Pennsylvania State University



-1524001047751457325152400Cold Chain Supply ChainBest PracticesPenn State Undergraduate StudentSam ShampainPenn State SupervisorAdeline LetiziaBecton Dickinson SupervisorJennifer De Weese - Fall 2009 -Table of Contents TOC \o "1-3" \h \z \u Executive Summary PAGEREF _Toc247511810 \h 2Recommendations to BD Biosciences PAGEREF _Toc247511811 \h 31.Maintain 2-8 oC or 2-25 oC for 24 hours PAGEREF _Toc247511812 \h 32.Maintain 2-8 oC or 2-25 oC for 5 days PAGEREF _Toc247511813 \h 73.Alternatives to Dry Ice PAGEREF _Toc247511814 \h 10Cold Chain Shipping in the Biological Industry PAGEREF _Toc247511815 \h 144.Trends in the Biological Industry PAGEREF _Toc247511816 \h 155.Beckman Coulter PAGEREF _Toc247511817 \h 176.Life Technologies PAGEREF _Toc247511818 \h 197.Spherotech PAGEREF _Toc247511819 \h 208.Ebioscience PAGEREF _Toc247511820 \h 219.Biolegend PAGEREF _Toc247511821 \h 22Cold Chain Shipping in the Pharmaceutical Industry PAGEREF _Toc247511822 \h 231.Trends in the Pharmaceutical Industry PAGEREF _Toc247511823 \h 242.Cold Chain Technologies PAGEREF _Toc247511824 \h 273.Minnesota Thermal Science PAGEREF _Toc247511825 \h 314.TCP Reliable PAGEREF _Toc247511826 \h 33Cold Chain Shipping in the Food Industry PAGEREF _Toc247511827 \h 371.Trends in the Food industry PAGEREF _Toc247511828 \h 382.Best Practices - Cross Docking PAGEREF _Toc247511829 \h 393.Best Practices - Outsourcing PAGEREF _Toc247511830 \h 394.Temperature Controlled Shipping PAGEREF _Toc247511831 \h 395.Regulations PAGEREF _Toc247511832 \h 406.Drivers for change PAGEREF _Toc247511833 \h 407.Example: Chocolate PAGEREF _Toc247511834 \h 418.Example: Cheesecakes and Instapak? TempGuard? Cold Chain Packaging PAGEREF _Toc247511835 \h 42General Packaging Solutions for Cold Chain Shipping PAGEREF _Toc247511836 \h 431.Coldpack Company Information PAGEREF _Toc247511837 \h 442.Coldpack Airliner Study PAGEREF _Toc247511838 \h 473.Entropy Solutions Green Box PAGEREF _Toc247511839 \h 514.Vacuum Insulated Panels PAGEREF _Toc247511840 \h 535.Alternatives to Dry Ice PAGEREF _Toc247511841 \h 55Conclusion PAGEREF _Toc247511842 \h 58Appendices PAGEREF _Toc247511843 \h 59Neopor Boxes PAGEREF _Toc247511844 \h 59Executive SummaryBecton Dickinson (BD) Biosciences ships their products to research and development firms both domestically and internationally. BD ships in single doses as well as multiple dose shipments. Many of these shipments have strict temperature and time requirements. If these requirements are not met the product will spoil resulting in major problems for both BD and the customer. Several factors can disrupt this cold chain from functioning properly. Seasonal temperature fluctuations as well as varying temperature profiles make the challenge of maintaining the internal product temperature increasingly difficult. Some customers have specific packaging requests, or may not be present at the time of delivery. These difficulties don’t even encompass the traditional supply chain issues such as inclement weather, shipping accidents, or infrastructure breakdowns. Succinctly, these issues make managing the cold chain difficult even if have perfect shipping procedures. The cold chain shipping industry is expanding with new products coming to market quickly. It is broken down into three distinct market segments: Biologicals, Pharmaceuticals, and Food. There are different challenges within each segment as well as different competitors. Certain third-party logistics (3PLs) ship biological and pharmaceutical products, but not food, and vice versa. Keeping up with this ever-changing industry is difficult.Just as the market players are always changing so are the products. Becton Dickinson requested information regarding sustainable alternatives to their current cold chain shipping practices. These alternatives should offer advantages in the areas of impact on the environment, packaging integrity, and minimal assembly. The alternatives were broken down by the temperature profile and the shipment duration. For product that need to maintain 2-8 degrees Celsius for 24 hours or 2-25 for 24 hours there are three single dose options applicable. They are Coldpack’s Airliner, Entropy Solution’s Inflater Pouch, and Cold Chain Technologies’ Kool Temp Insulated Envelope. For products that need to maintain 2-8 degrees or 2-25 degrees Celsius for 5 days, the KoolTemp PolyUrethane Insulated Cooler and Entropy Solution’s Greenbox seem the most viable alternatives. Finally, three alternatives to dry ice are detailed: Entropy Solution’s Pure Temp-40, Techni Ice Reusable Dry Ice Pack, and TCP Reliable’s ‘20 below’. Recommendations to BD BiosciencesThis section proposes alternatives to BD Bioscience’s current cold chain shipping practices. The proposed alternatives would substitute the current processes for shipping single doses domestically and internationally as well as multiple doses internationally. All alternative meet BD’s requirements of sustainable solutions that are environmentally friendly, require minimal assembly, and have package integrity. Maintain 2-8 oC or 2-25 oC for 24 hoursThe strongest and most viable alternatives for BD Biosciences within the single dose shipping product category is Coldpack?’s Airliner set of products . The Airliner product comes in various sizes, from the Airliner 001 (20 x 13.5 x 7.5 in.) to the Airliner 501 pouch which fits into UPS or large expedited shipping boxes. The Airliner is Coldpack’s primary product. It ensures that sensitive pharmaceutical and biological shipments maintain the +2 to +8 degrees Celsius temperature profile. According to an October article in Vaccine Weekly, Coldpack? introduced the flagship product at the recent PACK EXPO. The PACK EXPO is the packaging industry’s largest tradeshow. This year it was held in Las Vegas from October 5-7, with over 1200 exhibitors. The Airliner 501 pouch is the packaging solution that most closely aligns with the requirements of BD Biosciences. Another product available for single dose shipments is Entropy Solution’s Inflator Pack with E23 phase phase-change materials. This is not Entropy Solution’s most effective product however it is one of the most successful within the industry. Walmart was one of the first companies to fully endorse and begin to use it. They have found a lot of success with it. Finally, the third option for single dose shipping is Cold Chain Technologies’ KoolTemp Insulated Envelopes. The have a reflective exterior which reflects 97 percent of all radiant heat transfer. The manufacturer, Cold Chain Technologies has not won any awards for this specific product and the Kooltemp’s scientific effectiveness is unknown.ColdPack’s AirlinerThe Temperature Profile of the Airliner depends on the Phase Changing Material used. The Airliner can be combined with the full range of Phase Changing Materials, from low eutectic (-12 degrees Celsius) gel packs to dry ice. Coldpack’s Airliner is engineered using an extremely complicated process. It involves combining over 12 different materials to create this inflatable bag. In use, this inflatable pack is placed within a cardboard box, turning the cardboard box into an insulated cooler. The inflatable airliner is ribbed, which reduces the material requirement necessary for manufacturing. Not only is the Airliner available in a variety of sizes but also many thicknesses as well. Custom sizes can be negotiated with the manufacturer. AwardsThe company received the European Pharmapack Cold Chain Award during a recent conference in Paris. “Coldpack, an innovative insulated packaging solutions leader, announced that its AirLiner ? product, used in tandem with the company’s AntiFreeze Vaccine Backpack, has recently received two top international industry honors. Coldpack won the prestigious European Pharmapack Cold Chain Award because of excellence in innovative packaging for the transport of medicines, health products and medical devices.” The second award was the FPA (Flexible Packaging Association) 2009 Gold Achievement Award in Packaging Excellence. This award recognized the thermal insulating achievements of Coldpack’s AntiFreeze Backpack. The Backpack was approved by the World Health Organization as an effective vaccine transport system. CEO of Coldpack, Etienne P. Snollaerts responded:“The AirLiner has tremendous potential to significantly advance the way pharmaceuticals are shipped, helping them reach those who need them the most. These important international awards are validation that AirLiner can play a positive role in the supply chain especially for the last mile of the cold chain process. We are honored to be recognized on an international level.” Airliner 001 Airliner 018 Airliner 501 Pouch Airliner Precision Inflation Controller(fits inside a UPS expedited box)AdvantagesDisadvantagesWarehouse space reductions because Airliner occupies only 4% of the space an EPS liner of the same size occupies. Reduced shipping costs because overall packaging weight is significantly reduced Can avoid the use of gel packs - huge cost savingsSoft cushioning provides a barrier from shock and rough handlingHas three options for closure Velcro, double sided tape, and fold over in specific casesAirLiner can be used with all types of frozen refrigerants. Reduces Carbon Footprint by 96% (4 percent of the material used for EPS)Disposes CompactlyActual product cost not available - could be higher than comparable EPS foamLabor cost higher because of additional set-up timeWhen used with dry ice, the dry ice must be wrapped or bagged in a bubble wrap pouchAirliner must be inflated which could increase packaging time (2-16 seconds)Greenbox Inflater Pack with E23 Phase-Change Materials manufactured by Entropy SolutionsIt is “designed especially for single-dose shipments that must be maintained at 2–8 °C for 24 h or at 20–25 °C (i.e., controlled room temperature) for 24h” . It must be used with Entropy Solution gel packs, because of the size requirements within the Inflater pack. Walmart, one of the leaders in supply chain innovation was facing a significant problem when shipping their single doses to areas such as Hawaii and Alaska. 