Cold Chain Shipping Solutions Project - Penn State Personal Web ...

squeegovernorBiotechnologie

3 déc. 2012 (il y a 6 années et 10 mois)

577 vue(s)














C
OLD
C
HAIN
S
UPPLY
C
HAIN


B
EST
P
RACTICES







Penn State
Undergraduate

Student

Sam Shampain


Penn State Supervisor

Adeline
Letizia


Bec
ton Dickinson

Supervisor

Jennifer
De Weese









-

Fall

2009
-

Cold Chain Supply Chain Best Practices


Fall 2009





1

T
ABLE OF
C
ONTENTS


Executive Summary

................................
................................
................................
................................
...............

2

Recommendations to BD Biosciences

................................
................................
................................
....................

3

1.

Maintain 2
-
8
o
C or 2
-
25
o
C for 24 hours

................................
................................
................................
...........

3

2.

Maintain 2
-
8
o
C or 2
-
25
o
C for 5 days

................................
................................
................................
...............

7

3.

Alternatives to Dry Ice

................................
................................
................................
................................
....

10

Cold Chain Shipping in the Biological Industry

................................
................................
................................
.....

14

4.

Trends in the Biological Industry

................................
................................
................................
....................

15

5.

Beckman Coulter

................................
................................
................................
................................
............

17

6.

Life Technologies

................................
................................
................................
................................
............

19

7.

Spher
otech

................................
................................
................................
................................
.....................

20

8.

Ebioscience

................................
................................
................................
................................
.....................

21

9.

Biolegend

................................
................................
................................
................................
........................

22

Cold Chain Shipp
ing in the Pharmaceutical Industry

................................
................................
............................

23

1.

Trends in the Pharmaceutical Industry

................................
................................
................................
...........

24

2.

Cold Chain Technologies

................................
................................
................................
................................
.

27

3.

Minnesota Thermal Science

................................
................................
................................
...........................

31

4.

TCP Reliable

................................
................................
................................
................................
....................

33

Cold Chain Shipping in the Food Industry
................................
................................
................................
.............

37

1.

Trends in the Food industry

................................
................................
................................
............................

38

2.

Best Practices
-

Cross Docking

................................
................................
................................
........................

39

3.

Best Practices
-

Outsourcing

................................
................................
................................
...........................

39

4.

Temperature Controlled Shipping

................................
................................
................................
..................

39

5.

Regulations

................................
................................
................................
................................
.....................

40

6.

Drivers for change

................................
................................
................................
................................
..........

40

7.

Example: Chocolate

................................
................................
................................
................................
........

41

8.

Example: Cheesecakes and Instapak® TempGuard™ Cold Chain Packaging

................................
..................

42

General Packaging Solutions for Cold Chain Shipping

................................
................................
..........................

43

1.

Coldpack Company Information

................................
................................
................................
.....................

44

2.

Coldpack Airliner Study

................................
................................
................................
................................
..

47

3.

Entropy Solutions Green Box

................................
................................
................................
..........................

51

4.

Vacuum Insulated Panels

................................
................................
................................
...............................

53

5.

Alternatives to Dry Ice

................................
................................
................................
................................
....

55

Conclusion

................................
................................
................................
................................
...........................

58

Appendices

................................
................................
................................
................................
..........................

59

Neopor Boxes

................................
................................
................................
................................
..........................

59


Cold Chain Supply Chain Best Practices


Fall 2009





2

E
XECUTIVE
S
UMMARY


Becton Dickinson

(BD)
Biosciences ships their
product
s

to research and
development firms

both
domestically and internationally. BD ships in single doses as well as multiple dose shipments. Many of
these shipments have strict temperature and time requirem
ents. If these requirements are not met the
product will
spoil

resulting in
major
problem
s

for
both
BD
and the

customer.


Several factors can

disrupt this cold chain from functioning properly. Seasonal temperature fluctuations
as well as varying temper
ature profiles make the challenge of maintaining the
internal
product
temperature increasingly difficult. Some customers have specific packaging requests, or may not be
present at the time of delivery. These difficulties don’t even encompass the traditio
nal

supply chain
issues such as inclement weather
,
shipping accidents, or infrastr
ucture breakdowns. Succinctly, these
issues
make managing the cold chain difficult even
if have
perfect shipping procedure
s
.


The cold chain shipping industry is expanding

with new products coming to market quickly. It is broken
down into three distinct market segments
:

Biologicals
,
Pharmaceuticals
, and Food. There are different
challenges within each segment as well as different competitors. Certain
third
-
party logistic
s (
3PLs
)

ship

biological and pharmaceutical

products
, but not food, and vice versa.
K
eep
ing

up wit
h this ever
-
changing industry is difficult.


Just as the market players are always changing so are the products. Becto
n Dickinson
requested
information
regarding

sustainable alternatives to their current cold chain shipping practice
s. These
alternatives should offer advantages in the areas of impact o
n

the environment, packaging integrity, and
minimal assembly.


The alternatives were broken down by the

temperature profile and
the shipment
duration. For product
that need to maintain 2
-
8 degrees Celsius for 24 hours or 2
-
25 for 24 hours there are three single dose
options applicable. They are Coldpack’s Airliner, Entropy Solution’s Inflater Pouch, and C
old Chain
Technologies’ Kool Temp Insulated Envelope. For
products that need

to maintain 2
-
8 degrees
or 2
-
25
degrees Celsius

for 5 days,

the KoolTemp PolyUrethane Insulated Cooler and Entropy Solution’s
Greenbox
seem

the most viable alternatives. Finally
, three alternatives to dry ice
are
detailed
:
Entropy
Solution’s Pure Temp
-
40, Techni Ice Reusable Dry Ice Pack, and TCP Reliable’s ‘20 below’.





Cold Chain Supply Chain Best Practices


Fall 2009





3

R
ECOMMENDATIONS TO
BD

B
IOSCIENCES


This section proposes alternatives to BD Bioscience’s current cold chai
n shipping practices. The
proposed alternatives would substitute the current processes for shipping single doses domestically

and
internationally as well as multiple doses internationally. All alternative meet BD’s requirements of
sustainable solutions t
hat are environmentally friendly, require minimal assembly, and have package
integrity.



1.

Maintain 2
-
8
o
C or 2
-
25
o
C for 24 hours


The strongest and most viable alternatives for BD Biosciences within the single dose shipping product
category is
Coldpack™’s Airliner set of products . The Airliner product comes in various sizes, from the
Airliner 001

(20 x 13.5 x 7.5

in.
) to the Airliner 501 pouch which fits into UPS or large expedited shipping
boxes. The Airliner is Coldpack’s primary product. It

ensures that sensitive pharmaceutical and biological
shipments maintain the +2

to
+8 degrees Celsius temperature profile. According to an October article in
Vaccine Weekly
1
,

Coldpack™ introduced the flagship product at the recent PACK EXPO. The PACK EXP
O
is the packaging industry’s largest tradeshow. This year it was held in Las Vegas from October 5
-
7, with
over 1200 exhibitors. The Airliner 501 pouch is the packaging solution that most closely aligns with the
requirements of BD Biosciences.


Another
product available for single dose shipments is Entropy Solution’s Inflator Pack with E23 phase
phase
-
change materials. This is not Entropy Solution’s most effective product however it
is
one of the
most successful within the industry. Walmart was one o
f the first companies to full
y

endorse and begin
to use it. They have found a lot of success with it.


Finally, the third option for single dose shipping is Cold Chain Technologies’ KoolTemp Insulated
Envelopes. The have a reflective exterior which ref
lects 97 percent of all radiant heat transfer. The
manufacturer, Cold Chain Technologies has not won any awards for this specific product and the
Kooltemp’s scientific effectiveness is unknown.



