Ambient Profiles - Deciphering the Supply Chain Elements (Part 1)

Weather has fascinated humans for thousands of years because it has a positive or negative affect in daily life (e.g. food supply in gathering, hunting, fishing, agriculture, traveling, etc.). Throughout history men have created explanations for these climatic events that were not only poorly forecasted but also misunderstood. The ancient Greeks for example,attributed these climatic changes to specific gods and their temperamental natures to explain everyday weather and gave meaning to the world around them. Greek mythology includes many fascinating and colorful stories of more than 40 gods, goddesses, nymphs, monsters and heroes related to weather and climate. For example, Aeolus was the god and ruler of the winds. All occurrences of favorable or unfavorable weather were interpreted as a sign of divine intervention.

Aeolus, the Wind God (Source : http://www.flickr.com/photos/buecherwurm/486825832/in/photostream/)

Cold Chain Supply also demands understanding and managing the ambient temperature that a shipping container is exposed to during its transport (i.e. ambient profile) because these ambient temperatures greatly affect the cold chain supply performance. Ambient profiles can be not only as fascinating but also as intricate as Greek Mythology. Fortunately, Cold Chain Supply professionals do not need the Greek weather deities and their divine interventions to manage the ambient profiles but a set of tools and practices to manage the temperature and other logistics factors during transportation. Keep in mind (and this is an important concept) that the ambient temperature may or may not be the same as the actual weather temperature because a container can be stored inside a warehouse with a temperature different from the actual outdoor temperature .  So let’s start with two frequently asked questions many cold chain supply professionals deal with, “What is an ambient profile?” and “Why are ambient profiles important?”

An ambient profile refers to the ambient temperature that a shipping container is exposed to during its transportation. It is common to find three elements in an ambient profile; the temperature, the transit date and time and the logistical step associated to this temperature/date-time point. Note that placing an external temperature logger to collect temperature data will provide the temperature the loggers were exposed to but may not guarantee that the shipping container is always exposed to the same temperatures. Temperature variations in storage areas (refrigerated or non-refrigerated warehouses), carrier fleets (aircraft, trucks, etc) and logistics handling procedures could lead to differences in ambient temperatures. The geographical location and season in which the transport is performed may impact the temperature variations as well. A well managed supply chain will be less influenced by weather variations due to location and seasons because the shipping container is moving through controlled and semi-controlled conditions of storage, carrier fleet and logistics handling instructions.

Defining realistic ambient profiles is critical to the performance of the cold chain supply for many reasons:

1)   It supports the optimal packaging design of the shipping containers. An incorrect profile drives over or under designed shipping containers. For example, a profile with unrealistic extreme cold temperatures will require more insulation and less frozen gel packs to reduce the risk of product loss due to freezing. On the other hand, a profile with unrealistic mild cold temperatures will demand less insulation and more refrigerated gel packs but will introduce a higher risk for product freezing.

2)   It helps the selection of the right distribution and logistics partner. Long transit times as well as extreme temperatures recorded by the external temperature monitors may be an indication not only of limited supply chain integration but also poor collaboration among the distribution and logistics partners. This lack of integration and collaboration may increase risks such as product loss or delays.

3)   It helps to maintain the identity, strength, quality, and purity of the product from beginning to end. Unrealistic profiles create over and under designed containers that expose the product to unnecessary hot and cold temperatures. Creating a profile requires not only understanding of the storage and transportation steps but also proper management of the distribution and logistics partners to provide realistic expected temperatures for the shipping container design and to align the distribution and logistics handling procedures that protect the product.

4)   It ensures patient safety by maintaining the product temperature within the manufacturer’s recommended allowable temperature ranges for storage and distribution.

5)   It increases customer satisfaction by minimizing product loss or temperature deviations that require product quarantine and investigation. A product loss event may require reverse logistics to bring the product back to the manufacturing or distribution location, to send the product to a laboratory for further testing or to ship it to a controlled site for incineration (i.e. destruction). An investigation will delay the product release upon arrival and may cause a stock out situation. Finally, product losses activates lengthy and expensive insurance claims processes and delays also trigger severe financial penalties for not meeting the delivery dates stated in the contract (i.e. supply chain agreements).

6)   It reduces the safety stock and pipeline inventory by reducing transit time and temperature variability. Larger transit time and temperature variability increase the risk and this increased risk requires more inventory overall.

7)   It reduces material (i.e. shipping container) and freight costs by removing inefficiencies in a container design (under or over design). The unrealistic profiles usually drive over-design that translate in bigger and heavier containers because more insulating material and gelpacks are added. Bigger and heavier containers may also cause a capacity issue in the carrier fleet.

8)   Increases compliance by ensuring the container is qualified for the worst case scenario so the Quality team has less temperature deviations to process and the Regulatory team has a modular qualification document that can speed up the submission to new markets.

9)   It calibrates and validates the dynamic environment found in the logistics by ensuring regular confirmation that the distribution and logistics handling instructions are being followed by the logistics partners.

Selecting or building ambient profiles for the shipping container qualification is a difficult and intense task because an ambient profile requires a deep understanding of the distribution process and the logistics involved. In my next posts I will describe how to build or select ambient profiles.

Until then...

Carlos

Cold Chain Industry Forecast for 2,013

This year is almost over and 2012 went by so quick but brought so many learning experiences for me. I was fortunate to attend and speak in few cold chain conferences (US, Brazil and China) where I not only learned more about the cold chain supply challenges in emerging markets but also shared and validated my ideas with many people working with emerging markets. I’d like to share with you some of the key points I gathered this year and my predictions for cold chain in 2013.

