pharma - bio transport - february 2008
TRANSCRIPT
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S U P P LY- C H A I N I D E A S F O R H E A LT H C A R E
Sponsored by Pharmaceutical & Medical Packaging News
Supply-ChainStrategies
Technology streamlines the cold chain
see page 8
Premier Issue
February 2008
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EDITORIAL:Keys to the Cold Chain ................................................................................................................................................................................4By Daphne Allen
PERSPECTIVE:Put Temperature to the Test......................................................................................................................................................6By Don Pagel, President and CEO, Kodiak Thermal Technologies Inc.
FEATURE:Cold-Chain Challenges Heat Up............................................................................................................................8By John Conroy
TECHNOLOGY:Tagging for Temps......................................................................................................................................................................................................14By Anastasia Thrift
Controlled-Environment Cases ..............................................................................................................................16By Maximillian Del Rey
Sustainability by Design Prevents Packaging Waste ....................................................................................................................................................17By Carli Derifield, Director, Global Marketing, EnviroCooler
Continental Airlines Cargo Expands Cold-Chain Services..........................................................................................................................................................................................20By David Vaczek
ADVERTISER INDEX: ..................................................................................................................................................................................22
Contents
PHARMA-BIO TRANSPORT | February 2008 3
February 2008
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17 Cover: Photo courtesy Cardinal Health
In January 2008, FDA approved Evi-cel, a liquid fibrin sealant alreadyapproved for use during liver and vas-
cular surgery, for general surgery. Theagency reports that Evicel is intendedto be sprayed or dripped on small,oozing blood vessels. Once applied,it creates a covering that helps stopbleeding. Manufacturer Omrix Bio-pharmaceuticals Ltd. (Kiryat Ono,Israel) reports that one clinical studyshowed that it “achieved hemostasis inless than 10 minutes.”
Evicel requires well-controlledstorage. While frozen vials can be heldat -18°C or colder (i.e., frozen) for upto two years, unopened vials stored at2° to 8°C (i.e., refrigerated) can onlybe held for up to 30 days. It must bediscarded after spending 24 hours atroom temperature; it cannot be refrig-erated once brought up to room tem-perature; and it cannot be refrozenonce it has been thawed.
Even though Evicel has beenaround for a while in its previousindication (it was marketed asCrosseal for liver surgery use), it is agood example of the latest trend inmedicine. Made from human-plasmaproteins, Evicel is part of the biotech-nology boom giving doctors newtools to improve healthcare. TheWashington Institute of Thoracic andCardiovascular Surgery (Washington,DC) concluded that the use of Evicel“as a sealant for pulmonary andbronchial staple lines results in superi-or aerostasis . . . Successful aerostasis
following pulmonary resection shouldresult in greater patient comfort,lower complications, shorter hospital-ization, and lower overall cost.”
Given its storage conditions, however,maintaining Evicel’s efficacy requiresvigilance by all its handlers. And it is notalone. Market experts report that more
temperature-sensitive products are head-ed into healthcare. To protect these criti-cal products, new investments will berequired up and down the supply chain.Manufacturers will seek sophisticatedtransportation packaging; third-partylogistic providers will need to provideconsistently controlled and monitoredtransport; and hospitals and pharmacieswill need to ensure complete controlover inventories. The cold chain willneed to be tightened. New requirementsand solutions are emerging, involving animpressively diverse group of partnersalong the supply chain.
For instance, RFID-enabled refrig -erators ranging from 5 to 56 cu ft are
storing temperature-sensitive products athospitals around the country. Blue VectorSystems (Palo Alto, CA) supplies its EdgeManager appliances to control the RFIDreaders in the refrigerators, monitoringinventory and door access. Drug inven-tory is often monitored by distributors.“Hospitals are not inventory experts, andit is expensive,” says John Beans, BlueVector’s vice president of marketing“Now distributors can handle inventorymonitoring, 24 hours a day.”
With such monitoring, hospital costsmay also be more manageable. Suchsmart refrigerators may be installed inhospitals for free. In addition, inventorymay be kept leaner in a constantly moni-tored stock, with little risk to patients.Beans says that any time there are “high-cost temperature-sensitive drugs, hos -pitals do not want to store a lot of them.However, they do not want to run out ofthem, either. Patients could suffer.” Beanssees RFID-enabled refrigerators even -tually moving into point-of-use envi -ronments, perhaps close to procedurerooms.
Biotech-enabled drugs and medicaldevices are not just changing healthcare.They are changing the supply chain,transforming a good portion of it into acold chain. Partners that make up thelinks in that chain will need to worktogether to control and monitor temper-ature. New packaging and monitoringtechnology will be key.
Daphne Allen, [email protected]
Keys to the Cold Chain
4 February 2008 | PHARMA-BIO TRANSPORT
New requirements and
solutions are emerging,
involving an impressively diverse
group of partners along
the supply chain.
Editorial
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The needs of the transportationsector of the cold chain arechanging rapidly. The explosion
of the number of biotech companiesand the globalization of clinical trials,manufactur ing, and distr ibution inrecent years are demanding new tech-nology for the transport of ever-increasing numbers of temperature-sensitive payloads. With these newrealities of global pharmaceuticaltransportation also comes the need toupdate current testing standards.
Thermal packaging standards, test-ing, and recommended procedures arediscussed by a number of recognizedassociations and organizations such asthe Institute of Packaging Profession-als (IOPP), the International AirTransport Association (IATA), and thePharmaceutical Cold Chain InterestGroup (PCCIG), which is part of theParenteral Drug Association (PDA).However, primary testing protocolsand standards for testing thermalpackag ing have always been thepurview of the International SafeTransit Association (ISTA). There aretwo primary thermal packaging test-ing protocols from ISTA that mostcompanies focus on: Series 5B andSeries 7D.