1.1.

ColdPack’s Airliner


The Temperature Profile of the Airline
r depends on the Phase Changing Material used. The Airliner can
be combined with the full range of Phase Changing Materials, from low eutectic (
-
12 degrees Celsius) gel
packs to dry ice.


Coldpack’s Airliner is engineered using an extremely complicated
process. It involves combining over 12
different materials to create this inflatable bag. In use, this inflatable pack is placed within a cardboard



1

http://www.allbusiness.com/company
-
activities
-
management/product
-
management/13234400
-
1.html,

Cold Chain Supply Chain Best Practices


Fall 2009





4

box, turning the cardboard box into an insulated cooler. The inflatable airliner is ribbed, which reduces

the material requirement necessary for manufacturing. Not only is the Airliner available in a variety of
sizes but also many thicknesses as well. Custom sizes can be negotiated with the manufacturer.


Awards

The company received
the
European Pharmapac
k Cold Chain Award during a recent conference in Paris.

“Coldpack, an innovative insulated packaging solutions leader, announced that its AirLiner ® product,
used in tandem with the company’s AntiFreeze Vaccine Backpack, has recently received two top
inte
rnational industry honors. Coldpack won the prestigious European Pharmapack Cold Chain Award
because of excellence in innovative packaging for the transport of medicines, health products and
medical devices.”
2


The second award was the FPA (Flexible Packaging Association) 2009 Gold Achievement Award in
Packaging Excellence. This award recognized the thermal insulating achievements
of Coldpack’s
AntiFreeze Backpack. The Backpack was approved by the World Health Organization as an effective
vaccine transport system. CEO of Coldpack,
Etienne P. Snollaerts responded:

“The AirLiner has tremendous potential to significantly advance the
way pharmaceuticals are shipped,
helping them reach those who need them the most. These important international awards are
validation that AirLiner can play a positive role in the supply chain especially for the last mile of the cold
chain process. We are
honored to be recognized on an international level.”
3








Ai
rliner 001






Airliner 018









2

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090309005216&
newsLang=en

3

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20090309005216&
newsLang=en

Cold Chain Supply Chain Best Practices


Fall 2009





5




Airliner 501 Pouch



Airliner Precision Inflation Controller


(fits inside a UPS expedited box)



Advantages

Disadvantages



Warehouse space reductions because Airliner
occupie
s only 4%

of the space an EPS liner of
the same size occupies.



Reduced shipping costs because overall
packaging weight is significantly reduced



Can avoid the use of gel pack
s
-

huge cost
savings



Soft cushioning provides a barrier from shock
and rough handling



Has three options for closure Velcro, double
sided tape, a
nd fold over in specific cases



AirLiner can be used with all types of frozen
refrigerants.



Reduces Carbon Footprint by 96% (4 percent
of the material used for EPS)



Disposes Compactly



Actual product cost not available

-

could be
higher than comparable EPS
foam



Labor cost higher because of additional set
-
up time



When used with dry ice, the dry ice must be
wrapped or bagged in a bubble wrap pouch



Airliner must be inflated which could increase
packaging time (2
-
16 seconds)




1.2.

Greenbox Inflater Pack with E23
P
hase
-
C
hange
M
aterials manufactured by Entropy Solutions


It is “designed especially for single
-
dose shipments that must be maintained at 2

8 °C for 24 h or at 20

25 °C (i.e., controlled room temperature) for 24h”

4
.

It must be used with Entropy Solution
gel packs,
because of the size requirements within the Inflater pack.


Walmart, one of the leaders in supply chain innovation was facing a significant problem when shipping
their single doses to areas such as Hawaii and Alaska. 15
-
20 percent of Walmart’
s pharmaceuticals had



4

http://www.greenboxsystems.com/p
ress/articles/20081201pkgdig.htm

Cold Chain Supply Chain Best Practices


Fall 2009





6

to maintain room temperature (20
-
25 degrees Celsius) for 48 hours. Walmart began to use Greenbox’s
Inflater pack along with its E23 panel to maintain this temperature. This solution proved to be
extremely effective. Walmart also fo
und that its customers were pleased with the environmental
benefits of the Inflater pack, because it was
reusable

5



Awards

Entropy Solution’s Inflater Pack is under the Greenbox line of products. At the 2009 Greener Package
Awards, the Greenbox won the flagship award, the Greener Package Award, as well as the “Innovator of
the Year.” These awards cited the fact that the Gree
nbox is 100 percent bio
-
based, non
-
toxic, and
biodegradable. One Greener Package Award judge summarized the package: “In addition to innovative
materials and a system that minimizes product spoilage (in many ways the loss of product is a bigger
environmen
tal impact than single
-
use packaging and is rarely accounted for in LCA [Life Cycle Analysis]
studies), the effort to set up a comprehensive return
-
and
-
reuse process represents an in
-
depth
understanding of a systems approach.”

6




Inflater Pack with Gel

Packs



Advantages

Disadvantages



Inflates by puncturing two spots on the side
of the package for easy pack out



Fully Reusable



Entropy Solution’s gel packs are more
敦晥e瑩ve⁴U慮⁳ 慮T慲a⁧敬ep慣歳



100 percent organic



Phase changing materials are
non
-
toxic and
fully reusable



Cost savings because of reduced weight



Designed for reuse so may be more expensive
than traditional methods for single use



Requires the use of specific Entropy
Solution’s gel packs



Can only be used for specific temperature
pr
ofiles








5

http://www.greenboxsystems.com/press/articles/20081201pkgdig.htm

6

http://www.greenerpackage.com/bioplastics/greener_package_award_shipper_temperature
-
sensitive_products

Cold Chain Supply Chain Best Practices


Fall 2009





7

1.3.

KoolTemp™ Insulated Envelopes manufactured by Cold Chain Technologies


The KoolTemp insulated envelope should be used for overnight shipments. It can be used for various
temperature profiles depending on the phase changing material used. Similar to the Entropy Solution’s
Inflater pack,
if
a gel pack is required
,

the manufac
turer’s gel packs must be used. This is because of the
special space requirements for the KoolTemp Insulated Envelopes. It can be packed with standard dry
ice as well. An exterior standard overnight box may be used to provide additional protection.
7



A
wards

Cold Chain Technologies has not won any awards for this specific product and the Kooltemp’s scientific
effectiveness is unknown.





KoolTemp Insulated Envelopes



Advantages

Disadvantages



Light
-
weight material reduces freight costs



Insulated
with fibers that minimizes shock
and vibration



Reflective exterior reflects 97 percent of
radiant heat transfer



Can be used with Dry
-
ice, expanding the
applicable temperature profiles



For optimum results, envelope and payload
must be chilled to minimum tem
perature
within profile



Only applicable for overnight shipments



Must be closed with closure tape



Must use manufacturer’s gel packs




2.

Maintain 2
-
8
o
C or 2
-
25
o
C for
5 days


Standard EPS Coolers are extremely widespread and there are countless companies that manufacture
them. This makes them extremely inexpensive to purchase and use. The only way to offset this cost
would be to use a better insulating material that minimized

the gel packs requirement. Using fewer gel
packs would also reduce freight cost because of the lighter package. A more environmentally friendly



7

http://www.coldchaintech.com/products/insulated
-
e
nvelopes.php

Cold Chain Supply Chain Best Practices


Fall 2009





8

material would offer significant advantages over standard EPS coolers because of the harmful effects of
Styro
foam.


