Healthcare Supply Chain Playbook

8/2/2019 Healthcare Supply Chain Playbook

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Shipping strategiesfor global expansion

Navigating thetemperature-sensitive chain

New tools, tactics and technologiesfor real-time control

Best practices for global compliance

Pharmaceutical, biologics, medical devices

2011 EDIT ION

Sponsored by UPS

HEALTHCARE SUPPLY CHAIN PLAYBOOKCreating more efcient and agile supply chains
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HEALTHCARE SUPPLY CHAIN PLAYBOOK 2 / 40

Sponsored by UPS

CONTRIBUTORS3 A list of experts contributing to this playbook

INTRODUCTION

4 Re-thinking your supply chain

FEATURES7 Weighing cost against value for healthcare logistics

10 Coping with exponential growth of global shipping regs

13 New technologies for protecting product integrity

SPECIAL SPONSORED SECTION

15 UPS multi-modal capabilities uniquely suited to healthcare logistics

21 Contingency planning tips for healthcare manufacturers24 Case study: Volcano eruption sets UPS healthcare contingency planning into motion

26 UPS unveils new cold chain container solution

29 Whiteboarding: A tool for involving multiple stakeholders

30 When to use active packaging components

33 Testings role in package development and compliance

38 Package testing options
http://nextpage/http://nextpage/http://nextpage/


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CONTRIBUTORS Te following experts contributed to this playbook

ED ChURCh

President, International SafeTransit Association (ISTA)

JIm LUCIE

Senior Material Control Manager,AMAG Pharmaceuticals

GARy hUTChINSON

Principal, Modality Solutions, LLC(formerly of Amgen)

GEOFFREy GLAUSER

Consultant, Health & Human Services,U.S. Government

DAwN KREUz

Senior Stability Coordinator,Merck

KEvIN ODONNELL

Senior Partner,

Exelsius Cold Chain Management

PAUL hARBER

Principal,Modality Solutions LLC


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FORWARD RETURN TO CONTENTS

INTRODUCTION By Steve Sterling, Contributing Editor

Pharmaceutical, biologics, and medical device manuacturers have a

common objective: deliver the right lie saving product to the right place

at the right time in the right condition to have the best patient outcome.

To achieve that eectively, companies are learning the value o aligning

their global supply chain strategy with their corporate strategy, working

collaboratively with all supply chain stakeholders, and applying a newgeneration o best practices.

This is all the more important

given that two-thirds oHealthcare

Packaging readers revealed in a

recent survey plans to increase

the number o countries theyre

shipping to (see chart, p. 6.) Anda recent healthcare supply chain

survey rom UPS reveals that

healthcare companies plan to

increase the number o direct

shipments to healthcare providers

and retailers (see chart at right).

Re-thinkingyour supply

chain

Source: UPS 2011 Pain in the (Supply) Chain survey 250 respondents

STRATEGY CHANGES IN THE NEXT 18 MONTHS

Plan to keep the currentbalance of these

strategies the same

Increase the use ofdirect shipments to

providers & retailers

Increase the use ofwholesalers/

distributors

Increase the use ofdirect shipments

to patients

Multipleresponses

permitted

50%

22%

15%

7%
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To comply with a host o country-specic trade regulations and compliance requirements,

manuacturers are recognizing the need to work with logistics partners on the development

o proactive solutions that ensure regulatory compliance while simultaneously protecting

product integrity.

The current pharmaceutical supply chain worked well when the

blockbuster paradigm prevailed, says Wynn Bailey, head o supply chain

strategies, PricewaterhouseCoopers International Limited (PwC). But

pharmas ocus in a post-health reorm world is shiting rom products to

patients, and supply chain processes need to adopt the speed and agilityo other, more consumer-oriented industries such as consumer electronics

and mass retailing.

As pharmaceutical, biologics, and medical device manuacturers move

orward to align their supply chain strategy with their corporate strategy,

they will be taking great strides to assure proper delivery o their products,

improving the health o patients as well as their own scal well-being.

Eciency is the name o the game and the adoption o a more collaborative approach could

just be the key to unlocking this potential, says Jo Pisani, partner, global pharmaceuticals

and lie sciences at PricewaterhouseCoopers, in a recent news release. Working with others

accelerates and acilitates innovation, discovery and development, which in turn can

reduce costs and benet both large and smaller companies. Even small changes could yield

signicant savings.

continued

Re-thinking your

supply chain

Source: Healthcare Packaging Survey, September 2011 130 respondents

HOW MANY COUNTRIES DO YOU SHIP TO?

9 or fewer

10 to 19

20 to 29

30 to 49

50 or more

42%

22%

11%

7%

18%
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Companies that put a high degree o

conscientious eort into their processes

and procedures are the industry leaders,

according to Kevin ODonnell, Senior

Partner, Exelsius Cold Chain Management.

These organizations set the pace or

everyone else because they make sure

they have control over their processes,

map their distribution environment,

understand their logistics process, andhave robust quality management systems

in place with their service providers and

all o the partners in their supply chain.

They audit processes and have standard

operating procedures and service level

agreements in place.