15-20 percent of Walmart’s pharmaceuticals had to maintain room temperature (20-25 degrees Celsius) for 48 hours. Walmart began to use Greenbox’s Inflater pack along with its E23 panel to maintain this temperature. This solution proved to be extremely effective. Walmart also found that its customers were pleased with the environmental benefits of the Inflater pack, because it was reusable AwardsEntropy Solution’s Inflater Pack is under the Greenbox line of products. At the 2009 Greener Package Awards, the Greenbox won the flagship award, the Greener Package Award, as well as the “Innovator of the Year.” These awards cited the fact that the Greenbox is 100 percent bio-based, non-toxic, and biodegradable. One Greener Package Award judge summarized the package: “In addition to innovative materials and a system that minimizes product spoilage (in many ways the loss of product is a bigger environmental impact than single-use packaging and is rarely accounted for in LCA [Life Cycle Analysis] studies), the effort to set up a comprehensive return-and-reuse process represents an in-depth understanding of a systems approach.” Inflater Pack with Gel PacksAdvantagesDisadvantagesInflates by puncturing two spots on the side of the package for easy pack outFully ReusableEntropy Solution’s gel packs are more effective than standard gel packs100 percent organicPhase changing materials are non-toxic and fully reusableCost savings because of reduced weightDesigned for reuse so may be more expensive than traditional methods for single useRequires the use of specific Entropy Solution’s gel packsCan only be used for specific temperature profilesKoolTemp? Insulated Envelopes manufactured by Cold Chain TechnologiesThe KoolTemp insulated envelope should be used for overnight shipments. It can be used for various temperature profiles depending on the phase changing material used. Similar to the Entropy Solution’s Inflater pack, if a gel pack is required, the manufacturer’s gel packs must be used. This is because of the special space requirements for the KoolTemp Insulated Envelopes. It can be packed with standard dry ice as well. An exterior standard overnight box may be used to provide additional protection. AwardsCold Chain Technologies has not won any awards for this specific product and the Kooltemp’s scientific effectiveness is unknown. KoolTemp Insulated EnvelopesAdvantagesDisadvantagesLight-weight material reduces freight costsInsulated with fibers that minimizes shock and vibrationReflective exterior reflects 97 percent of radiant heat transferCan be used with Dry-ice, expanding the applicable temperature profilesFor optimum results, envelope and payload must be chilled to minimum temperature within profileOnly applicable for overnight shipmentsMust be closed with closure tapeMust use manufacturer’s gel packsMaintain 2-8 oC or 2-25 oC for 5 daysStandard EPS Coolers are extremely widespread and there are countless companies that manufacture them. This makes them extremely inexpensive to purchase and use. The only way to offset this cost would be to use a better insulating material that minimized the gel packs requirement. Using fewer gel packs would also reduce freight cost because of the lighter package. A more environmentally friendly material would offer significant advantages over standard EPS coolers because of the harmful effects of Styrofoam. EPS foam is an extremely standard and widespread cold chain shipping product. However, there are two alternatives that may provide significant advantages over EPS foam containers. Cold Chain Technologies manufactures the KoolTemp Polyurethane Insulated cooler which has a much higher R value than EPS or XPS foam. It is also much more environmentally friendly and can be reused countless times, another important advantage. The second alternative is the Greenbox. The Greenbox is Entropy Solution’s most successful product and quite possibly the most effective and successful product within the cold chain shipping industry. This award winning product is made of 100% organic material and can be reused many times. Its performance is unparalleled and is the best insulated container on the market.Cold Chain Technologies’ KoolTemp Polyurethane Insulated CoolerKoolTemp Polyurethane Insulated Coolers are an ideal choice to maintain expensive payloads between 2°C to 8°C during demanding shipping conditions. The high R value makes it an excellent choice for international shipments. The KoolTemp Polyurethane Insulated Cooler is a one piece molded cooler which is shipped with an outer corrugated box. It is available in standard sizes along with custom sizes and printing upon request. It has a much higher R value than standard EPS or XPS foam. Most importantly this reusable container is environmentally friendly and contains no CFCs or HCFCs.AwardsCold Chain Technologies has not won any awards for this specific product and the Kooltemp’s scientific effectiveness is unknown. KoolTemp Polyurethane Insulated CoolerAdvantagesDisadvantagesHigh R value can maintain the strictest temperature requirementsHigh R value reduces the gel pack/dry ice requirementIdeal for 2-8 degrees Celsius but can be used with dry iceCompletely reusableEnvironmentally friendly, no ozone depleting materials in manufacturingHigher cost than EPS foamMust replace corrugate for reuseMolded container increases necessary storage space Entropy Solution’s GreenBoxThe Greenbox can maintain payload temperatures from -40°C to +70°C for up 120+ hours or five days. Greenbox packaging comprises a tinted-green, reusable, outer HDPE shipping container that resembles a mailing container. Resistant to moisture, crushing and scuffing, the outer plastic-corrugated container is practically impervious to repeated exposure to packing tape. It houses a set of reusable/recyclable Thermal-Lok? insulation panels, made using recycled carbon silica and what Entropy refers to as a nanotechnology-based manufacturing process in a patented, proprietary packing protocol that provides them with an R value of 40. Entropy Solutions' president Eric Lindquist claims that the panels have a thermodynamic insulating capacity that's 10 times greater than EPS or PU foam. (Hartman) Most importantly the Greenbox is made of 100% organic based material and is full reusable. The Greenbox is available in a variety of sizes and temperature profiles. AwardsAs previously stated the Greenbox won at the 2009 Greener Package Awards, the Greenbox won the Greener Package Award, as well as the “Innovator of the Year.” (see p.5) Greenbox Systems: Thermal Management SystemsAdvantagesDisadvantagesMost effective and sustainable packaging solution on the marketAvailable for almost all temperature profilesMore flexible shipping times because of expanded shipping duration profileRush delivery not necessaryCan be reused up to 100 times Made of 100% organic materialCustomers have the option of recycling the box internally or it can be sent to an Entropy Solution’s reclamation centerExtremely costly and not cost effective unless reused To use the Greenbox you must purchase the entire system (specific gel packs, packing tape, organic PCMS)Time consuming pack outAlternatives to Dry IceDry ice is at the temperature of -78 degrees Celsius. It maintains this temperature as it sublimates. Because of the various shipping regulations put on the transport of dry ice, avoiding it can be a significant advantage. If it is not packed properly there can be burn injuries, as well as product exposures. This creates handling issues for the shipper as well as the receiver. Dry Ice is not extremely harmful to the environment; however it does produce the greenhouse gas, Carbon Dioxide. There are more environmentally friendly alternatives on the market. The first alternative to BD Bioscience’s current practice is the PureTemp -40 Solution, manufactured by Entropy Solutions. Entropy Solutions has a full line of PureTemp products, across various temperature profiles and for use in many different industries. This product is a safe alternative to dry ice, and emits no greenhouse gases. The Techni Ice Reusable Dry Ice pack is another alternative that has uses across many different industries. Once hydrated, the pack can be frozen to any temperature down to -190 degrees Celsius. This makes this product very flexible as well as inexpensive in use. Finally, the third sustainable alternative is TCP Reliable’s ‘20 below’. This product as advertised maintains a temperature of -20 degrees Celsius. It is available as a pouch or as a gel pack, is fully reusable, and can be disposed of in the standard municipal waste stream. Entropy Solutions: The PureTemp - 40 SolutionThe PureTemp -40 Solution is the first sustainable alternative to dry ice to come to the market. It is completely reusable and not harmful to the environment. It is best for applications where reuse is applicable because then the cost benefits can be fully utilized. Another major advantage is that it requires no special handling. Several relevant authorties and organizations have recommended this product. Indeed the US Department of Agriculture lists the material in its Biopreferred purchasing program. Dr. Rafik Bishara, Ph.D., chairman of the Pharmaceutical Cold Chain Interest Group (PCCIG) and Parenteral Drug Association (PDA), said of the Pure Temp -40 Solution, “I am pleased with this technically based, data-supported solution, which is answering an unsatisfied need in the shipment of frozen medicinals while being environmentally friendly and with economical value.” PureTemp - 40 SolutionAdvantagesDisadvantages100% renewable and biodegradablePureTemp can be used more than 20,000 times with no thermal degradation More environmentally friendly (Dry ice produces carbon dioxide)Requires no special handlingDoes not alter the ph level of any drugs and can be shipped with all products Much higher cost than traditional dry ice Is not economical unless reuse is applicableMost often used with Entropy Solution’s Greenbox Only one supplier vs. dry ice which is accessible from many suppliers Techni Ice? Reusable Dry Ice Packs HDR (Heavy Duty Reusable) Model (4 layer/ply model)The Techni Ice Reusable Dry Ice pack maintains whatever temperature it is frozen to, up to -190 degrees Celsius. It is a highly versatile product. They are scientifically more effective than traditional dry ice. To use one you must hydrate the 11X16 inch sheets then freeze the sheet to the required temperature. These packs have both recreational and commercial uses. Techni Ice Reusable Dry Ice packAdvantagesDisadvantagesCan be frozen down to -190 degrees CelsiusLess costly than traditional dry ice Scientifically proven to be more effective than dry iceReusable and not toxicSheets are 11X16 inches?