Series 5B, Focused Simulation Guidefor Thermal Performance Testing of Tem-perature Controlled Transport Packaging,is “designed to provide a laboratorysimulation based on actual field-measured and observed hazards and
levels. Measured hazards will typicallyinclude complex-shaped random vibra-tion, multitiered drop height distribu-tion, temperature and humidityextremes and/or cycling, and dynamicor static compressive loads. Series 5 arenot performance tests per se, but guidesto the creation of focused simulation
user-defined tests,” ISTA writes. Asnoted, Series 5 outlines a testing anddata gather ing methodology thatallows var ious testing laborator iesand companies to create their ownprotocols based on real field data.This procedure is by far the mostwidely used in the industry.
6 February 2008 | PHARMA-BIO TRANSPORT
Perspective
Put Temperature to the TestTemperature-sensitive parcel packaging needs new testing standards.
Don Pagel, President and CEO, Kodiak Thermal Technologies, Inc.
Series 7D, Thermal Controlled TransportPackaging for Parcel Delivery System Ship-ment, is described as covering only “basicrequirements: atmospheric conditioning,vibration and shock testing,” writesISTA. In the preface of the procedure,ISTA notes that “it can be used forindividual or comparative perfor-mance analysis of standard or insulat-ed transpor t packages againstnormally encountered conditions.”Series 7D not only outlines testing pro-cedures, but also specifies 12 thermalprofiles ranging from 24 to 72 hours forboth summer and winter. These profilescan be used to determine the efficacy ofproposed packaging as well as offeringthe ability to compare one package toanother. ISTA describes 7D profiles asgeneral simulations that are “not intend-ed to represent the worst-case thermalexposure in the small-parcel shipmentenvironment.”
As pharmaceutical and biotechcompanies begin to outsource moreand more of their transpor tationprocesses, it is imperative that thesecomparative profiles more closelymeet the needs of today’s and tomor-row’s global transportation realities sothat vendor packaging can effectivelybe evaluated and qualified.
THE REALITIES OF A GLOBAL INDUSTRYWith the completion of the first
rough draft of the Human GenomeProject (HGP) in 2000, the develop-ment of genetic and biologically basedproducts is increasing every year.According to the annual report on theglobal top 100 biotechnology compa-nies by Euromoney InstitutionalInvestor PLC, the biotech industrygrew by more than 23% from 2005 to2006 (Euromoney Institutional InvestorPLC, 2007, p. 26) up from 17% in theprior year. Given the very nature of thebiotech industry, many of the productsgenerated by these companies are tem-perature sensitive. Consequently, thenext 5 to 10 years will also show dra-matic increases in demand for all formsof temperature-sensitive transportationthroughout the world.
International transport for finishedgoods, clinical trials, active pharmaceu-tical ingredients, and raw materials willincrease cor respondingly, creatinggreater potential failure points in cus-toms delays, missed or canceled flights,and simple human error.
With the combination of increaseddemand and a more global need,enhancements to current testing stan-dards for packaging qualifications areneeded in order to meet the new reali-ties of the temperature-sensitive prod-uct packaging industry. The 72-hourtest (the upper-limit on the ISTA tests)is no longer long enough, nor are the
existing Series 7D profiles based onreality to allow for effective packagingcomparisons.
RECOMMENDATIONSRecommendations for increasing the
difficulty of testing standards for dispos-able and reusable parcel packaging mustbe considered. All international profilesshould be extended to 120 hours,allowing for better time-failure controlas well as modifying the cycle limits(specifically in time) to represent morecommon transportation realities. Thefollowing are a series of five tests thatwould give a much closer comparativecapability. Each test should be run withboth minimum and maximum loads.
120-Hour Summer Profile. Thisprofile would represent warehouse stor-age at 25°C, a truck pick up time of 8hours at 40°C, an international flighttime of 12 hours at 0°C, and anothertruck delivery time of 8 hours at 40°C.
120-Hour Winter Profile. Thisprofile would represent warehousestorage at 18°C, a truck pick up timeof 8 hours at -10°C, an internationalflight time of 12 hours at 0°C, and
another truck delivery time of 8hours at -10°C.
40°C Test-to-Failure Profile.This test would show the impact onthe payload over extended periods oftime at the upper temperature con-trol. It is designed to show how longthe package can protect the productwithout intervention.
Minus 10°C Test to Failure Pro-file. This test would show the impacton the payload over extended periodsof time at the lower temperature con-trol. It is designed to show how longthe package can protect the productwithout intervention.
120-Hour 25°C Constant Profile.This test would determine the truelongevity of the packaging for a termthat would meet most needs.
These recommended testing profilesare not intended to meet all extremes.However, they should represent a muchmore realistic pattern for chamber test-ing packaging products. Additionally,the data derived from these tests can,with robust packaging, allow for thecreation of mathematical models thatcan be used for more-specific profilesto determine packaging modificationsas required by extreme lane conditions.
Determining the future needs of thecold-chain transportation industryshould be a high priority for all life sci-ence companies. With the increase inbiotech products expected to beapproved and the increase in globalsourcing, production, and tr ials, wemust plan now for what projects to bean explosive growth rate over the next5 to 10 years.
WORKS CITEDEuromoney Institutional Investor PLC.
(2007, June 6). Global top 100 biotech-nology companies ranked by revenue.Med Ad News, p. 26.
ISTA. (2006). ISTA 7 Series Develop-ment Test Procedure 7D 2006. RetrievedJanuary 15, 2007, from www.ista.org:www.ista.org/members/downloads
ISTA. (2007). ISTA Tests. RetrievedDecember 21, 2007, from www.ista.org:http://www.ista.org/Testing/Tests.htm ■
PHARMA-BIO TRANSPORT | February 2008 7
Determining the future needs of the cold-chain
transportation industry should be a high priority.
If you’re a pharmaceutical manufac-turer or wholesaler, you want theinsulin that you shipped Monday to
arrive at the doctor’s office on Tuesday,ready for patient appointments. Youdon’t want the containers perched onpallets in the sun outside a cargo termi-nal at Pittsburgh International Airportfor two hours on Tuesday afternoon,waiting for refrigerated trucks.
