«La décision de proposer un salon à Lausanne souligne la position forte de la Suisse francophone dans les secteurs de la chimie, de la biotechnologie et du laboratoire en général. Cette communauté peut profiter de cette opportunité pour s’informer des nouveautés proposées sur le marché et d’un réseautage intensif, qui aura lieu cette année juste devant les portes de l’EPFL.» Matthieu Paris, Direct procurement buyer. EPFL
NV Logistics sera présent à cette importante foire le 4 et 5 Octobre 2017.
Venez nous visiter sur notre stand C33.
Information supplémentaire sur le site web de ILMAC
A challenge with scientific and human implications.
An interview with Florence Chiodini, PhD.
Geneva University Hospital (HUG) | Geneva Cornea Bank (BDCG)
.Geneva University Hospital (HUG) is the largest medical establishment in Geneva city and canton.
It has a long history of excellence and is seen as one of the most important medical institutions in Switzerland.
Attached to the Faculty of Medicine of Geneva University, it is also a radiant research centre.
And what’s more, the hospital is an integral part of a region called West Switzerland, reputed as a fertile ground for innovation in biotechnology and the life sciences.
One of HUG’s strong points is their clinical research. Through close and active collaboration with the World Health Organisations (WHO), HUG reaches a world-wide scientific audience, enjoying strong recognition both nationally and internationally.
Our guest today (and NV Logistics client)
Florence Chiodini, PhD, is a biologist at HUG’s Ophthalmology Clinic. She is in charge of coordinating the Geneva Cornea Bank’s activities.
The Geneva Cornea Bank (BDCG) is a part of HUG’s Cell Therapy Laboratory. At macro level, it provides a service regulated by the Federal Office of Public Health (FOPH) which is part of the Federal Department of Home Affairs.
But before going any further, the image here below lets us situate our eye’s cornea.
The cornea is the transparent front part of the eye that covers the iris, pupil and anterior chamber. The cornea, with the anterior chamber and lens, refracts light.
Florence Chiodini, what’s your role?
We’re a laboratory that analyses, preserves and distributes corneas. I am in charge of coordinating the Geneva Cornea Bank’s activities.
Running a Cornea Bank is a highly regulated and controlled affair. When a person dies at HUG, clearly established processes come into play.
Specific databases match corneas with patients.
An important task that is assigned to me is the maintenance and management of up-to-date databases.
How does the cornea transplantation process work?
There are three demanding steps a cornea has to overcome before it may enter into the Geneva Cornea Bank.
Step 1.
The person responsible for the cornea bank communicates with the local donor coordinators who do the identification of potential cornea donors.
When a person has died, they consult the medical record.
During one year, there are between 1200 and 1500 deaths at the Geneva University Hospital.
Step 2
When no contra-indications are found to cornea donation, the coordinator contacts the relatives to seek consent for cornea donation.
This standard procedure is always performed, even if the deceased person already gave his agreement on a donor card.
Step 3
When consent is given and no other medical contra-indications are found, the coordinator organises the procurement of the corneas by an ophthalmologist.
The corneas are placed in separate sterile receptacles, containing a biological solution which ensures their conservation.
They are then deposited at the cornea bank by the coordinator and stocked in a special chamber for a period of quarantine.
The biologist is responsible for their reception and storage until serological, bacteriological and morphological analyses are complete.
Images plastic flask above, and Biologist provided by HUG Communications Department
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The Geneva cornea bank is important – a quick look at some numbers …
Corneal transplantation, also known as corneal grafting or Keratoplasty is one of the most performed transplantation operations in the world. Over 100’000 interventions happen every year. In Switzerland, the number is around 500.
However, we have a cornea shortage in our country, with an estimation of 800 patients awaiting a cornea transplant.
Cornea banks can also be found in Bern, Zurich, Lucerne, Olten and Lausanne. In Geneva, the number of patients awaiting a cornea is estimated to be around 80.
Corneas spend only a short time at the cornea bank, 30 days being the maximum. Once admitted and ready, our challenge is to collaborate with the ophthalmologic surgeons, set priorities and get the precious tissue to the patient who needs it most.
NB: Did you know that corneal transplantations are being practiced since 1887? The physician who performed the first operation was Dr. Arthur von Hippel (1841-1916).