The growth in emerging markets has been faster than the logistics expansion efforts to support this growth, so the logistics industry has seen many changes. One of those changes is the available carriers to support the emerging markets. The long-haul routes, historically dominated by American and European airlines, are now a competition ground where Latin American, Asian and Middle East carriers that have shown a deeper knowledge of their regional Markets and have not only gained market share by expanding the network to include hubs in the European and US cities but also responded to the cold chain needs by investing in their fleet, facilities and trained personnel. Carriers are also increasing the amount of narrow-body aircrafts in their fleets, especially in  regional markets to take advantage of the more fuel-efficient smaller aircrafts and the flexibility to respond to changes (i.e. expansion and contraction) in passenger demand. All these changes in the carriers’ network has increased the level of complexity in managing cold chain logistics for emerging markets because the logistics process by nature includes a high number of participants and interfaces.

The  freight forwarders and logistics providers (3PL) have also stepped up to the challenges and understand that they must orchestrate the supply chain complexity and its participants to obtain a fast, efficient and resilient supply chain. They have understood that they are not just an extension of the airlines cargo sales. The traditional model where freight forwarders sold cargo space at standard rates on a commission basis is no longer applicable, and the freight forwarders must create value to their customers by actively optimizing costs and reducing risks. This integration of the freight forwarders has increased information sharing among carriers, containers suppliers, and other participants.

Regulations, standards and other industry good practices on temperature-controlled distribution as well as supply chain integrity (security) have grown exponentially, which confirms the demand expansion in emerging markets and the need to communicate among the logistics participants. Regulatory bodies in emerging markets have actively created or updated the regulations which may not have a global alignment yet. Many industry organizations have also created standards and pushed them to their members with limited success in the adoption of these new standards. Due to the increase in the need for security, the customs clearance process in many countries has become longer and the few countries with shorter clearance time are today the exception.

A increased demand for information sharing (temperature records, tracking, etc) and linking temperature records to each logistics step to help the supply chain participants monitor the process have resonated with the suppliers of these tracking devices and they have responded with cloud-based systems, but the adoption has been slow.

In 2013, I expect to see the following:

1) More collaboration among freight forwarders, carriers and container suppliers to optimize cargo (cube and weight) by designing containers with the right balance weight and volume for the vessel selected (aircraft, truck, etc.). This effort will be supported by the stability data for distribution that pharma and biotech companies are creating. They are aware that missing or delayed stability data for distribution will create over-designed containers and transportation. I foresee a bigger need for a narrow-body shipping containers that will support distribution in regional markets.

2) The increased integration among the participants and optimization may decrease the revenue for some participants (e.g. Freight Forwarders, carriers, etc), so these participants must actively work to offset the revenue decrease by creating services that add value to the supply chain. One example where value can be added is ensuring the best volume and weight balance in the vessel by aggregating demand of light and dense products. Another example will be providing storage and conditioning for containers to free up space and resources at the pharma companies.

3) An alignment of the current regulations and industry standards. I also expect more information sharing so each supply chain participant understands how all the parts fit together. Training and logistics audits will become more popular to ensure these standards are being used correctly. I see an opportunity for freight forwarders to take the lead in providing the training and audit services.

4) More cloud-based systems to integrate freight forwarder, temperature and manufacturer data and make it available not only to the consignee, but also the carriers, health authorities and customs. The need for cloud-based platform to share information is valid for global and domestic distribution because information flow will help optimize the supply chain cost and risks and will benefit the participants by highlighting the processes that can be improved to create value.

I am looking forward to the learning and networking opportunities that the next year will bring. Please feel free to reach out to me with your cold chain questions and predictions for 2013.

Until my next article.

Carlos Castro

Chilling out in Brazil

Last week I was in Sao Paulo, Brazil attending to the 6^th Pharma Logistics and Cold Chain Conference organized by IQPC. It was my first time attending this event and I did not know exactly what to expect but I was excited from the speakers and topics listed in the agenda. I was delighted and surprised with the quality of the event and I’d like to share my impressions for those of you who are considering attending next year’s event and learning more about cold chain supply in Brazil.

I was very impressed about the quality of the event because the speakers, the topics that were presented as well as the audience itself was very diverse and offered something for everyone. Among the topics discussed were local regulations, validation, distribution (import to Brazil, domestic and last mile), security, ambient profiles, logistics optimization, etc. The speakers not only came from private but also from government companies. One of the strong points of this conference was the comprehensive review of the Brazilian regulations which is very helpful in understanding the framework for cold chain supply in Brazil.

I learned from the conference that the cold chain professionals in Brazil are facing similar challenges.  One of the concerns is the cold chain capacity and/or infrastructure at the major airports. There is a need to integrate and collaborate with the government authority (INFRAERO) to streamline the import process. Another concern is ensuring the proper storage condition while the cargo is waiting for clearance and expanding the cooler capacity at airports, especially at those cities different then Sao Paulo and Rio. Some improvements can be made by engaging the freight forwarders, carriers and pharma companies to understand better the process at the airport. Another challenge is the limited capacity of reefers for ground transportation. The current trucking companies do not seem to fulfill the requirements of the industry so there is a demand for a better service. One of the participants pointed out that sometimes customs release the cargo but the truck or reefer  is not there so the products are moved to inadequate areas for storage (outside the warehouse) to free up warehouse space. It is important to mention that the major airport in Sao Paulo is running at 80-90% capacity.

I think the event can be improved by adding a panel that includes one representative of each link in the supply chain. Having a panel will provide a more complete view of the process and will benefit the audience because they can see how these links work together. The panel should include representatives from of the freight forwarder, airline, ground handler, manufacturer, health (ANVISA) and customs (INFRAERO) authorities. Having someone from the INFRAERO would really help understand the pinch points.  Another recommendation would be to include the trucking companies so they hear first-hand the capacity constraints the manufacturer and freight forwarders are experiencing. Trucking companies can then gauge the demand and plan the expansion to meet the industry needs.