To help you re-think your global supplychain strategy, we have interviewed industry experts rom across the healthcare supply

chain or best practices and pitalls to avoid. Weve also included benchmark research

rom Healthcare Packaging readers on the state o their supply chains, supplemented with

benchmark research rom UPSs own annual Pain in the (Supply) Chain survey results.

We hope you nd the inormation in this playbook actionable and useul.

Thanks or reading.

continued

Re-thinking your

supply chain


HOW MANY ADDITIONAL COUNTRIESDO YOU PLAN TO SHIP TO?(in the next 12 months)

Noincrease

Up to 10% increasein the number of

countries

Up to 50% increasein the number of

countries

Up to 25%increase in the

number of countries

More than50% increase

in the numberof countries

34% 44%

17%

4%

1%


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Weighing cost against valuefor healthcare logisticsThere are three components that comprise a companys business objective in terms o the

logistics process: improving service levels, reducing supply chain cost, and reducing capital

needs. By examining options available to reduce transportation cost, reduce inventory levels,

optimize the distribution network, improve the ability to orecast accurately, and improve

core processes, companies are prepared to develop the supply chain solution that best suits

their goals.

As companies assess where logistics cost improvements can be made, they learn the

limitations o traditional thinking that merely looked to suppliers or cost reductions. They

become aware that by not changing the undamental way they do business, they miss the

opportunity to create a long-term sustainable solution that would have long-term benets to

the business.

One o the most important steps that manuacturers logistics partners can take is to

establish written Standard Operating Procedures and Quality Agreements, says Paul Harber,

principal at Modality Solutions LLC.

It is vital to link up regulatory aairs and quality assurance teams with a manuacturers

quality assurance organization. This enables the kind o inormation sharing that provides or

best practices in the solutions creation. It is also important to establish a quality agreement

between the supply chain logistics partners and the manuacturer or how the shipper is


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going to move the product,

how it will control it in transit,

and to have spelled out all the

specic requirements associated

with that product, including the

development o contingency plans

that can be executed i a shipment

needs to be diverted.

Gary Hutchinson, ormerly withbiotech giant Amgen and currently

principal at Modality Solutions

LLC, explains, The involvement

o quality assurance has become

even more prevalent with the

growing number o biologics

products reaching the market as

well as the increasing stringentregulatory requirements. For

example, the Food & Drug

Administration now requires that the temperature on the product must be maintained

throughout the transportation cycle. Manuacturers have learned that it only takes one

temperature excursion to put shipments worth millions o dollars on hold until urther

analysis is done. With a thorough understanding o what needs to be done throughout the

supply chain to protect the product, companies can ensure the ecacy o the product.

continued

Weighing cost

against value forhealthcare logistics


MOST PRESSING SUPPLY CHAIN ISSUES

Regulatory compliance

Managing supply chain costs

Product security

Product damage or spoilage

Access to globalor emerging markets

Changing distribution andgo-to-market channels

Meeting customers changingdemands for services

Product tampering

or counterfeiting

Multipleresponses

permitted

200920102011

60%

73%

64%

64%

55%

61%

40%

56%29%

42%

40%

40%

18%

29%

26%

12%

42%

34%


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UPS and the Logistics of HealthcareAt UPS, we understand its a patient, not a package:someones health depends on your companyshealthcare supply chain. Hear from our team ofexperts on what sets us apart.

Video: Trends inHealthcare Logistics

John Menna, Director of Global

Strategy, UPS Healthcare Logistics,

discusses insights from UPSs 2011

Pain in the (Supply) Chain Survey.

thenewlogistics.com/healthcaretrends

Video: Tour a

UPS HealthcareFacilityTake a tour led by our

team of experts.

thenewlogistics.com/healthcaretour

thenewlogistics.com/healthcare

Opportunity costs

While managing logistics costs are essential, so too is

understanding and evaluating opportunity costs. Reaching

specic markets while theres demand, the impact o being

late to market, the value o being a rst mover in thatmarket, and the value o brand integrity all need to be

actored into logistics cost discussion.

Jim Lucie, senior material control manager, AMAG

Pharmaceuticals, notes, Strategies will dier depending

on the value o your shipment. In some cases the lowest

shipping cost may not provide the most value. For example,

we have low volume, high value shipments, which means

spending several thousand dollars to ship multi-million

orders enables us to minimize risk and optimize our market

opportunity.

continued

Weighing cost against value

for healthcare logistics
http://www.healthcarepackaging.com/playbook/ups/forwardhttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretrendshttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcarehttp://thenewlogistics.com/healthcarehttp://thenewlogistics.com/healthcaretourhttp://thenewlogistics.com/healthcaretrendshttp://www.healthcarepackaging.com/playbook/ups/forwardhttp://prevpage/


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Coping with exponential growthof global shipping regsTo date there are thousands o

dierent regulations, guidance,

and best practice documents

that have been administered by

the health ministries o specic

countries, industry associations,

or global non-governmental

organizations such as the World

Health Organization or the

Centers or Disease Control and

Prevention. World events such as

9/11, which resulted in 26 new

regulations aecting organizationsthat import or export to the United

States, have added additional

complexity.

Recent research rom UPSs annual Pain in the (Supply) Chain survey indicates that changes in

legislation in general, and changes in customs laws in particular, are among the top concerns

o healthcare products manuacturers. And (See charts accompanying this story.)