What makes your Geneva Cornea Bank and Laboratory special?
A cornea transplant in progress.
Rules and regulations surrounding all activities of a cornea bank are plentiful and require our utmost attention.
Geneva is a new cornea bank. We came into operation in March 2013 and we apply the most up-to-date scientific knowledge and best practice to both the bank’s infrastructure and related processes. For example, we work in a Clean Room, see next chapter.
All our processes have been certified by Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products.
Geneva Cornea Bank (BDCG) meets the highest health safety regulations, set by both Swiss and European authorities.
A certified « Clean Room »
Preparation & Storage
Quality Control
Release of the corneal transplant to the surgeons
Working area under laminar flux in Clean Room.
bla bla
bla bla
Images provided by HUG Communications Department.
Our laboratory in Geneva is the only one in Switzerland to dispose of such a space.
A Clean Room, in French “Salle Blanche”, is a well-defined area where key parameters such as temperature, humidity and pressure are constantly maintained at pre-determined levels – hence preventing environmental contamination.
This will no doubt change in future, as regulations evolve and the availability of a Clean Room becomes mandatory.
At present, our certified Clean Room reinforces Geneva University Hospital’s (HUG) reputation for excellence, and gives us a powerful strategic advantage.
What made you sign a partnership with NV Logistics?
As you’ve seen in the previous passages, the field we operate in is delicate and highly regulated. An absolute must is certification by Swissmedic, Switzerland’s regulation body.
We could not possibly implement the best of all processes internally (the procedures that define how corneas enter our Cornea Bank) and then fail when we release and distribute (transport) the tissue to its final destination.
We must work with Swissmedic predefined procedures and regulations at EVERY STEP of the process.
NVLogistics, and more specifically Vital Logistics, their biological and pharmaceutical transport division – are currently the only independent transporter in the French part of Switzerland to be Swissmedic certified.
This key factor, combined with their excellent reputation, made it easy for us to select NVLogistics as our preferred shipper and partner for the Cornea Bank project.
With NV Logistics we’re worry-free.
As previously stated, we operate with full certification at all levels of our supply chain and as such, we only collaborate with organisations who are Swissmedic certified.
A transporter such as certified NV Logistics is able to provide us with all the authorizations necessary – Swiss and European – to transport our corneas within Switzerland and Europe.
The transporter with whom we partner must be able to implement existing protocols & regulations regarding temperature, time, traceability and specific packaging.
Let’s take « Packaging » as an example.
NV Logistic’s advice has been precious. Our many open and stimulating discussions culminated in a customised packaging solution which fulfils our very specific needs.
Corneas are immersed in a biological solution which ensures their conservation. Maintaining the solution at pre-defined and constant temperate levels is essential for keeping the tissue at its optimum state.
We achieve this with a Triple Layer System for packaging and a fleet of vehicles which are equipped to maintain temperatures at requested levels.
The photo here below shows the various components:
The primary receptacle: Sealed plastic flask (packed in a leak proof plastic bag).
The secondary receptacle: a sealed pot.
The tertiary receptacle: an aluminium-clad thermo protection box.
Do you work exclusively on Swiss territory?
Since going operational in March 2013, the majority of cornea shipments occurs on Swiss territory.
As far as Europe, we maintain close collaboration with the Tissue & Cell Bank of the Lyon Civil Hospices – Les Hospices civiles de Lyon (HCL) – with whom we’ve signed an Interbank Convention.
In case of an emergency, we can exchange matching corneas. Having a transporter who can handle international transport immediately and with all necessary certification is obviously a great advantage for all concerned.
Additional resources
The HUG Press Release (in French) announcing the opening of the Geneva Cornea Bank (April 2013).
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This interview was conducted by Piero Zappaterra while a student at HES So.
Piero is candidate for an MscBA in Orientation Management and Service Engineering.
Images under Creative Commons Licence:
The schematic diagram of the human eye with thanks to Mikael Häggström
The Cornea Transplant image was generously provided by Obis International (via Flickr)
Office picture (via Kinnarps)
Profitez de cette exposition pour venir nous visiter afin de découvrir plus en détails les services offerts par notre département « Vital Logistics » spécialisé dans la logistique pour l’industrie des sciences de la Vie.