(9X13X1 after hydrating)?and can be cut to different sizes Can fit a wide range of temperature profiles and durations Usually frozen in Blast freezers down to -80 for dry ice applications (time consuming set up)Must be hydrated before use, which may be difficultUnproven in the cold chain shipping marketTCP Reliable’s ‘20 below’This product is an effective alternative to dry ice when it would be used to maintain -20 degrees Celsius. It is available as panels or as a pouch. It must be conditioned at -25 degrees to freeze the product and will begin to melt at -20 degrees. ‘ 20 below’ panels ‘20 below’ packAdvantagesDisadvantagesSafe to handleWater soluble and reusableCan be disposed of in standard municipal waste stream Available in two different forms (panels/pack)Can be used with any insulated shippedMore expensive than standard dry ice Panels require additional set up timeCold Chain Shipping in the Biological IndustryIn the Biological Industry cold chain shipping has become incredibly important. Cold chain shipping is taken care of one of two ways depending on the company. Companies either use a 3PL to take care of their cold chain shipping end to end, or pack their own box and then have a 3PL ship it for them. Some 3PLs only ship biological products, others ship all products. Almost all companies that ship biological products in bulk use a 3PL. No company takes care of its own cold chain shipping. Companies that pack their own box use a 3PL such as Fed-Ex or UPS for shipping. This differs from the end to end 3PL method where the box is being packed by the manufacturer, who therefore chooses the specific packaging technique. The packager makes the decisions on green/not green, price, size, etc. There are a few major issues in the biological cold chain shipping industry, some of which have to do with the cold chain shipping industry as a whole. The best practices usually are the ones that are the cheapest but most effective. However, it varies from company to company depending on their needs. For instance, the most effective packages are reusable and therefore more eco-friendly. However there are better temperatures controlling results with the expensive technologies, but they can only be used in cases where the box can be reused (see the Beckman Coulter section for more details). With one time shipping packaging, choices are more limited. List of companies and packaging solutions studied:Beckman Coulter Life Technologies (Invitrogen) Spherotech Ebioscience BiolegendTrends in the Biological Industry Introduction This chapter details three of the leading products for cold chain shipping: the Coldpack’s Airliner with Vaccine pack, the Greenbox Inflater pack and Entropy’s Puretemp -40 phase-change materials.ISTA 7D testing“Another change likely to affect cold-chain packaging is the phase-out of disposable packaging. It's already occurring in Europe, Japan, and China, and Lindquist predicts that similar requirements eventually will be adopted in the US.”"Convincing the pharmaceutical industry to change takes time, but we're sure it's coming," says Snollaerts. Coldpack and AcuTemp operate laboratories certified by the International Safe Transit Association (ISTA)They perform tests at their facility that abide by the ISTA Test Procedure 7D (The test that I sent the email about)They need to conduct real world testing: tests need to be done during both summer and winter, so might not be completed before a few months.AntiFreeze Vaccine Backpack with AirlinerFigure SEQ Figure \* ARABIC 1. ColdpackCold Pack vaccine pack with inflater pack inside won an award. (see Figure 1). The Vaccine pack is reusable but inflator pack goes insideSpecial Citation for Social Responsibility (Also a Gold Award Winner in Packaging Excellence) : efficacy and shelf life can be greatly impacted by temperature fluctuations, extremes in both heat and cold will have a negative impact. Designated as an approved vaccine transportation system by the World Health Organization, the Coldpack AntiFreeze Vaccine Backpack solves this challenge through its award winning patented technology, which offers superior thermal and air cushion protection. The Coldpack AntiFreeze Vaccine Backpack facilitates the safe, secure, stable, and successful transport of priority medical vaccines.Greenbox Inflator Pack with E23 phase-change materials, Entropy SolutionsIt is recommended for single dose: “designed especially for single-dose shipments that must be maintained at 2–8 °C (i.e., refrigerated temperature) for 24 h or at 20–25 °C (i.e., controlled room temperature) for 48 h”.Walmart is one of the first companies to full endorse and begin to use it.PureTemp -40 phase-change material, Entropy SolutionsAlternative to dry ice 100% renewable and biodegradableCan be reused over and over The US Department of Agriculture lists the material in its Biopreferred purchasing programMore environmentally friendly (Dry ice produces carbon dioxide)Sources: CoulterCompany OverviewBeckman Coulter, Inc. is the leader in manufacturing biomedical testing instrument systems. These systems make many laboratory processes easier. They also produce consumables used in clinical diagnostics and life science. These consumables must be refrigerated. Cold Chain Partner: ArvatoBeckman Coulter was having trouble managing their cold chain. To help they referred to the company Arvato Services which is a subsidiary of Arvato AG. Arvato Services focuses on supply chain management and customer retention for both Europe and markets outside of Europe. They have 30,000 employees in over 30 countries. They are an end to end 3PL - over 650 million shipments per year. One of their main focuses is after sale logistics such as repairs and returns. Beckman was having trouble shipping to hospitals and labs. Arvato helped by:creating regional distribution centers:Lognes, France: 8,000 stock-keeping units (SKUs)Monheim, Germany: 15,000 SKUsHigh Wycombe, England: 1,000 SKUscreating a replacements parts distribution center near Brussels airport for fast delivery:Express delivery allowed shipments to be dropped off at night. Pick up would occur upon drop-off if necessary (Arvato took care of disposal)All international shipments passed hazardous-good regulations – this mostly includes temperature controlled shipments (2-8degrees) Overview of Arvato - Temperature Controlled ShipmentsArvato focuses on the visibility throughout the cold chain.They have over 50 sensors in a shipment with alarms that go off when the temperature goes out of the 2-8oC range.They have performed tests for all of the emergency temperatures and their results have improved accuracy.When shipping in boxes, Arvato uses Neopor? boxes. Neopor is actually a material produced by NEOPOR System GmbH, a company in Nuertingen, Germany who was recently bought by BASF. The Neopor is used to insulate buildings and houses. It naturally absorbs some infrared rays and reflects other radiations making it a great thermal insulator. The Neopor box has a special shaped inner wall and doubly secured lid validated for the temperature ranges 2 to 8 °C and 2 to 25 °C, up to 48 hours regardless of the outside temperature.Figure SEQ Figure \* ARABIC 2. Neopor BoxMany different packages have been developed that take advantage of this extremely effective Neopor technology. Two companies, Delta T and Storopack, both joined together to produce a few of these packages.A list of some of the boxes that Delta T uses can be found in the Appendix 1. Their Foam Boxes consist of latest technology Styrofoam or Neopor. Foam boxes can be used for one way or mutiple shipments. Validation data for many applications for all temperature ranges are available. Sources: Technologies Company OverviewLife Technologies is the combination of Invitrogen Corporation and Applied Biosystems, Inc. Invitrogen is the leading provider of consumables and reagents. Applied Biosystems provides systems solutions and isn’t involved with cold chain shipping. Life Technology products are found in 90 percent of the labs in the United States. Cold Chain PracticesInvitrogen charges an extra when they need to pack with dry ice. I do not have any information on exact prices. Invitrogen ships directly to customers.Sources: SpherotechCompany OverviewSpherotech was established in 1992 to manufacture and produce micro particles for biomedical and diagnostic applications. Their headquarters are 25 miles north of Chicago. Cold Chain Partner: FedExSpherotech’s preferred carrier is Fed Ex.Their standards for shipping are listed on the company website. If Spherotech receives an order by 3:30 CST it is shipped out that day. Temperature sensitive items will get to their destination by 3:00 the next day for a charge of $30.00. Their shipping methods seem to be very similar to BD’s ones; they use Fed Ex instead of UPS. Sources: OverviewEbioscience is a biological production company that specializes in the production of reagents and antibodies. They started in 1999 and are located in San Diego. They pride themselves in being the leaders of innovation in the field and they are flexible in meeting the researchers need. Ebiosciences is the preferred supplier of UPenn for all of their life sciences products. UPenn is leveraging the amount of product they order annually and using strategic sourcing. Cold Chain PracticesEbioscience ships their products in different sizes depending on the projects’ needs. They ship in 25 tests or 50ug as well as larger sizes for larger projects (1 mg or bulk size). They offer a 105% money back guarantee if their product doesn’t match the quality standards that they promised. Customers outside of the United States must order Ebioscience’s product from a regional distributor. Ebiosciences ships to these distributors with a transit time of 2-10 days. To aid with distributing their product to customers in Germany, Ebioscience purchased NatuTec a German biological and pharmaceutical company located in Frankfurt, Germany. This allows Ebioscience to offer their customers faster lead times, fast order processing and a wider range of products. NatuTec is now promising their customers receipt of their product within 1-3 days of the order. Sources: OverviewBiolegend is a biotechnology company that specializes in high quality antibodies for biomedical research. Their products are strictly for biomedical research and therefore are not FDA regulated. Cold Chain PracticesMost products are shipped at ambient temperature. However some products, such as recombinant proteins, are shipped with dry ice in separate shipment.Sources: Cold Chain Shipping in the Pharmaceutical IndustryImproving Cold Chain shipping is emerging as one of the biggest trends in the pharmaceutical industry. Many companies are beginning to focus on it and trying to adopt practices better than that of their competitors. There are countless conferences on this topic in which prominent companies within the industry explain some of their best practices. Like the biological industry, cold chain shipping is mostly provided by 3PLs. Many companies that ship in bulk use 3PLs to ship their product and provide RFID information the entire time. Temperature monitors are extremely popular within the industry, mostly because of how expensive some of these pharmaceutical shipments are. If a whole reefer (truckload), of pharmaceutical product is spoiled because of out of range