EPS foam is an extremely standard and widespread cold chain shipping product. However, there are
two alternatives that may provide significant advantages over EPS foam containers.


Cold Chain Technologies manufactures the KoolTemp Polyurethane I
nsulated cooler which has a much
higher R value than EPS or XPS foam. It is also much more environmentally friendly and can be reused
countless times, another important advantage.


The second alternative is the Greenbox. The Greenbox is Entropy Solution
’s most successful product
and quite possibly the most effective and successful product within the cold chain shipping industry.
This award winning product is made of 100% organic material and can be reused many times. Its
performance is unparalleled and

is the best insulated container on the market.



2.1.

Cold Chain Technologies’
Kool
T
emp Polyurethane Insulated Cooler


KoolTemp Polyurethane Insulated Cooler
s are an ideal choice to maintain expensive payloads between
2°C to 8°C during demanding s
hipping
conditions.

The high R value makes it an excellent choice for
international shipments
.
8


The Kool
Temp Polyurethane Insulated Cooler is a one piece molded cooler which is shipped with an
outer
corrugated

box. It is available in standard sizes along with
custom sizes and printing upon request.
It has a much higher R value than standard EPS or XPS foam. Most importantly this reusable container is
environmentally friendly and contains no CFCs or HCFCs.


Awards

Cold Chain Technologies has not won any awards

for this specific product and the Kooltemp’s scientific
effectiveness is unknown.





KoolTemp
Polyurethane Insulated Cooler






8

http://www.coldchaintech.com/products/kooltemp
-
polyurethane
-
insulated
-
containers.php

Cold Chain Supply Chain Best Practices


Fall 2009





9


Advantages

Disadvantages



High R value can maintain the strictest
temperature requirements



High R value reduces the gel
pack/dry ice
requirement



Ideal for 2
-
8 degrees Celsius but can be used
with dry ice



Completely reusable



Environmentally friendly, no ozone depleting
materials in manufacturing



Higher cost than EPS foam



Must replace corrugate for reuse



Molded container increases necessary
storage space




2.2.

Entropy Solution’s GreenBox


The Greenbox can maintain payload temperatures from
-
40°C to +70°C for up 120+ hours or five days.


Greenbox packaging comprises a tinted
-
green, reusable, outer HDPE
shipping container that resembles
a mailing container. Resistant to moisture, crushing and scuffing, the outer plastic
-
corrugated container
is practically impervious to repeated exposure to packing tape. It houses a set of reusable/recyclable
Thermal
-
Lok™
insulation panels, made using recycled carbon silica and what Entropy refers to as a
nanotechnology
-
based manufacturing process in a patented, proprietary packing protocol that provides
them with an R value of 40
.
Entropy Solutions' president Eric Lindqui
st claims that the panels have a
thermodynamic insulating capacity that's 10 times greater than EPS or PU foam.

(
Hartman)

Most
importantly the Greenbox is made of 100% organic based material and is full reusable. The Greenbox is
available in a variety of
sizes and temperature profiles.


Awards

As previously stated the Greenbox won
a
t the 2009 Greener Pac
kage Awards, the Greenbox won
the
Greener Package Award, as well as the “Innovator of the Year.”

(see p.5)







Greenbox Systems: Thermal
Management Systems


Cold Chain Supply Chain Best Practices


Fall 2009





10


Advantages

Disadvantages



Most effective and sustainable packaging
solution on the market



Available for almost all temperature profiles



More flexible shipping times because of
expanded shipping duration profile



Rush delivery not
necessary



Can be reused up to 100 times



Made of 100% organic material



Customers have the option of recycling the
box internally or it can be sent to an Entropy
Solution’s reclamation center



Extremely costly and not cost effective unless
reused



To use the Greenbox you must purchase the
entire system (specific gel packs, packing
tape, organic
PCMS
)



Time consuming pack out





3.

Alternatives to Dry Ice


Dry ice is at the temperature of
-
78 degrees Celsius. It maintains this temperature as it sublimates.
Because of the various shipping regulations put on the transport of dry ice, avoiding it can be a
significant advantage. If it is not packed properly th
ere can be burn injuries, as well as product
exposures. This creates handling issues for the shipper as well as the receiver. Dry Ice is not extremely
harmful to the
environment;

however it does produce the greenhouse gas
,

Carbon Dioxide. There are
mor
e environmentally friendly alternatives on the market.


The first alternative to BD Bioscience’s current practice is the PureTemp
-
40 Solution, manufactured by
Entropy Solutions.

Entropy Solutions has a full line of PureTemp products, across various tem
perature
profiles and for use in many different industries. This product is a safe alternative to dry ice, and emits
no greenhouse gases.


The Techni Ice Reusable Dry Ice pack is another alternative that has uses across many different
industries. Once
hydrated
,

the pack can be frozen to any temperature down to
-
190 degrees Celsius.
This makes this product very flexible as well as inexpensive in use.


Finally, the third sustainable alternative is
TCP Reliable’s ‘20 below’. This product as advertised

maintains a temperature of
-
20 degrees Celsius. It is available as a pouch or as a gel pack, is fully
reusable, and can be disposed of in the standard municipal waste stream.







Cold Chain Supply Chain Best Practices


Fall 2009





11

3.1.

Entropy Solutions: The PureTemp
-

40 Solution


The PureTemp
-
40 Solution

is the first sustainable alternative to dry ice to come to the market. It is
completely reusable and not harmful to the environment. It is best for applications where reuse is
applicable because then the cost benefits can be fully utilized. Another maj
or advantage is that it

requires no special handling.
9


Several relevant authorties and organizations have recommended this product. Indeed t
he US
Department of Agriculture lists the material in its Biopreferred purchasing program
.
Dr. Rafik Bishara,
Ph.D., chairman of the Pharmaceutical Cold Chain Interest Group (PCCIG) and Parenteral Drug
Association (PDA), said of the Pure Temp
-
40 Solution, “I am pleased with this technically based, data
-
supported solution, which is answering an
unsatisfied need in the shipment of frozen medicinals while
being environmentally friendly and with economical value.”
10




PureTemp
-

40 Solution



Advantages

Disadvantages



100% renewable and biodegradable



PureTemp can be used more than 20,000
times with no thermal degradation



More environmentally friendly (Dry ice
produces carbon dioxide)



Requires no special handling



Does not alter the ph level of any drugs and
can be shipped with all products



Much higher

cost than traditional dry ice



Is not economical unless reuse is applicable



Most often used with Entropy Solution’s
䝲敥
n
bo砠



Only one supplier vs. dry ice which is
accessible from many suppliers







9

http://www.entropysolutionsinc.com/technology.htm

10

http://www.greenboxsystems.com/press/20090428.doc

Cold Chain Supply Chain Best Practices


Fall 2009





12

3.2.

Techni Ice™ Reusable Dry Ice Packs HDR (Heavy Duty
Reusable) Model (4 layer/ply model)


The Techni Ice Reusable Dry Ice pack
maintain
s

whatever temperature it is frozen to, up to
-
190 degrees
Celsius.

It

is a highly versatile product. They are scientifically more effective than traditional dry ice. To
u
se one you must hydrate the 11X16 inch sheets then freeze the sheet to the required temperature.
These packs have both recreational and commercial uses.
11




Techni Ice Reusable Dry Ice pack



Advantages

Disadvantages



Can be frozen down to
-
190 degrees
Celsius



Less costly than traditional dry ice



Scientifically proven to be more effective
than dry ice



Reusable and not toxic



Sheets are 11X16 inches

(9X13X1 after
hydrating)

and can be cut to different sizes



Can fit a wide range of temperature profiles
and durations



Usually frozen in Blast freezers down to
-
80
for dry ice applications (time consuming set
up)



Must be hydrated before use, which may be
difficult



Unproven in the cold chain shipping market

















11

http://www.dryicepacks.com/Scripts/prodView.asp?id
product=17

Cold Chain Supply Chain Best Practices


Fall 2009





13

3.3.