I see a great opportunity for immediate collaboration to ensure there is a resilient supply chain before Brazil hosts the World Cup and the Olympic Games, two major events that will stress all logistics capabilities. I would love to see how much advancement will be made by next year in closing these gaps. This task concerns all supply chain links because the weakest link will set the pace of the supply chain.  So there is a lot to work to do and I believe an update of the logistics capabilities will be available in the next IQPC Brazil conference. I am looking forward to next year event.

CARLOS CASTRO

The IATA Label - Will it stick? Part II: The Path Forward

What is the path forward?

A label alone will not guarantee trained personnel to handle the cargo or is it a substitute for a program that supports GMP and GDP practices. Training programs and records, airport audits, facility inspections, a single SOP (among shipper, freight forwarders and airlines) and other tools will ensure the cargo is managed properly so collaboration is critical. Anyone of the supply chain links can take the lead to engage the others. It is not easy to break the silos and be in someone else's shoes. I recommend the healthcare logistics person to lead the effort because he or she is more familiar with the product, its storage and distribution temperatures and have tools to work with such as SOP, audits, service level, training, etc.

I recommend you work with your consignee, freight forwarder and airline(s) to determine the best set up. In general, AWB, Booking, Label and SOP must be aligned to the requirements but communication is fundamental before assuming that matching the storage temperature requirements is a bullet-proof solution. Collaborating with your consignee or affiliates (Regulatory, Quality, Logistics, etc) will provide the feedback to define the best way to handle the cargo downstream.

In my opinion, there are many excellent airline temperature-controlled programs available and airlines that have these programs in place are doing a great job in compiling the requirements of the biotech and pharmaceutical industry. These airline programs are designed to prevent mishandling by setting up SOP’s, training personnel, auditing and upgrading facilities. I believe that is why the IATA label has had a very slow or no implementation by the IATA airlines members. Unfortunately, most of the upgrading is taking place in EU and US airports but I think the bigger needs are at destination (downstream), when the shipping container performance is compromised by delays at the customs and sanitary inspections. Airlines are working in difficult conditions with fuel prices rising and cargo demand contracting so they are very conscious that what drives the service level is the price you pay for booking your cargo, not the IATA label, or the labels your warehouse or freight forwarder attached to the cargo; not even on what's written in the AWB (Air Waybill). Airlines will code your cargo in their system according to the service level you paid and most airlines already have time and temperature-sensitive labels and training associated to the service level you paid. Simply… you get what you pay for.

There are mixed comments posted in many websites or groups stating that the risk for delay or even declining to move the cargo is higher unless the label is adopted. In today's business environment where the air cargo capacity is shrinking, most airlines are hungry for business and have their own time and temperature labels (temperature controlled programs) so I expect the airlines to keep showing flexibility to move the cargo as long as you are paying the service level. My advice is to request your freight forwarder to confirm with the airline at the moment of booking and ensure the booking is done to the service level you need. Airlines will certainly work hard to meet your needs.

As of today, the IATA label is mandatory and I do commend the IATA TTTF group for taking such a big step and somehow forcing the collaboration among the supply chain links. IATA has provided many caveats in the label implementation to increase the flexibility for complying with its mandate but also to prevent disruption in the supply chains. Based on these caveats the word “mandatory” could be interpreted as voluntary in many cases because:

1) It only applies to cargo booked as temperature and time sensitive. Not every airline has a time and temperature program in place and may not call it that way.

2) It is up to each airline to accept or reject the use of the label. IATA recognizes that the Booking, AWB and SOP are the drivers and the label is just a reminder that the other three components must be in place.

3) If an incomplete IATA label is applied, then the AWB, SOP and booking complement the information for the cargo handling.

What is my proposal?

My proposal to IATA to create a voluntary certification program (not just a label) that certifies the airlines’ temperature controlled programs so these airlines can carry the IATA-certified program logo (similar to the Envirotainer certification program or the ISTA certification program for containers). IATA can standardize booking practices, SOP structure and contents, recommend infrastructure, training, auditing methods, etc for the temperature controlled programs available. I strongly believe IATA made a great effort to standardize labels and bring GDP awareness to the airlines. I recommend contacting IATA and sharing your experience because the more feedback the better aligned will be the freight forwarder and airlines to the industry needs. An IATA representative will be speaking at the IQPC’s 10th Annual Cold Chain & Temperature Control Global Forum in Chicago this September, so it may be a good opportunity to hear what IATA strategy and results behind the label effort are up to today. Unfortunately only a few IATA airlines or freight forwarders attend these events so I would encourage freight forwarders, airlines, shipping container suppliers and other supply chain links to attend the conference. This will also ensure a plurality of the feedback and ensure that we get new, fresh and perhaps different opinions because the cold chain supply pool is small yet.

Please feel free to reach to me directly if you have more questions.

Until the next post,

Carlos

References:
(1) http://www.iata.org/whatwedo/cargo/Documents/time-and-temperature-label-industry-communication.pdf
 (2) http://www.iata.org/whatwedo/cargo/Documents/time-and-temperature-label-faq.pdf
(3) http://en.wikipedia.org/wiki/International_Air_Transport_Association
(4) http://en.wikipedia.org/wiki/Air_waybill
(5) http://www.worldtek.com/wp-content/uploads/2011/03/Time-and-Temperature-Oliver-Evans-Removed.pdf
(6) http://www.cnsc.net/events/Documents/kevin-o%27donnell-presentation.pdf

The IATA Label - Will it stick?