temperature, millions of dollars can be lost. Companies understand this, and monitor their bulk shipments very closely. Other companies use a dedicated shipper such as FedEx or UPS to ship their product but pack it themselves. The standard pharmaceutical cold chain products are the same as other industries; gel packs, EPS coolers, dry ice. Cold Chain Technologies, Minnesota Thermal Sciences, and TCP Reliable, have created shipping products with distinct advantages over these standard products. They have advantages in regards to cost, efficiency, and also positive environmental impacts. These products are detailed below. List of companies and packaging solutions studied:Cold Chain TechnologiesMinnesota Thermal SciencesTCP ReliableTrends in the Pharmaceutical Industry IntroductionOne of the biggest trends in the industry is in the area of PCMs, or Phase Changing materials. Typically many companies have implemented a ‘passive’ system, but may need to pursue more of an ‘active’ system. An active system involves machine operated cooling systems to be put in with the product. “Traditionally, the industry has depended on water-based gel packs for cooling higher temperature ranges, and dry ice for lower ranges, or, alternatively, the use of “active control” via battery-powered cooling and heating systems. Now, PCMs are reshuffling the industry options.”Pharmaceutical and Cold ChainCold chain is a huge part of the pharmamaceutical/biological shipping market. Temperature-sensitive drugs represent about 10% of the roughly $240 billion pharmaceutical distribution industry, according to the Healthcare Distribution Management Association (Arlington, VA). A wider variety of diagnostic or clinical-trial materials are also coming under more demanding temperature-controlled shipping requirements, as are blood products and vaccines.Typically gel packs and dry ice materials are used to ship. The typical temperature profiles are similar to BD’s requirements.Most pharmaceutical products requiring cold chain distribution fall within a temperature range of 2 to 8°C. The most commonly used agents for control temperature are water-based gel-packs or cool-packs, commonly used in 2-8° shippers.Many companies are looking to get away from Dry Ice, and are looking into alternative solutions. There are three main reasons to use a material besides Dry ice:Dangerous because it can cause a cold burn if it touches the skinCostSublimation: “The other issue with dry ice is that it undergoes a process called sublimation, in which it transitions directly from solid form to gaseous form, so the cold chain package must be designed to take this property into account,” notes Anthony Alleva, technical services manager, TCP Reliable (Edison, NJ) The result is some alternative solutions that will be researched further. Here is a brief overview of them organized by the company that manufactures them. Minnesota Thermal SciencesThey released the first container that can store material for up to -50°C. It is referred to as the Credo Series 50 M. “We’re very excited to introduce a container that will preserve medical samples better than any other option in the marketplace and cut down on exorbitant shipping costs,” Schlenker says. “Another advantage is that the container will hold payloads at -50°C for three days, but after five days it will still be below -18°, which is still viable for most frozen medical requirements.”TCP Reliable TCP has made some boxes to compete with the traditional EPS Styrofoam as well as Entropy Solution’s famous Greenbox. The main products are referred to as Phase 5 and Phase 22 but there are other products for different temp ranges.“Phase 5 is designed to have a 5°C phase change temperature for use in 2- to 8°C applications,” Alleva explains. “Another such product is called Phase 22, which is designed to have a 22°C phase change temperature for use in 20- to 24°C applications.”Decision between an active and a passive solutionActive systems tend to be the most expensive option but can offer huge benefits in terms of quality. With the in-transit information companies can be assured that their product gets there with the right temperature. Active systems are more important with larger shipments, and are not that practical for single dose uses. Last summer, UPS Healthcare Logistics (Atlanta) went live with an enhancement of its product-tracking capabilities through its worldwide network, called ProActive Response. The service puts a sophisticated analytical system alongside the product tracking, so that, for example, temperature-sensitive shipments can be monitored for delivery delays that might cause temperature conditions to go out of range. With the UPS network, trained personnel can replenish stocks of coolant, or assist in rerouting the shipment to keep it within spec.Single Dose OptionsEntropy Solutions: Inflater PackTCP Reliable: prequalified single shipment containers rated 96 hours at 2 to -8 degreesMinnesota Thermal Sciences: primarily used in the Army - S Series container with a 3.6 in cubic payload and maintains temperature for up to 36 hoursSources: Chain Technologies IntroductionCold Chain Technologies provides thermal packaging solutions as well as many services across the globe. They have facilities in Massachusetts, Tennessee, and Nevada. Their major brands are the KoolTemp[TM] insulated containers, Koolit[R] refrigerants. All of their products meet the regulations of USDA, HACCP, DOT, as well as the requirements for UPS and Fed Ex. They engaged in strategic relationships with strategic partnerships with Topa Packaging in Europe, and Foam Fabricators Inc. in the United States. Topa packaging is one of the leading cold chain solution providers for Europe. They are located in the Netherlands and manufacture all of the KoolTempTM containers (EPS, PUR) and Koolit refrigerants (bricks, gels, mats). Topa Packaging mostly serves the pharmaceutical, biotech, and healthcare sectors. Foam Fabricators is one of the “best EPS shape molders in North America, as well as a global supplier.” This partnership was formed to better serve Cold Chain Technologies’ customers need geographically. Once again Cold Chain Technologies has an extremely wide range of products. There best product seems to be the Insulated Envelopes. The rest of the products seem to be something very similar to what is all over the industry and offered by many other companies. Their products come in a wider range of sizes, than most companies typically offer. KoolTemp? Polyurethane Insulated ContainersIdeal for 2-8 degree rangeMust be combined with a gel pack Polyurethane has a much better R value than traditional EPS packaging“The recyclable components of the KoolTemp PUR contain a non ozone- depleting formulation (no CFCs or HCFCs), and are EPA compliant.”EPS molded and EPS Panel Offered in a variety of sizes Competitive adavantage is that they have many manufacturing facilities so you can order them Just in TimeKoolTemp? Insulated Envelopes Can be used with or without Koolit mat (gel pack)“Available in popular sizes, the KoolTemp insulated envelope can be used with or without standard overnight boxes for further protection.” Reflective outside serves to prevent further heat loss (reflect 97%)Seals with pinch of inner seal lock or adhesive tapeSizes:IE912 Zip with Closure Flap Size 12" x 16" Seal-to-Seal 50 Env/CartonIE1216 Zip Lock with Closure Flap Size 12" x 16" Seal-to-Seal 50 Env/CartonKoolit? Foam BricksHolds shape whether thawed or frozenBetter than all of CCT’s other products in regards to holding temperaturePuncture resistantAvailable in a variety of sizesKoolit? Gel PaksAvailable in a variety of sizes and a variety of cooling temperatures ranging from (0°C [32°F] and -23°C [10°F])Puncture resistantCan be folded to fit inside the insulated envelopes Available in three different pouch materials ; Thick Polyethylene, Metallized Laminate, and Sweat-Proof FilmAlso available in a saddlebag which wraps around the product providing even packaging:Koolit? Gel BottlesFor heavy duty usesPuncture proofHolds 0 degrees Celsius temperatureGreen Initiatives Source: PMPG News, August 2008“In 2005, The Sustainable Packaging Coalition provided an ambitious definition of a sustainable package as one that is:Is beneficial, safe, and healthy for individuals and communities throughout its life cycle.Meets market criteria for performance and cost.Is sourced, manufactured, transported, and recycled using renewable energy.Maximizes the use of renewable or recycled source materials.Is manufactured using clean production technologies and best practices.Is made from materials healthy in all probable end-of-life scenarios.Is physically designed to optimize materials and energy.Is effectively recovered and utilized in biological and/or industrial cradle-to-cradle cycles.”Environmental Impact of EPS: 95 percent airEPS can be reused and does not have to be thrown out Cold Chain Technologies allows you to drop off your EPS Cooler at many locations across the United StatesAlso many mail in locationsEnvironmental Impact of Koolit Refrigerants:Within the gel packs is a water soluble starchPack can be cut open and disposed of in the normal waste streamOutside plastic can be recycled wherever (low density polyethylene (LDPE), #4) is accepted Sources: Thermal ScienceIntroductionLocated in Plymouth Minnesota, MTS provides thermal packaging with the highest degree of temperature control. The products are very expensive but more effective than standard. MTS is fully ISTA certified: “MTS uses its highly precise ISTA-certified thermal lab to ensure Credo? containers perform at the highest level of thermal control. Capable of constant ambient hot +40°C and cold -20°C tests, the lab also performs ISTA standard summer and winter shipping profiles and custom client shipping profiles for product development and measurement.”“The solution, the Original Golden Hour? Container, saved countless lives and was considered so revolutionary that it was recognized with the U.S. Army’s Greatest Inventions Award.”