TCP Reliable’s ‘20 below’


This product is an effective alternative to dry ice when it would be used to maintain
-
20 degrees Celsius.
It is available as panels or as a pouch. It must be conditioned at
-
25 degrees to freeze the product and
will

be
gin to melt at
-
20 degrees.
12




‘ 20 below’ panels


‘20 below’ pack



Advantages

Disadvantages



Safe to handle



Water soluble and reusable



Can be disposed of in standard municipal
waste stream



Available in two different forms (panels/pack)



Can be used with any insulated shippe
d



More expensive than standard dry ice



Panels require additional set up time










12

http://www.tcpreliable.com/products/gel
-
packs
-
phase
-
change
-
materials/20
-
below
-
20d
-
c

Cold Chain Supply Chain Best Practices


Fall 2009





14

C
OLD
C
HAIN
S
HIPPING
IN THE

B
IOLOGICAL
I
NDUSTRY


In the Biological Industry cold chain shipping has become incredibly important. Cold chain shipping is
taken care of one of
two

ways depending on the company.
Companies either use a 3PL to take care of
their cold chain shipping end
to end
,

or pack their own box and then have a 3PL ship it for them.
Some
3PLs only ship
biological

products
,
others
ship all products
.

Almost all companies

that ship biological
products

in bulk use a 3PL.

No company takes care
of
its

own cold chain shi
pping.



C
ompa
nies
that pack
their own box
use a 3PL such

as Fed
-
Ex or UPS

for shipping
. This differs from the
end to end 3PL method

where

the box is being packed by the manufacturer,
who therefore
chooses the
specific packaging technique.
The

packager
makes the decisions
on green
/not green
, price, size,

etc.


There are a few major issues in the biological cold chain shipping industry,
some of which have to do
with the

cold chain
shipping
industry as a whole.
The best practices usually are the ones th
at are the
cheapest but most effective
. However
,

it varies from company to company depending on their needs.
For instance,

the most effective packages are reusable and therefore more eco
-
friendly.
However

t
here

are better temperatures

controlling result
s with
the
expensive technologies
,
but they can only be used
in cases where the box can be reused
(
see

the
Beckman Coulter

section for more details
)
.

W
ith one
time shipping packaging,
choices are more limited.



List of companies

and packaging solutions

studied:



Beckman Coulter



Life Technologies (Invitrogen)



Spherotech



Ebioscience



Biolegend



Cold Chain Supply Chain Best Practices


Fall 2009





15

4.

Trend
s in the
Biological

Industry


4.1.

Introduction


This chapter

details three of the leading p
roducts for cold chain shipping: the

Coldpack’s Airliner with
Vaccine pack, the Greenbox Inflater pack an
d

Entropy’s Puretemp
-
40 phase
-
change materials
.



4.2.

ISTA 7D testing


“Another change likely to affect cold
-
chain packaging is the phase
-
out of disposable packaging. It's
already occurring
in Europe, Japan, and China, and Lindquist predicts that similar requirements
eventually will be adopted in the US.”

"Convincing the pharmaceutical industry to change takes time, but we're sure it's coming," says
Snollaerts.


Coldpack and AcuTemp operate
laboratories certified by the International Safe Transit Association (ISTA)



They perform tests at their facility

that abide by the
ISTA Test Procedure 7D (The test that I sent
the email about)



They need to conduct real world testing
: tests need to be done
during both summer and winter,
so might not be completed before a few months.


4.3.

AntiFreeze Vaccine Backpack with Airliner



Figure
1
. Col
d
pack


Cold Pack vaccine pack with inflater pack inside won an award. (
see Figure 1
)
. The
Vaccine pack
is
reusable but inflator pack goes inside


Special Citation for Social Responsibility
(Also a Gold Award Winner in
Packaging Excellence
)

:

http://www.flexpack.org/ACHIEV/W
inners/2009_winners.asp


Vaccine efficacy and shelf life can be greatly impacted by temperature fluctuations, extremes in both
heat and cold will have a negative impact. Designated as an approved vaccine transportation system by
the World Health Organizati
on, the Coldpack AntiFreeze Vaccine Backpack solves this challenge through
Cold Chain Supply Chain Best Practices


Fall 2009





16

its award winning patented technology, which offers superior thermal and air cushion protection. The
Coldpack AntiFreeze Vaccine Backpack facilitates the safe, secure, stable, and s
uccessful transport of
priority medical vaccines.


4.4.

Greenbox Inflator Pack with E23 phase
-
change materials, Entropy Solutions


It is recommended for single dose:
“designed especially for single
-
dose shipments that must be
maintained at 2

8 °C (i.e., refrige
rated temperature) for 24 h or at 20

25 °C (i.e., controlled room
temperature) for 48 h”
.


Walmart
is
one of the first companies to f
ull endorse and begin to use it.


4.5.

PureTemp
-
40 phase
-
change material, Entropy Solutions




A
lternative to dry ice



100%
renewable and biodegradable



Can be reused over and over



The US Department of Agriculture lists the material in its Biopreferred purchasing program



M
ore environmentally friendly (Dry ice produces carbon dioxide)


Sources:



http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=615815&sk=&date=&
pageID=2



http://www.packagedesignmag.com/issues/2009_03/p38.shtml


Cold Chain Supply Chain Best Practices


Fall 2009





17

5.

Beckman Coulter




Company Overview

Beckman Coulter, Inc. is the leader in manufacturing biomedical testing instrument systems. These
systems make many laboratory processes easier. They also produce consumables used in clinical
diagnostics and life science. These consumables must be refrige
rated.


Cold Chain Partner: Arvato

Beckman Coulter was having trouble managing their cold chain. To help they referred to the company
Arvato Services which is a subsidiary of Arvato AG.

Arvato Services focuses on supply chain management
and customer retention for both Europe and markets outside of Europe. They have 30,000 employees
in over 30 countries. They are an end to end 3PL
-

over 650 million shipments per year. One of their
mai
n focuses is after sale logistics such as repairs and returns.


Beckman was having trouble shipping to hospitals and labs. Arvato helped by:



creating regional distribution centers
:

-

Lognes, France
:
8,000 stock
-
keeping unit
s (SKUs)

-

Monheim, Germany
: 15,000
SKUs

-

Hig
h Wycombe, England: 1,000 SKUs



creating

a replacements parts distribution center near Brussels airport for fast delivery
:

-

Express delivery allowed shipments to be dropped off at night. Pick up would occur
upon drop
-
off if necessary (Arvato took ca
re of disposal)

-

All international shipments passed hazardous
-
good regulations


this mostly includes
temperature controlled shipments (2
-
8degrees)


Overview of Arvato
-

Temp
erature

Controlled Shipments

Arvato focuses on the visibility throughout the cold
chain.

They have over 50 sensors in a shipment with alarms that go off when the temperature goes out of the
2
-
8
o
C range.

They have performed tests for all of the emergency temperatures and their results
have improved
accuracy.

When shipping in boxes,
Arvato uses Neopor® boxes.

Neopor is actually a material produced by NEOPOR
System GmbH, a company in Nuertingen
, Germany who was recently bought by BASF.
The Neopor is
used to insulate buildings and houses.
It naturally absorbs some
infrared

rays and re
flects other

radiations

making it a great thermal insulator.