GREATEST BARRIER TO PROVIDING QUALITYAND AFFORDABLE HEALTHCARE

6%9%

12%

20%

47%

Changing/increasingmanufacturing

guidelines

Changing/increasingdistribution guidelines

Changes in healthcarelegislation/healthcare reform

Limited globalinfrastructure

Changing/increasingcustoms laws for raw

materials and export ofhealthcare meds/devices


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Changes within the industry,

like the advent o biologics and

medical devices, result in the

ongoing revision o the regulatory

documents, according to Kevin

ODonnell, senior partner, Exelsius

Cold Chain Management. There

has been increased scrutiny on the

part o global regulators o both

the supply chain and the amounto drugs entering this particular

sector.

Since global compliance and

regulatory constraints are an ever

changing landscape, they must be

managed continuously, says Gary Hutchinson, ormerly with Amgen and currently principal

at Modality Solutions. Additionally, with the wide variation in the rigidity o controls amongcountries, manuacturers ace the challenge o putting in the necessary levels o controls and

monitoring to achieve compliance as well as to assure product integrity, without adding cost

by over engineering their processes and procedures.

Manuacturers may enter a new country and not understand all the regulations that are

associated with transporting and storing products in those countries. Logistics partners can

play a key role in expediting global supply chain logistics by providing trade management

continued

Coping with

exponential growthof global shippingregs


HIGHEST BARRIERS TO GLOBAL EXPANSIONCountry regulations

Intellectual propertyprotection

Quality of productsproduced in-country

Product security

Limited infrastructure

Managing multiplelogistics providers

Managing globalsuppliers

Multipleresponses

permitted

42%

31%

29%

26%

24%

13%

13%


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solutions. With the processes

and procedures in place to

stay inormed o the current

regulations and requirements,

logistics partners can assure

companies that their products are

in compliance.

Dawn Kreuz, senior stability

coordinator, Merck, explains,Considering the ramications o

the global supply chain, logistics

partners play a vital role because

they have a comprehensive view

o the overall picture and know

what is occurring in this ever

changing environment. They have

put together the resources so they can collaborate with customers and provide real timeinormation on regulations and what is happening in individual shipping lanes.

continued

Coping with

exponential growthof global shippingregs


RATE THE IMPORTANCEOF SUPPLY CHAIN COMPLIANCE

3%

45% 52%

0%

Of utmostimportance Important

Somewhat important Not important


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New technologies forprotecting product integrityProtecting the integrity o pharmaceutical, biologics, and medical devices entering the global

market has been enhanced by advances in the ow o inormation. Manuacturers have

moved rom knowing when the product should arrive, to knowing what is actually going on

with a shipment in transit through tracking and tracing capabilities, and they are beginning to

implement technologies that enable them to know what is going on inside the shipment and

intervene i necessary.

Leading logistics partners are actively engaged in introducing GPS Global System or Mobile

Communications (GSM), a solution that will allow the shipper to monitor a container and its

products. Not only will this solution enable geographic location monitoring 24/7 by using a

GPS transmitter, but by using sensors on the inside o the container the company can also

monitor the temperature, the condition o the batteries that are running the ans inside the

container, and the condition o the panels that provide heat or cooling. This will enable thelogistics partner to intervene and take action in the event that something is going wrong

beore the products integrity is jeopardized.

Global distribution o biologics requires comprehensive documentation o the environmental

and transportation rigors to which the product will be exposed. Since biologics have a

radically dierent molecular prole, they are more sensitive to temperature, pressure, shock,

Since biologics havea radically dierent

molecular profle, they

are more sensitive totemperature, pressure,

shock, and vibration.


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and vibration, says Paul Harber, principal at Modality Solutions. To ensure their ecacy at

point o use, knowing the precise conditions they will be subject to during transit is critical.

U.S.-made medical devices entering the global market place are subject to very stringent

regulations, including what happens to the device at the end o its lie. Consequently,

manuacturers not only have to develop the orward supply chain, but must also provide

or the ongoing ow o consumables, repair or replacement parts. They must also develop

a reverse logistics strategy or material that is either too valuable to be let behind in the

channel once it reaches its end o lie or cannot be let behind in the channel because it

includes material that cannot go into a landll.

continued

New technologies for

protecting productintegrity


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SPONSORED SECTION

A recent survey conducted by Healthcare Packaging magazine specically

or this Playbook reveals that the most inuential actor on selecting a

logistics partner is demonstrated expertise handling sensitive products

such as pharmaceuticals, biologics, and medical devices (see chart).

For UPS Healthcare, Its a patient, not a package is more than a slogan, it

is a commitment supported by an extensive strategy built on collaboration

with its customers, teams o experts, and the implementation o

supporting technologies to get the right lie saving products to the right

place at the right time in the right condition to have the best patient

outcome. With 30 dedicated healthcare distribution acilities around theworld, the companys unique oering integrates warehousing, distribution

and transportation with compliance, packaging, monitoring technology,

and intervention capabilities. UPSs continuous investment in new

technologies provides customers with world-class product protection.