It's been more than 2 months since the IATA (International Air Transport Association) announced (June 2012) the status change of the IATA Time and Temperature Sensitive Label from voluntary to mandatory with an effective date of July 1, 2012. The IATA label is to be affixed on the shipping containers to ensure the carriers handle the cargo within the temperature range expected by the shipper. The IATA label status switch had a very short notice (about 30 days) so it took many people by surprise, even to those (including me) who were aware of the label since its debut in the first quarter of 2010. When I learned about this change I rushed to open and read the IATA letter announcing the status change. IATA Time and Temperature Task Force (TTTF) also included a FAQ (Frequently Asked Questions) section to support the status change which I also read a few times. We need to remember that IATA only regulates its members (i.e. most airlines) and does not regulate pharmaceutical or biotech companies, freight forwarders, ground handlers, customs inspectors, etc. Today the application of the IATA label is still unclear because it states shipments "booked as time and temperature sensitive" need the label but it concedes many exceptions to its use. If a freight forwarder does not book your cargo as time and temperature sensitive then the IATA label mandate does not apply. We also need to keep in mind that perishable is not the same as "time and temperature sensitive".

Source: http://www.iata.org/whatwedo/cargo/tracker/june-2012/pages/tt-label.aspx

I do have experience working in cold chain supply and have been using GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) strategies to actively manage temperature controlled chains for over 10 years so here it is my take on the IATA label.

Do we need the IATA label?

This is not a black and white situation and I can think of arguments for keeping as well as for dismissing the label. A label attached to the shipping container supports the need for communication and when used correctly it can help manage the temperature-controlled requirements in a supply chain, end to end. The value of GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) is to establish a framework to operate and manage healthcare supply chains that goes much deeper than labels so I believe that the standardized IATA label is the beginning of a bigger project.

On the other hand, there are already many labels and it is frequent to find the shipper (Warehouse) attaching multiple shipping labels, the freight forwarders adding labels too (tamper evident, security, etc), and finally the carriers (i.e. airlines) affixing labels linked to the service level purchased. Adding another label to shipping containers may increase confusion and the new label may become lost among the existing labels. I believe that most labels attached today have a function and they are intended for certain supply chain links (trucking, customs, airlines, receiving warehouse, etc). The IATA label may only be recognized by airlines and ground handlers at the airports but there are more supply chain steps outside the airport environment. Standardizing these multiple “airport” labels seems like a great idea but each airline has specific training and procedures associated to the temperature controlled service offered which is also constantly evolving to differentiate an airline from its competitors.

What are the benefits of a single (IATA) label?

The expected benefits of the label were forecasted and grouped in 4 categories by the IATA TTTF. Below I list the expected benefits:

1) Better identification by providing one unique, universally accepted and recognized label that displays the temperature range during transportation.

2) Faster supply chain transit handling by increasing visibility and awareness.

3) Greater reliability and accuracy by reducing delays due to inaccurate or inconsistent handling information.

4) Decreases risk by reducing mishandling and adverse exposure.

Currently, the IATA label may not be delivering the expected benefits because:

1) The label is not universally accepted and recognized by all cargo stations yet. The message has not cascaded down to all the airlines and even for those airlines that got the message, not all their stations are aware of the label. This effort could take many months if not years. Creating awareness outside the airport environment so other supply chain links recognize the IATA label may require an enormous amount of energy, resources and time.

2) In my experience, the visibility is not provided by any label but rather by the booking (paid service level) which sets the service level. Airlines will flag the cargo in their system, add an airline specific label and treat the cargo accordingly to the mutually agreed (by all supply chain links) SOP (Standard Operating Procedures). Airlines offer many service levels and they are not likely to confuse a priority cargo in the same way they do not confuse first class and coach passengers. The AWB (Air Waybill) service level is linked to the booking and the AWB text must support the booking. The booking (purchased service) defines how the cargo is moved throughout the airline network and everyone in the airline organization is trained to recognize the flagged cargo (first class passenger).

3) Standardization of handling temperature range in Air Waybill, Booking and Label and SOP may not be the best practice. The handing temperature depends on the country regulations you are dealing with and the temperature range in the AWB for some countries may need to match the country product registration and the same applies to some labels affixed to the shipping container. In these cases, the booking (annotations in the airline system) and SOP need to be aligned on the temperature range to handle the shipping container (different from the AWB).

4) The label may also cause delays because if the temperature range written in the IATA label cannot be supported by the facilities at the origin, transfer or destination airports, some Customs or Sanitary officers may stop and place the cargo in quarantine for non-compliance. One country that comes to mind is Brazil, where the Customs can hold the cargo at the customs warehouse (administered by INFRAERO - Empresa Brasileira de Infra-Estrutura Aeroportuária) and request the Sanitary Organization (ANVISA - Agência Nacional de Vigilância Sanitária) to review discrepancies between actual handling conditions and AWB instructions to make sure that the product quality has not been compromised. For some other countries, the AWB must match the storage temperature included in the product country registration (usually the range +2°C to +8°C) and not the transit temperature range so the transit temperature is managed at the SOP level and is flagged in the airline systems. In these cases, the IATA label may not be reducing the mishandling or delay risks or increasing the visibility or accuracy but have the exact opposite effect.

I suspect that the IATA label may not fully deliver the benefits planned by the TTTF group unless some changes are made to support the complex global supply chains. A benefit not accounted for is that the IATA label created communication and collaboration among the supply chain links because each participant was shaken from its comfort zone and forced to work together to understand this new label requirement. This is especially true for the people who do not actively manage their logistics and stay in their comfort zone (silos).

Part II - Coming soon ...