The Neopor box has a special shaped inner wall and
doubly secured lid validated for the temperature ranges 2 to 8 °C and 2 to 25 °C, up to 48 hours
regardless of the outside temperature.

Cold Chain Supply Chain Best Practices


Fall 2009





18


Figu
re
2
. Neopor Box


M
any different packages have been developed that take advantage of this extremely effective Neopor
technology.
Two companies
,

Delta T and Storopack
,

both joined together to produce a few of these
packages.


A

list of some of the boxes that Delta T uses

can be found in the Appendix

1
. Their Foam Boxes consist of
latest technology Styrofoam or Neopor. Foam boxes can be used for one way or mutiple shipments.
Validation data for many applications for all temperatu
re ranges are available.



So
urces:



http://www.storopack.com/en/products_solutions/technical_moulded_parts/materials/neopor.
html



http://www.plasticsportal.net/wa/plasticsEU~en_GB/portal/show/content/products/foams/foa
ms_commodities



http://www.storopack.co.uk/uk/casesstudies/casestudies_packaging_solutions.html



http://www.arvato
-
services
-
healthcare.com/en/services
-
and
-
solutions/integrated
-
solutions/cold
-
chain/cold
-
chain
-
management.html




http://www.arv
ato
-
direct
-
services.de/en/reference
-
beckman
-
coulter.html




Cold Chain Supply Chain Best Practices


Fall 2009





19

6.

Life Technologies




Company Overview

Life Technologies is the combination of Invitrogen Corporation and Applied Biosystems, Inc. Invitrogen
is the leading provider of consumables and reagents. Applied Biosystems provides systems solutions
and isn’t involved with cold chain shipping. Life T
echnology products are found in 90 percent of the labs
in the United States.


Cold Chain
Practices

Invitrogen charges an extra when they need to pack with dry ice
. I do not have any information on
exact prices.
Invitrogen ships directly to customers.


Sources:



http://www.invitrogen.com/site/us/en/home/Produc
ts
-
and
-
Services/Supply
-
Center.ht
m
l




Cold Chain Supply Chain Best Practices


Fall 2009





20

7.

Spherotech




Company Overview

Spherotech was established in 1992 to manufacture and produce
micro particles

for biomedical and
diagnostic applications. Their headquarters are 25 miles north of Chicago.


Cold Chain Partner: FedEx

Spherotech’s preferred carrier is Fed

Ex.

Their standards for shipping are listed on the company website. If Spherotech receives an order by 3:30
CST it is shipped out that day. Temperature sensitive items will get to their destination by 3:00 the next
day for a charge of $30.00.

Their sh
ipping methods seem to be very similar to BD’s ones; they use Fed Ex instead of UPS.


Sources:



http://www.spherotech.com/



http://www.linkedin.com/companies/spherotech
-
inc




Cold Chain Supply Chain Best Practices


Fall 2009





21

8.

Ebioscience




Company Overview

Ebioscience is a biological production company that specializes in the production of reagents and
antibodies.
They started in 1999 and are located in San Diego.
They pride themselves in being the
leaders of in
novation in the field and they are
flexible in

meeting the researchers need.

Ebiosciences is the preferred supplier of UPenn for all of their life sciences products. UPenn is
leveraging the amount of product they order annually and us
ing

strategic sourcing.


Cold Chain
Practices

Ebioscience ships
their products in different sizes depending on the projects’ needs. They ship in
25
tests or 50ug as well as larger sizes for larger projects (1 mg or bulk size). They offer a 105%
money back
guarantee if their product doesn’t match the quality standards

that they promised.

Customers outside of the United States must order Ebioscience’s product from a regional distributor.
Ebiosciences ships to these distributors with a transit time of 2
-
10 days.

To aid with distributing their product to customers in

Germany, Ebioscience purchased NatuTec a
German biological and pharmaceutical company located in
Frankfurt, Germany.
This allows
Ebioscience

to offer
their

customers faster lead times, fast order processing and a wider range of products. NatuTec
is now p
romising their customers receipt of their product within 1
-
3 days of the order.


Sources:



http://www.natutec.de/en/cms/822
-
479/natutec
-
is
-
now
-
part
-
of
-
ebioscience
-
.html




http://www.purchasing.upenn.edu/buyinfo/suppliers/pm_suppliers/ebioscience.php



http://www.lifesciencesworld.com/life
-
science
-
news/view/117201




Cold Chain Supply Chain Best Practices


Fall 2009





22

9.

Biolegend




Company Overview

Biolegend is a biotechnology company that specializes in high quality antibodies for biomedical research.
Their products are strictly for biomedical research and
therefore

are not FDA regulated.


Cold Chain Practices

Most products are shipped at ambient

temperature. However some products, such as recombinant
proteins
, are

shipped with dry ice in separate shipment.


Sources:



http://www.biolegend.com/support/#faq





Cold Chain Supply Chain Best Practices


Fall 2009





23

C
OLD
C
HAIN
S
HIPPING
IN THE
P
H
ARMACEUTICAL
I
NDUSTRY


Improving Cold Chain shipping

is emerging as one of the biggest trends in the pharmaceutical industry.
Many companies are beginning to focus on it and trying to adopt practices better than that of their
competitors
. There are countless conferences on this topic in which prominent companies within the
industry explain some of their best practices.


Like the biological industry, cold chain shipping is mostly provided by 3PLs. Many companies that ship in
bulk use 3
PLs to ship their product and provide RFID information the entire time. Temperature monitors
are extremely popular within the industry, mostly because of how expensive some of these
pharmaceutical shipments are. If a whole reefer (truckload), of pharmace
utical product is spoiled
because of out of range temperature, millions of dollars can be lost. Companies understand this, and
monitor their bulk shipments very closely.


Other companies use a dedicated shipper such as FedEx or UPS to ship their product

but pack it
themselves. The standard pharmaceutical cold chain products are the same as other industries; gel
packs, EPS coolers, dry ice. Cold Chain Technologies, Minnesota Thermal Sciences, and TCP Reliable,
have created shipping products with distinc
t advantages over these standard products. They have
advantages in regards to cost, efficiency, and also positive environmental impacts. These products are
detailed below.



List of companies

and packaging solutions

studied:



Cold Chain Technologies



Minnesota Thermal Sciences



TCP Reliable



Cold Chain Supply Chain Best Practices


Fall 2009





24

1.

Trends
in
the Pharmaceutical
I
ndustry



1.1.

Introduction


One of the biggest trends in the industry is in the area of PCMs, or Phase Changing materials. Typically
many companies have implemented a ‘passive’ system, but may need to pursue more of an ‘active’
system. An active system involves machine operated coo
ling systems to be put in with the product.


“Traditionally, the industry has depended on water
-
based gel packs for cooling higher temperature
ranges, and dry ice for lower ranges, or, alternatively, the use of “active control” via battery
-
powered
cooli
ng and heating systems. Now, PCMs are reshuffling the industry options.”


1.2.

Pharmaceutical

and
Cold Chain


Cold chain is a h
uge part of the pharma
maceutical
/biological shipping market.

Temperature
-
sensitive drugs represent about 10% of the roughly $240

bill
ion pharmaceutical
distribution industry, according to the Healthcare Distribution Management Association (Arlington, VA).
A wider variety of diagnostic or clinical
-
trial materials are also coming under more demanding
temperature
-
controlled shipping requir
ements, as are
blood products

and vaccines.


Typically gel packs and dry ice materials are used to ship. The typical temperature profiles are
similar to
BD’
s requirements.