UPS multi-modal capabilitiesuniquely suited to healthcare logistics


MOST IMPORTANT FACTORIN DECIDING ON LOGISTICS PARTNER

(aside from cost)

Demonstrated expertisehandling sensitive products such

as pharmaceuticals, biologics,and medical devices

Reliable access tothe markets whereI do business and

intend to grow

Understanding ofglobal compliance-related

logistics issues

Collaborativeproblem solving

50%

23%

15%

12%


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SPONSORED SECTION


Collaboration

Dirk Van Peteghem, vice president healthcare logistics, UPS Healthcare, explains, When

we begin working with a customer, we meet with them to determine the exact protection

their product needs and how we can best deliver value. It is critical or us to have a precise

understanding o temperature requirements, compliance and product requirements,

packaging and transportation modes, and shipping lanes, and the customers business

requirements. That is the oundation o our ability to deliver value or a customer and also

gain their trust in our expertise in handling their shipments.

Once we have the customer requirements, our engineers develop a customer-specic

solution. In some cases, we might advise customers to use dierent packaging given our

temperature prole studies or we might advise they use dierent routes. We have packaging

experts, transportation experts, regulatory aairs, as well as other resources that provide

comprehensive insight into all aspects o developing an optimal solution. UPSs unique

strength is our ability to address the our essential components packaging, monitoring,

intervention and compliance required to ensure product protection.

continued

UPS multi-modalcapabilities uniquelysuited to healthcarelogistics


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SPONSORED SECTION


Monitoring and intervention

UPS oers UPS Temperature True or air reight and UPS Proactive Response or the U.S.

package network. Both services use the companys worldwide control towers to monitor

shipments and most importantly intervene in the event anything goes wrong. Van Peteghem

stresses, The ability to intervene is

a tremendous asset and is critical

to the value that UPS delivers.

Monitoring alone just provides

data and oten that data comes

too late. We continue to invest in

expanding our control towers and

also implement new technologies

that improve our ability to

intervene with the shipment i

needed.

UPS works with its customers to

develop intervention plans that

are customized according to

what actions the customer wants to be taken. Preset actions are established. For example,

the customer can request a notication phone call and make situation-specic decisions, or

continued



IMPORTANCE OF CONSULTATION WITH LOGISTICSSUPPLIER ON GLOBAL COMPLIANCE ISSUES

Extremelyimportant Important

Notimportant

at all

45%49%

6%


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SPONSORED SECTION


request that actual physical intervention be taken or that the product be rerouted, shipped

back, destroyed, or a new product shipped.

Van Peteghem reports, We are beginning to see a shit away rom passive temperature data

loggers, which basically record historical temperature and then present the data ater the

act, to more real-time actively transmitting temperature sensors. Real-time temperature

inormation on a shipment enables real-time intervention, which is key to success.

As the technology evolves, remote, real-time intervention will be possible. This will enable

us to remotely activate a container to increase the heating or cooling to prevent a shipment

rom going outside the temperature range critical to product ecacy. At UPS we have a team

that keeps track o the latest monitoring and packaging technologies and tests them in our

network so we can advise our customers on state-o-the-art developments that are benecial

to them.

Given the high value o pharmaceutical, biologics, and medical devices, healthcare companies

are increasingly concerned about security. Van Peteghem explains, Particularly with the

high value o some biologics, we see healthcare companies need more stringent security

solutions to prevent the loss o millions o dollars o product and more importantly to ensure

that product ecacy is not compromised. Since we control our own network, we are able to

reduce the number o hand-os and minimize the risk o loss, thet and diversion.

continued



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SPONSORED SECTION


We are seeing growing interest in emerging vibration monitoring capabilities in combination

with other sensor technologies or security purposes. By combining data points rom the

shock and vibration, acceleration, and geoencing, which sets geographical parameters that

the shipment must remain within, we have the ability to develop smart algorithms to truly

interpret the data and determine i it might provide evidence o a thet situation. This is a

shit rom merely receiving a data eed rom sensors to data eeds that are interpreted by

algorithms to enable timely decision making.

Matthew Connelly, vice president o network operations, UPS, says, As supply chains become

more complex in nature, monitoring product shipments on a global basis is becoming an

increasing need or our customers. Our global control towers, which provide monitoring and

intervention capabilities, and our global transportation network make us uniquely positioned

to provide exceptional product protection to meet global shipping requirements. The

exibility and capabilities o our global, multi-modal network are particularly valuable when

weather or mechanical problems require us to implement contingency plans. Such plans are

designed to ensure product integrity and a continuous ow o product and shipment visibility

or our customers. (For more on contingency planning, see p. 21.)

continued



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SPONSORED SECTION


World-class ofering

While many companies have expertise in packaging, compliance, monitoring, or intervention,

UPS has the ability to provide all our.

We are a one-stop shop, states Van Peteghem. We have packaging experts, we have

the monitoring capabilities in our control towers worldwide, we have dedicated Quality

Assurance and Regulatory Aairs experts globally, and we have the intervention capabilities

to provide our customers with an optimal solution. In addition, we oer training or our

employees on proper handling o our customers products. It is critical to us that our

healthcare employees worldwide have a uniorm response to handling technologies, reading

data sheets, and reacting to adverse events.

Aware o the changing needs o its healthcare customers, UPS is constantly evaluating and

investing in technologies to ensure that its customers benet rom leading edge solutions.