As the global market for insulin andother bioengineered drugs continues togrow, this scenario and others are puttinga strain on all the links in the supplychain for temperature-controlled prod-ucts—pharmaceutical manufacturers,wholesalers, packagers, and third-partylogistics (3PL) providers alike.
Given the growing global reach ofbiologics, the problem is even moreacute outside the United States. DavidBang, CEO of LifeConEx LLC (Plan -tation, FL), told Future Pharmaceuticalmagazine that a typical international de -livery of cold chain pharmaceuticals caninvolve “three airports, three groundhandlers, two different airlines, twotruckers, one freight forwarder, and onecustoms broker.” Different regulations intwo countries and three different climatezones compound the complexity, henoted. A joint venture between DHLGlobal Forwarding and Lufthansa Cargo,Bang’s company was established tohelp alleviate this problem by offeringend-to-end transport of temperature-controlled drugs.
The industry is responding with sev-eral solutions, among them efforts like
Cold-Chain Challenges Heat UpDiagnosis: for temperature-controlled products, complex supply lines jeopardizedrug efficacy and patient care. Prescription: consolidate the cold chain.
By John Conroy
8 February 2008 | PHARMA-BIO TRANSPORT
Feature
Decreasing the amount of handling along the supply chain, with third-party logistics assistance,could reduce product risk. Photo courtesy Cardinal Health.
DHL’s to reduce the number of hand-over points needed to move a product toits final destination. Customers have beeninvolved in an ongoing effort to out-source “noncore business or logistics-related work” to shippers for the past sixyears, says Angelos Orfanos, vice presi-dent, Americas, life sciences and health-care for DHL (Plantation, FL).
In December 2007, FedEx announceda pilot program in collaboration withAmSafe Br idport (Phoenix) to useAmSafe’s compressor-driven technologycontainer. The temperature-controlledshipping container “has the ability to dialin temperatures between 4° and 25°C,”capturing “70–80% of all temperature-controlled refrigeration products beingshipped,” claims Jeff Sitzlar, manager ofbusiness development for FedEx.
Freight transportation giants such asDHL, FedEx, UPS, and other 3PLs areconfronting several converging trends,according to Orfanos. With biotech lead-ing the way, industry forecasts from LEKConsulting, McKenzie & Co., andDPWN Inhouse Consulting reportgrowing revenues for the pharmaceu-tical industry’s life sciences market, hepoints out.
A 2001 forecast by LEK Consultingpredicted the life sciences segment of the
pharmaceutical industry will grow at acompound annual growth rate (CAGR)of 12% through 2007, with the tempera-ture-controlled portion of the segmentestimated to grow at a CAGR of 22%during the same period, Orfanos says. Amore recent forecast by DPWN InhouseConsulting estimates an industry CAGRof 6.6% through 2012, he notes.
In addition, 39% of all life sciencesproducts were forecast to be tempera-ture-controlled drugs by 2007, with the
remaining 61% dry, noncontrolledproducts. In 2001, those figures were15% for the former category and 85%for the latter. Temperature-controlledproducts can include those kept at thecontrolled room temperature (CRT) of15° to 25°C, Orfanos says.
“The whole concept of maintainingtemperature during transport is a hugepart of the industry, and it’s going togrow,” says Eric Isom, manager of ware-house operations for Sentry LogisticSolutions (Indianapolis). The 3PL distrib-utor operates a foreign trade zone thatallows international pharmaceutical andbiotech clients to bypass importationregulations such as “customs, paperwork,dues, and tariffs,” he says.
One sign of the explosive growth inthe cold chain that Isom has seen sincejoining the industry in 1998 is the numberof conferences on the topic. “From 1998up to 2001 you may have been able tofind one seminar a year that was talkingabout this,” he says. “Now if you searchthe Internet, I would venture to say youcould find 50 to 100.”
Many of the seminars no doubt focuson the welter of state, federal, and globalcompliance regulations governing cold-chain operations that are figuratively andliterally all over the map. Canada, forinstance, “has very strict guidelines ontheir product coming in as far as thecold-chain parts, says Isom. “In the Unit-ed States, there are lot of guidelinestelling you to do it, but there’s not alwaysa lot of detail telling you how to do it.”
A British health official for the Medi-
PHARMA-BIO TRANSPORT | February 2008 9
Additional trends affecting the cold chain include the
emergence of new markets in countries such as
China and India.
When accounting for the cost of validated overnight shipping, consolidation could lower prices significantly. Photo courtesy Sentry Logistic Solutions.
cines and Health Care Products Agency,known as MHRA, emphasized the dele-terious effects of temperature excursionsat a recent conference Orfanos attended.John Taylor, MHRA’s group manager forregulatory assessment, remarked that 43%of all major deficiencies recorded by anagency inspector in 2004 and 2005 wererelated to storage and transportation tem-peratures, according to Orfanos.
“There’s been a huge change in themarket’s product profile,” he says. “Manyof the new products are bioengineeredproducts and bioengineered productshave larger molecular structures, whichmakes them much more susceptible totemperature and humidity variations.”Bioengineered drugs include insulin,coagulants, interferons, cytokines,enzymes, hormones, and interleukins.The protein-based drugs are used to treatdiseases such as hemophilia, diabetes,cancer, cystic fibrosis, and hepatitis.
Additional trends affecting the cold
chain include the emergence of newmarkets in countries such as China andIndia, regulatory challenges, securityconcerns, and a run of mergers in thehealthcare and 3PL spaces, Orfanossays. India is now producing genericdrugs, including biologics that requiretemperature control, Orfanos notes.“That’s creating new challenges,” he says,because the supply chain is now stretch-ing “to new manufacturing sites in therest of the world.”
Back in the States, post-9/11 securityconcerns are having an impact on thecold chain as well. In November 2001the United States launched the Customs-Trade Partnership Against Terrorism(C-TPAT), a voluntary antiterrorismprogram designed to smooth cooperationbetween the industrial supply chain andU.S. Customs and Border Protection.
