Apr 20, 2007Biopharmaceutical manufacturing products provider Millipore will begin selling filtration products with integrated RFID technology to allow its customers—drug manufacturers—to access data about the filter on the production floor. The new filter with RFID functionality, named SMART Technology, is slated to become commercially available at the end of April, says George Adams, group product manager of Millipore's bioprocess division.
Millipore filters—cylindrical devices of varying sizes made from thin films of such plastics as polyvinylydenediflouride (PVDF) in a plastic filter cartridge—are used during several phases of biopharmaceutical manufacturing to remove particulates, bacteria and viruses from medications. The removal of these contaminants is very crucial to the biopharmaceutical industry. Therefore, the proper functioning of the filters is essential.
To ensure that filters work properly, Millipore tests them after manufacture. Testing consists of determining the size of pores in the filter membrane, which must be smaller than the minutest material targeted for removal, such as a virus. Integrity testing is performed by wetting the filter and pressurizing it with gas. The pressure at which gas begins to flow freely through the membrane is its "value." The biopharmaceutical manufacturers that buy these filters also carry out similar tests on the production floor, then compare their results with those resulting from Millipore's tests. In most cases, the records regarding these tests are kept on paper.
With RFID, the system could be more automated. While Millipore eventually intends to market a system combining RFID tags with integrated sensors to allow end users to track the filter's condition as it is being used to manufacture medications, the system being released now has a fairly simple concept: It provides users on the production floor access to the filter's integrity value, as determined by Millipore's testing.
With the new system, certain Millipore filters will be embedded with a passive 13.56 MHz Tagsys RFID inlay complying with ISO 15693. Millipore chose such an inlay because its short read range reduces the chance of reading a neighboring filter's tag by mistake. The inlays are embedded in tags produced by industrial air-filtration company Tack Smart Filter Technology of the Netherlands. Millipore will write data onto the inlay specific to the filter's lot number and serial number, as well as the integrity test specifications. Northern Apex-RFID is providing RFID integration services.
Currently, the results of the integrity test are printed on a paper shipped with the filter. That paper, however, can get separated from the filter long before it reaches the production floor, causing it to be retested by the drugmaker. With an RFID-enabled filter, the user can now check the value gained from the first test, conducted by Millipore, by scanning the RFID inlay and comparing that value with the one resulting from its own test. The biopharmaceutical's RFID reader can then print the results of both tests.
In the future, he states, Millipore will begin testing sensors integrated with the Tagsys RFID tag to be used with the filters, beginning with temperature sensors. Gauging the temperature of the filter could enable biopharmaceutical manufacturers to verify that they have achieved the proper temperatures—for example, when sterilizing the filter. In such a case, Millipore would provide middleware for fixed and portable readers.
Initially, the RFID tags will be embedded only in the filters that are most critical for manufacturers and, thus, provide the most value for the cost increase resulting from RFID system. The tags will raise the cost of the filter by a small percentage, Adams says, while the AccuSMART RFID readers, with a built-in printer, will cost $10,000 to $15,000. "We want to introduce this into the marketplace, where almost all end users will see value," Adams says. "We will introduce it in stages," he adds, while keeping an eye on the dropping cost of RFID tags as well.
Millipore will be sending a pre-notification letter to its customers, alerting them to the fact that it will be embedding some of its filters with SMART Technology filters. After that, he says, adoption rates will vary depending on the customer.
Several global biopharmaceutical companies have tested the SMART technology, Adams says, though he declines to name them. These firms will be investing in RFID readers to use the new system as it becomes commercially available sometime in the next few weeks.
