Belgian Drugmaker Uses RFID to Help It Test Its Products’ Stability

By Claire Swedberg

The company is utilizing a custom solution involving bar codes and radio frequency identification to track which products are at its facility, where they are located and the phases of testing they have undergone.

A global pharmaceutical firm based in Belgium, with help from systems integrator RFIDea, has created a solution that employs RFID and bar codes to track the movements of more than 70,000 bags of products annually as they undergo testing at the company, which has asked to remain unnamed.

The system's development began in 2007, using bar codes and RFID tags, as well as RFIDea's stock inventory management system (SIMS). Workers scanned a bar-coded label on each product as it arrived for research-and-development stability testing from all of the company's manufacturing sites throughout Europe, and also read an RFID label affixed to the plastic bag in which that product was stored, prior to testing.

At present, the expanded SIMS solution utilizes both RFID and bar codes to track not only pharmaceutical products, but also chemicals used at the laboratories. Last year's expansion, says Jérôme Coulon, RFIDea's sales and project manager, enabled the firm to track which chemicals are used during the testing of products at the labs.

The company's analytical resources department is responsible for testing the stability of new products developed at its manufacturing sites. To accomplish this goal, the goods are stored at the site, the aging process is monitored, and any changes made to the product, or to the bags, is then recorded by the laboratory staff. In addition, chemicals are used to perform the stability testing.

Prior to the introduction of RFIDea's SIMS solution, staff members were required to manually track details regarding the step of the testing process that each product had reached, where the product was located within the facility and how long it had remained at any given location. This information is critical to the test's validity, so the data had to be manually gathered on paper in painstaking detail, and then be double-checked in order to ensure that mistakes were never made.

RFIDea's solution was developed to eliminate the need for manual tracking, thereby reducing the risk of errors, while also decreasing the amount of time workers spent writing down details or checking another individual's work. First, in 2007, RFIDea studied the processes by which products were received, stored, tested and finally discarded. The firm then began developing the system during a series of installations, Coulon says, beginning with proof-of-concept testing and a pilot, followed by the permanent deployment of both bar coding and RFID tracking using a PDA, a tunnel reader and wall-mounted fixed interrogators throughout the facility.

Products first arrive at the site in bags, packed in boxes shipped on pallets. Staff members use the boxes' existing bar-code information to receive the products and store information about them in the SIMS solution. Each employee carries a high-frequency (HF) 13.56 MHz badge complying with the ISO 15693 standard, the unique ID number of which is linked to that person's identity in the SIMS software.

A logistician (a member of the drugmaker's logistics team) first reads his or her own badge, using a Psion handheld computer with a built-in RFID reader, then inputs details regarding the product being received—either manually, or by scanning a bar code. The data is sent—via a Wi-Fi connection or, when plugged into a PC, a USB cable—to the SIMS software, which receives and interprets the data and forwards that information to the drugmaker's inventory-management system. The SIMS software also sends instructions to the PDA, indicating where each item should be stored (there are multiple chambers designed for the storage of different products at specific temperatures).

Upon arriving at the dictated storage chamber, the logistician first presents his or her badge to an RFID reader, thereby storing a record of who moved the product into storage, then scans a bar code attached near the appropriate chamber's entrance, as well as the bar code on the product box or pallet, using the handheld device. That data is then transmitted to the SIMS solution, which stores that action and also issues instructions to the operator indicating where within the chamber the items should be housed.

Several weeks later, once testing is conducted, the SIMS software queries the company's laboratory information management system (LIMS), then sends picking instructions to operators on their PDAs. Those operators remove the appropriate bags from their boxes and place them in a plastic tote, which can hold up to 80 bags at a time. A Toshiba Tec printer situated on a mobile cart prints HF tags to be adhered to each bag as staff members scan the bar code on the box in which that bag arrived. The SIMS software then links the label's unique ID with data about the product to which it is attached, such as the item's name and quantity, when it was received and where it was stored.

Upon taking the loaded plastic tote to the laboratory, the logistician must, before entering, first go to a tunnel reader, have his or her own RFID badge read, and then place the plastic box inside the tunnel (which was developed by RFIDea, with a built-in Tagsys RFID reader and antenna), in order to have all of the RFID labels interrogated. At that time, if the SIMS software determines that an item is missing or incorrect, an alert is displayed on a monitor mounted above the reader. This process eliminates the need for a validation operator to review another operator's picking work before approving the items for use within the lab.

The products are then stored in small chambers within the lab until required. Each time that an item is removed from storage, tested or returned to storage, a laboratory analyst reads his or her own badge tag, as well as the product tag, and responds to prompts using a graphical user interface on a wall-mounted reader or PDA. A record of every activity pertaining to each product, as well as the time and the identity of the staff member involved in that activity, is stored in the SIMS software and shared with the company's management system.

Finally, when a product is scheduled to be discarded, it is moved to an area containing bins. At that location, another wall-mounted reader interrogates the worker's badge, along with the tag of each product being discarded. All wall-mounted readers were designed and developed by RFIDea, using off-the-shelf HF RFID interrogators.

The company, which uses several vendors for its RFID tags, opted to employ HF tags rather than UHF, Coulon says, since HF tags can be read more effectively in the presence of liquids, while UHF tags' longer read range was deemed unnecessary for this particular application.

Most recently, the drug company has been applying RFID tags to bottles of chemicals used during laboratory testing. By utilizing the tags, employees can track what is being used, along with its expiration date and which worker is using it, by first reading the tag, and then responding to prompts on the wall-mounted or handheld reader.

Altogether, the pharmaceutical company is employing approximately 72,000 RFID tags annually, in addition to more than 30 readers, including handhelds, fixed interrogators and tunnel readers. "This is a system that is continuously improving," Coulon states, as the drug manufacturer and RFIDea determine new ways in which to use the technology. The system allows the firm to easily know where its products are located, how long they have been there and when they were last tested.