References:
(1) http://www.iata.org/whatwedo/cargo/Documents/time-and-temperature-label-industry-communication.pdf
 (2) http://www.iata.org/whatwedo/cargo/Documents/time-and-temperature-label-faq.pdf
(3) http://en.wikipedia.org/wiki/International_Air_Transport_Association
(4) http://en.wikipedia.org/wiki/Air_waybill
(5) http://www.worldtek.com/wp-content/uploads/2011/03/Time-and-Temperature-Oliver-Evans-Removed.pdf
(6) http://www.cnsc.net/events/Documents/kevin-o%27donnell-presentation.pdf

Are you winning the supply chain Tetris? (EN) / Jugando Tetris y removiendo las ineficiencias de espacio en su cadena de frío (ES)

Are you winning the supply chain Tetris? (EN)

Some of my readers sent me questions about my post on how the Dutch East India Company (VOC) not only used the synergy between packaging design and logistics but also established a symbiosis among the supply chain links to enhance the chain and asked me to expand on the synergy between packaging design and logistics and the symbiosis among the supply chain links. So I will discuss  the synergy between packaging and logistics in this post but will cover the symbiotic effect that comes from the collaboration among the supply chain links in a later post.

When I think about the synergy between packaging and logistics, the game Tetris comes to my mind. In this game (Tetris), the player must optimize the space with  blocks by rotating and placing them without gaps. These blocks come in 7 shapes and fall one by one while the player orders them as quickly as possible. If the player does not optimize the space, the  buzzer goes off and it is game over.

Source: www.freegames99.com

Drawing a parallel to cold supply chain, you can think that your products are the shapes that must be ordered for distribution (inbound and outbound). If you do not use the space properly for these high-value biotech and pharma products and leave empty spaces and/or add excessive non-value added packaging components (e.g. thermal insulation, refrigerant, dry ice, etc), the load density decreases and you will not only be paying high dollars but also adding risk to your distribution.

Unfortunately, managing biotech and pharma cold chain supplies is more complex than  playing the Tetris game because the biotech and pharma products are not limited to 7 shapes and they  evolved (i.e. new products, different temperature requirements, last-mile distribution varies per country, etc) so the optimization is not as easy as the game and one must be careful to avoid a game over scenario (i.e. product lost, excessive operating costs, etc). The goal must be set to reduce the landed cost and minimize the risks.

Only through collaboration with your supply chain links you will enjoy a robust and resilient supply chain where you can not only measure the benefits in your landed costs, but also in emission reductions, shorter transit times, smaller packaging waste, etc. Below are a few considerations that must be taken into account to reduce  empty or misused space.

1. Evaluate your supply chain (transportation, warehouse, etc) in terms of unused or misused space because those are savings opportunities. A sound approach (described in previous posts) is design from the outside in rather than from the inside out.
2. If you have some flexibility in your stability requirements, incorporate them into your package design (or re-design).
3. Shipping containers designed to protect products left unattended for extended periods in extreme weather conditions are over-engineered so you must collaborate with your freight forwarder, carriers and ground handlers, customs agents, etc to have a well-lubed chain. Storing a shipping container with frozen and refrigerated gels into a refrigerator does not allow the frozen gels to be thawed, so the risk of freezing the product is greater.
4. Develop pack-out diagrams to identify product and package configurations as they flow in the supply chain. Limiting these pack-out diagrams to the warehouse packing process is common in most industries. The goal is to maximize the load density during distribution, especially in the transportation mode that has more limitations (usually airfreight and within the airfreight the narrow body aircraft) or is more expensive.

There are many software programs that can easily find the unused space (short list provided below). Identifying the misused space is more difficult and optimizing to the minimum amount possible of non-value added packaging requires an orchestration of knowledge, communication and collaboration from all supply chain links.

http://www.capesystems.com/index.htm

http://www.topseng.com/index.html

http://stackbuilder.codeplex.com/

http://www.koona.com/qpm/

http://www.magiclogic.com/

http://www.logensolutions.com/default.html

http://www.iris-it.com/en/products/robotics/palletization-software.html

http://www.cubemaster.net/Subscription/home.asp

Squeezing out the empty space around components inside product cartons, boxes, shipping containers and trucks to maximize the load density can be performed with one of the following software programs. Packaging experts have a variety of solutions to support the landed cost reduction efforts without increasing risk (physical or thermal damage). Changes in insulation material, corrugated board specification, flute orientation, etc are tools available to packaging engineers that must be included in the design and validation to prevent an increase on the risks.

I leave you with some questions to test your knowledge about your packaging and unused space in your supply chain.

1. What is the product /packaging ratio in terms of volume and weight?
2. How is your packaging perceived by your carriers and customers?
3. Have you collected the feedback of your supply chain links and shared it with the packaging group?
4. What metrics are you using to evaluate your suppliers and the available containers?

I am looking forward to hearing your comments and questions.
 

Until next time,

Carlos

Jugando Tetris y removiendo las ineficiencias de espacio en su cadena de frío (ES)

Algunos de mis lectores me enviaron preguntas sobre mi artículo de la VOC y cómo VOC no sólo utilizó la sinergia entre el diseño de embalajes y logística, sino que también estableció una simbiosis entre los participantes de la cadena de suministro para mejorarla. Mis lectores me sugieren que explique más de esta sinergia y simbiosis, así que este artículo lo dedico a la sinergia entre el embalaje y la logística y, cubriré la simbiosis asociada a la colaboración entre los participantes de la cadena de suministro en un artículo posterior.

Cuando pienso acerca de la sinergia entre el empaque y la logística, recuerdo el videojuego Tetris. En este videojuego (Tetris), el jugador debe optimizar el espacio con bloques que recibe girandolos y colocándolos sin dejar espacios vacíos. Estos bloques, de 7 formas, llegan de uno en uno, mientras que el jugador debe ordenarlos rápidamente. Si el jugador no optimiza el espacio, los bloques se acumulan y pronto el juego se acaba.