Ces services spécifiques vous offrent des solutions afin de garantir l’intégrité de vos produits soumis au respect de la chaîne de froid durant leur transport ou leur stockage.
A cette occasion, nous vous aiderons à optimiser vos coûts pour vos prochains transports grâce à une analyse personnalisée de vos besoins.
Vous trouverez plus d’information sur le site officiel de Labotec en cliquant sur ce lien.
For your easy reading, we have divided this report into three parts.
1. The Client’s Challenge
2. NV Logistics’ Answer
3. The End Result
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1. The Client’s Challenge
Historically there was no cornea bank in the Geneva catchment area. Patients who needed a cornea transplant had to rely on cornea stocks located in other Swiss cantons, or even abroad. Cornea banks exist at Lucerne, Zurich, Berne, Lausanne and Olten. Beginning 2013, Hôpitaux Universitaires de Genève (HUG) decided to establish a cornea bank for patients in the Geneva region. The process of stocking human tissue for transplantation is highly regulated both at Swiss and international levels. Swissmedic*, the Swiss regulatory agency, sets strict rules at every step of the process.
Collaboration with a Swissmedic certified shipping company was an absolute must for HUG.
*Swissmedic is the Swiss therapeutic agency monitoring authority.
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2. NV Logistics’ Answer
Through extensive interaction with many clients over the years, we at NV Logistics observe an increasing and world-wide move towards ever more stringent safety regulations in the life sciences field. Eager to stand out from the crowd and remain a top notch supplier, we wanted to get our competencies, our processes and our infrastructure validated. Hence, we allocated time, effort and resources to acquire the much sought after Swissmedic certification for transporting, distributing and stocking medicinal products.
NV Logistics gained Swissmedic certification in February 2013 and to our knowledge we’re currently the only certified shipping company in the French part of Switzerland.
We were extremely pleased to be chosen by Hôpitaux Universitaires de Genève as their privileged partner for cornea transportation. The partnership agreement between HUG and NV Logistics was signed in April 2013.
In order to be selected by HUG as their preferred partner, we were required to fulfil 6 selection criteria which we list here below:
2. Adhere to the Good Distribution Practices (GDP) scheme.
GDP is a quality scheme for warehouse and distribution centres. We closely collaborate with Mr. Claude Ammann who brings to the table 25 years of experience in the pharmaceutical industry and biotechnology fields (Zyma, Ciba-Geigy, Novartis, Valibio, Apoxis, TopoTarget). .
3. Guaranteed CRT (Controlled Room Temperature)
NV Logistics guarantees a CRT of +15°C à +25°C for HUG cornea transport. This implies maintaining the CRT from the moment the cornea leaves the hospital’s clean room to the moment the cornea is safely deposited into the hands of the recipient. Reporting: Temperature data is being captured throughout the whole transport journey and assembled in a report which is delivered to the client at completion of the transport mission. See also point 5. Real Time Shipping Visibility. .
4. Up-to-date know-how and consulting services.
We share our extensive knowledge and expertise in key areas such as Classification, Packaging and Transport.
a. Classification
Based on interviews with the cornea bank’s scientific team and our deep understanding of the classification regulations as determined by UNEC / ADR, we were able to identify our client’s cornea shipments as meeting the Exceptions regulations under section 3.6.2.2.3 of the IATA Dangerous Goods Regulations (DGR) manual. Consequently, we recommended the classification as « non-infectious biological substance ».
Shipping corneas as non-infectious biological substance is an opportunity for HUG to make considerable cost and time savings.
Two previous articles in our series « Shipping biological substances » talk extensively about the merits of judicious classification. We’ve written short tutorials and provide cheat sheets you can download. Check them out by clicking on the titles here below. Are you reckless or overcautious (1/3) and It’s all about smart classification (2/3). .
b. Packaging
We were delighted to be part of the Cornea Bank’s scientific team. Based on in-depth discussions and insights gained, we were able to draw up customised specifications and then commissioned a packaging company to create a project-specific cornea packaging solution for HUG. Corneas are immersed in a biological solution which ensures their conservation. Maintaining the solution at pre-defined and constant temperate levels is essential for preserving the tissues at their optimum state. We achieve this with a Triple Layer System for packaging, and a fleet of vehicles who’re equipped to maintain the packaged substances’ temperatures at requested levels. The photo here below shows the various components:
The primary receptacle: Sealed plastic flask (packed in a leak proof plastic bag).