Most pharma
ceutical

products requiring cold chain distribution fall within a temperature range of 2 to
8°C. The most commonly used agents for control temperature are water
-
based gel
-
packs or cool
-
packs,
commonly used in 2
-
8° s
hippers.


Many companies are looking to get away from Dry Ice, and are looking into alternative solutions. There
are three main reasons to use a material besides Dry ice
:

1.

D
angerous because it can cause a co
ld burn if it touches the skin

2.

C
ost

3.

Sublimation:
“The other issue with dry ice is that it undergoes a process called sublimation,
in which it transitions directly from solid form to gaseous form, so the cold chain package
must be designed to take this property into account,” notes Anthony Alleva, technic
al
services manager, TCP Reliable (Edison, NJ)


The result is some alternative solutions that will be researched further. Here is a brief overview of them
organized by the company that manufactures them.






Cold Chain Supply Chain Best Practices


Fall 2009





25

1.3.

Minnesota Thermal Sciences


They r
eleased

the first container that c
an store material for up to
-
50
°C
. It is referred to as the Credo
Series 50 M.


“We’re very excited to introduce a container that will preserve medical samples better than any other
option in the marketplace and cut down on exo
rbitant shipping costs,” Schlenker says. “Another
advantage is that the container will hold payloads at
-
50°C for three days, but after five days it will still
be below
-
18°, which is still viable for most frozen medical requirements.”


1.4.

TCP Reliable


TCP
has made some boxes to compete with the traditional EPS Styrofoam as well as Entropy Solution’s
famous Greenbox. The main products are referred to as Phase 5 and Phase 22 but there are other
products for different temp ranges.




“Phase 5 is designed to
have a 5°C phase change temperature for use in 2
-

to 8°C applications,” Alleva
explains. “Another such product is called Phase 22, which is designed to have a 22°C phase change
temperature for use in 20
-

to 24°C applications.”


1.5.

Decision between an active a
nd a passive solution


Active systems tend to be the mo
st

expensive option but can offer huge benefits in terms of quality.
With the in
-
transit information companies can be assured that their product gets there with the right
temperature. Active systems
are more important with larger shipments, and are not that practical for
single dose uses.


Last summer, UPS Healthcare Logistics (Atlanta) went live with an enhancement of its product
-
tracking
capabilities through its worldwide network, called ProActive

Response. The service puts a sophisticated
analytical system alongside the product tracking, so that, for example, temperature
-
sensitive shipments
can be monitored for delivery delays that might cause temperature conditions to go out of range. With
the UP
S network, trained personnel can replenish stocks of coolant, or assist in rerouting the shipment
to keep it within spec.

Cold Chain Supply Chain Best Practices


Fall 2009





26


1.6.

Single Dose Options




Entropy Solutions:
Inflater Pack



TCP Reliable
:
prequalified single shipment containers rated 96 hours at 2 to
-
8 degrees



Minnesota Thermal Sciences
:

primarily used in the Army
-

S Series
container

with a 3.6 in cubic
payload and maintains temperature

for up to 36 hours


Sources:



http://www.pharmaceuticalcommerce.com/frontEnd/1278
-
cold_chain_envirotainer_delta_acutemp_logistics_ULD.html


Cold Chain Supply Chain Best Practices


Fall 2009





27

2.

Cold Chain Technologie
s


2.1.

Introduction


Cold Chain Technologies provides thermal packaging solutions as well as many services across the globe.

They have facilities in

Massachusetts, Tennessee, and Nevada
. Their major brands are the
KoolTemp[TM] insulated containers, Koolit[R] refrigerants. All of their products meet the regulations of
USDA, HACCP, DOT, as well as the requirements for UPS and Fed Ex. They engaged in strategic
relationships with strategi
c partnerships with Topa Packaging in Europe, and Foam Fabricators Inc. in the
United States.


Topa packaging is one of the leading cold chain solution providers for Europe. They are located in the
Netherlands and manufacture all of the KoolTempTM conta
iners (EPS, PUR) and Koolit

refrigerants
(bricks, gels, mats). Topa Packaging mostly serves the pharmaceutical, biotech, and healthcare sectors.


Foam Fabricators is one of the “best EPS shape molders in North America, as well as a global supplier.”

T
his partnership was formed to better serve Cold Chain Technologies’ customers need geographically.


Once again Cold Chain Technologies has an extremely wide range of products. There best product
seems to be the Insulated Envelopes. The rest of the prod
ucts seem to be something very similar to
what is all over the industry and offered by many other companies. Their products come in a wider
range of sizes, than
most companies
typically offer.



2.2.

KoolTemp™ Polyurethane Insulated Containers






Ideal for
2
-
8 degree range



Must be combined with a gel pack



Polyurethane has a much better R value than traditional EPS packaging


“The recyclable components of the KoolTemp PUR contain a non ozone
-

depleting formulation (no CFCs
or HCFCs), and are EPA compliant.”



Cold Chain Supply Chain Best Practices


Fall 2009





28

2.3.

EPS molded and EPS Panel







Offered in a variety of sizes



Competitive adavantage is that they have many manufacturing facilities so you can order them
Just in Time


2.4.

KoolTemp™ Insulated Envelopes







Can be used with or without
K
oolit mat (
gel pack)




Available in popular sizes, the KoolTemp insulated envelope can be used with or without
standard overnight boxes for further protection.”



Reflective outside serves to prevent further heat loss (reflect 97%)



Seals with pinch of inner seal lock
or adhesive tape



Sizes
:

o

IE912 Zip with Closure Flap Size 12" x 16" Seal
-
to
-
Seal 50 Env/Carton

o

IE1216 Zip Lock with Closure Flap Size 12" x 16" Seal
-
to
-
Seal 50 Env/Carton












Cold Chain Supply Chain Best Practices


Fall 2009





29

2.5.

Koolit™ Foam Bricks






Holds shape whether thawed or frozen



Better than
all of CCT’s other products in regards to holding temperature



Puncture resistant



Available in a variety of sizes


2.6.

Koolit™ Gel Paks






Available in a variety of sizes and a variety of cooling temperatures ranging from (0°C [32°F] and
-
23°C [10°F])



Puncture

resistant



Can be folded to fit inside the insulated envelopes



Available in three different pouch materials ; Thick Polyethylene, Metallized Laminate, and
Sweat
-
Proof Film



Also available in a saddlebag which wraps around the p
roduct providing even
packaging:





Cold Chain Supply Chain Best Practices


Fall 2009





30

2.7.

Koolit™ Gel Bottles






For heavy duty uses



Puncture proof



Hold
s

0 degrees Celsius temp
erature


2.8.

Green Initiatives


Source:

PMPG News, August 2008


“In 2005, The
Sustainable Packaging Coalition provided an ambitious definition of a sustainable package
as one that is:



Is beneficial, safe, and healthy for individuals and communities throughout its life cycle.



Meets market criteria for performance and cost.



Is sourced
, manufactured, transported, and recycled using renewable energy.



Maximizes the use of renewable or recycled source materials.



Is manufactured using clean production technologies and best practices.



Is made from materials healthy in all probable end
-
of
-
lif
e scenarios.



Is physically designed to optimize materials and energy.



Is effectively recovered and utilized in biological and/or industrial cradle
-
to
-
cradle cycles.”


Environmental Impact of EPS:




95 percent air



EPS can be reused and does not have to be thrown out



Cold Chain Technologies allows you to drop off your EPS Cooler at many locations across the
United States



Also many mail in locations


Environmental Impact of Koolit Refrigerants
:



Within the gel
packs i
s a water soluble starch



Pack can be cut open and disposed of in the normal waste stream



Outside plastic can be recycled wherever
(low density polyethylene (LDPE), #4) is accepted


Sources:



http://www.coldchaintech.com/products/kooltemp
-
polyurethane
-
insulated
-
containers.php


Cold Chain Supply Chain Best Practices


Fall 2009





31

3.

