A symposium on serialization and track and trace at Pharmapack Europe will explore the current requirements and offer ideas to tackle implementation challenges.

Pharmaceutical companies continue to face “a persistent and increasing threat from counterfeits that has led authorities and major life science companies to work on a reliable track-and-trace system for drugs and medical devices with marketing authorization,” reports Jean-Luc Lasne, international business development & alliance director, Adents Pharma.

And while “there are many reasons with legislation being one of the main drivers . . .things like patient safety and counterfeits are a major concern to the pharmaceutical industry as well,” adds Bart Vansteenkiste of Domino. “Item-level serialization is also a very important first step in a full ‘track-and-trace’ system, which will be required in the second phase of some of the legislations, like the Drug Quality and Security Act in the United States.”

Lasne and Vansteenkiste will be speaking during a symposium on serialization and track and trace at the upcoming Pharmapack Europe (www.pharmapackeurope.com/). They will be joined by Michel Bullen of Optel Vision, Atif Chaughtai of Axway, Christophe Picot of Oravis, and Silvere Duchemin of Unither Pharmaceuticals.

“Track and trace is obviously something the industry is very interested in as well for the obvious reason it gives them a much better control of the supply chain and control of their products,” says Vansteenkiste. “In case something is wrong this will allow them to determine where the batch or item sits in just one click.”

Similarly, Lasne says that serialization “will also help to achieve business benefits through compliance. These benefits will come from the reinforcement of product controls that serialization provides, such as better visibility of the whole supply chain, with a precise knowledge of product genealogy and more accurate 
shipments.”

And, “some countries also want to prevent stolen products [from being]reinserted at some point in the supply chain,” says Bullen, who serves as track & trace solution manager at Optel Vision. “In order to do so, the product must be tracked at every step while it moves throughout the supply chain up to the wholesaler. However, in order to avoid having to open shipping cases at every step, the cases also carry a unique serial number. This case serial number is associated in a database to the item serial numbers inside the case. The parent-to-children association is called aggregation, and it allows traceability, also called track and trace. This is already live in some countries such as China and Turkey, thanks to central government operated databases.”

Companies do face implementation challenges. “In terms of coding equipment, customers will need to make sure that the printers they choose are capable of handling the high communication speeds. If we think about the current situation where a printer is repeating the same print image throughout the whole batch, you can imagine this is fairly simple for a system to receive one message every couple of hours and then print that over and over again,” notes Vansteenkiste. “With item-level serialization, a line with an output of 300 products per minute will require a coding device that can handle five different prints a second, including five different 2-D codes! This is in most cases a [completely] different device than the one you currently find on a packaging line. Domino has been working very hard over the last couple of years to be technically prepared for this new challenge. Now we can handle over 500 codes per minute with the two most commonly used technologies for 2-D Data Matrix coding, being laser and thermal ink-jet. Also in thermal-transfer overprinting, we are the only one to be able to handle over 300 serial codes a minute.”

In addition to addressing the need for serialization at high speeds, Lasne says “for vision, industrial cameras now enable high-speed controls and greater flexibility as all inspections and features can be configured at server level.”

And “it is also important that the new installation adapts to existing lines, which all have their own specificities,” he adds. “Equipment suppliers have developed specific mark-and-verify modules to meet serialization requirements. They include a marking device, a camera, and an ejection station. Some also include tamper-evident labels or a vignettes application. These modules aim to secure the process and offer great flexibility when box format changes are necessary. It is the safest and most appropriate way to equip packaging lines with a minimum of production downtime.

“Another challenge will be compliance of the packaging line for aggregation (establishment of a hierarchical link at each stage of the packaging process), that must be in place within one to ten years, depending on the regulation,” continues Lasne. “Aggregation will necessitate more consequential investment as it will require the installation of cameras at each step of the packaging line and this could affect productivity. The advantage of aggregation is to offer better transparency in the supply chain and allow real-time localization of a product within it.”

Optel Vision’s Bullen points out that “one of the packaging line implementation challenges is to maintain a maximum OEE (Overall Equipment Effectiveness). Adding inspection and tracking equipment on a line can drop the line speed and affect the company profits. Optel Vision addresses this challenge by providing adapted solutions. Our project management methodology (rather than pushing a ‘canned’ product that never perfectly suits the application) enables each customer to get a solution that is truly adapted with his operations and requirements. Each solution is designed to integrate the packaging line without altering the production rate.”

In addition, space can be “difficult to manage,” says Bullen. “Production line machines can take a lot of space, and adding one system can be problematic. Machine manufacturers are challenged to offer small systems to fit in their customer’s lines. The Flying CartonTracker, engineered by Optel Vision, is one good example of a system that answers customers’ space challenges. It handles printing and inspection on cartons. Instead of having to break up the packaging line conveyor to insert the machine, the Flying CartonTracker is installed over the existing conveyor and essentially grips the product (through vacuum cups) to make them ‘fly’ over the conveyor while they get their printed Data Matrix and get inspected.”

Track-and-trace systems are also “subject to the behavior of the machines on which they are fixed,” says Bullen. “As an example, carton serialization requires to integrate printing and inspection system on the existing line. Vibrations produced by the equipment (conveyors, etc.) can also affect the printing and the inspection. To overcome this challenge, track-and-trace manufacturers have developed stand-alone units that integrate into the line in order to avoid these risks of vibrations.”

With serialization, “the volume of data will considerably increase in the short term, as one item will now contained two pieces of information: the product and the data associated with that product,” Lasne points out. “An initial approach was to stock all data locally at the line level, with a database to be defined. This approach is risky for two main reasons. As the amount of data is growing considerably, storage capacity on a computer will rapidly saturate, which can lead to a decrease in productivity as the computer will automatically slow down. The second reason is the risk of critical data loss in the case of a crash on the line. The second approach is to consider serialization as an information system project. Indeed, pharmaceutical companies do not only have to produce quality drugs, but also to associate quality data with the production. This requires a corporate view to homogenize the information system across all sites. In this case, no critical data is stored on the line and all information is automatically backed up and saved on a site server supervising the whole serialization process. No data is stocked on the line computer, which will always be running at full capacity, allowing full speed production.”

Vansteenkiste says that “a common mistake is that companies still see this an engineering problem, and it’s also not only about the coding devices and the camera systems that will have to be put on the packaging line. It is a lot more than that! It will involve IT, marketing, quality, etc. In fact, serialization will affect the entire way of doing business, so it is crucial to involve senior management and to have their buy-in from day one. And also companies will have to understand that the success of their solution will depend on each single part of their solution. Even what may appear to be a minor detail at first like the choice of ink can make or break a solution. If you have a invested a lot of time and money in a fantastic solution and codes are unreadable at the end of the cycle everything falls to pieces. Any system will be as good as it worst part!”

Bullen agrees, stating that “serialization should be handled as a company project rather than a department project. Not only the IT and the production departments are impacted but also validation, logistics, quality control, and marketing should also be involved.”

“We want to emphasize that to get their serialization project right, customers must first have an overview of data exchange from a corporate IT point of view,” Lasne adds. “A number of mark and verify machines are available today on the market to print serialized data in a reliable manner. However, very few, if any, handle data in a way that is suitable for future predictable or unpredictable regulatory changes which will definitely lead to software upgrades and requalifications.”