temperature begins to fall outside the range, bat-
PROS

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teries are replenished or the system may have an added feature that
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enables it to be plugged in during a delay to maintain operation. As
a result, this design helps reduce the risk of theft and may help with
compliance to certain regulations.
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Determining whether an active or passive system is the best solu-

CONS

tion is based on several factors including temperature, volume and

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destinations. Here is what you should consider when choosing a

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packaging system:
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D U E F > @ I F @ ? I 9 < A F E L D > D F E ? L a

Temperature
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1. Does the product need to be frozen, refrigerated or at a con-

trolled room temperature?
2. What is the required temperature range? Can product be out of
this range for any period of time?
3. What temperature will the package be exposed to during transit
based on its final destination? As an example, is the product
shipping from the US to Australia where climates may be
opposite at various times of the year?
4. Are different types of systems needed for summer versus
winter pack outs, or is one universal configuration sufficient for
year round shipping?
a. If separate systems, at what temperature is it necessary to switch
from winter to summer pack out and vice versa?

Volume of Product
1. What are the typical payload requirements? How much space
is needed?
2. How much product is being sent? Is it a uniform number of
units to each locale or will volumes vary?
3. How much is being sent? Is it a uniform number of units to
each locale or will the volume vary by destination?

Transit Times
1. Are destinations all or primarily domestic (24 hour delivery)?
2. Are they mostly going to international locations (48 to 96
hours delivery)?
3. Is it a mix of domestic and global destinations?

For international destinations, it’s important to factor in the amount

of time needed to clear customs, in addition to transit times.

Advances in technology have made monitoring temperature easier

and more accurate. With an array of available devices – from those
that give an alert when the temperature falls outside of its range to
others that provide actual, real time readings – as well as a range of
price points, it’s difficult to know which to choose.

Types of Temperature Monitoring Devices

USB-Enabled: Data is gathered by a drive that is connected to a

USB port in the temperature monitoring device. Upon delivery it is
removed from the device and connected to a computer’s USB port.
The results can then be emailed to the shipper immediately in a PDF
format if necessary.

Direct Information Download: For enhanced security, other de-

vices must be retrieved and sent back to the shipper either by the
recipient or the transportation partner. Once received, the informa-
tion is downloaded directly from the device.

Other Considerations
1. How long can the device record? Will it withstand the
length of the trip?
2. When should it begin recording?
3. At what intervals should it record?

Essentially, the device should conform to the specific pack out. And
like pack outs themselves, monitoring devices must be used based
on the manufacturer’s specification. This includes paying careful
attention to where the device is positioned. If it is placed up against
a frozen gel pack, for instance, it could potentially send false read-
ings. It is recommended to use these devices as a redundancy even
when working with active packing systems that provide tempera-
ture data.
visable to conduct a series of dry runs to ensure the systems work.
Although pre-qualified passive designs are tested in a lab environ-
ment, which are typically fairly accurate, live transit testing is al-
ways a wise investment – especially if you have a commodity that
is rare or very expensive to manufacture.

The actual testing can be fairly simple. Use a temperature device

and ship some water at a refrigerated or frozen temperature to a
variety of challenging locations to determine if the system is robust
enough to perform under the logistics and environmental conditions
in which it will be used. A typical testing scenario might consider
a packaging system with a 72-hour transit life. If tests to various
destinations indicate that performance starts to degrade around the
65-hour or 66-hour mark, it may be prudent to move up to a system
that provides a 96-hour life to reduce or even eliminate the margin
of error.

While some companies may prefer to handle the investigation and

final determination as to which packing systems are best, not all
have the resources to dig as deeply as is necessary. Thus, others opt
to work directly with a cold chain transportation specialist from the
outset. Partnering with a third-party expert gives shippers access
to a much deeper knowledge base since experts in the field have
been exposed to a wide variety of “real life” shipping scenarios
using various packaging configurations, both active and passive.
Their knowledge and experience can help quickly identify the best
configuration available in the market for your specific needs.
Planning and communication becomes critcal when a transportation
partner enrters the equation, especially when it comes to the actual
movement of packages. While evaluating cold chain transportation
specialists, consider the following attributes:

• Works with shippers to pick up packages closer to flight

departure times
• Knows in advance what the import/export and customs
processes/required permits are at each point of entry
• Has an established communication protocol to alert shippers of
delays and determine whether consignee can place shipment
in the proper environment after business hours
• Determines after hours and weekend delivery protocols, as
appropriate
• Provides door-to-door or customs broker services
• Advises on expected transit, customs clearance, recovery
and delivery times by country

The best transportation specialists will also have strong relation-

ships with airlines that have expertise in cold chain services. These
airlines have established SOPs and handling procedures and usu-
ally offer custom facilities such as cold rooms and freezers at air-
ports. They typically have specific density and loading procedures
for cold chain shipments, and give preferred cargo positioning on
the aircraft itself. For instance, shipments are not positioned near
a cargo door where they might be exposed to significant tempera-
ture variations. Pilots are notified as to what is on board, and may
even have the ability to regulate temperature in cargo areas from the
cockpit. Ground crew is trained to handle these special shipments as
well, further expediting movement and ensuring packages or active
units are not kept on the tarmac and exposed to the elements.
minimize the time a product is contained in the packaging system.
Internal considerations, as well as information that will be impor-
tant to share with a transportation partner includes:

• What is being shipped?

• How much (size and weight)?
• How frequently?
• What time of year?
• To where?
• What are the lane segments?
• Pick up ready times?
• What is the transit time?
• What other time constraints exist?
• What is the necessary temperature range?
• At what temperature does viability of the product degrade?
What is the stability data?
• What external temperatures need to be considered?
• Active or passive shipping configurations?
• Temperature monitoring employed?
• What are the per country regulatory requirements for imports?
How does this impact time in customs?

Remember, since delays can happen for any reason – weather, me-
chanical issues, unexpected customs holdups and more – it’s impor-
tant to have a clearly detailed SOP in place. Should the transporta-
tion partner open the box and replenish coolant in the event that
temperature is compromised, or refrigerate the package if the delay
extends beyond the system’s time constraints?
Whatever instructions are appropriate for each project, proper com-
munication with the transportation specialist and having escalation
and after business hours contacts in place will minimize the risk of
any vulnerabilities.

QuickSTAT specializes in shipping time and temperature-sensitive

clinical research samples, investigational drugs, biological materi-
als, clinical supplies and dangerous goods. Our experts are dedicat-
ed to making sure your worldwide shipments get to wherever they
are going on time, integrity intact.

North American Centre European Center

800 856 7828 +44 (20) 8757 7590
+ 001 (718) 995-3616 ext. 8
Asian Center
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