The secondary receptacle: a sealed pot.
The tertiary receptacle: an aluminium-clad thermo protection box.
c. Transport
We own the transport chain from A-Z. Entirely in-house – and using our own modern fleet of cold-chain approved vehicles – we’re able to guarantee a controlled and seamless transport solution during which temperature is maintained at the prescribed range of +15°C à +25°C. .
5. Real Time Shipping Visibility
NV Logistics is equipped to provide GPS & GSM real time tracking. We use RouteWatch® to improve shipment visibility. Through our TEMS Web Portal (Transportation Environmental Monitoring System), our client has access to live monitoring – for example by viewing a map indicating the exact position of the transporting vehicle. The TEMS portal also handles alerts through its alerts management system, and more. Our RouteWatch web page explains the menu of services which fulfil the specific needs of pharmaceutical and biotech industries. .
6. Cost
Our handpicked and loyal staff brings up-to-date know-how and emotional commitment to the task. Being able to rely on competent and committed people makes it possible for us to continuously fine-tune and improve our internal processes. Being agile and lean is a competitive advantage for us, making our solutions, performance and pricing extremely competitive.
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3. The End Result
Geneva’s Cornea Bank is one of only few in Europe who respond to the latest and strictest regulations at all levels of the supply chain.
As a Swissmedic certified shipping company we’re pleased to be the privileged shipping partner of this worthwhile project.
Transport is, indeed, a crucial safety element and hence a responsibility we take very seriously. As and when HUG extends its collaboration to include other cornea banks, inside and outside of Switzerland, everything is already in place. As Swissmedic certified shippers, we are always up-to-date with the latest regulatory information, we make sure all necessary authorisations are in place, and we deliver on time. In a field as new and delicate as shipping biological substances, an ongoing and mutually trusting working relationship between the client and the supplier is absolutely essential. Our partnership with HUG continues to be highly successful because the corneal bank’s busy team knows that they can rely on us, come what may.
This makes it possible for the HUG team to dedicate more of their precious time to what they’re really good at: being doctors and scientists.
Disclaimer: Whilst we strive to make our articles and tutorials as accurate as possible, NV Logistics SA cannot be held responsible for any changes in rules & regulations initiated by various worldwide organisations, including governments and others.
Unfortunately, many shipments are over-classified.
Consistently declaring biological materials as infectious when they are not, has at least two negative consequences:
By continuously overstating your case, you decrease vigilence and, therefore, make shipping less safe than it could be.
You inflate your company’s cost and induce longer delivery delays.
In fact, did you know that it is against the regulations to misclassify commodities, even as a precaution?
So, what IS the best way to classify? Let us take you for a quick tour.
The Tutorial – Shipping Biological substances.
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Lesson 2. – The secret’s in the Classification.
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Scenario 1: When nobody really knows …
You need to ship a human specimen, say blood, which has not been tested for pathogens, i.e. little is known of the medical condition of the person providing the sample.
The regulations allow for subjective medical judgment based on known facts and scientific or medical opinion.
Unfortunately, such a judgement is not always available, or people are reluctant to commit.
This leads – quite naturally – to shippers going for what they think is the road of caution: the UN3373 classification.
That’s fair enough, but be aware that UN3373 Classification comes at a cost!
Conclusion
1. Some airlines will not accept Category B shipments. Examples: Lufthansa and Air France.
With a restricted choice of airlines, rapid and direct transport to and from areas best served by those airlines is not possible.
2. All airlines take extra time and extra care when it comes to inspecting Category B UN3373 shipments. This results, more often than not, in longer transport times due to shipping and customs delays. In the worst case, delays can lead to the spoilage of the shipped commodities.
3. Classified shipments require time consuming preparation time by selected and trained staff – which results in higher shipping cost.
Scenario 2: The non-believers who pretend …
Another typical consequence of an over-classified shipment is inconsistency, because the staff involved doesn’t – in their heart of hearts – consider the shipment as Category B.
This leads, for example, to shippers labelling the package as Category B and quite amazingly, composing the invoice or airway bill by saying something like: “tissue sample, not infectious”.
Conclusion
Lack of consistency spells trouble with customs and airlines staff, creates delays and wastes everyone’s time.
