Using RFID Technology to Ensure the Traceability of French Plasma for Fractionation20/04/2015 - The LFB group, Biolog-id and the French Blood Transfusion Service (Etablissement Franšais du Sang/EFS) have announced the introduction of an RFID1 traceability system developed by Biolog-id for LFB.
The LFB group, Biolog-id and the French Blood Transfusion Service (Etablissement Français du Sang/EFS) have announced the introduction of an RFID1 traceability system developed by Biolog-id for LFB. All bags containing plasma for fractionation leaving EFS centres will henceforth incorporate RFID chips, which will facilitate their registration at LFB, the only company fractionating this plasma.
The Biolog-id system, a world first
The system developed by Biolog-id for tracking and tracing blood products using RFID, has been selected by LFB for use in managing, storing and monitoring all bags containing plasma for fractionation, that leave EFS centres in France2, to be fractionated by LFB in order to produce medicinal products. Biolog-id is the first operator in the world to offer this kind of overall traceability solution for blood products. And its solution has been selected by LFB for tracking all EFS bags containing plasma for fractionation.
Introducing the system is a joint initiative involving LFB, Biolog-id and the EFS, the solution having been co-developed by Biolog-id and LFB.
RFID labelling was authorised by the French National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament/ANSM) on July 26, 2012, and the technology will henceforth be used in all 14 regional branches of the EFS in mainland France.
Upstream and downstream traceability
By attaching an RFID tag to every plasma bag, Biolog-id’s solution ensures that every unit can be tracked automatically from preparation at the EFS centre through to fractionation by LFB. “Following a development and validation process conducted over a number of years, we have been able to show that the integrity of critical data is protected throughout, even when frozen or stored at temperatures ranging from - 40° C to - 80° C,” explained Jean-Claude Mongrenier, CEO of Biolog-id. “Toxicological studies conducted with LFB have demonstrated that there is no interaction with raw materials, such as the salting out of heavy metals, and that the legal information encoded in the tag (donation number, product code, expiry date, etc.) remains intact.”
For the EFS, Biolog-id’s solution means that they no longer have to perform secondary labelling and that the plasma unit sorting process is automated once they have been quarantined, all of which significantly improves production rates. “RFID offers real progress regarding the traceability of the bags of plasma we deliver. The French Blood Transfusion Service produces and delivers some 3,000,000 bags every year. We are sure this technology will improve efficiency whilst at the same time ensuring that all bags received by LFB are fully traceable. Blood product safety and quality are a major priority for us. The EFS is one of the main players in the French health system, and we are determined to ensure that our practice is both exemplary and innovative,” said Stéphane Noël, Head of Production and Operations at the EFS.
For LFB, this technology will increase efficiency when receiving and recording plasma from the French Blood Transfusion Service (EFS). The RFID receiving line installed at LFB’s Les Ulis site reads a box’s RFID tag in a matter of seconds, as well as the RFID tags of all 25 bags in the box, before they are stored in a cold room. The RFID sorting line enables bags that are to be prepared for fractionation to be registered and tracked individually once they have been scanned, at a rate of one bag every 2 seconds.
Contactless data transmission makes it possible to read the contents of closed boxes, thus reducing product handling to a minimum. “Several thousand litres of plasma are processed every week at our factory in Les Ulis, in Essonne. Not only does RFID increase productivity, it also increases efficiency and responsiveness during processing, whilst at the same time providing a robust technology for ensuring traceability. It’s a technological breakthrough that will enable LFB to better absorb business growth,” explained Dr Patrick Bergeat, Deputy General Manager – Operations and Industrial Manager at LFB.
For Biolog-id, this partnership with LFB and the EFS will serve as a major reference, accelerating the company’s international growth, particularly in the United States, and strengthening its position of leadership in Europe. Some sixty international patents have been registered to protect innovations developed by the company, and a study is currently underway at the EFS Auvergne-Loire regional branch regarding the potential extension of the technology to the management of red blood cells and platelets. Other countries are already using this solution. Biolog-id is grateful to its partners for supporting both its international growth and the development of its technological expertise.
Biolog-id is a solutions designer-integrator specialising in the development of identification and traceability applications based on a high-performance technology, RFID. Biolog-id specialises in global traceability solutions for labile blood products, plasma and chemotherapy.
Biolog-id’s expertise was recognised in 2012 at the Paris HIT exhibition, when it received an award in the ‘Innovation and maturity of integration of information systems’ category, for its innovative blood product traceability solution. The previous year, Biolog-id’s plasma bag traceability and management solution was nominated at the International Conference on RFID held in Orlando, where it was a finalist. Its development of the concept of connected bags has made it a member of the circle of experts in eHealth.
LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products and drugs derived from living tissue, which are used to treat serious, often rare, diseases. It operates in three main therapeutic areas - haemostasis, immunology, and intensive care.
LFB is the world’s 6th largest manufacturer of plasma-derived medicinal products and the number one in France, as well as being a European leader in the development and production of proteins and innovative biotechnological treatments.
The LFB group focuses its efforts on research and a growth strategy targeting international development. Its products are currently sold worldwide in over 40 different countries. In 2014, total turnover reached 501.9 million euros.
About the EFS
The French Blood Transfusion Service (Etablissement français du sang/EFS) was created in 2000 and is responsible for the safety of the blood transfusion chain, from donor to recipient. Operating within the ethical donation framework, the primary mission of the EFS is to ensure self-sufficiency in blood products throughout the country. Whatever the donation may be (whole blood, platelets, plasma), the EFS is the sole operator and fulfils its mission throughout both mainland France and its overseas territories, in all collecting some 10,000 donations every day. In addition to its core business, the EFS also conducts therapeutic and research activities, whose aim is to ensure that patients benefit from progress made in science and medicine. The 9,800 employees of the EFS help provide treatment for over 1 million patients every year.
1 RFID: Radio Frequency IDentification
2 Plasma for fractionation collected and prepared in French Blood Transfusion Service (Etablissement Français du Sang/EFS) centres in France is then forwarded to LFB, who have the exclusive right to fractionate all plasma collected in France by donation. LFB uses the plasma to manufacture hospital prescribed medicinal products in its factories (two in France), used to treat serious, and often rare, diseases. Plasma for fractionation is used for manufacturing plasma-derived medicinal products, particularly albumin, coagulating factors and immunoglobulins of human origin.
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