Source: www.freegames99.com

Haciendo un paralelo a la cadena de frío, se puede pensar que los productos son los bloques que deben ser ordenados para su distribución (entrante y saliente). Si usted no utiliza el espacio adecuadamente para estos productos biotecnológicos y farmacéuticos y deja espacios vacíos y /o añade demasiados componentes con poco valor agregado como el embalaje (aislamiento térmico, refrigerantes, hielo seco, etc), estará disminuyendo la densidad de carga y no sólo tendrá que pagar mas flete, sino también adicionará riesgo a su distribución.

Desafortunadamente, la gestión de cadena de frío en compañías biotecnológicas y farmacéuticas es más complejo que el videojuego Tetris, ya que los productos biotecnológicos y farmacéuticos no se limitan a 7 formas sino que también evolucionan (es decir, productos nuevos y diferentes requisitos de temperatura, la distribución en la última milla varía por país, etc ) por lo que la optimización no es tan fácil como el videojuego y hay que tener cuidado para evitar perder (es decir, producto perdido, los costos excesivos de operación, etc.) El objetivo se debe establecer para reducir el costo y minimizar los riesgos.

Sólo mediante la colaboración con todos los participantes de la cadena de suministro uno podrá disfrutar de una cadena sólida y resistente a los riesgos, donde no sólo se puede medir los beneficios en sus costos, sino también en la reducción de emisiones, reducción de tiempos de tránsito, los residuos de envases, etc. A continuación presento algunas consideraciones que deben tenerse en cuenta para reducir el espacio vacío o mal usado:

1. Evaluar la cadena de suministro (transporte, almacén, etc) en términos de espacio no utilizado o mal utilizado porque estas son las oportunidades de ahorro. Un enfoque sólido (que se describe en posts anteriores) es el diseño de afuera hacia adentro en vez de desde dentro hacia fuera. 
2. Si usted tiene cierta flexibilidad en los requisitos de estabilidad, debe incorporarlas en el diseño (o rediseño) de su embalaje. 
3. Los embalajes de transporte diseñados para proteger a los productos durante largos períodos en condiciones climáticas extremas están sobre-diseñados por lo que debe alinear al agente de carga, transportistas y operadores de manejo de carga, los agentes de aduanas, etc, para tener la cadena sincronizada y así se minimiza el tiempo de tránsito y el riesgo al producto. El almacenamiento de un embalaje de transporte, que típicamente incluye geles congelados y refrigerados en el aislamiento térmico, en un refrigerador no permite que los geles congelados se descongelen, y incrementan el riesgo de congelación del producto. perciben sus embalajes?
4. Desarrollar diagramas para identificar las configuraciones del producto y embalajes en la cadena de suministro. Limitar estos diagramas al proceso de embalaje en el almacén es común en la mayoría de las industrias. El objetivo es maximizar la densidad de carga durante la distribución, especialmente en el modo de transporte que tiene más limitaciones (generalmente carga aérea y dentro de la carga aérea, el avión de fuselaje estrecho) o es más caro.

Hay muchos programas de software que pueden encontrar fácilmente el espacio no utilizado (lista a continuación). Identificar el espacio mal utilizado es más difícil y la optimización de la cantidad mínima de envases o materiales sin ningún valor agregado requiere de una orquestación de los conocimientos, la comunicación y la colaboración de todos los participantes de cadena de suministro.

http://www.capesystems.com/index.htm
http://www.topseng.com/index.html
http://stackbuilder.codeplex.com/
http://www.koona.com/qpm/
http://www.magiclogic.com/
http://www.logensolutions.com/default.html
http://www.iris-it.com/en/products/robotics/palletization-software.html
http://www.cubemaster.net/Subscription/home.asp

Eliminar el espacio vacío alrededor de los componentes dentro de las cajas de productos, embalajes de transporte y camiones para maximizar la densidad de carga se puede calcular con uno de los programas de software. Expertos de embalaje tienen una variedad de soluciones para apoyar los esfuerzos de reducción de costos sin incrementar el riesgo del producto (daño físico o térmico). Los cambios en el material de aislamiento, especificación de cartón ondulado (corrugado), la orientación del corrugado, etc son las herramientas disponibles para los ingenieros de embalaje, que deben ser incluidos en el diseño y validación para evitar el aumento del riesgo.

Les dejo algunas preguntas para poner a prueba su conocimiento acerca de su embalaje y el espacio no utilizado en su cadena de suministro.

1. ¿Cuál es la relación producto / embalaje en términos de volumen y de peso?
2. ¿Cómo las compañías de flete y sus clientes
3. ¿Ha recolectado y compartido las sugerencias de los participantes de su cadena de suministro con su especialista de embalaje?
4. ¿Qué indicadores está utilizando para evaluar a sus proveedores y los contenedores disponibles?

Tengo muchas ganas de escuchar sus comentarios y preguntas.

Hasta la próxima,

Carlos

The flat earth theory in cold chain supply (EN) / La teoría de la tierra plana en la cadena de frío (ES)

The flat earth theory in cold chain supply (EN)

I remember the terrestrial globe at home and the story about Christopher Columbus' voyage to find a new trading route to the Indies but he instead arrived to a new continent. I was too little to be concerned about trading routes or a new continent so my attention went to another part of the story, the common belief that the earth was flat with an abyss at the edge where monsters awaited for the sailors who dared to go that far. I looked at the terrestrial globe again and asked why some people believed that flat earth theory? How did men prove that our planet was a sphere? I was pleasantly surprised to learn that men in different times and at different places had demonstrated the roundness of the earth through observation and science centuries before Columbus’ voyage. I learned that Columbus had read other people's work (Greek and Arab astronomy) and knew that the earth was not flat so he took a calculated risk with the information available at that time. Today the idea of a spherical-shape earth is not only well known but also accepted by everyone.

