Orion tries out Stora Enso's RFID
are carrying out a trial of pharmaceuticals packages equipped with
RFID (Radio Frequency Identification) tags for every stage of the
supply chain using a system that defies the conventional approach
of centralisation.
It is the first trial of its kind in Europe and comes as a respond to anticipated stricter traceability standards in the US.
The FDA has already reaffirmed its recommendation that RFID technology be used widely throughout the pharmaceutical industry by 2007 to ensure security and safety.
According to the World Health Organisation (WHO), 10 per cent of pharmaceutical packages in the world do not contain the drug they are supposed to.
Thus, Orion decided to test Stora Enso's RFID system using pill bottles with Marevan, its anticoagulant for the prevention and treatment of blood clots.
The trial, which started in November and will run till April, also involves Finnish packaging manufacturer Jaakkoo-Taara, wholesale distributor Oriola, which is an Orion subsidiary, and seven pharmacies in Finland and Estonia.
It employs Stora Enso's PackAgent software, which has been developed by Stockway, a Finnish specialist software provider, and enables products to be tracked and authenticated at both item and pallet level.
Crucially, PackAgent's distributed IT network allows various parties in the trial to share information without including other unauthorised members of the supply chain.
"This system does not use a central database where data is fed but a new protocol for communication between server to server which all authorized partners can access," Kirsi Viskari, Stora Enso's manager for intelligent solutions, told In-PharmaTechnologist.com.
"We also performed a test with an artificial recall and pharmacists were able to easily identify the cases that were supposed to be sent back."
The tagging begins at Jaakkoo-Taara with the attachment of RFID passive tags to the cartons of individual Marevan bottles, so when Orion Pharma fills the bottles with pills at its production site it encodes each tag with a unique serial number for the carton, as well as the batch number and the expiry date for the drug.
Once a batch of drugs is ready for shipment, individual items are packed in cases and an RFID tag is attached to each case encoded with a unique ID number, with matching information about the contents of each case kept in the PackAgent system.
Orion then reads the case tags to keep track of where each batch is going, and from then on data from any subsequent readings is transferred to PackAgent software where it can be accessed by other members of the supply chain.
As soon as Oriola receives the cases the tags are read again so that the drugs can be authenticated and their location recorded.
The tags are read again when they leave Oriola's facility, and, once delivered to the pharmacies, the tag attached to each bottle's carton is scanned when unpacked, including also at the point of sale, to ensure the drug is in the right place.
"We are looking for ways to streamline our logistics operations and co-operation with our suppliers and to put us in a better position to face future challenges as regards the traceability of products," said Huhta-Koivisto from Orion Pharma.
"For us, the possibility of integrating the solution into our own business management system is an important advantage."
Apart from RFID, PackAgent is compatible with various other identification technologies, and it can also be used to provide consumers with an easy way to authenticate products via the internet, although this capability was not tested in the trial.