Minnesota Thermal Science




3.1.

Introduction


Located in Plymouth
Minnesota, MTS
provides thermal packaging with the highest degree of
temperature control.
The products are very expensive but more effective than standard.



MTS is fully ISTA certified: “MTS uses its highly precise ISTA
-
certified thermal lab to ensure

Cr
edo®
containers perform at the highest level of thermal control. Capable of constant ambient hot +40°C and
cold
-
20°C tests, the lab also performs ISTA standard summer and winter shipping profiles and custom
client shipping profiles for product development

and measurement.”


“The solution, the Original Golden Hour
®

Container, saved countless lives and was considered so
revolutionary that it was recognized with the
U.S. Army’s

Greatest Inventions Award
.”


“Minnesota Thermal Science provides innovative, scientific solutions both domestically and abroad for
the safe transportation of sensitive pharmaceutical, blood and biologic products.” One of their main
customers is the milit
ary because they are able to offer precise temperature profiles and ensure that
these temp
erature

profiles are kept for long periods of time. They offer packaging that hold
temperature for longer than any other company.


They are known primarily for thei
r Credo Box however they have many solutions for a
ll different
temperature ranges.


They seem very expensive and more practical for tissue transport (more important items)
.


W
ebsite of
their
products
:

http://www.credothermal.com/SolutionFinder/CredoSolutionFinder_Detail.aspx?pid=24



3.2.

Single Dose Product




Called the Military/Government Solutions


Factor VI
I



Portable pack that can hold up to 2 vials of blood for up to 72 hours in a normal temperature
profile



Not used for shipping the product (strictly for carrying)



Cold Chain Supply Chain Best Practices


Fall 2009





32

Specifications
:


Payload Capacity (liters/cubic inches)

0.06 / 3.61

Payload Area
Dimensions (L x W x H)

Cylinder (1" Diameter) x 4.6"

Exterior Dimensions (L x W x H)

5" x 3" x 7.5"

Tare Weight

2 Lbs

Thermal Performance

48 Hrs

ISTA Summer Profile


Outer Container

Soft
-
sided Carrier

Insulator

Vacuum Insulation Panel


3.3.

Outer Boxes




F
rom left to right
:

Brown V3C
,
Pelican Case
,
Plastic Corrugate,

White V3C


3.4.

Conclusion


MTS has a lot of packaging products most of which are expensive for single doses. Their main customer
is the army because of the high volume they ship as well as the accuracy needed.


Most of their solutions are using one of the outside boxes seen above

in combination with their
effective inner material. The inner liners of these boxes are standard size and the liner
can be changed
depending on the exact temperature profile
required
. This gives a lot of flexibility but
it may not be that
practical
for
one time uses.


Sources:



http://www.sovereign
-
publications.com/credothermal.htm



http://www.credothermal.com/AboutMTS/About_CredoAdvantage.aspx#precise



http://www.mdtmag.com/scripts/ShowPR.asp?P
UBCODE=046&ACCT=0008100&ISSUE=0903&R
ELTYPE=NP&PRODCODE=1910&PRODLETT=A&CommonCount=0



Cold Chain Supply Chain Best Practices


Fall 2009





33

4.

TCP Reliable




4.1.

Introduction


Located in Edison
,

New Jersey
, TCP Reliable offers many temperature controlled packaging solutions.
Their main goals are to limit the use of EPS packaging and offer alternative PCM solutions to what is
currently on the market. In 2006, TCP
aquired

all of the assets of Cryopak, a lea
ding refrigerant
manufacturer. All of the testing done on TCP’s packaging is done by DDL, a package and material testing
company. They combined companies back in 2007 but operate separately.


TCP Reliable and Alternative Technology Pharma, a company loc
ated in Canada
,

signed a contract in
2006 to serve
together
the cold chain shipping needs for North America. “Under this agreement, TCP
will be the exclusive reseller and distributor of the ATP's cold chain services and monitoring solutions for
the US mar
ket. Under this same agreement, ATP will be the exclusive sales agent of TCP's temperature
controlled packaging solutions in Canada.” More importantly
,

t
he pharmaceutical and life sciences
market in North America, including pharmaceutical developers, im
porters, manufactures, wholesalers,
transporters, and retailers, will be the primary target of ATP and TCP companies. The pharmaceutical
and life sciences industry annually suffers billions of dollars in losses due to cold chain break
-
ups and
product degra
dation.”


“By performing all services under one roof, in strict conformance with ISO 9001:2000, ISTA and ASTM
test methodology, and FDA good manufacturing practices, TCP gives you exceptional responsiveness,
consistency, and accountability.”


TCP Reliable
has a
n

extensive list of products for uses similar to BD’s.


4.2.

Alternative to Dry Ice


Brand Name “20 below”
:



“This specialty gel is designed to be a safe and effective alternative to dry ice. It is specifically for
engineered for freezing applications. As

with all of the TCP refrigerants,

20 Below

is water
soluble and re
-
usable. “



It can be used with any insulated shipper.


Conditioning temp. to freeze product
:

Below
-
25 ° Celsius

Conditioning temp to melt product
:

Above
-
15° Celsius

Disposable in std.
municipal waste stream
:

Yes

Reusable
:

Yes


Cold Chain Supply Chain Best Practices


Fall 2009





34

Sizes:

Cryo
-
Gel
-
20 Case,
hardpack

5.375" x 5.375"

0.85 lb

20 Gel Case
, CG
-
1075
-
20

5.5" x 7"

0.75 lb

20 Gel Case
, CG
-
1100
-
20

5.5" x 7.75"

1.00 lb

20 Gel Case
, CG
-
1150
-
20

5.5" x 9.5"

1.50 lb


4.3.

Alternative for
2
-
8 degrees


Brand name “Phase 5”
:



Packaging material offers improvements over the standard PCMs because it

holds the
temperature better.



Best used in conjunction with panels connected to form an inner cube inside of the outward
protective material (EPS cooler,
Greenbox
)




If the temperature
-
sensitive product must be maintained within 2°


8° C,
the
Phase 5
™ TCP

is filled with
a material t
hat undergoes phase change at 5°C. This is exactly in the middle of the desired range.
Because it can hold 5°C longer than a conventional phase change material (which undergoes phase
change at 0° C, and has very little heat capacity at 5°C), significantly
less material is required. In addition,
the phase change material can be placed in direct contact with the temperature sensitive product
because there is no risk of freezing. This reduces the size of the final package because no dunnage or air
gaps are req
uired.



Figure
3
.
A
dvantages of Phase 5 over Conventional Gel Packs

Cold Chain Supply Chain Best Practices


Fall 2009





35

Phase/Freeze Point
:

5° Celsius

Conditioning temp. to freeze product
:

Below 0 ° Celsius

Conditioning temp to melt product
:

Above 10 ° Celsius

Disposable in std.

municipal waste stream
:

Yes

Reusable
:

Yes


Sizes:

Phase 5™


Case
-
TCP small

5.5"L x 5.5" W x 1"H

.66lbs +/
-

1.5%

Phase 5™


Case
-
TCP large

9.25"L x 7 " W x .75"H

1.1lbs +/
-

1.5%


They have a product that holds temperature from 20
-
24 degrees. That is not within the profile’s BD is
looking for however.


4.4.

