NV Logistics est heureuse de contribuer au retour des compétitions de tir-à-l’arc !!!
Behind the scenes series #1
NV Logistics est heureuse de contribuer au retour des compétitions de tir-à-l’arc !!!
Behind the scenes series #1
.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.
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.
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.
An important task that is assigned to me is the maintenance and management of up-to-date databases.
There are three demanding steps a cornea has to overcome before it may enter into the Geneva Cornea Bank.
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.
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.
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.
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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).
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.
Preparation & Storage | Quality Control | Release of the corneal transplant to the surgeons |
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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.
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.
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.
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:
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.
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)
Our client, Debiopharm Group, transforms promising molecules into innovative therapies.
Founded in 1979 and headquartered in Lausanne, Switzerland – Debiopharm’s main area of expertise is oncology, but they also develop medication in therapeutic areas such as immunology and infectious diseases.
For your easy reading, we have divided this report into three parts.
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1. The Client’s Challenge |
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2. NV Logistics’ Answer |
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3. The End Result |
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Cross trade shipping is the transportation of goods between two countries, outside of the country where the client (the paying party) is located.
Isothermal packaging, also referred to as insulated shipping systems, are solutions that conserve goods at a particular temperature for a specific period of time.
A competent shipper will dedicate his expertise to choosing the optimal system, based on a client’s exact specifications.
To learn more about packaging, please read our How to get cold chain shipping right tutorial. Your bonus: an easy to use Shipping Profile Checklist (infographic), ready for download and print.
As the handling and transport of temperature sensitive substances is becoming more tightly regulated worldwide, cold chain is a highly sought-after service. Typical users are in the life sciences field: biomedical companies, hospitals, research laboratories, and also in the food industry.
A cold chain is a system which is made up of:
Its aim is to keep substances at a guaranteed temperature range whilst transporting them from destination A to destination B.
Cold chain systems can be very complex, requiring impeccable planning and disciplined implementation by experienced shippers.
Recommended!
Check out our Cold Chain Tutorials series which include practical infographics for download and print. We provide ready to use check lists covering must-have data such as temperature, product volume, transit times, and more.
How to get Cold Chain Shipping right | Setting the scene for best value (1/3)
How to get Cold Chain Shipping right | Active and Passive shipping solutions (2/3)
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NV Logistics is experienced and fully equipped to execute cross trade shipping.
Internal expertise is backed up by collaboration with worldwide partners, judiciously chosen for their know-how in the biopharmaceutical/life sciences environment. Amongst others: World Cargo Alliance (WCA) and SFS Pharma Logistics.
When a customer places a cross trade shipping order with us, we coordinate (on behalf of the client) the shipment from A-Z. Each step is documented and communicated to the client’s internal project manager.
For this specific project, goods needed to be moved from the departure location in Austria to Vienna airport. We interacted with and monitored activities with both the local packaging supplier and the local shipping representative.
Once arrived in the US, our local shipping agent welcomed the goods at the airport, monitored the import formalities and moved the goods from the airport storage to the final client destination.
The Debiopharm shipping brief required a guaranteed and validated temperature range of between 2-8º C. In other words a non-interrupted cold chain between Austria and the USA .
Based on the client’s described needs, we evaluated several solutions and submitted our preferred choice – fully documented – to Debiopharm for their approval.
For this specific shipping request we retained:
©Laminar Medica Insulated shipping systems.
Laminar Chilltherm® CTC 506 Summer*
*The destination point being North Carolina, the average temperature range of that location at that specific season made us choose the Summer configuration.
Want to learn more about Laminar system assembly? View this video – and/or download this PDF.
NV Logistics’ internal decision processes are based on experience, technical know-how and predefined checklists. Download our temperature checklist, for your immediate practical use.
We strive to provide the safest solution at optimised cost/performance ratios.
The success of cold chain transport relies on eliminating all possible leak points throughout the whole shipping journey. When we coordinate shipping missions on behalf of our clients, these 3 elements are essential, and dear to us:
1. Safe isothermic packaging.
Each isothermal packaging system comes with its own (sometimes complex) instruction set. The availability of competent packaging staff is, therefore, essential.
For Debiopharm we ensured that:
2. Exact shipping documentation.
For optimal cold chain shipping, time is of the essence. We ensured that documents such as bills of lading and pro-forma invoices strictly conformed with the regulations of the importing country.
We have an attitude to shipping documents that could be qualified as a little pedantic 😉 but our zeal is usually rewarded! We consistently achieve highly performant import events.
For Debiopharm, we submitted initial drafts to our importing agent in the USA who suggested a few minor changes, thus ensuring smooth customs clearance.
Debiopharm’s internal staff duly reissued revised documents which we forwarded to our local agent (USA) for final approval. We then received the “OK to ship”.
3. Product temperature integrity proof.
An essential component of cold chain transport is the monitoring of temperature levels throughout the journey. Monitored data in the form of temperature charts is being delivered to the client at termination.
But if the client so desires – we’re fully equipped to provide live monitoring during the journey.
For Debiopharm, we ensured that the local representative at departure point in Austria embedded adequate temperature logger devices.
Our agent in the USA arranged for the recuperation of the temperature logger devices. He made sure that the data logger reports were ready as soon as the shipment was delivered to the client’s location.
Hence the client had immediate access to crucial cold chain data which, in the end, determines the shipment’s success.
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This is the concluding message (after delivery was completed) we received from Debiopharm’s project manager.
Thank you very much for your message and your exceptional service concerning this shipment.
Moral:
For cold chain shipping to be successful, all components must be “just right”, and each individual professional who is part of the chain needs to do “the right thing”.
We like to compare ourselves to a conductor of an orchestra. A symphony touches our heart if each individual artist is given the chance to shine – so that each single action becomes an exceptional part of an exceptional outcome.
At NV Logistics we take the trust our clients bestow on us very seriously.
One of the best ways to earn trust is complete transparency. This starts with ongoing and clear communication during the whole shipping journey.
Here are 2 examples of how we communicate.
1. Photo sent to Debiopharm’s project manager in Lausanne.
2. Client Response.
“Thank you very much for this reassuring update. I will also take advantage of your nice photos to provide the recipient with an idea of the volume this package represents”.
2. Arrival announcement sent to goods’ recipient in North Carolina (USA).
NV Logistics’ US representative sent this message to the recipient of the goods:
“Just wanted to confirm that the shipment is in good order and in route to you. With the rain and storms that have been in the area they are anticipating arrival between 13h30 and 14h30 this afternoon.
The driver will be awaiting permission to open the container and remove the two data loggers. He will take these with him.”
3. The following report, rendered by the two data loggers, was subsequently sent to the client.
The recorded temperature data shows a consistent maintaining of the range at the requested levels, i.e. an average of 4.3° C
Photo credits:
Feature photo Vienna (Austria)
kindly provided by Flickr and photographer Martin.
Feature photo Charlotte (North Carolina)
kindly provided by Flickr and photographer James Willamor
Creative Commons License.
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For your easy reading, we have divided this report into three parts.
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1. The Client’s Challenge |
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2. NV Logistics’ Answer |
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3. The End Result |
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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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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:
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1. Swissmedic certification. |
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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). . |
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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. . |
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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. ClassificationBased 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 ».
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). . |
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b. PackagingWe 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:
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c. TransportWe 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. . |
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5. Real Time Shipping VisibilityNV 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. . |
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6. CostOur 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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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.
NV Logistics
Halle de fret 5
Porte 5 – Etage E
Bureau 076 / 103
Case postale 1117
CH-1211 Genève 5 Aéroport
Tel. +41.22.577.47.47
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