Source: http://pbmo.wordpress.com/2011/03/24/

One common misconception in cold chain supply is perhaps that product storage and distribution temperatures are the same. The idea that the products’ long-term storage temperature is not the same as the distribution temperature can be easily forgotten. I often use the example of how milk and ice cream are handled from the store to the home kitchens. We store (long-term) ice-cream in frozen conditions but we certainly expose it to warmer conditions for transportation purposes for short periods (i.e. from the store freezer shelves to our home refrigerator). Cold chain products will be exposed in the same manner to warmer (or colder too) conditions as it moves downstream the supply chain. Customers may not be fully aware that the ice cream or milk they purchased has been exposed to warmer temperatures for short periods of time because the effect to product quality is negligent. The containers are taken out of the target refrigeration temperature range for a short period and later placed back to the proper conditions without compromising the product quality.

In the biotech and pharmaceutical industries, we find that the stability studies are mandatory by health authorities and these studies are performed following a strict and standardized method outlined by the International Committee of Harmonization (ICH). In most companies, the Quality Stability group performs these studies and the Regulatory group uses the results to establish storage temperature and product shelf life, to file the drug product registrations and to answer questions from regulatory bodies. Stability studies are lengthy and expensive and are specific to the primary container and the manufacturing site so changes to an approved stability study are not easy and may require new submissions, inspections and possible questions from the regulatory bodies. The stability data shows how stable the product is when stored at the ICH conditions and is used to establish the product shelf life (i.e. expiration date).

On the other hand, a standardized method to define the distribution temperature has not been available. Therefore it is common to find that many companies only performed the long-term stability studies and established storage temperatures. Companies with only storage temperature have the flat-earth view because they assumed that distribution temperature must be the same as the storage temperature. This flat-earth view creates many supply chain inefficiencies because of the need of extra protection due to the fear of the unknown (i.e. conditions outside the ICH long-term stability studies).

There are other companies that have ventured out to find the distribution temperatures and devised many tests such as accelerated stability, temperature cycling and freeze-thaw cycles. These accelerated studies conditions are also defined by ICH but the temperature cycling and the freeze-thaw cycles represent  a wide variety of testing conditions. The lack of a standardized method has created a plethora of conditions that are product specific or company specific.  Earlier this year, the Parenteral Drug Association (PDA) published a report that aims to standardize the testing conditions for these cycling and freeze-thaw studies. The PDA technical report is the first step in an effort to harmonize the method to calculate the allowable temperature range to support distribution. One drawback of this technical report is that proposed conditions are called “examples” with a disclaimer that these conditions need to be evaluated on a case by case. The technical report resembles the educated risks that Columbus took and I suspect that as more companies adopt these cycling and freeze thaw studies, the need to standardize the conditions will trigger collaboration among industry, regulatory bodies and organizations such as PDA.

Why is it important to define the temperature for distribution? Again taking an educated risk will provide companies the distribution stability needed to assemble a stability budget. Therefore, even though fluctuations in temperatures exist during the distribution process it can be managed.  Only a few companies have taken the initiative to generate the stability data for distribution and today this stability data for distribution still remains unclear. I believe the PDA technical report  is a good step toward the standardization. Companies that do not adopt the stability studies to support distribution will be forced to over design in the shipping containers, freight services, warehousing, and other manufacturing operations because the storage stability provides a smaller range of conditions to operate.

I leave you with few questions:

1. Does your company have a stability budget?
2. Has your stability group performed accelerated stability studies? freeze-thaw studies? cycling studies?
3. Are you collaborating with the stability group to start the accelerated, freeze-thaw, and cycling studies at the same time as the ICH product stability studies?

I look forward to your comments and will continue talking about the stability budget and the impact of those studies in managing the cold supply chain. 

Until next post,

Carlos

References

http://www.ich.org
http://www.pda.org

La teoría de la tierra plana en la cadena de frío (ES)

Aún recuerdo el globo terráqueo de mi casa y aquella historia del viaje de Cristóbal Colón en la búsqueda de una nueva ruta comercial hacia las Indias, en su lugar él llegó a un Nuevo Continente. Era yo muy pequeño como para interesarme en las rutas de comercio o en un continente nuevo es por ello que mi atención se enfocó en otra parte de la historia, “la creencia común de que la tierra era plana, con un abismo en el borde, donde los monstruos esperaban a los marineros que se atrevían a ir tan lejos”. Miré el globo terráqueo y pregunté ¿por qué algunas personas creían esa teoría de la Tierra plana? ¿Cómo los hombres demostraron que nuestro planeta era una esfera? Me sorprendió gratamente saber que los hombres en diferentes tiempos y en diferentes lugares habían demostrado la redondez de la tierra a través de la ciencia y siglos de observación antes del viaje de Colón. Me enteré también de que Colón había leído la obra de otras personas (la astronomía griega y árabe) y sabía que la Tierra no era plana y tomó un riesgo calculado con la información disponible en ese momento. Hoy en día la idea de una Tierra esférica no sólo es popular, sino también aceptada por todos.