Partnering with its customers, the company has gained the insight into the challenges they

ace and their concerns in serving the global market. By implementing proven packaging

solutions, monitoring technology, and intervention capabilities and continuously evaluating

opportunities and products to improve its ability to ensure product protection, UPS has

transormed its Its a patient, not a package motto into a company- wide way o lie.

continued



21/40



SPONSORED SECTION

Natural or man-made events can and do cause disruptions to shipments (see chart).

The key way to counter such disruptions is to actually plan or them.

When UPS works with its customers to develop contingency plans, it begins by validating a

customers key requirements or their shipments. Since customers have dierent priorities

or shipments when a contingency situation arises, actors like speed, time in transit, service,

maintaining the temperature o healthcare products, and costs need to be claried. The ideal

situation is to have a dened communication tree and plan to acilitate real-time connections

to the right decision makers. A proper line o communication ensures validation o any new

requirements so that customers needs can be met.

Our unique value is that we are a multi-modal provider, oering a ull suite and complement

o transportation services and modes, notes Matthew Connelly, vice president o network

operations, UPS. We have a very large airline, robust small package capabilities as well as

truckload and less-than-truckload services. Add to that, a large orwarding component where

we can also utilize other airlines and cargo carriers as well as ocean capabilities, and we have

the exibility in place to easily adjust or contingency situations.

Contingency planning tipsfor healthcare manufacturers

Source: Healthcare Packaging Survey,September 2011 130 respondents

HAVE YOU EXPERIENCEDSHIPPING DELAYS OR

DISRUPTIONS DUE TO NATURALOR MAN-MADE EVENTS?

(in the last two years)

No

Yes

56%44%


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SPONSORED SECTION


Customers can acilitate the development o a contingency plan by having a dened

communication ow within their organizations so that the plan incorporates key touch

points. By providing their logistics partner with their critical requirements in a contingency

mode, in priority order, the plan can be constructed to meet those needs.

Connelly reports, One o our value adds is that we provide our customers very good visibility

o shipments within our network and that is a critical operational necessity in a contingencysituation.

Healthcare supply chain contingency planning

Healthcare manuacturers have unique needs in a contingency situation that ocus on

maintaining service to meet the critical needs o patients and ensuring that product handling

requirements are met so product ecacy is not compromised. With a high level o visibility

into each shipment, UPS knows what is on a shipment and where that shipment is at all times.

Connelly says, UPS has additional oversight that strictly monitors key healthcare shipments.

We have a network o control towers globally, which are actually large oversight operations

that monitor the movement and ow o our healthcare customers shipments. The control

towers operate as a global network or visibility and intervention capabilities to cover all time

continued

Contingencyplanning tipsfor healthcaremanufacturers


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SPONSORED SECTION


zones and regions. They are extensive operations where real-time inormation is available on

world news and weather situations as well as multiple-screen tracking o shipments. This is a

specially-trained contingency group that can respond in real time to a healthcare shipment

that is in distress due to weather or mechanical breakdown o an aircrat or truck. The group is

able to respond and execute the contingency as well as to have alignment with the customer

or communication.

By developing a contingency plan that provides visibility o the shipments at all times, a

clearly dened communication tree so that the right people with the right skill sets are

engaged globally, and a design that is exible and nimble, healthcare product manuacturers

can be assured that they have taken a sound, proactive step to preparing or potential

situations that might jeopardize their shipments. In addition, by leveraging UPSs integrated

multi-modal capabilities and extensive shipment visibility, manuacturers can make a

quantum leap in creating a world-class contingency plan.

continued

Contingencyplanning tipsfor healthcaremanufacturers


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SPONSORED SECTION

When Eyjafallajkull, Icelands most active volcano, erupted in April

2010, causing disruption to air travel in North and Western Europe, UPSs

contingency plan that leveraged its multi-modal capabilities and extensive

shipment visibility technologies enabled it to minimize the events impact

on customer shipments. The situation demonstrates the importance o

having a well-constructed contingency plan to ensure that products reach

their destinations in spite o unexpected situations that could potentially

jeopardize delivery.

Matthew Connelly, vice president o network operations, UPS, explains,

When the volcano erupted, we moved our hub operations rom Cologne,

Germany, to Madrid, Spain where we set up a temporary hub. We were

able to divert our aircrat and network to operate out o Madrid. Our ability to shit our

operations quickly enabled us to eectively alter our air network and continue to service our

customers. Our multi-modal capabilities enabled us to shit modes o transportation because

we operate one integrated network, while other carriers operate separate networks or

each mode.

Case study: Volcano eruptionsets UPS healthcare contingencyplanning into motion

Photo courtesy o NASA


25/40


SPONSORED SECTION


Although the volcanos eruption wreaked havoc on the express trade lane in and out o

Europe or most carriers, our express shipments or southern Europe werent impacted at

all and the express shipments or northern Europe might have had one additional day o

transit because they had to be truck ed up rom Spain. Essentially we were able to maintain

seamless shipping into and out o Europe and meet the needs o our customers supply chains

in very unusual circumstances.