“Minnesota Thermal Science provides innovative, scientific solutions both domestically and abroad for the safe transportation of sensitive pharmaceutical, blood and biologic products.” One of their main customers is the military because they are able to offer precise temperature profiles and ensure that these temperature profiles are kept for long periods of time. They offer packaging that hold temperature for longer than any other company. They are known primarily for their Credo Box however they have many solutions for all different temperature ranges. They seem very expensive and more practical for tissue transport (more important items).Website of their products: Single Dose ProductCalled the Military/Government Solutions – Factor VIIPortable pack that can hold up to 2 vials of blood for up to 72 hours in a normal temperature profileNot used for shipping the product (strictly for carrying)Specifications:Payload Capacity (liters/cubic inches)0.06 / 3.61Payload Area Dimensions (L x W x H)Cylinder (1" Diameter) x 4.6"Exterior Dimensions (L x W x H)5" x 3" x 7.5"Tare Weight2 LbsThermal Performance48 HrsISTA Summer ProfileOuter ContainerSoft-sided CarrierInsulatorVacuum Insulation PanelOuter Boxes From left to right: Brown V3C, Pelican Case, Plastic Corrugate, White V3CConclusionMTS has a lot of packaging products most of which are expensive for single doses. Their main customer is the army because of the high volume they ship as well as the accuracy needed. Most of their solutions are using one of the outside boxes seen above in combination with their effective inner material. The inner liners of these boxes are standard size and the liner can be changed depending on the exact temperature profile required. This gives a lot of flexibility but it may not be that practical for one time uses. Sources: Reliable IntroductionLocated in Edison, New Jersey, TCP Reliable offers many temperature controlled packaging solutions. Their main goals are to limit the use of EPS packaging and offer alternative PCM solutions to what is currently on the market. In 2006, TCP aquired all of the assets of Cryopak, a leading refrigerant manufacturer. All of the testing done on TCP’s packaging is done by DDL, a package and material testing company. They combined companies back in 2007 but operate separately. TCP Reliable and Alternative Technology Pharma, a company located in Canada, signed a contract in 2006 to serve together the cold chain shipping needs for North America. “Under this agreement, TCP will be the exclusive reseller and distributor of the ATP's cold chain services and monitoring solutions for the US market. Under this same agreement, ATP will be the exclusive sales agent of TCP's temperature controlled packaging solutions in Canada.” More importantly, “the pharmaceutical and life sciences market in North America, including pharmaceutical developers, importers, manufactures, wholesalers, transporters, and retailers, will be the primary target of ATP and TCP companies. The pharmaceutical and life sciences industry annually suffers billions of dollars in losses due to cold chain break-ups and product degradation.”“By performing all services under one roof, in strict conformance with ISO 9001:2000, ISTA and ASTM test methodology, and FDA good manufacturing practices, TCP gives you exceptional responsiveness, consistency, and accountability.”TCP Reliable has an extensive list of products for uses similar to BD’s. Alternative to Dry IceBrand Name “20 below”: “This specialty gel is designed to be a safe and effective alternative to dry ice. It is specifically for engineered for freezing applications. As with all of the TCP refrigerants, 20 Below is water soluble and re-usable. “ It can be used with any insulated shipper. Conditioning temp. to freeze product: Below -25 ° CelsiusConditioning temp to melt product: Above -15° CelsiusDisposable in std. municipal waste stream: YesReusable: Yes Sizes:Cryo-Gel -20 Case, hardpack5.375" x 5.375"0.85 lb20 Gel Case, CG-1075 -205.5" x 7"0.75 lb20 Gel Case, CG-1100-205.5" x 7.75"1.00 lb20 Gel Case, CG-1150-205.5" x 9.5"1.50 lbAlternative for 2-8 degreesBrand name “Phase 5”:Packaging material offers improvements over the standard PCMs because it holds the temperature better.Best used in conjunction with panels connected to form an inner cube inside of the outward protective material (EPS cooler, Greenbox)If the temperature-sensitive product must be maintained within 2° – 8° C, the Phase 5? TCP is filled with a material that undergoes phase change at 5°C. This is exactly in the middle of the desired range. Because it can hold 5°C longer than a conventional phase change material (which undergoes phase change at 0° C, and has very little heat capacity at 5°C), significantly less material is required. In addition, the phase change material can be placed in direct contact with the temperature sensitive product because there is no risk of freezing. This reduces the size of the final package because no dunnage or air gaps are required. Figure SEQ Figure \* ARABIC 3. Advantages of Phase 5 over Conventional Gel PacksPhase/Freeze Point: 5° Celsius Conditioning temp. to freeze product: Below 0 ° CelsiusConditioning temp to melt product: Above 10 ° CelsiusDisposable in std. municipal waste stream: YesReusable: YesSizes:Phase 5?? Case -TCP small5.5"L x 5.5" W x 1"H.66lbs +/- 1.5%Phase 5?? Case -TCP large9.25"L x 7 " W x .75"H 1.1lbs +/- 1.5%They have a product that holds temperature from 20-24 degrees. That is not within the profile’s BD is looking for however. Outward packaging solutionsPharmatuff? and ThermalTuff?Standard EPS coolers with density 1.25# and 1.5#Molded Insulated Containers (EPS)Lock into each other and available in smaller sizes for single doses such a 6.37"x4.7”x5" Fabricated Containers (EPS)Tem-Pak Box (avail. in brown with no printing or white with std. printing)Can either be sent already assembled or as separate pieces to be assembled on site Also available in custom sizes Polyurethane Molded Containers (PUR)Super K insulation for longer periods of timeDo not always need to add a gel pack to itSources: Chain Shipping in the Food IndustryCold Chain shipping in the food industry is becoming a highly competitive field. Companies are looking into improving their cold chain process to make it a competitive advantage for them. Environmentally sound products are a major trend in the industry. Outbreaks of disease and contamination have increased regulations by the FDA and other organizations. We will see much more regulation in the near future. Most of the food products that are shipped are in large quantities filling Reefer or full truckloads. Most of the temperature regulation is maintained through active transport, and generators are usually utilized. Companies are not willing to risk a spoiled product when lives are at stake. Companies that ship cakes or chocolate through online ordering have products similar to BD’s requirements. They ship usually with EPS molded coolers, built custom depending on the product. The shipping method across the industry usually changes when food is sent to Hawaii or Alaska because of the distance and distinct temperature profile. Companies must be careful shipping to other parts of the country in the summer because of the high temperatures. Trends in the Food industry There are many specific trends within the cold chain shipping of Food. One important trend is that there is a distinct shift in the size of shipments because of the increasing customer demands. Customers are expecting a much more flexible supply chain. Customers are upset when the product they want isn’t there, forcing food companies to use a highly responsive supply chain with small LTL shipments. Companies are often focusing on increasing their perfect order percentages. Once again this is because of the increasing consumer demands. Other trends are, forward DCs, globalization and consolidation, trading partner collaboration, sustainability, and capacity issues. Transportation and warehousing methods are shifting, and many firms are using 3PLs to manage one or the other. Changing Business ModelSmaller more frequent ordersOrder fulfillment is new fundamental business requirementPerfect OrdersOn timeAccurateCompleteForward DC’sGlobalization and ConsolidationManufacturers3PL’sRetailersTrading Partner CollaborationCapacity IssuesTransportationWarehousingSustainabilityThe refrigerated and frozen food market has been growing over the past 10 years in the U.S.. The need for reliable cold chain shipping methods has therefore increased significantly.Best Practices - Cross DockingRon Cain, president and chief executive officer of TMSi Logistics, a third party logistic provider, headquartered in Fernandina Beach, Florida said, “One way that companies are conquering these challenges is through cross-docking, a practice that has demonstrated great improvements in the transportation of perishable goods." This is because of the increased pressure for customer service and freshness, and shipping variety. According to the 2007 Food Logistics Industry Report, 43 percent of responders said that they have recently increased their cross docking practices. Many of these companies are beverage and food shippers. Companies that ship a high volume in short periods of time can have the most benefit. Along with cutting labor, storage, and transportation costs, cross-docking improves the level of service a company can ensure. A successful cross-docking plan is flexible enough to address unexpected events such as shipment delays, production delays, and demand swings, all of which affect the ultimate quality of service provided."Unlike traditional shipping and warehousing methods, cross-docking is a dynamic and responsive model that eliminates the rigid, linear value environments of outdated supply chains," said Cain.Best Practices - Outsourcing“The trucking industry is comprised of an extensive network of trading partners, including suppliers, manufacturers, distributors, and retailers. All aspects of business, including cross-docking and effective cold chain management, have, therefore, become a collaborative effort”, Cain said."As a result, many companies responsible for refrigerated transportation are choosing to outsource their cold chain operations to a third party logistics provider."Cain said outsourcing to a 3PL allows a company to focus on core competencies, leaving the work of managing cold chain - and its cross-docking scheme - to a qualified collaborator.To achieve all the possible benefits of cross-docking, he advised companies to: "Assess whether your existing infrastructure is capable of making the change to cross-docking, or if there is greater benefits in entrusting your cold chain operations to a qualified third party provider."Temperature Controlled Shipping “We believe there are four steps to the safety of perishables”, says Elizabeth Darragh, director of supermarket and food strategic marketing for Sensitech Inc., a Beverly, MA-based provider of cold chain monitoring instruments, information and analysis:the product needs to be pre-cooled properlythe trailer needs to be pre-cooled properlythe trailer needs to be loaded properlyyou need to maintain proper temperature during transitThe only way to have consistent effective practices is for the whole industry to adopt them. “The supply chain has a clear responsibility in fulfilling all the post-harvest requirements of the product and that includes keeping