“That’s not only a trend, it’s a currentevent that puts pressure on all the par-ties,” Orfanos says, noting that a product
in the cold chain has a “defined time-line” to get to its final stop. A companythat is out of compliance with C-TPATregulations or FDA and USDA guide-lines may find its product delayed, and it’seasy to imagine the consequences for thecooling medium inside the containers.“You may not be able to afford to getstuck at the airport waiting for a productto be released as your dry ice is melting,”Orfanos says.
Changes in the regulatory climate arealso putting some heat on the industry.Regulators worldwide have expandedthe definit ion of a temperature-controlled product, Orfanos says. Whilehistorical cold-chain temperatures rangebetween 2° and 8° C, the industry hasrecently seen “an evolution to the 15° to20°C range.” Considered room tempera-ture, this range “has evolved in regula-tors’ minds as a controlled-temperaturezone” referred to as temperate or ambi-ent, he notes.
10 February 2008 | PHARMA-BIO TRANSPORT
FeatureFeature
Regulation watchers with an eye on cold-chain management call “temperature-abused” products worthless. Photo courtesy Cardinal Health.
The expanded definition of tempera-ture-controlled product has led manycountries to pass laws mandating thatmanufacturers ensure that drugs are keptin the range stated on the label, accordingto Orfanos. “Those governmental bodiesare saying if this product needs to be keptat that temperature then you, the manu-facturer, have delegated the temperaturerequirement for that product,” he says. “Ifyou’re going to ship it from Point A toPoint B you need to maintain [the prod-uct’s] efficacy.” Regulators around theworld have taken the label designationsand said, “‘Okay, fine, but now you’ve gotto meet that requirement.’ ”
And if you don’t? “A product couldpotentially be delayed in reaching itsdestination, requiring analysis, or in theworst case, being deemed spoiled,”Orfanos says. Spoilage could occurwhen a combined accumulated rangeof temperature excursion reaches acertain length of time deemed unac-ceptable by the manufacturer’s qualityassurance department.
“A number of regulatory and stan-dards-based guidance documents havebeen published over the last two years,”says Henry Ames, director of strategicmarketing for Sensitech (Beverly, MA),which specializes in cold-chain solutionsfor monitoring temperature-sensitiveproducts from the beginning to the endof the supply line. These include theNovember 2005 publication of USP<1079>, the general guidance documentcovering good storage and shippingpractices by the U.S. Pharmacopeia.Other documents addressing productefficacy and patient safety includeTechnical Report 39 (“Guidance forTemperature-Controlled MedicinalProducts: Maintaining the Quality ofTemperature-Sensitive Medicinal Prod-ucts through the Transportation Envi-ronment,” revised in 2007), by theParenteral Drug Association, as well asregulatory publications from Canada,Ireland, and other countries.
Revised by a cold-chain workinggroup within the Parenteral Drug Asso-ciation, Technical Report 39 harmonizessupply-chain best practices with EU reg-
ulations. One of the key recommenda-tions is that transportation companiesestablish quality management systemswith a designated decision maker. USP<1079> offers a range of storage andshipping guidelines and recommenda-tions. The 15-page document coversareas such as establishing temperatureprofiles, monitoring during shipping,qualification protocol, and receipt ofpharmaceuticals. On this last topic, USP<1079> recommends transfer of arrivingproduct to “a manufacturer-designatedstorage environment within two hoursof receipt,” for instance.
“All supply-chain partners need towork together to ensure product qualityand patient safety,” Ames says. These twin
goals have led Ames to argue that stream-lining the cold chain and the pharmaceu-tical industry’s push for an anticounterfeitelectronic pedigree system are linked. Themajority of counterfeited drugs tend tobe temperature-controlled products, henotes, because those typically cost morethan noncontrolled drugs.
“You need to look at all pressures tostreamline the pharmaceutical supplychain, which would include a desire toreduce counterfeit drugs as well as drugsthat have been adulterated through tem-perature abuse,” Ames asserts. “There is astrong correlation between counterfeitdrugs and temperature-sensitive drugs.Adulteration includes external factorssuch as temperature, shock, vibration,humidity, and pressure.”
An authentic product that’s been“temperature abused,” even though it’sthe genuine article, “is worthless,” Amesreasons. “You really have to [be vigilant
about] both to maintain product safety,and streamlining the supply chain helpsto reduce the risk and address some ofthe issues with either diverted productentering the supply chain in complexdistribution channels or thermal excur-sions that may occur.
“The benefit to streamlining the sup-ply chain can help address both prob-lems,” he concludes, “and there are anumber of supply-chain partners thathave recognized the growth in this mar-ket and the need for more specializedservice offer ings. FedEx CustomerCritical, UPS Health Care Shared Net-work, and DHL LifeConEx are allgood examples.”
Similarly, Keith Sinclair believes thecold chain and e-pedigree matters are“two distinct but related things.” Thedirector of operations for biopharmaceu-ticals distributor FFF Enterprises (Temec-ula, CA), Sinclair agrees the industry hasbeen paying greater attention to main-taining product integrity throughout thesupply chain. “Once it gets out of themanufacturer’s hands, it’s a matter of howthe wholesaler is handling it,” he says.
As a result, the regulatory spotlight hasshifted to the wholesaler, and “there’sbeen talk of FDA stepping in,” Sinclairsays. “I think what’s happening is confu-sion between pedigree and channelintegrity. Pedigrees do not create channelintegrity. They just document who hashandled a product, but not how. Andhow a product is handled, whether it’s acold-chain product or not, defines theintegrity of the channel. When [FDA] istalking about getting involved, they’rereally talking about pedigree.”
Although Sinclair agrees with the needfor “a good pedigree system,” he says thisendeavor has mostly been left up tostates’ boards of pharmacy. FFF’s methodof narrowly defining the channel—frommanufacturer to distributor to healthcareprovider—contributes more to channelintegrity than any pedigree can, he says.