An explicit wording for a correctly classified shipment (see the next chapter entitled « The Third Way ») could be:
“Human cornea, non-infectious, not restricted”
The Third (Smart) Way.
The third way is about being aware of and having a clear understanding of the rules & regulations in vigour.
Result: each shipment will yield the safest AND most cost effective solution.
According to IATA Exceptions 3.6.2.2.3 of the IATA Dangerous Goods Regulations (DGR) manual, it’s perfectly acceptable to ship a biological commodity as non-infectious if it is known not to contain pathogens or is unlikely to contain them.
Click on the image here below to bring up the full IATA DGR Manual. The Exceptions section starts on page 129.
For your convenience and easy reference.
Run through our 4-step checklist before declaring your shipment as category B.
Step 1.
Get a medical judgement as to whether or not it is likely that the commodity contains an infectious substance.
There is no requirement to be totally sure. The regulations recognize that a clear « black and white » determination cannot always be made.
If the scientists/doctors think (based on accepted medical/scientific principles) that a DNA sample cannot reasonably contain such a pathogen, then it is not infectious.
For example, if the shipment is made up of a human cornea sent to a lab for initial compatibility testing (in view of transplantation), and if the donor is unlikely to have an infectious disease, then it is really OK to classify your shipment as non-infectious.
Step 2.
If the samples come from oncology patients who are not known to have an infectous disease, then it is not infectious.
Step 3.
If a given commodity contains infectious pathogens – for example human blood samples taken from patients with HIV, HPV, Hepatitis C, then infectious Category B, UN3373 applies.
Step 4.
And most importantly, there are many commodities that meet the Exceptions 3.6.2.2.3 section of the IATA Dangerous Goods Regulations (DGR) manual, such as blood and blood products intended for transfusion, or substances which do not contain infectious pathogens, or which in any case will not cause disease in humans or animals.
Click on the image to download the 4-step checklist PDF file, ready for print.
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In a nutshell …
Once a judgment has been made, or in the case of a lack of such judgment (for example if medical advice is not available), the regulations on how to proceed are fairly clear.
.You have 3 choices:
1. Apply the infectious category A
2. Apply the infectious category B
3. Go for the non-infectious Third (Smart) Way.
As previously mentioned, use consistent wording across all paperwork destined to the airline and government agencies. This avoids delays, cost and spoilage.
About the “Shipping Biological Substances” Tutorials
We give you 3 Lessons, spanning over 3 separate articles.
In Lesson 1, Article 1/3, we set the scene by providing a recap of essential labelling and packaging regulations.
In Lesson 2 (above), you discover easy to use action steps that guide you through smart Classification.
Lesson 3, Article 3/3 – “Smart Classification. A case study” (yet to be published), presents a concrete example which unveils the process we use at N/V Logistics to achieve optimal classification.
Disclaimer:
Whilst we strive to make our articles and tutorials as accurate as possible, NV Logistics SA cannot be held responsible for any changes in rules & regulations initiated by various worldwide organisations, including governments and others.
Recently, a British mother was convicted for letting her 10 year old daughter walk to school on her own. The current interpretation of the law accused her of being reckless.
At the same time, many educators and psychologist fear that by being overprotective we deprive our children of essential pillars necessary for growing into autonomous and self-confident human beings.
Doing the right thing.
Doing the right thing requires our active attention.
« OK” choices can be made by understanding the law and the rules, and by applying these rigidly.
But optimal decisions – the ones most of us seek – happen when we place a given challenge into its proper context, when we draw from the richness of our experience and when we’re confident enough to trust our sound judgement.
Reverting back from parenting to the world of shipping biological substances, doing the right thing is of utmost importance.
If we’re reckless we endanger the environment and our fellow human beings. As an organisation, we lay ourselves open costly incidents and legal penalties. In the worst case, we could even bring a company to its knees.
If we’re overprotective, we over engage already tight resources such as time and money, hence depriving our company of precious resources that may be better allocated elsewhere.
The secret is in the Classification
When talking with clients, we’ve found that appropriate Classification is one of the most challenging aspects of shipping biomedical materials.
The rules and regulations pertaining to the transportation of biological substances and infectious materials are increasingly complex.
