Now imagine tracking products for and with about 250 pharmaceutical companies. That's the task that will face Somerset, NJ-based Catalent Pharma Solutions, Inc. when e-pedigree regulations are in place. Formerly Cardinal Health's Pharmaceutical Technologies and Services Div., Catalent provides development, manufacturing, and packaging services for pharmaceutical, biotechnology, and consumer health companies in nearly 100 countries. In this article, Catalent's Akan Oton (shown) provides a contract manufacturer/packager's perspective on serialization, authentication and track-and-trace technologies in pharmaceutical distribution, based on his recent presentation at the Brand-Protection Packaging Forum in Schaumburg, IL.
"We're the largest contract packaging, drug development, and contract manufacturing organization in the world," said Oton, Catalent's global marketing director. Oton addressed an audience of about 115 at the Brand-Protection Packaging Forum. The following insights from Oton come from that presentation.
• As contract packagers, we are concerned about counterfeiting in the industry, as we intend to put in place track-and-trace solutions in our facilities to help manufacturers stem this.
• One of the big challenges is not as much how to package products but how to apply track-and-trace on packaging lines at high rates and subsequently ensure integration with multiple IT systems.
• In the clinical trial supplies portion of our business, when we procure drugs for comparative studies for customers, we also need to make sure they're not counterfeit. We've got a lot of analytical support to make that determination as the impact to our customers is considerable given that the average pharmaceutical company spends about $800 million developing a drug.
• We started pilot testing RFID back in 2002 to get a handle on the robustness of the technology, read rates, scrap rates, etc. I don't see a major difference between RFID and serialized bar codes from a manufacturer's point of view. They are complementary technologies. Whichever works better in your firm is the one you should choose. From a distributor's point of view, RFID clearly has advantages as it does not have a line-of-sight requirement.
• Legislators want a unique number on each product that must pass down the distribution chain to create a pedigree for that product. Legislators aren't telling us how or what method to use. However, for serialized bar codes, because of the line-of-sight requirement, you have to create parent/child relationships, so that what's in the box is the same as what's on the label, and on the case. This allows distributors to "infer" what is inside.
• In deciding whether to use preprinted or coded tags, our preference is to print or code at the packaging line because it's more controllable, particularly in high-speed operations. For lower-speed or smaller-scale processes, I think you can do it offline in a preprinted manner. Once you get to bottle lines that run at 300-min speeds, it's more efficient to print or encode at the line.
• Many decisions being made in the pharmaceutical industry regarding packaging equipment and tracking are going to change in the next two years based upon equipment providers getting more up to speed on performance levels when it comes to tracking.
• Because the pharmaceutical business is FDA-regulated, you should keep data on your products for five to seven years. That's a challenge when you're talking about putting a number on each bottle and storing that information, especially for us with multiple products from about 250 customers.
• To store some of this information, we work with a company that provides serialization databases to generate individual package numbers. These databases must be auditable. A concern of ours dealing with many customers and different databases is making sure that one customer's number isn't the same as another's, so considerable thought went into making sure our approach to generating numbers was unique for all customer products. The unique codes are then transmitted to the customer's certified EPCglobal e-pedigree partner. It is this partner that creates the actual pedigree for the manufacturer.
• Although we're agnostic when it comes to the selection of 2D bar codes or RFID, there are some limitations to both. Today RFID tags do have modest scrap rates. Although the tags aren't as reliable we'd like, we expect they soon will be. In the distribution environment today however, 99.9% isn't good enough. It needs to be higher than that at the item level. At the case level, that number is more than fine. If you're working with liquids, RFID read rates won't be suitable-opt for 2D bar codes. And if you're working with biologics, where there could be stability issues associated with radio frequency, you should utilize 2D bar codes. In terms of 2D barcodes, the primary limitation is lack of line-and-sight and the need for inference.
• We have a relationship with Secure Symbology in which they host data for you, will generate numbers, and will work with you for RFID tagging and 2D bar codes. In concert with Catalent, this provides a complete serialization solution.
• With RFID technology, we looked at just about every vendor out there. We chose Alien Technologies. The failure rate on their UHF Gen 2 tags were low, and their next-generation products appear to be better than those from competitive companies that we have seen so far.
• In the pharmaceutical business, it's all about compliance and making sure everyone in the distribution chain is protecting patient safety.