Sinclair does note that monitoring oftemperature during shipping “could tieback to electronic pedigree” if RFIDtechnology were successfully developed.There’s been industry talk that the
PHARMA-BIO TRANSPORT | February 2008 11
Ames notes that ultimate responsibility for product
safety, in the United States atleast, rests with the
pharmaceutical manufacturer.
12 February 2008 | PHARMA-BIO TRANSPORT
Feature
“RFID chip could potentially eventrack temperature,” he says. “If pedigreeis put in place using RFID, the technol-ogy could also be used to track temper-ature in transit.”
This prospect raises exciting possibili-ties in terms of cold-chain streamlining.“Imagine treating yourself at home, andyou have an RFID scanner,” Sinclair says.“You get the product from the pharmacy,scan it r ight there,” and determinewhether you received the correct drugand whether the drug stayed within themanufacturer’s stated temperature range.No one’s holding his breath, however, asadoption of the technology has beenslowed by concerns over cost, standardsdevelopment, and the impact of radiowaves on proteins, Sinclair points out.
As Ames notes, all links in the supplychain need to collaborate for the greatergood, but in the United States at least,ultimate responsibility for product safety rests with the pharmaceutical man-ufacturer. In his position as director ofmarketing and business developmentfor packaging company TegrantCorp./ThermoSafe Brands (DeKalb,IL), Richard Ellinger has observed that3PLs “are taking more responsibilitywhen handling the repackaging end ofthe business because the 3PLs are follow-ing the lead of the manufacturers.” Henotes that USP’s General Chapter<1079> requires shippers and distribu-tors “to follow the proper storage andshipping requirements, as indicated bythe manufacturers.”
ThermoSafe’s mail-order fulfillmentcustomers, in particular, have shownincreased interest in pursuing opportu -nities in the 3PL space, Ellinger says. Headds that the company’s business has seen“nothing dramatically different fromwhat we’ve faced in the past.” However,in terms of ThermoSafe’s market, henotes that the company services pharma-ceutical and biotechnology manufactur-ers “the same way we service the 3PLs,because their needs are more similar thanthey’ve ever been before.”
Those needs involve a high level ofcomplexity, says Rob Brown, vice pres-
ident of specialty sales for CardinalHealth (Dublin, OH). CardinalHealth’s 3PL division, special pharma-ceutical services, has “17 clients sellingtherapeutic biologicals requiring cold-chain distribution. “The key thing thatpresents difficulty in the cold chain,more than product characteristics, isthe delivery requirement,” he says.
Cold-chain products stored with awholesaler “may have 20 days worth ofinventory, and if they go throughwholesale channels, the requirementsare complex,” Brown says. “The more-complex need is shipping directly to aphysician’s office for a scheduled ad -ministration. Some clients get orders at
10 A.M. on Monday that need to beshipped overnight because at 11 A.M.the next day the patient is showing upfor administration.”
For a 3PL transporting products to awholesaler, “it is a very expensive pieceof the cold chain,” Brown explains.“Most everything goes overnight in coldchain, so you’re mostly shipping UPSor FedEx parcel shipments. If it’s abiotech [product] the volume is not ashigh as traditional [drugs], so you’respending a lot of dollars in overnightshipments versus Less-Than-Truckload(LTL) shipments.”
However, Cardinal Health believesthere are plenty of opportunities to con-solidate transportation because its 17cold-chain clients “pretty much ship tothe same people,” Brown says. “We thinkthere’s an opportunity around consoli-
dating the transportation to those similarcustomers.” Counting the cost of validat-ed shippers, overnight transportationcosts, and conversion to truckloads, con-solidation could be up to 15–20% lessexpensive, Brown says.
Brown says a 3PL can usually limitliability exposure if it follows the man-ufacturer’s quality assurance instruc-tions defining “the packagingconfiguration. As long as we follow thatconfiguration, we’re not liable.” Caus-ing a product to freeze by putting it ina gel pack for shipping when the cus-tomer’s SOP calls for an ice brick is anexample of a lapse that could lead tothe manufacturer filing a liability claimwith the transportation provider, he says.
Variability is most common in thetransportation link for 3PLs, Brownnotes. Studies by companies such asSensitech “show what happens whenproduct goes up in a plane. It is amaz-ing the variance of temperature in thehulls of those planes,” he says.
Reducing those variables and decreas-ing the number of handoffs will mitigateproduct risks, asserts Donald Nolde, vicepresident of sales and marketing, ColdChain Technologies (Holliston, MA).“The fewer people handling product, thebetter off you’ll be,” says Nolde, whosecompany specializes in cold-chain ship-ping containers. “We have seen the needfor third-party logistics increase over thelast few years, and I believe that will con-tinue with the biotech sector. Our task atCold Chain is to make their job easierand with better compliance by providingimproved and simplified packagingsolutions.”
Says Nolde: “We’re focusing on thefact that at the end of the day, whetheryou’re a 3PL, or a pharmaceutical manu-facturer, or a biotech company, it’s yourresponsibility to ensure that small mole-cule or large molecule [products] arrivein unadulterated and safe condition. I’vegot two daughters. Do I want them toreceive a drug that’s not in good condi-tion? Obviously, I do not.”
And those words are bound to reassurepatients as well. ■
Changes in the regulatory climate are also putting some
heat on the industry. Regulatorsworldwide have expanded
the definition of a temperature-controlled product, Orfanos says.
Transportation systems wired fortemperature monitor ing aregoing wireless. Several companies
are pooling their resources to meet thecold-chain demands of medical andpharmaceutical packagers through activeand passive RFID.
A partnership between AeroScout(Redwood City, CA) and DHL (SanMateo, CA) has used WiFi-based activeRFID technology to track pharmaceuti-cal products through the supply chain fora leading healthcare company. The tagproducer and the international cargocompany teamed with Microlise (Not-tingham, United Kingdom) to monitortemperature fluctuation for a trial runbetween Belgium and Sweden last May.