cold temperatures if need be, or just holding the produce at the proper temperatures,” explained Humfeld. The best way to ensure perfect orders and that the product maintains temperature is through RFID information as well as temperature monitors. Having a web-based customer interface will even further facilitate the process by providing the customer with a real-time ordering process. It can provide the customer with a wealth of temperature information as well but that could be too intrusive. RegulationsOverall the cold chain food industry is much more regulated than the biological or pharmaceutical industries.Food shipping is mainly regulated by:DHHS - department of Health and Human services FDA - Food and Drug AdministrationFSIS - Food Safety and Inspection Service USDA - US Department of AgricultureThe FDA established the Hazard Analysis and Critical Control Point (HACCP). It was lasat updated in 2004. This is a method whose aim is to prevent chemical, physical and biological hazards to food products. Its main concept is that there are Critical Control Points where actions can be taken to significantly reduce potential hazards. The HACCP has major implications on the cold chain shipping industry.Drivers for change Global food supply chains are aggressively fighting for where the food is sourced from. If freshness is not maintained, customers will switch suppliers. Whatever cold chain functions the best will be selected. Many food products are being sourced from all over the globe creating even more pressure. People demand fresh product even when it isn’t locally grown in season.The main drivers of the changes in the food cold chain shipping are:Consumers tastes and preferences Competition and production efficiency: companies around the world are realizing how important cold chain and supply chains are Advances in technology: media and web have brought much more visibilityInstitutional pressures and regulatory requirements: outbreaks of disease are increasing pressure. “A recent announcement suggests that by 2005 food manufacturers in Singapore will need to be HACCP accredited and this can be expected to flow through to transport and cold chain management.”Environmental considerationsInternational and globalization influences Political influencesThe food supply chain is extremely difficult to manage. For instance, from the field to the table of the consumer there are 39 steps to move a piece of broccoli.The food industry is facing increasing pressure to adopt sound cold chain practices. Many already have been adopted in Australia. (see the article for more details)A lot of the new cold chain shipping strategies are driven by the consumer.Example: ChocolateChocolate is shipped using standard EPS coolers along with gel packs. Usually the shipping cost is absorbed by the customer if they are located in a region that requires the additional cost. Otherwise chocolate is shipped with no quality guarantee. For instance, the website has the following disclaimer:The warm weather shipping season for the US and Canada is??? June, July, August.If you live in one of the southern or coastal states (CA, AZ, NM, TX, LA, MS, AL, GA, FL), warm weather shipping applies much sooner. If you choose to ship other than the recommended method we can NOT guarantee your shipment.If you live in one of the southern or coastal states (CA, AZ, NM, TX, LA, MS, AL, GA, FL, VA, NC, SC), and do not select Overnight Air shipping, we will add gel packs to your order. The cost is $7.50.The following information has been posted on a blog by a person who says she has been shipping chocolate for years:“If the temperature is going to be over 80 degrees where you are shipping, use a cold pack. To avoid damaging the chocolate, do not put the cold pack directly on the chocolate. A layer of packing peanuts works well. Also, wrap the chocolate in plastic (or cover it with a sheet of bubble wrap to keep moisture that will condense on the gel pack from getting the chocolate wrapper wet.”“When I ship to places where the temperature is above 85, I also use insulated bubble wrap. This has mylar film on both sides that reflects heat out and keeps cold in. I've been known to use two layers of this insulated bubble wrap combined with all of the tricks above when it's really hot. I also use Perishable stickers.”Example: Cheesecakes and Instapak? TempGuard? Cold Chain PackagingSealed Air the manufacturer of the Instapak TempGuard was one of the 2009 top 25 Green Supply Chain Partners as presented by Inbound Logistics.Sealed Air Instapak proved its “greenness”: Its package and design labs removed two million pounds of excess packaging, it introduced an improved line of high-performance shrink films that are 20 percent thinner, and it developed a new Jiffy Mailer product made from 100-percent recycled newspapers and kraft material. Sealed Air is looking to reduce greenhouse gas emissions by 12 percent between 2006 and 2010.The pictures below show EPS cooler that can be molded to the specific size of the product that is to be shipped. They are a very economical. During seasonal temperature fluctuations, they are the best way to ship and also offer a cushion and protection to the product. -Sources:Presentation On “Trends And Challenges In The Cold Supply Chain”, Dr. Robert Novack, 2009, Penn StateRefrigerated Transporter, July 1, 2008, Cross-Docking - Logistics technique reduces costs, improves service, David A Kolman, pg. 38 Packaging Solutions for Cold Chain ShippingColdpack and Entropy solution are two cold chain shipping product manufacturers that have products that align with BD’s requirements. Coldpack is located in San Diego, California and manufactures the famous Airliner. The Airliner acts as a box liner and replaces EPS foam. They also have an Airliner inflatable envelope that works for shipping single doses. Entropy Solutions, located in Minneapolis, Minnesota, has two industry leading products. Their first is the Green box, which is an environmentally friendly alternative to EPS foam. Entropy Solutions also manufactures the Inflater pack, which is used to ship single doses for companies such as Walmart. These two companies offer the best alternatives to BD Biosciences current processes. Vacuum Insulated Panels are a relatively new packaging solution available for cold chain shipping. They have the highest R Value of any material used in shipping, 4-10 times that of EPS. The high R value is because in-between the walls of each individual panel is a space of evacuated air. Six panels are put together to form a shipping box. This technology is used to insulate buildings and is extremely effective. The high cost of the material is the major disadvantage. Dry Ice alternatives are scarce within the cold chain packaging market. Dry Ice itself is extremely inexpensive and therefore almost always used. To reduce injury and to avoid the intense packaging restrictions some companies have switched to some of the available alternatives. However, many of the options are not cost effective at this point because dry ice is so widespread. List of companies and packaging solutions studied:Cold PackEntropy GreenboxVacuum Insulated PanelAlternatives to Dry IceColdpack Company InformationIntroduction“Coldpack(TM) is an innovative insulated packaging company, which provides cold chain solutions for the shipping of temperature-sensitive products worldwide. Its primary product, AirLiner(R), is a revolutionary inflatable, insulating liner that easily converts a corrugated box into a cooler. “It offers significant saving in regards to storage space and environmental impact. Because it makes the shipping box much lighter it may imply shipping costs savings as well. According to an October 5 article in Business Week, “Coldpack(TM), an innovative insulated packaging solutions leader, today announced it will preview the company's latest environmentally friendly product, the Pharmaceutical Pouch, at the packaging industry's largest tradeshow, PACK EXPO. The pouch, a high-performance inflatable thermal envelope, uses Coldpack's award-winning AirLiner(R) technology to ensure that sensitive pharmaceutical shipments remain within the necessary temperature range of +2 degrees C to +8 degrees C during the transportation period.” This pharmaceutical airliner pouch could be the same as Coldpack’s Airliner 501 pouch, just now they are outlining the actual use for it.Coldpack has European offices located in Paris, France and US offices located in San Diego California. Within the last five years they have expanded their business away from just airliner products and are now offering a gel pack, called the Pelton-Shepherd brand. It is best used in conjunction with the Airliner. The Airliner“A smarter packaging solution than traditional foam products, AirLiner enables shippers of expedited perishables to protect the temperature, improving the presentation and extending the quality of their brands, all while reducing supply chain costs as well as the carbon footprint of businesses that choose the product.” A few characteristics of the Airliner:Occupies only 4 percent of the space a EPS liner of the same size occupies. Ships cheaper and easier because it folds up (inbound cost reduction)Soft cushioning provides a barrier from shock and rough handlingAvailable in a variety of sizes and can be purchased at a custom size (minimum order required)Available in a variety of thicknesses as well Has three options for closure - Velcro double sided tape, and fold over in specific casesWhen Airliner is used with dry-ice, dry-ice needs to be wrapped in a specific bag to improve effectivenessOffers significant improvements over standard foam (see graph below)Airliner PouchThe 501 pouch is sized to fit standard overnight and 2-day shipping boxes, often times allowing the use of complimentary shipping boxes from expedited shipping services. The 2 and 4 baffle thicknesses are both perfect for small or flat products and are well suited for expedited product sampling. effects -“The Airliner? only uses 35% of the raw materials to produce a rigid foam packaging of the same size” -Since the Airliner is only 4% of the size of EPS foam with the same characteristics, it results in a 96% carbon footprint reduction.Awards The Coldpack AirLiner? received a prestigious international industry awards in March 2009.