“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry,” cautions Charles A. Smith, senior systems consultant at Horizon. “There is a direct cost of product recall, where positive identification of counterfeits can be difficult, without the identification and data handling capabilities provided by serialization.”
Smith will be speaking at this year’s Pharmapack Europe during a day-long technical symposium on serialization and track and trace. “How to Understand and Deploy All Aspects of Track & Trace in the Pharmaceutical Industry” will take place on February 12 and feature a number of industry speakers.
Counterfeit threats appear to exist throughout the world, but developing a single solution can be challenging, as “globally there are significant differences in the current requirements in different countries,” explains Smith.
Michel Bullen, track & trace solution manager for Optel Vision who is speaking with Smith and others, points to such regulatory requirements as drivers for implementation. “The first true driver has been Turkey, which came up with an aggressive plan to be the first country starting with serialization (without aggregation) in 2010. That first requirement forced pharmaceutical manufacturers to equip their lines with appropriate coders to print a 2D Code also called Datamatrix.”A typical unit for handling carton in serialization courtesy Opten Vision.
Bullen adds that California’s electronic pedigree law pushed serialization even further. The “law talked about not only assigning unique serial numbers on item level, but also about recording the relationship between children package serial numbers and parent package serial numbers. This parent-to-child association is called aggregation. Even though the California law has never been enforced as such, a U.S. national law, thus preempting the California law, was voted in November 2013 even before the foreseen California law application date. The USA law now refers to item-level serialization to be implemented in 2017 and track and trace, which necessitates aggregation, in 2023. However, many pharmaceutical manufacturers were already getting prepared to address the initial California law before the new USA law alignment. This has forced solution providers such as Optel Vision to think outside the box and develop various ways to record serialization/aggregation events on manual or automated packaging lines. In the meantime, other countries also announced their serialization requirements. The most significant ones are India, China, Argentina, Brazil, the European Union, and South Korea.”
Smith, Bullen, and fellow speakers will explain serialization program development and implementation. Smith has 33 years’ experience specializing in project engineering, industrial automation, and computerized applications for pharmaceutical, medical device, and petrochemical industries. During his presentation, Smith will share insights on how to develop process maps for the serialization process and use of quantified risk assessment to drive improvements to the design process.
Bullen will discuss real implementations of various track and trace line configurations. “Our first goal is to educate on the latest packaging requirements and standards. Another aspect will explain how each department within a manufacturing plant is affected and the challenges they could encounter,” he says.
Given all the requirements around the globe, Bullen argues that “implemented solutions be capable of meeting any country regulation.” Otherwise, he says, “the other approach, which is having lines dedicated for specific countries, would result in adding more packaging lines and expanding the plants. In terms of resources, budget, and space, this is impossible for most companies. We recommend manufacturers carefully choose their solution provider in order to making sure that the solution consists of modules, which allow the individual aggregation levels to be turned on or off. The architecture should also be capable of handling various serial number formats, and very important, to allow for an easy configuration to support more formats in the future.”
Smith advises that “given the range of requirements internationally, an effective approach is to define a manufacturing and distribution technical infrastructure that allows configuration to meet individual national requirements, but based on international standards from groups like GS1 for Item Physical Coding, Global Trade Identification Numbers (GTIN), Global Location Number (GLN), and Electronic Product Code Information Services (EPCIS). Adoption of standards reduces the costs of implementation and ongoing operation/support, as equipment and systems suppliers can directly offer solutions for which they have direct experience.”
Taking a modular approach offers several benefits, says Bullen. “We recommend having only one controller per packaging level controlling cameras, printer, and ejection station even though such a controller can manage multiple cameras. This could mean that the overall solution needs an extra controller but its additional cost will be rapidly compensated due to increased flexibility and adaptability. We advocate the same approach when linking packaging line controllers with the IT infrastructure. The connection point with IT should be a small module isolated from the underlying software. This means that any change involving an IT connection would only affect that small module. Such a change would be very fast to implement and will only have a minimal validation impact.”
Requirements at multiple levels must be considered, says Smith. “At the manufacturing level, identification needs to be made of which products—stock keeping units—are produced at which packaging lines, supplying which countries. As part of this product analysis, plans for new product introduction will also have to be considered, for serialization impacts on both new and existing packaging equipment. At the warehouse level, how are the various product levels currently handled, including shipping cases and pallets)? Also aspects like 3rd-party suppliers and distributers may need to be included. At the distribution level, cold chain and other specialized requirements for airfreight may apply. The overall aim is to securely identify the product, thus addressing counterfeiting, product diversion concerns, and support product recalls.”