Temperature and vehicle location datawere broadcast via GPS from AeroScouttags to Microlise monitors. The strategyaimed to give supply-chain visibility tomultiple custodians along the shippingroute. Microlise’s Transport ManagementCenter software enabled monitoringthrough Web browsers.
This real-time location system softwarerepresents the bulk of advancing RFIDtechnology in the year to come, accord-ing to Raghu Das, CEO of smart-pack-aging consulting company IDTechEx. Inhis predictions for 2008, Das said suchmedical usage of active RFID taggingstill has untapped potential.
“Fully active versions are larger andmore expensive, but can be reused suchas with the AeroScout tag,” Das says.“There are many solutions but not manyimplementations of it in the pharmacold-supply chain yet.”
In a second example of utilizing RFIDfor cold-chain management, Intelligent
Devices Inc. (Ottawa, ON, Canada) andEvidencia LLP (Memphis, TN) collabo-rated to introduce a passive RFID,probed-temperature recorder called theLog-Ic ThermoProbeRF. Released lastDecember, ThermoProbeRF has awireless capacity for checking anddownloading detailed time andtemperature history.
With the Log-Ic ThermoProbeRF,drug manufacturers can program fortime and temperature alarms via user-friendly software, according to the twocompanies. They say they have a power-ful, easy-to-use monitor that can estab-lish the core temperature of dry iceshipments of temperature-sensitivepharmaceuticals.
“The main benefit is the ability to usethe device to monitor core packagingtemperature and therefore to have truetemperature readouts, and not ambient
temperature,” Alex Salomon, generalmanager of Evidencia, says. “It’s huge interms of the service and quality of ser-vice they provide.”
The small scale of the technologyaccommodates many package shapes andsizes. Its credit-card-size thickness couldallow for better stacking and less breakagethan nonwireless temperature recorders.“Our tag lies flat on the polyurethaneand offers extreme resistance to stackingor crushing,” Salomon says. A handheldreader detects the thermometer’s inputfrom up to 400 meters away.
“Commercial passive RFID tags withsensors are very rare,” Salomon says. Heoffers evidence taken from customerfeedback, experience, trade shows, andpublications. From this, IntelligentDevices and Evidencia have determinedthat their product is unique. “This is atiny field,” Salomon says. ■
Tagged for TempsActive, passive RFID tags free the cold chain from wires.
By Anastasia ThriftManaging Editor
14 February 2008 | PHARMA-BIO TRANSPORT
Technology
The Log-Ic ThermoProbeRF attaches to a passive RFID tag to provide the core temp of packages.
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P allet-sized insulated containermanufacturer Hermani AG(Palm Beach, FL) is working
with the University of Florida to testits containers’ readability distances anduse with e-pedigree to ensure tem-perature and theft-prevention abilityduring transport.
Although these tests are still inprogress, Hermani’s containers havealready seen a growth in sales to pharma-ceutical and medical cold-chain trans-port customers, says Emilio Lopez,managing director of Hermani.
“The Red Cross of Australia main-tained frozen blood for 10 days in theRoll 1000 using 10 [eutectic] plates.”The Australian Red Cross (ARC) for-merly shipped frozen blood by air—atvery high costs—Lopez says. Her-mani’s pallet-sized containers allowedthe or ganization to ship it by groundwhile ensuring the blood kept its tem-perature. ARC did not want to usedry ice, Lopez says, because too muchwould have been needed to maintaintemperature.
Hermani’s line of Bac and Roll con-tainers, available in volumes rangingfrom 50 to 1400 L, employ passive-coldenergy to keep products at temperature.The company’s eutectic plates determinethe length of time that the container willmaintain temperature. The plates canmaintain both extreme positive and neg-ative temperatures.
“Hermani’s eutectic plates come in sixstandard temperatures, but we can make
eutectic plates that reach –114°C to114°C without dry ice or electricity,”Lopez says.
The 1079-L Roll 1000, with its stan-dard plate load, can maintain 2° to 8°Ctemperatures for 96 hours. With moreplates, ranges can be pushed further,although capacity will diminish. Sub-freezing temperatures can be sustainedlonger, with use of Hermani’s –21°C and–26°C eutectic plates.
Pharmaceutical and medical packag-ing comprises about 20-25% of Her-mani’s business for 2008, Lopez says, andthe industry promises to take a largerrole in the future.
“Biotechnology, red cel l–baseddrugs, and the storage of dry ice havepromoted the growth of our insulatedcontainers,” Lopez explains. “Whenthey see and use the container, thefeedback is phenomenal.”
Hermani’s customers, Lopez says, arewaiting for an e-pedigree mandatebefore implementing RFID. Hermanihas not yet equipped its cold containerswith RFID for customers, but Lopezdoes not foresee a problem equippingthem when the need arises.
The University of Florida’s final e-pedigree testing will be confirmed onFebruary 11; its report will be readyto be released for commercializationby the end of February.
A major pharmaceutical manufacturer,however, validated one Hermani con-tainer for a product that needed to main-tain –40°C without external power. The
company transported the Roll 220 ashort distance between buildings withouteutectic plates. The results were positive,and the manufacturer is now evaluatingits purchase options.
Hermani’s 221-L Roll 220 unit hasreceived considerable attention at recenttrade shows, Lopez says.
“The response has been excellent andcustomers are interested in shippingpharmaceutical and biotechnology prod-ucts in a more controlled environment,”he says. “At the same time, they wantflexibility in obtaining the insulated con-tainer system without getting into a con-tract. We are seeing a lot of interest fromAsia, especially for the transport of phar-maceutical ingredients.”
Lopez says customers were attractedto the idea of cold containers that didnot need to be opened during trans-port. Companies were also impressedby Hermani’s extensive testing andeutectic plates.
“There are many insulated containersin the market,” Lopez says, “but mostmanufacture just the bin and don’toffer options for the cold energy. Somedo come with gel packs or other mate-rials, but the selection is just one ortwo sizes.”