Source: http://pbmo.wordpress.com/2011/03/24/

Un error común en la cadena de frío es quizás asumir que la temperatura de almacenamiento y de distribución del producto son las mismas. Es fácil olvidarse que la temperatura de almacenamiento a largo plazo de los productos no es la misma que la temperatura de distribución. A menudo utilizo el ejemplo de cómo la leche y el helado se manejan desde la tienda a la mesa del consumidor. Tenemos el almacenamiento (largo plazo) de helados en la tienda en condiciones de congelación, pero sin duda lo exponemos a condiciones más cálidas cuando lo transportamos por períodos cortos ( p.e. desde el congelador de la tienda a la nevera del consumidor). Los productos de cadena de frío se exponen de la misma forma a condiciones más cálidos o más frías cuando se transportan a lo largo de la cadena de suministro. El consumidor quizás no sepa que el helado o la leche que compra han sido expuesto a temperaturas cálidas durante períodos cortos de tiempo debido a que el efecto de la calidad del producto es insignificante. Los envases son expuestos fuera del rango de temperatura de refrigeración durante un corto período y luego se regresan a las condiciones apropiadas, sin comprometer la calidad del producto.

En las industrias biotecnológicas y farmacéuticas, encontramos que los estudios de estabilidad del producto son obligatorios por mandato de las autoridades sanitarias. Estos estudios se llevan a cabo siguiendo un método riguroso y estandarizado descrito por la Conferencia Internacional de Armonización o ICH, por sus siglas en inglés International Conference of Harmonization. En la mayoría de las empresas, el departamento de Estabilidad de Producto lleva a cabo estos estudios y el departamento de Asuntos Regulatorios utiliza los resultados para establecer la temperatura de almacenamiento y vida útil del producto, para obtener los registros sanitarios y responder a las preguntas de los organismos sanitarios. Los estudios de estabilidad son largos y costosos y específicos para el empaque primario y el lugar de fabricación, es por eso que los cambios a un estudio de estabilidad aprobado no son fáciles y pueden requerir un nuevo registro sanitario, inspecciones y posiblemente una auditoría de los organismos sanitarios. Los estudios de estabilidad de producto demuestran la estabilidad del producto y ayudan a establecer las condiciones de almacenaje recomendadas por el fabricante para obtener la máxima vida útil del producto (es decir, la fecha de expiración).

Por otro lado, no existe un método normalizado para definir la temperatura de distribución. Por lo tanto, es común encontrar que muchas empresas sólo realizan los estudios de estabilidad a largo plazo y así establecen las temperaturas de almacenamiento. Las empresas que sólo utilizan la temperatura de almacenamiento tiene el punto de vista de la tierra plana, ya que asumen que la temperatura de distribución debe ser la misma que la temperatura de almacenamiento. Este punto de vista de la tierra plana crea muchas ineficiencias en la cadena de suministro debido a la necesidad de protección adicional debido al miedo a lo desconocido (es decir, condiciones distintas de los estudios de estabilidad a largo plazo establecidos por ICH).

Hay otras compañías que se han arriesgado a buscar las temperaturas de distribución y muchas han diseñado pruebas de la estabilidad en condiciones aceleradas, ciclos de temperatura y ciclos de congelación-descongelación. Estos estudios en condiciones aceleradas también las define ICH pero los estudios de ciclos de temperatura y ciclos de congelación-descongelación representan una amplia variedad de condiciones de ensayo. La falta de un método normalizado ha creado una plétora de condiciones que son específicas de producto o específica de compañía. A principios de este año, la Asociación de Drogas por vía Parenteral, o PDA del Inglés Parenteral Drug Association, publicó un informe técnico que apunta a normalizar las condiciones de prueba de estos estudios de ciclos de temperatura y ciclos de congelación-descongelación. El informe técnico de la PDA es el primer paso para armonizar el método para establecer la temperatura de distribución. Una limitación de este informe técnico es que las condiciones propuestas se llaman "ejemplos" y se hace la advertencia de que estas condiciones deben ser evaluados caso por caso. El informe técnico se asemeja al riesgo calculado que Colón tomó, y yo preveo que a medida que más empresas adopten estos estudios de ciclos de temperatura y ciclos de congelación y descongelación, la necesidad de estandarizar estas condiciones de ensayo dará lugar a la un trabajo colaborativo entre la industria, los organismos reguladores y organizaciones como la PDA.

¿Por qué es importante definir la temperatura de distribución? Un riesgo calculado proporcionará a las empresas, la temperatura de distribución necesaria para armar un presupuesto de estabilidad. Por lo tanto, a pesar de que existen fluctuaciones en las temperaturas durante la distribución éstas se pueden gestionar adecuadamente. Sólo unas pocas empresas han tomado la iniciativa para generar los estudios de estabilidad para la distribución y en la actualidad estos estudios de estabilidad para la distribución aún siguen siendo desconocidos. Creo que el informe técnico de la PDA es un buen paso hacia la normalización. Las empresas que no adopten los estudios de estabilidad para apoyar la distribución se verán obligadas a sobre-diseñar los embalajes de transporte, los servicios de transporte, el almacenaje y otras operaciones de fabricación debido a que la estabilidad de almacenamiento proporciona una gama más pequeña de las condiciones para operar.

Les dejo algunas preguntas:

¿Su empresa tiene un presupuesto de estabilidad?

¿Su Departamento de la Estabilidad realizado estudios de estabilidad acelerada? ¿Estudios de ciclos de temperatura? ¿Estudios de ciclos de congelación - descongelación?

¿Está colaborando con el Departamento de Estabilidad para iniciar los estudios de la estabilidad acelerada, de ciclos de temperatura y de ciclos de congelación-descongelación, en conjunto con los estudios de estabilidad de ICH?

Espero sus comentarios y seguiremos hablando del presupuesto de estabilidad y el impacto de estos estudios de estabilidad en la gestión de la cadena fría.

Carlos

Referencias

http://www.ich.org
http://www.pda.org