Outward packaging solutions




Pharmatuff™ and ThermalTuff™

o

Standard EPS coolers with density 1.25# and 1.5#






Mol
ded Insulated
Containers (EPS)

o

L
ock into each other and available in smaller size
s for single doses such a 6.37"
x
4.7”x
5"






Fabricated Containers (EPS
)







Cold Chain Supply Chain Best Practices


Fall 2009





36

4.5.

Tem
-
Pak Box (avail. in brown with no printi
ng or white with std. printing)




C
an either be sent already assembled or as separate pieces to be assembled on site



A
lso available in custom sizes






4.6.

Polyurethane Molded Containers (PUR)




Super K insulation for longer periods of time



D
o not always need

to add a gel pack to it



Sources:



http://www.tcpreliable.com/about



http://news.thomasnet.com/companystory/486298



http://www.tcpreliable.com/products/insulated
-
shipping
-
containers




Cold Chain Supply Chain Best Practices


Fall 2009





37

C
OLD
C
HAIN
S
HIPPING IN THE
F
OOD
I
NDUSTRY


Cold Chain shipping in the food industry is becoming a highly competitive field. Companies are looking
into improving their cold chain process to make it a competitive advantage for them. Environmentally
sound products are a major trend in the industry.

Outbreaks
of disease and contamination have

increased regulations by the FDA and other organizations. We will see much more regulation in the near
future.


Most of the food products that are shipped are in large quantities filling Reefer or full truckloads. Most
of the temperature regulation
is

maintained through active transport, and generators are usually
utilized. Companies are not willing to risk a spoi
led product when lives are at stake. Companies that
ship cakes or chocolate through online ordering have products similar to BD’s requirements. They ship
usually with EPS molded coolers, built custom depending on the product. The shipping method across
the industry usually changes when food is sent to Hawaii or Alaska because of the distance and distinct
temperature profile. Companies must be careful shipping to other parts of the country in the summer
because of the high temperatures.


Cold Chain Supply Chain Best Practices


Fall 2009





38

1.

Trends
in

the

Food

industry


There are many specific trends within the cold chain shipping of Food. One important trend is that
there is a distinct
shift

in the size of shipments because of the increasing customer demands. Customers
are expecting
a much

more flexib
le supply chain. Customers are upset when the product they want isn’t
there, forcing food companies to use a highly responsive supply chain with small LTL shipments.
Companies are often focusing on increasing their perfect order percentages.
Once again
this is because
of the increasing consumer demands.


Other trends are, forward DCs, globalization and consolidation, trading partner collaboration,
sustainability
, and capacity issues. Transportation and warehousing methods are shifting, and many
firms
are using 3PLs to manage one or the other.




Changing Business Model

o

Smaller more frequent orders

o

Order fulfillment is new fundamental business requirement



Perfect Orders

o

On time

o

Accurate

o

Complete



Forward DC’s



Globalization and Consolidation



Manufacturers

o

3PL’s

o

Retailers



Trading Partner Collaboration



Capacity Issues

o

Transportation

o

Warehousing



Sustainability


The refrigerated and frozen food market has been growing over the past 10 years

in the U.S.
. The need
for reliable cold chain shipping methods has
therefore increased significantly.



Cold Chain Supply Chain Best Practices


Fall 2009





39

2.

Best Practices
-

Cross Docking


Ron Cain, president and chief executive officer of TMSi Logistics, a third party logistic provider,
headquartered in Fernandina Beach, Florida said, “One way that companies are conquerin
g these
challenges is through cross
-
docking, a practice that has demonstrated great improvements in the
transportation of perishable goods." This is because of the increased pressure for customer service and
freshness, and shipping variety.


According t
o the 2007 Food Logistics Industry Report, 43 percent of responders said that they have
recently increased their cross docking practices. Many of these companies are beverage and food
shippers.

Companies that ship a high volume in short periods of time
can have the most benefit.

Along with cutting labor, storage, and transportation costs, cross
-
docking improves the level of service a
company can ensure. A successful cross
-
docking plan is flexible enough to address unexpected events
such as shipment del
ays, production delays, and demand swings, all of which affect the ultimate quality
of service provided.

"Unlike traditional shipping and warehousing methods, cross
-
docking is a dynamic and responsive model
that eliminates the rigid, linear value
environments of outdated supply chains," said Cain.


3.

Best Practices
-

Outsourcing



The trucking industry is comprised of an extensive network of trading partners, including suppliers,
manufacturers, distributors, and retailers. All aspects of business, in
cluding cross
-
docking and effective
cold chain management, have, therefore, become a collaborative effort
”,

Cain

said.

"As a result, many companies responsible for refrigerated transportation are choosing to outsource their
cold chain operations to a third

party logistics provider."

Cain said outsourcing to a 3PL allows a company to focus on core competencies, leaving the work of
managing cold chain
-

and its cross
-
docking scheme
-

to a qualified collaborator.

To achieve all the possible benefits of cross
-
docking, he advised companies to: "Assess whether your
existing infrastructure is capable of making the change to cross
-
docking, or if there is greater benefits in
entrusting your cold chain operations to a qua
lified third party provider."


4.

Temperature Controlled Shipping



“We believe there are four steps to the safety of perishables
”,

says Elizabeth Darragh, director of
supermarket and food strategic marketing

for Sensitech Inc., a Beverly, MA
-
based provider
of cold chain
monitoring instruments,

information and an
alysis:

1.

the product needs to

be pre
-
cooled properly

2.

the trailer n
eeds to be pre
-
cooled properly

3.

the trailer needs

to be loa
ded properly

4.

you need to maintain pro
per temperature during transit


Cold Chain Supply Chain Best Practices


Fall 2009





40

The only way to have consistent effective practices is for the whole industry to adopt them.

“The
supply chain has a clear responsibility in fulfilling all the post
-
harvest requirements

of the product and
that includes keeping cold temperatures if need b
e, or just holding

the produce at the proper
temperatures,” explained Humfeld.


The b
est way to ensure perfect orders and that the product maintains temperature is through RFID
information as well as temperature monitors.
H
aving a web
-
based customer inte
rface will even further
facilitate the process by providing the customer with a real
-
time ordering process. It can provide the
customer with a wealth of temperature information as well but that could be too intrusive.


5.

Regulations


Overall the cold chai
n food in
dustry is much more regulated than the biological or pharmaceutical
industries.


Food shipping is mainly regulated by:



DHHS
-

department of Health and Human services



FDA

-

Food and Drug Administration



FSIS

-

Food Safety and Inspection Service



US
DA

-

US Dep
artment

of Agriculture


The FDA established the
Hazard Analysis and
Critical Control Point (HACCP). It was lasat updated in
2004. This is a me
thod
whose aim is to

prevent chemical, physical and biological hazards to food
products. Its main concept is that there are Critical Control Points where actions can be taken to
significantly reduce potential hazards.
The HACCP
has major implications on the cold chain shipp
ing
industry
.


6.

Drivers for change


Global food supply chains are aggressively fighting for where the food is sourced from. If freshness is
not maintained, customers will switch

suppliers
. Whatever cold chain
functions

the best will be
selected. Many fo
od products are being sourced from all over the globe creating even more pressure.
People demand fresh product even when it isn’t locally
grown
in season
.


The main drivers of the changes in the food cold chain shipping are:



Consumers tastes and preferences



Competition and production efficiency
:

companies around the world are realizing how
important cold chain and supply chains are



Advances in technology
:

media and web have brought much more visibility



Institutional pressure
s and regulatory requirements
:
outbreaks of disease are increasing
pressure. “
A

recent a
nnouncement suggests that by 20
05 food manufacturers in Singapore will
Cold Chain Supply Chain Best Practices


Fall 2009