“Coldpack , an innovative insulated packaging solutions leader, announced that its AirLiner ? product, used in tandem with the company’s AntiFreeze Vaccine Backpack, has recently received two top international industry honors. First, the Cold Chain Award from Pharmapack and next, the Flexible Packaging Association s (FPA) 2009 Gold Achievement Award, along with the Special Citation for Social Responsibility. Coldpack’s AirLiner? technology, used in conjunction with its AntiFreeze Vaccine Backpack, was recognized by each respective organization for its role in helping to maintain and transport temperature-sensitive immunizations in an eco-friendly package. The prestigious European Pharmapack Cold Chain Award highlights innovations in professional packaging or products that aid in the transport of medicines, health products and medical devices, and was bestowed to Coldpack during a recent conference in Paris. The FPA 2009 Gold Achievement Award in Packaging Excellence honored the thermal insulating achievements of Coldpack s AntiFreeze Backpack. The Special Citation for Social Responsibility was granted to the AirLiner ? for innovatively addressing societal and wellness issues. The latter recognized Coldpack’s designation by the World Health Organization (WHO) as an approved vaccine transportation system. Approved providers help to solve the challenge of safely and successfully facilitating the transport of priority temperature-sensitive medical vaccines.”Amazing effects on the last mile when it comes to shipping important vaccine products …“These important international awards are validation that AirLiner can play a positive role in the supply chain especially for the last mile of the cold chain process where it is crucial to deliver needed vaccines and medical items in an insulated, temperature-controlled package, commented Coldpack CEO, Etienne P. Snollaerts. The AirLiner has tremendous potential to significantly advance the way pharmaceuticals are shipped, helping them reach those who need them the most. We are honored to be recognized on an international level.”Sources: Week, March 27, 2009, Coldpack AirLiner? Receives Prestigious International Industry Awards, Expanded Reporting; Pg. 1776Coldpack Airliner StudyIntroductionA study was conducted in May of 2008 by 4 MIT students about Coldpack. The studies goal was to analyze Coldpack’s business and how it could expand into the Grocery (Specialty and Traditional), Pharmaceutical and Specialty Medical cold chain shipping markets. They had some nice findings and it shows the competitiveness of these markets. It seems that all companies are still using the old-tech EPS coolers, because of cost savings. The EPS cooler market is highly competitive so prices are low for these coolers. The inflator packs (Airliner) are much more environmentally friendly however most costly. This is why cold pack is looking at expanding into the specialty shipping industries, with low volumes and specific shipping needs. Airliner Product“Coldpack’s primary product offering, the Airliner, is based on very complex technical processes. Over 12 different types of materials are used to create the Airliner, which is an inflatable bag inserted into a cardboard box to keep shipped items cool. In addition, the ribbing in each type of Airliner is created by custom dies used to control the wall thickness of the product.” Weight and space savings are the two advantages. Airliner is reusable. Comparison to EPSPer unit and set up costs are higher for the Airliner than for EPSMust blow up air-liner which could increase labor costsWill never compete on price, unless inflator market expandsStarted to focus on niche markets, cheese, CHOCOLATE, online deliveryWith airliner you do not need to use gel packs, any PCMAlso saving in regards to weightEnvironmentally much better than EPS“EPS is still an industry standard for food, drug, and other perishable ambient cold supply chains (in low and high volume quantities). The Coldpack airliner system is functionally equal to or slightly better than EPS when compared at same width of insulation for the performance characteristic of duration or distance at temperature. For the environment it is much better. (see Figure 1)Environmental Factors (EPS versus Coldpack)Figure SEQ Figure \* ARABIC 4. Environmental ImpactColdpack’s ability to expand/Current use in IndustriesColdpack is still a small company (as of 2008). They are looking to expand into all of the major cold chain shipping markets.Grocery Market- Broken up into Traditional Fresh and Specialty FreshTraditional:Fresh food is a small percentage of the Traditional (500B for whole traditional market)Big retailers such as Walmart have so many suppliers that it might be difficult for them to streamline their shipping practicesVery small percentage are Cold chain Specialty (100B in sales):Specialty grocers have a higher need for small parcel refrigerated shipping Preference for food locallyGrocers are vertically integrated (Whole foods own a fishery in Glouchester)- use EPSCold Pack could add value by adding freshness and internalize the shipping methodPharmaceuticalLittle opportunity for Cold-pack, most of market is done in large quantities Three major pharma distributors: McKesson, Cardinal Health and AmerisourceBergen (together 200B in revenue)Largest 90B in revenue – only 600,000 on EPS coolers Trends in industry that will benefit Cold pack:“Focus on environmental footprint and sustainability ““Increased need for temperature stability protection”Industry cares much more about the trade-offs between cost and performance than environmental effects.Specialty MedicalLarge market, cold chain is a large percentage of that marketInvitrogen (one of the companies researched) ships directly to the customer .Others use 3PLs like McKesson Specialty- 500 million in revenue (10 million on cold chain shipping products – not just EPS)Many other cold chain shipping companies make competitive products. This industry is taking off.Products have differing offerings such as:Indicator labels - says when it goes out of the temperature range Data Loggers - tells the exact temperatureInsulated packaging- may need ice, dry ice, gel packsCompanies that make these products:Minnesota Thermal Science International Safe Transit Association TCP Reliable Cold Chain Technologies Talecris Biotherapeutics, Inc. R.N.C. Industries, Inc Coldkeepers, LLC Termika US ThermaFreezeProducts Corp. Coldpack will have a lot of competition in the Specialty Medical segment however the profitability is high. The airliner product offering will be of huge benefit to many of the companies in the industry, especially those who ship single doses. ConclusionIt seems that within the major industries Coldpack is not being used as a cold chain shipping product supplier. The Airliner has not taken off yet, but will in the future. The MBA students from MIT concluded that the industry where Coldpack can have the most impact/profitability is the Specialty Medical. BD may want to look into Coldpack’s Airliner Product. Sources: site allows you to request information. (NB: as a Penn State student, I am not allowed to contact a company to request information for research purposes)Entropy Solutions Green Box IntroductionEntropy Solutions seems to produce the best cold chain shipping products in the industry. They are one of the leading companies and featured in many articles. They have two main products, the Green box and the Inflater Pack. The green box is for multiple units being shipped together and the Inflater pack is for single doses. The green box is offered in many different sizes and is the more environmentally friendly option out there. The inflater pack is environmentally friendly as well. Walmart’s problemWalmart’s specialty medical division was having problems shipping to Hawaii.“The state's logistics and warm temperatures were wreaking havoc on the company's mail-order shipments of high-value, temperature-sensitive prescription drugs to patients in Hawaii with special health conditions or complex, chronic conditions.”“Actually, the problem was twofold. First, common carriers that transport the medications were occasionally holding the Hawaiian shipments at a main hub until there were enough packages to warrant a delivery to outlying islands. This delay was causing shipments to exceed the cold-chain capacity of the packaging.The second issue was the availability of patients to receive the shipments. Even though the Specialty Pharmacy staff was diligent in contacting the intended recipients to ensure they would be home when the drugs were set to arrive, sometimes things came up, people weren't home when they said they would be, and consequently, the package containing the medication would, perhaps, sit on a doorstep for hours at a time, often in the hot sun. This would also exceed the packaging's temperature-insulating capabilities.”Walmart Specialty Pharmacy sector began using the Green box and the Inflater Pack.The Green BoxGreenbox packaging comprises a tinted-green, reusable, outer HDPE shipping container that resembles a mailing container. Resistant to moisture, crushing and scuffing, the outer plastic-corrugated container is practically impervious to repeated exposure to packing tape. It houses a set of reusable/recyclable Thermal-Lok? insulation panels, made using recycled carbon silica and what Entropy refers to as a nanotechnology-based manufacturing process in a patented, proprietary packing protocol that provides them with an R value of 40.Entropy Solutions' president Eric Lindquist claims that the panels have a thermodynamic insulating capacity that's 10 times greater than EPS or PU foam.They refer to the phase changing material inside as the ‘secret sauce.’ They say that the closest thing to it is vegetable oil. They have PCM for all kinds of temperature profiles. Environmentally Friendly/ ReusableSavings occur because the product does not have to be shipped overnightShip regular because the Greenbox holds the temperature for longer “We typically have a reuse rate of 20 times,” affirms Lindquist. “That's conservative, as tracking reveals an average of 55 uses in a Fed-Ex/UPS circulation. Some customers have used their fleet of Greenbox containers more than 100 times.”Once a person receives the medication they can send the Greenbox to an Entropy reclamation center that will send it back to the original shipper. Walmart uses Greenbox for when they ship to Hawaii or Alaska.