Shiting a hub requires broad, multi-level coordination. It includes everything rom ling

ight schedules, making sure ground support is available to o load the planes, repair and

maintain aircrat, setting up a new truck network to eed out o the alternate location, and

ensuring that customs brokerage is in place. Our contingency plan solution was extremely

well received by our customers and it really shows the advantages o our ully-integrated,

multi-modal capabilities. It also demonstrates our ability to take the steps needed to shit an

operation as well as design a new operation (new truck schedules, aircrat routings) and bring

all those capabilities together.

continued

Case study:Volcano eruptionsets UPS healthcarecontingencyplanning into motion


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SPONSORED SECTION

UPS oers an innovative air reight container or healthcare products, providing an

unparalleled level o shipment monitoring and product protection or temperature-sensitive

pharmaceuticals, vaccines and biologics.

Only available through UPS, thePharmaPort 360addresses a key industry issue o

saeguarding healthcare shipments in the supply chain by enabling near real-time monitoring

and maintaining product temperatures in extreme outside conditions.

Amid the tremendous surge o temperature-sensitive therapies coming to market, its critical

to have the most reliable solutions in place to help ensure the sae supply o healthcare

products while also driving cost and operational eciencies or healthcare manuacturers,

said Mark Davis, product manager, UPS Healthcare Logistics. The stakes are high when theres

a patient at the end o the supply chain, and UPS strongly believes that the PharmaPort 360

will ensure better protection o potentially lie-saving therapies.

Manuactured by Cool Containers, LLC or UPS, the PharmaPort 360 is designed with input

rom both the lie sciences and transportation industries. The unit is ully validated and tested

and exceeds rigorous healthcare industry standards or temperature-sensitive compliance

during transportation.

UPS unveils new cold chaincontainer solution

WATCH VIDEO
http://www.healthcarepackaging.com/playbook/ups/forwardhttp://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://ups.com/pp360http://www.healthcarepackaging.com/playbook/ups/forward


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SPONSORED SECTION


The PharmaPort 360 container maintains strict temperatures by utilizing both heating and

cooling storage technology, allowing it to tolerate a signicantly wider range o extreme

ambient temperature changes. The container more eectively maintains temperatures critical

or protecting medicines that need to stay within the required 2-8C to prevent spoilage.

The PharmaPort 360 also sustains its protective temperature range or more than 100 hours,

which is an important actor as more supply chains extend globally and healthcare products

need to travel arther to reach markets.

The containers temperature control and monitoring systems are powered by an AC

rechargeable battery. The units technology replaces the need or dry ice, thus eliminating the

associated handling ees and hazardous materials charges. Also, the PharmaPort 360 will hold

critical 2-8C temperatures 38 percent longer than current dry ice container solutions.

Unlike other containers on the market, the PharmaPort 360 has built-in sensors that not only

monitor shipment condition and GPS location but transmit this data to UPSs global control

towers via GSM, a standard global cellular network. Agents proactively monitor the container

or select heartbeats such as internal and external temperatures, near real-time location and

battery lie. When alerts are triggered indicating a potential risk, UPS agents can intervene

with pre-established contingency plans to rescue a shipment in distress and prevent

product loss.

continued

UPS unveils newcold chain containersolution
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SPONSORED SECTION


Product losses rom temperature excursions and mounting scrutiny rom regulatory

authorities are pressuring healthcare companies to strengthen supply chain compliance and

gain more control through shipment data, Davis added. Having the inormation to prove

that the integrity o a vaccine or human tissue has been preserved in-transit, or example, is

almost as critical as the contents o the package.

The PharmaPort 360s unique design also allows or more exibility or ight options. While intransit mode, the container neither consumes energy nor emits external heat, vapor or gasses,

allowing the unit to y in both upper and lower deck aircrat positions. This oers more

routing options, especially in constrained transportation lanes. The Federal Aviation Authority

also has approved the PharmaPort 360 to y on both narrow-body and wide-body aircrat,

allowing or a high degree o exibility in ight selections and opening access to markets

globally.

As a part o UPSs latest temperature-sensitive capabilities, the PharmaPort 360 is available

exclusively throughUPS Temperature True, a service designed to saeguard temperature-

sensitive shipments. The service includes priority routing o shipments, temperature-sensitive

handling and storage, around-the-clock proactive monitoring and intervention services in the

event o unexpected delays.

continued

UPS unveils newcold chain containersolution
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Whiteboarding: A tool forinvolving multiple stakeholdersWhen companies move to expand globally, they oten build the supply chain to support the

business strategy. By involving all o the key stakeholders in a white boarding session, the

requirements o everyone involved in the supply chain are documented and addressed. This

enables every stakeholder to understand that the supply chain is not just product moving in

a linear direction, it is actually a ow o goods, unds, and inormation that has to be careully

managed and balanced.

The diagram o the interactions rom a white boarding session demonstrates the needs o

point o care, point o use o the product, and how all the needs come back through the

supply chain to aect all o those involved in the supply chain. This oundational level o

knowledge is the rst step or understanding undamental requirements where eciencies

are possible.

Kevin ODonnell, senior partner, Exelsius Cold Chain Management, stresses, Everyone

involved in the liecycle management o healthcare products needs to be involved to ensure

that the product to its point o use creates a contiguous supply network thats collaborative

and emphasizes preventive measures to protect the quality o the drug.