Hermani’s new concept in cold-chain logistics pushes customers’ flexi-bility to new heights. Its eutectic platesallow containers to sustain tempera-tures for longer periods without exter-nal energy. Its designs might becomethe (cold) wave of the future. ■
Controlled-EnvironmentCasesTested insulation methods keep cases cool.
By Maximillian Del ReyAssistant Editor
16 February 2008 | PHARMA-BIO TRANSPORT
Technology
The environmental impacts ofproduct packaging and its wasteare an issue of growing impor-
tance and concern worldwide. Allorganizations use various quantities ofmaterials and other resources to packagetheir products to survive distribution andother harmful elements. Biopharma-ceutical organizations transportingbillions of dollars worth of temper-ature-sensitive products glob-ally on an annual basis are no exception.
According to EPA, yearlymunicipal solidwaste in the UnitedStates has increasedfrom 88 million tonsin 1960 to 229 mil-lion tons in 2001.Containers andpackaging made upalmost one-third ofthose 229 million tons.Industry in the UnitedStates reportedly creates7.6 million tons of nonhaz-ardous waste each year.Industrial packaging contributessignificantly to that figure.
Global regulations to reduce packag-ing waste have grown. More than 25countries have environmental packagingdesign requirements, and 35 have pack-age reporting and advanced disposal fees.The European Union Packaging Direc-tive (EUPD) has established recoveryand recycling rates for waste packaging,
required reductions in the heavy metalcontent of packaging, and dictated dis-posal of packaging waste. Following the
enactment of the EUPD, producerresponsibility for packaging has gainedprominence globally as a key strategy for
addressing packaging waste.
DEFINING GREENSustainable packaging has become a
goalpost of being “green” in the 21stentury. The Sustainable PackagingCoalition has outlined cr iter ia for
general sustainability objectives.They’ve listed objectives that can
mesh with business considerationsrelated to packaging’s life cycle. These
objectives cover sourcing, manufactur-ing, and transporting to maxi-
mize the use of renewable orrecycled mater ial. (See
sidebar on page 19 for afull list.)
At best, sustainablepackaging leaves nofootprint—no traceof material creationand processing, trans-
port, and mater ialrecycling. To stay green
beyond the present, thetruly environmental ly
conscious must focus onsustainable design.
SUSTAINABLE DESIGN:CRADLE-TO-CRADLE
Organizations embrace sustainabledesign practices for being both envi-ronmentally sound and good busi-ness. Rather than being legislatedinto action, leader businesses activelyexamine their tota l impact andopportunity as a trigger for increased
Sustainability by DesignPrevents Packaging WasteCradle-to-cradle cycles minimize waste and give new life to used materials.
By Carli DerifieldDirector, Global MarketingEnviroCooler
PHARMA-BIO TRANSPORT | February 2008 17
Technology
Polyurethane packing components receive newlife through EnviroCooler’s innovative program.Image courtesy EnviroCooler.
competitive advantage, creative levers,profitability, and as a tool to increasepositive perception and market share.
Cradle-to-cradle cycles represent afundamental shift from damage-min-imization and damage-managementstrategies to take environmental sen-sitivity to the next level. When aproduct returns to industry at theend of its useful life, its materials areused to make equally valuable newproducts. The raw materials used inits manufacture do not need mini-mizing because they will not becomewaste in a landfill. Industry can savebillions of dollars annually by recov-er ing valuable mater ials from usedproducts.
GREEN PARTNERS In October 2007, Amgen, Eli Lilly,
and EnviroCooler pioneered a globalcradle-to-cradle program for Enviro-
Cooler’s BioSphere platform, calledthe EnviroCooler R-Value Program.It provides an incentive for clients to
purchase and return BioSphere com-ponents in multiple locations acrossthe globe. Green Partners of the pro-gram also receive a discount on allfuture BioSpheres , which couldinclude components previously inthe cradle-to-cradle cycle.
“EnviroCooler has always been‘green,’ ” says Rod Derifield, Enviro-Cooler’s CEO. “We have alwaysdesigned environmentally-consciouscradle-to-grave products that wereburned clean for energy at the end oftheir life cycle. The natural progressionfor us was to take it to the next leveland design cradle-to-cradle programs,where our products or product compo-nents can be circulated in closed loops
18 February 2008 | PHARMA-BIO TRANSPORT
Technology
Companies have begun to use the worldwide R-Value program, protecting resources while gaining pricing incentives by becoming Green Partners.Image courtesy EnviroCooler.
Future BioSpheres could include components
previously in the cradle-to-cradle cycle.
and reused a number of times.”While the R-Value Program itself is
nothing new, it is unique in the worldof Bio-Transportation, where biophar-maceutical organizations invest signifi-cantly in high-end solutions for thesafe and compliant transportation ofTSPs. “It really is no different fromtrading in your computer or old dish-washer,” says Don Wilson, senior man-ager, eng ineer ing, at Amgen Inc.“What ends up happening is the same:You keep the good pieces and reusethem, and you replace the bad.”
Successful alignment projects likethis one often require a creative leap ofimagination, either in recognizing con-nections or in finding innovative,effective ways of connecting the dots.
“The dots in this case were thatAmgen was spending a lot of moneyon the BioSphere to transport goodsinternationally but once they reachedtheir final destination, prematurely
they had also reached the end of theirlife cycle,” says Gary Hutchinson,director, global transportation, AmgenInc. “From our own testing, we knewthe design was more robust. So, welooked for another dot, and that waswhere and how we could extend thelife of the BioSphere and be able toutilize that extended resource at any ofour locations across the world, whenwe need it.”
EnviroCooler’s Global Manufactur-ing Network has been integral to thesuccessful implementation of the pro-gram in four of its five locations sinceOctober 2007. Each of the four loca-tions not only manufactures new andreplacement components for theBioSphere, but they a l so act as R-Value Program portals for reenter-ing returned and recertified compo-nents into the R-Value Prog ramclosed loop for the remainder of itslife cycle.