Together with heightened enforcement and penalties, companies in the life sciences industry are seeing this evolution as an issue of concern.
It’s not surprising then that the knee-jerk reaction of many internal or external shippers is to take the safe road. And, at first glance, who can blame them?
The temptation lurks, indeed, to indiscriminately apply the most protective labelling to a shipment, rather than making smart transport decisions based on attentive case by case evaluation.
When companies favour default shipping over case by case evaluation, they lay themselves open to an exploding transport budget as well as inefficient transport solutions.
How not to use a sledge hammer to crack a nut.
Understanding regulation and applying it judiciously is key to making smart and efficient shipping decisions.
Please stay with us for our
“Shipping Biological Substances” Tutorial.
which is made up of 3 Lessons, and spans over 3 separate articles.
In this Lesson 1/1 we give you a recap of essential labelling and packaging regulations.
Lesson 2/3 – It’s all about smart classification – takes you through a set of concrete action steps. These’ll help you make sound classification decisions.
In Lesson 3/3 – A Case Study (yet to be published) –we use a client example to demonstrate the approach we used to achieve optimal classification.
If you want to receive more articles & tutorials straight to your Inbox, please complete the form in the sidebar (top right).
The most widely applied regulatory scheme for the transportation of dangerous goods is based on a document put together by the United Nations Economic Commission for Europe (UNECE). It is entitled UN Recommendations on the Transport of Dangerous Goods.
This document forms the basis for most regional, national and international regulatory schemes.
It goes without saying that each country in turn has its own set of rules and regulations that complement the founding UN document.
What’s more, in accordance with the Ordinance on Safety advisors, NV Logistics has appointed an external Security Advisor who sets up and monitors regulatory compliance of transportation, documentation and packaging of dangerous goods.
Fortunately, most national laws are purposely harmonized with the UN international regulations. This means that in general, the requirements for classifying biologicals are standard worldwide.
The UN document mentioned previously divides dangerous goods into nine classes.
The World Health Organization (WHO) divides this class into two categories: Category A: Infectious and Category B: Samples (virus cultures, pathology specimens, used intravenous needles).
Click on the image to download a printable version, for your reference.
European regulations concerning the international transport of dangerous goods by road.
Accord Dangereux Routier (ADR)
Category A
Category A shipments are rare, as there are only a few laboratories in the world authorised to receive such substances.
Category A covers:
UN 2814- Infectious substances affecting humans and animals: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
UN 2900- Infectious substances affecting animals only: An infectious substance that is not in a form generally capable of causing permanent disability of life-threatening or fatal disease in otherwise healthy humans and animals when exposure to themselves occurs.
To determine whether your commodity is Category A, refer to the IATA Dangerous Goods Regulations (DGR) manual. This document is the global reference for shipping dangerous goods by air and the only standard recognized by airlines. You can order the manual here:
UN 3373- Biological substance transported for diagnostic or investigative purposes, which includes most patient samples.
In other words, pathogens not listed in the Category A table. Common examples of Category B samples are HIV, HPV, Hep C, and so forth.
Conclusion
Classifying a shipment starts by A or B Classification – and we may well leave it at that. Many organisations do!
The objective of this series of articles and the pertaining tutorial lessons is to invite motivated professionals such as yourself to “do the right thing”. With more insights at your disposal, you’ll be in a position to nourish a more nuanced view.
Please sign up for our next article and Lesson 2, where you discover easy to use action steps that guide you through the Classification process.
About the “Shipping Biological Substances” Tutorials
We give you 3 Lessons, spanning over 3 separate articles.
In Lesson 1, Article 1/3, we set the scene by providing a recap of essential labelling and packaging regulations.
In Lesson 2, Article 2/3, you discover easy to use action steps that guide you through smart Classification.
Lesson 3, Article 3/3 – “Smart Classification. A case study” (yet to be published), presents a concrete example which unveils the process we use at N/V Logistics to achieve optimal classification.
Disclaimer:
Whilst we strive to make our articles and tutorials as accurate as possible, NV Logistics SA cannot be held responsible for any changes in rules & regulations initiated by various worldwide organisations, including governments and others.
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Step 1.
The Tutorial – Shipping Biological substances.
In a nutshell …
Understanding regulation and applying it judiciously is key to making smart and efficient shipping decisions.