30/40



When to use activepackaging componentsAcross the pharmaceutical and medical device industries, its common or products to be

packaged in passive thermal containers because they are economical and provide product

protection. However, the introduction o biologics, which are increasingly temperature

sensitive, and the shit to real-time monitoring, has led to the development o active thermal

packaging.

Gary Hutchinson, principal at Modality Solutions, LLC, says, Manuacturers continue to invest

in the development o packaging innovations that minimize the need or intervention to

protect pharmaceutical, biologics, and medical devices. This has led to a move rom passive

systems, which rely on gel ice, polyurethane, and vacuum panels, to active systems. Active

systems generally use sensors to monitor a package a thermostat connected to an outside

power supply regulates upper and lower temperatures. Active systems provide alerts i

parameters are exceeded, ensuring immediate intervention without breaking the chain

o custody since the packages do not have to be opened or intervention. While an active

packaging system has to be validated just like a passive system, it provides tight control and

minimizes supply chain security issues.

Industry wide, there is a trend toward using real-time actively transmitting temperature

sensors, says UPSs Dirk Van Peteghem, vice president healthcare logistics. Unlike passive

temperature data loggers, which basically record historical temperature and then present the

data ater delivery, real-time temperature inormation enables real time intervention, which is

Industry wide, thereis a trend toward

using real-time

actively transmittingtemperature sensors.
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critical or protecting the product.

This technology continues to

evolve and in the uture remote,

real-time intervention may

become a reality.

Hutchinson o Modality Solutions

adds, Phase change materials, in

which heat is absorbed or released

when the material changes rom

solid to liquid and vice versa,

are another packaging option.

Although they are costly or single

use applications, in multiple use

applications, they can be cost

eective. The challenge with

multiple use is reverse logistics.

The material has to be returned, so shipment costs and the expense o validating that thematerial is still eective needs to be considered.

The ability o new packaging materials to provide dierent degrees o insulation enables

manuacturers to select the best solution or their needs, according to Georey Glauser,

Conceptual Mindworks, Inc., consulting to the Biomedical Advanced Research and

Development Authority, U.S. Dept. o Health & Human Services. He continues: Expanded

polystyrene might give an R actor o 2 to 3.5; i you require greater insulation, polyurethane

continued

When to use

active packagingcomponents


WHAT NEW SUPPLY CHAIN TECHNOLOGIES

ARE YOU INVESTING IN?(currently and next 12 months)

Real-time monitoring

Track-and-trace

Time/temperature tags

inside packs

Temperature-protectivepackaging (gel packs,

cooler packs)

Sustainable packaging 32%

25%

21%

32%

25%


32/40



packages can provide an R value o 2.5 to 4.5. Although the R values o vacuum insulated

panels start at 40, they are more costly.

Dirk Van Peteghem, vice president healthcare logistics, UPS Healthcare, reports, Coupled

with the need or strict temperature control, healthcare companies are also interested in

technologies to address thet and security concerns. There is growing interest in smart

algorithms that interpret data points rom things like shock, vibration, acceleration, and

geoencing which is tracking i a shipment goes out o its expected route to assess

evidence or determining possible thet situations.

continued

When to use

active packagingcomponents


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Testings role in packagedevelopment and complianceWith the expansion into global markets, pharmaceutical, biologics, and medical device

package testing has become increasingly important as products are subjected to varying

conditions en route to their international destinations. With the stricter regulatory

constraints, package testing requirements are not limited to temperature, but oten include

vibration, humidity, pressure, and shock. By ollowing a systematic method to document the

eectiveness o packaging, manuacturers can cost eectively ensure product ecacy and

meet global regulatory requirements.

Having a detailed product stability prole at the outset o the packaging development

process is essential because it provides the inormation about what the product can

withstand and remain ecacious, says Georey Glauser, Conceptual Mindworks, Inc.,

consulting to the Biomedical Advanced Research and Development Authority, U.S. Dept.

o Health & Human Services. Investing in a stability study that supplies comprehensive

inormation enables manuacturers to avoid costly over engineering because packaging

decisions are made on precise data.

There are three steps to developing a packaging solution. It begins with design qualication,

which is not necessarily reviewed by regulatory agencies, but is the manuacturers test

to see what works based on the products stability prole. It also involves researching

the temperatures in the lanes through which the shipment will travel. In the second step,

operational qualication, a series o tests is done in controlled testing chambers to simulate

There is a generalrule among regulatory

authorities worldwide:

i you didnt documentit, you didnt do it.


34/40



the variables in the shipping environment. The idea is to document that the package can be

handled in more extreme temperatures without jeopardizing the products integrity. Finally,

in perormance qualication, the product is actually shipped with temperature monitors

inside the package to document actual conditions during transit.

Since package perormance qualication testing is controlled by domestic and international

regulatory agencies, it must be perormed in a structured and organized manner. The

documentation, including the rigors o data and inormational reports, must be available or

regulatory review.

Kevin ODonnell, senior partner, Exelsius Cold Chain Management, notes, There is a general

rule among regulatory authorities worldwide: i you didnt document it, you didnt do it.