“Projects like this of course presentinherent risks initially,” says Paul Har-ber, associate engineering consultant,Eli Lilly & Co. “But they can alsooffer dramatic possibilities to unlockexisting latent potential for positivechange. Innovation and creativity rep-resent some of the most valuable andunlimited resources at our disposal inthe quest for a sustainable world.”
The best designers will affirm thatthey do not set out to solve problems,but rather to create solutions. Greatdesign is therefore an optimisticendeavor. ■
Carli Derifield joined EnviroCooler asits first director of marketing in 2006. HerMSc in Oceanography and her 12 years ofexperience within the pharmaceutical, supplyautomation, and consulting industries acrossEurope, Australia, and the United Stateshas aided the promotion of EnviroCooler’sapproach as a bio-pharma shipping solution.
PHARMA-BIO TRANSPORT | February 2008 19
Packaging PillarsAccording to the Sustainable Packaging Coalition, these criteria should be followed to incorporate sustainability into businesses. The group says sustainable packaging:
• Is beneficial, safe, and healthy for individuals andcommunities 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-life scenarios.• Is physically designed to optimize materials and
energy.• Is effectively recovered and utilized in biological
and/or industrial cradle-to-cradle cycles.
As best industry practices for cold-chain shipping develop, pharmaand bio-drug firms are looking
for support from transport solutionproviders. Several years ago, ContinentalAirlines Cargo (Houston) launched itsClimateSecure program for providingcontrol and visibility for sensitive cargoconsignments.
The carrier is extending its focus onthe cold chain with the planned launchthis year of a new product for maintain-ing ambient temperatures on the groundand in flight.
“In offering the ClimateSecure ser-vice, we made the decision to developSOPs for temperature-sensitive drugshipments. We have implemented proce-dures that very much mirror the Chapter17 regulations [in the air industry’s Per-ishable Cargo Regulations (PCR)],” saysMark Mohr, manager, product develop-ment and specialty sales.
“We are the only U.S. carrier with astructured temperature-controlledproduct for providing the best tem-perature management that we canprovide, in places that we can control.We have a huge lead, and we intendto maintain that lead,” Mohr adds.
The new solution includes temper-ature-controlled cargo carts for hold-ing noncontainerized freight on theground and at ramp staging areas. Thespecially modified units are made byRefr iger ated Container Supply (LaPorte, TX), whose solutions includecontainers used for storage of batteries
for NASA’s international space station.ClimateSecure has offered priority
shipment services for RKN andRAP-style containers, which are loadedinto Continental wide-body aircraft,Boeing 767s and 777s. “We are primarilya narrow-body airline. The cargo cartswill support temperature-controlledhandling, geared to the narrow-bodyplanes and palletized passive packouts.
Pharma shippers approached us for amethodology for handling these con -ditions. The tarmac is absolutely theweakest link in the temperature-controlchain, where cargo is exposed to climateextremes. The ground is where we reallyhave the most opportunity to assist phar-
ma companies and their packaging sup-pliers,” says Mohr.
“Whether it’s 100ºF on the tarmac,or below zero, we can ensure that weare meeting label storage require-ments,” he adds.
Chapter 17 of the PCR, adopted lastyear by the International Air TransportAssociation, defines good storage prac-tices for handling medicinal products,referencing guidance from groupsincluding the World Health Organi -zation and the International Phar -macopoeia. The regulations coverrequirements for storage areas and stor-age conditions and for ensuring mainte-nance of storage conditions in
20 February 2008 | PHARMA-BIO TRANSPORT
Technology
Continental has evaluated cargo bin temp control options for various aircraft types to accommodate,and not restrict, shipping capacity.
Continental Airlines CargoExpands Cold-Chain ServicesAir cargo handler is modeling its offerings after good storage practices adopted bythe International Air Transport Association.
By David VaczekSenior Editor
transport. Trained personnel must knowexactly what to do with containers toensure quality assurance.
PCR’s Chapter 4 notes that cargo-hold temperatures are often difficult topredict. “Contrary to the commonmyth, air transportation temperatures inthe cargo holds are not necessarily cold.In fact, they are in many cases quitehigh, despite the fact that at 10,000 ftaltitude the aircraft structure is exposedto very cold air of about –55ºC.”
The capacity for aircraft cargo bintemperature control varies by aircrafttype, so shippers have to know theplane’s configuration and availablelocations beforehand.
Boeing’s new Dreamliner 787s canbe equipped with segmented temper-ature-controlled cargo compartmentsfor heating and cooling, but the costmay be prohibitive. According to oneindustry source, a control system is a$250,000 investment, with another$250,000 for fuel consumed keepingit airborne.
Mohr says Continental has evaluat-ed cargo bin temp control options forvarious aircraft types. The standard ver-sion of the 787 has the ability to man-age temps to a certain degree in the rearpit, with an option for front pit con-trol. “You have to determine whetherthere will be enough perishable cargoto make that investment in the for-ward temperature control pit. One ofthe hazards is you don’t want torestr ict your capacity to load othercargo.”
The carrier is affixing temperaturesensors to containers in ongoing tem-perature studies in warehouses, on theramp, and in aircraft. “This is a value-added service to provide customerswith the documentation they need fordemonstrating product storage condi-tions,” Mohr says.
Pharma firms are in the market forsuch specialized services, for meetingFDA drug storage requirements andbest practice guidance from the U.S.Pharmacopoeia and the ParenteralDrug Association. In defining air car-rier requirements for GMP, GSP, and
GDP, the PCR’s Chapter 17 referencesthe drug industry’s need for mainte-nance of product quality throughoutthe logistics chain.
“Loss of quality is a cumulative pro -cess whereby every little break adds up.A question that everybody involved in
the cold chain should ask is this: ‘Is therequired transit temperature well main-tained during the whole process orwhilst in my custody?’ ” the PCR states.
The whole idea is to make sure thatall involved are aware and know what isexpected of them. ■
PHARMA-BIO TRANSPORT | February 2008 21
22 February 2008 | PHARMA-BIO TRANSPORT
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