“It costs us about fifty-percent less to ship the Greenbox to states such as Hawaii and Alaska than it does typical paperboard packages,” Soucey explains. Walmart pharmacies are also able to ship larger amounts of payload in smaller overall containers, further reducing its distribution-related expenses.”Entropy’s Inflater PackAvailable in three versions, the Inflator Pack comes in 9x11- and 12x14-in. sizes that stay inflated for 24 or 48 hr.There is no need for an outside box (even more cost savings)Walmart use this whenever they are shipping single doses Inflates itself when two spots are punctured on the side of the package (Advantage over the cold pack Inflator pack)More “green” that the Coldpack AirlinerSources: Insulated PanelsIntroductionA VIP (Vacuum Insulated Panel) is a product used to line the inside of a cold chain shipping box. They have an extremely high R-value for their size. They can be made to almost any size and to specific box dimensions. A VIP is essentially a core surrounded by foil, metallic, or plastic material. “The core of the vacuum insulated panel is an open-cell material that allows a vacuum to be pulled on the assembly. There are several types of cores that are currently being used in vacuum insulated panels: polystyrene, polyurethane, and a combination of silica, titania and carbon. The core is wrapped in a metallic or mylar foil, and the vacuum applied. The metallic film is sealed to maintain the vacuum for a long period of time.” A VIP is very similar to the aforementioned inflatable packs that line the EPS coolers. AdvantagesDisadvantagesHigh R Value (highest of any container)Low Shipping Weight (lighter than standard EPS)ReusableHigh Cost (Not suitable for low volume/high value products)Durability (If the vacuum seal were to break the product inside would be ruined. This is not good if it is handled many times)Availability (Few manufacturers offer VIP containers and it is therefore difficult to get a high volume)Nanocool’s PackagingThe Nanocool pack is convenient for uses of 2-8 degrees. It does not require using a gel pack. Because it is air tight, Nanocool allows reducing the overall size and weight and therefore provides savings on shipping costs. By pressing a button on the Nanocool pack, it activates and cools the package to 4 degrees Celsius in less than five minutes. The Nanocool pack is a single-use product. Termika Med Termika Med manufactures two products – the Criomed and Criomed Plus.“By using this practical and flexible thermal container in the transportation of medical products such as vaccines, serums and insulin, we have increased the quality of distribution of these medications.”These products are used by freezing the bag prior to use, which enables the internal diffuser to chare and then maintain the necessary temperature. Sources: to Dry IceIntroductionThere are many rules when shipping perishable goods using dry ice. These rules are set by the DOT (Department of Transportation) and the International Air Transport Association (IATA). The IATA defines a shipment a perishable good if its “contents deteriorate over a given period of time if exposed to harsh environmental conditions, such as excessive temperature or humidity.” Dry ice is at the temperature of -78 degrees Celcius. It maintains this temperature as it sublimates. The biggest advantage is that it changes directly from a liquid to a gas therefore not saturating whatever it is being packed with. The major disadvantage is that it is highly regulated and hard to deal with. There can also be burn injuries if it isn’t packed properly. According to Andy Glode from the University of New Hampshire these are the requirements for shipping dry ice:Gas venting: packages must allow for release of carbon dioxide gas. Dry ice must never be sealed in a container with an airtight seal such as a jar with a threaded lid or a plastic cooler. Package integrity: a package containing dry ice must be of adequate strength for intended use. It must be strong enough to withstand the loading and unloading normally encountered in transport. It must also be constructed and closed in order to prevent any loss of contents that might be caused by vibration or by changes in temperature, humidity, or altitude. Package materials: do not use plastics that can be rendered brittle or permeable by the temperature of dry ice. This problem can be avoided by using commercially available packages intended to contain dry ice. Labeling: It is possible that the carrier of the package will have specific labeling when using dry ice. It is important to consult the package carrier when you are shipping dry ice to determine their specific labeling requirements. The outermost container must be labeled with a hazard class 9 label, UN 1845, and total weight of dry ice in kilograms. The label should be affixed to a vertical side of the box (not the top or bottom) and oriented as in the figure below.Figure SEQ Figure \* ARABIC 5. Dry Ice LabelThe following chart shows how much dry ice is needed to ship specific amounts of food:Entropy Solutions: The PureTemp - 40 SolutionBy far the most popular alternative to dry ice is Entropy solution’s The PureTemp - 40 SolutionAs defined by Entropy solutions the following are its major advantages:While dry ice can be used one time only, PureTemp can be used more than 20,000 times with no thermal degradationWhile dry ice emits carbon dioxide, PureTemp produces zero emissions and is a 100 percent renewable, biodegradable and earth-friendly phase change materialWhile dry ice shipments face restrictions due to carbon dioxide emissions, PureTemp is not restricted in any mode of transportation as part of the GREENBOX? Thermal Management SystemWhile dry ice complicates the handling of a shipment, such as replenishment needs, PureTemp requires no special handlingWhile the use of dry ice may alter the pH levels of certain drugs, PureTemp is safe for use with any product - for example, pharmaceuticals, plasma, clinical devices or even food items - that needs to be kept at deep-frozen temperatures throughout the duration of a shipmentTechni Ice? Reusable Dry Ice Packs HDR (Heavy Duty Reusable) Model (4 layer/ply model)Another alternative to standard dry ice are reusable dry ice packs. They are indeed more effective that dry ice.Some of the advantages of the Techni Ice reusable dry ice packs are listed below:Can be frozen down to -190 degrees CelsiusUsually frozen in Blast freezers down to -80 for dry ice applicationsDry Ice pack is submerged in water to hydrate and activate the polymerNext step is to freeze the bag to the required temperatureReusable and not toxicSheets are 11X16 inches?(9X13X1 after hydrating)?and can be cut to different sizes Figure SEQ Figure \* ARABIC 6. Techni Ice Dry Ice Pack =Sources: foam will continue to be the most widespread cold chain shipping product across the industry, however new sustainable alternatives are emerging. Companies are noticing the harmful environmental effects of EPS foam, and realize that having an environmentally friendly solution could become a company’s competitive advantage. Thus, the cold chain shipping market is exploding with new entrants and new sustainable options. All are much more eco-friendly and most can be reused, enhancing their effectiveness. Of the array of new options, a few have been identified as the most applicable to the needs of BD Biosciences. To maintain 2-8 degrees for 24 hours or 2-25 for 24 hours the best alternatives for single dose shipments are Coldpack’s Airliner, Entropy Solution’s Inflater Pouch, and Cold Chain Technologies’ Kool Temp Insulated Envelope. All three products are new entrants to the market and finding growing success within it. They have much less material than EPS foam, require less gel packs, and are safer to the environment. Entropy Solution’s Greenbox and Cold Chain Technologies’ KoolTemp Polyurethane Insulated Cooler are sustainable alternatives to for 2-8degrees or 20-25 for 5 days. They are made of better insulating material, and are available for reuse. While they may cost more than EPS foam, the reduction in PCMs can offset this cost. Finally, there are three substitutes to dry ice available. They are TCP Reliable’s ’20 below’, Entropy Solution’s PureTemp -40, and Techni Ice Dry Ice Packs. All three don’t emit the harmful greenhouse gas carbon dioxide as dry ice does, and are much safer to handle. Conclusively, as the cold chain shipping market expands so will the market competitor’s product lines. As these product lines expand companies will have to continue to research them and learn which is the most applicable to their needs. Focusing on expert cold chain shipping practices will be a trend of the future. AppendicesNeopor BoxesSource: BoxThis re-usable Neopor box consists of one part MonoBox and one part TripleBox. The MonoTripleBox can be used to transport blood bags, test tubes or other products inside 2 pair of TempShells or TempFrames. Protective outer packaging is avaliable when products need to be sent by post.Outer dimensions (LxWxH): 390 x 290 x 290 mmInner dimensions (LxWxH): 270 x 155 x 120 mmMaterial: Neopor (TM)Insulation: 60 - 80 mmPackaging unit: 4 pcsWeight: 0.75 kgColor: greyTripleTriple BoxThis re-usable Neopor box consists of two part TripleBox. The TripleTripleBox can be used to transport blood bags, test tubes or other products inside 3 pair of TempShells or TempFrames.Protective outer packaging is avalable when products need to be sent by post.Outer dimensions (LxWxH): 390 x 290 x 350 mmInner dimensions (LxWxH): 270 x 155 x 180 mmMaterial: Neopor (TM)Insulation: 60 - 80 mmPackaging unit: 4 pcsWeight: 0.9 kgTransPorter Black 30LB 1000 22 uk sturdy, insulated transport box Dimensions (mm) outside: 646x368x340Dimensions (mm) inside: 470x285x230Volume: 31LUp to 50mm wallsMaterial: expanded polypropylene, blackSturdy, ergonomic handles, stackable, seal able.Cooling elements can be proper placed in four different positions above productsReady for attachment of RFID tags for temperature control and identificationFits with: 3400ml accumulator and elements TempShel Elements and Frames.Hepta BoxNeopor Box with 40L inner volumeThe HeptaBox can be used in combination with delta T cooling elements and TempShells. The box is perfect for one way shipments or long distant cold chains. Outer dimensions: 590 x 400 x 285 mmInner dimensions: Insulation: approx. 40 mmPackaging unit: 1 pcsWeight: 2.0 kgColor: greySF12Neopor Box with 12L inner volume. The SF12 can be used in combination with delta T cooling elements. The box is perfect for one way shipments or short distant cold chains. Outer dimensions: 305 x 215 x 305mmInner dimensions: 240 x 150 x 200 mmInsulation: approx. 20 mmPackaging unit: 4 pcsWeight: 0.33 kgColor: whiteSF40Polystyrene Box with 40L inner volume. The SF40 can be used in combination with delta T cooling elements and TempShells. The box is perfect for one way shipments or long distant cold chains. Outer dimensions: 570 x 450 x 350 mmInner dimensions: 470 x 350 x 250 mmInsulation: approx. 50 mmPackaging unit: 6 pcsWeight:2.8 kgColor: whiteSF75Polystyrene Box with 75L inner volume. The SF75 can be used in combination with delta T cooling elements and TempShells. The box is perfect for one way shipments or long distant cold chains. Outer dimensions: 600 x 490 x 485 mmInner dimensions: 500 x 380 x 390 mmInsulation: approx. 50 mm ................
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