Dawn Kreuz, senior stability coordinator, Merck, reports, The stability proles o products

have become increasingly more important because regulatory constraints are becoming

more and more stringent. Having comprehensive data arms manuacturers with the

documentation that is essential to answer the broad range o questions that agencies are now

asking.

Glauser o Conceptual Mindworks explains, The bottom line is show me the data. You have to

be able to show that the method in which you are shipping temperature-controlled materials

is indeed satisactory and enables them to withstand the rigors o exposure in the various

orms o transport. Regardless i the shipping method is passive, active, or semi-active, it is

essential to test and gather data that proves that the material can withstand 20 or 48 or 72 or

96 hours o cold chain transport.

continued

Testings role

in packagedevelopment andcompliance


35/40



Planning: the critical component

To avoid costly over engineering without sacricing perormance that would compromise

product ecacy, the packaging solution must suit the shipping environment it will encounter.

The solutions testing must be repeatable and consistent. By perorming ongoing tests,

quarterly or annually, and documenting the results, manuacturers can demonstrate that the

eectiveness o the packaging in protecting the product and have accurate data available or

regulatory agencies.

The critical element in perormance qualication testing, in which temperature monitors areplaced inside the package next to the product, is planning, says Glauser. Beore the package

is shipped, inormation about how it will be transported needs to be gathered. Glauser says

this inormation includes knowing ahead o time the answers to the ollowing questions:

1. What ights it will be on

2. How long will the ights be

3. Whos going to be handling the material on the ront end and on the back end

rom a cold chain perspective

4. Does the aircrat need to be met by rerigerated trucks

5. How much time is there between the time the aircrat lands and the material

enters customs

continued

Testings role



36/40



6. Whos the customs broker

7. How experienced are they in handling temperature-controlled materials

through customs

8. Do they also have to get it cleared through the local regulatory agency

9. What documents are needed rom the regulatory agency in order to clear customs.

Fastidious planning is the key to a successul perormance qualication shipment. I you do

your homework, you know that it will work. You have to have agreements with the reight

orwarders and carriers and the assurance that they not only have the expertise to handle

temperature-controlled materials, but that they also have intervention controls in place, and a

contingency plan to address exceptions, such as a cancelled ight.

Gary Hutchinson, principal at Modality Solutions LLC, adds, With the move to multi-

modal transportation, packaging engineers are recognizing the value o working with a

knowledgeable logistics partner to develop and test new packaging technologies. Together,they are not only creating more robust packaging solutions, but they are also collaborating on

the monitoring and control o packages based on the conditions the package will encounter

during transit.

continued

Testings role



37/40



continued

Testings role


Tomorrows cold chainwill require more than cold

The 35 to 46F (2 to 8C) temperature range is a common cold chain discussion area, but

temperature control in ambient and other ranges, as well as regulatory matters and evolving

sectors are gaining importance in the lie cycle o temperature-controlled healthcare-related

products.

These issues, along with cost pressures, a ocus on core competencies, and virtual company

models are driving an increase in outsourcing and the need or robust and transparent

partnerships, says Courtney Becker-James, International Quality and Productivity Center

(IQPC) The biopharmaceutical market, worldwide, is set or high growth.

This growth o novel biological therapies, including monoclonal antibodies, cell therapies,

cytokines, and new vaccines, is setting the scene or tomorrows cold chain, demanding an

increase in specialty packaging, handling, and distribution as a result o vibration sensitivitiesat certain requencies and the eects o relative humidity.


38/40



Package testing options

There are a number o resources that manuacturers can use or testing their packages

eectiveness. Depending upon their packaging testing needs during various phases o

packaging development, companies can leverage the expertise o logistics suppliers,

independent laboratories, or qualied associations.

ISTA (International Sae Transit Association), which pioneered the concept o package

perormance testing and certication, developed its Standard 7E protocol that is designedto evaluate the eects o external temperature exposures o individual packaged products

shipped through a parcel delivery system. Ed Church, ISTA president, states, Our goal in

developing the ISTA Standard 20 protocol, which includes the Standard 7E set o global

thermal proles, is to oer a design and qualication process that provides the structure and

path to design, test, veriy, and independently certiy a specic Insulated Shipping Container

(ISC) or use.

In the logistics environment, youve got variations in temperature, vibration, humidity, andpressure, says Gary Hutchinson, ormerly with Amgen and currently a principal at Modality

Solutions. Particularly with the introduction o biologics, the ability o all actors to have

some impact on the drug product itsel have become an increased concern. Thats one o

the reasons were investing in the development o a simulation laboratory, which will be

available to manuacturers, oering dynamic testing o all variables in a controlled, simulated

environment.

In the logisticsenvironment, youve

got variations in

temperature, vibration,humidity, and

pressure.

HEALTHCARE SUPPLY CHAIN PLAYBOOK


39/40



Logistics carriers such as UPS also have a wealth o package testing experience. Mark Davis,

product manager, UPS Healthcare Logistics, states, At UPS we work to provide inormation to

customers about best practices in selecting the types o packaging, including eective ways

to procure materials, and we have one o the worlds best packaging testing laboratories.

Ater a customer gives us a validated package, we do the tests to determine how the package

will perorm through the UPS network, through all the dierent sorting stations, etc.

continued

Package testing

options


40/40

40 / 40

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