By “allowing configuration at an equipment level,” explains Smith, manufacturers can “allow appropriate level of labelling at carton, bundle, shipping case and pallet level to meet national requirements. Higher levels, such as ERP/planning systems, need to consider aspects of Master Data (National Drug Codes NDC/GTIN/GLN) to mirror such configuration needs,” Smith says.
The pharmaceutical industry has already accomplished much. “A number of the major pharmaceutical companies have pilot implementations on their own manufacturing sites,” observes Smith. “It is reported that a recent survey in Europe showed that approximately 50% of companies had some level of serialization project in place.” Horizon has helped a number of multinational companies with implementation, and the company has been a member of the multinational development teams being responsible for the implementation of a number of packaging lines to meet Turkish and Chinese requirements, he adds.
Bullen reports that Optel Vision has “added a lot of features that were first asked by one customer but then later utilized by all of the following ones.” He offers the following examples:
- Quality Assurance Sampling, identification of which serial numbers are taken out as a quality assurance sample
- Serialized Batch Rework on any line within the packaging department of a plant.
- Case or pallet count number, printed on the labels together with the serial number and available in the final
- Reconciliation and Line Performance reports
- Dedicated label layout for partial containers
Challenges do remain, but companies continue to make progress. Bullen says that reliable 2-D Code (Datamatrix) print quality had been a challenge. “On some cartoners, the expiry and lot data used to be applied through embossing. The printing quality was very low and was not affected by the cartoner’s vibrations. [However] printing 2-D codes requires a higher quality approach and a camera inspection system to ensure its quality. Ever since printing a 2-D Code became a requirement, it was quickly clear that printing inside a cartoner was not always possible, forcing pharmaceutical manufacturers to add an extra machine for printing cartons without the constraints due of vibrations and poor stability found in some older cartoners.”
Bullen says that acquiring aggregation information without risk of error had also been a challenge. “Methods based on reading the child serial numbers before they go into in a parent container level proved in many occasions to have major flaws, very often resulting in huge rework operations. The ideal method is to read the child serial numbers while they are already inside the parent container. As serial numbers are sometimes not visible anymore once packed inside a parent container, technologies such as using a secondary tracking code, with visible or invisible ink, have been developed,” he says. “Also manual packing stations became easier to use by operators due to the introduction of clear and protected operational flows, eliminating the possibility of human errors.”
“Thanks to the mandatory connection to the IT infrastructure, necessary to receive serial numbers and transfer reports, other data can now be transferred electronically to the packaging lines,” Bullen adds. “For example, the expiry date, lot number, material identification data, and the label layouts can now flow from the plant master data server directly to the packaging line controller. Where data used to be manually entered on the line, very often on different points of entry, this way of working eliminates risks of making errors and reduces the line setup time.”
Line efficiency could still be an issue. “Typically the packaging lines most critical for the implementation of serialization, are also the lines that are most heavily in use,” says Smith. “This gives issues both for planning of equipment shutdown to allow changes, and often an initial impact on Operational Efficiency (OEE) as the equipment returns to production after modification. Also, it may not be feasible to modify some older equipment so replacement may be required.”
Operator needs must be considered. “For manual packing stations, the ergonomic aspect and user friendliness of the solution is critical,” adds Bullen.
And technology is key. “For automatic packing stations, the quality and robustness of the camera inspections had to be greatly improved in order to make sure that all the children inside a container are read all the time in a reproducible way. Otherwise, one wrong reading would cause the whole case to be ejected!” warns Bullen.
In terms of data handling, “there are a number of solutions currently available from specialist companies that handle serial number provisioning, and the appropriate logging of serialization event data,” explains Smith. “Some solutions use available modules from Enterprise Resource Planning systems like SAP's OER/AII subsystems and some solutions have evolved from companies with experience with vision systems and industrial data handling. However, the Ministry of Health data handling mechanisms are still under development, with groups like the European Union still running development trials.”
And Smith advises pharmaceutical companies to plan well ahead. “One important aspect that should be considered for serialisation projects is increasing workload of the equipment suppliers in Europe. In recent years, Team Horizon has observed the key companies as becoming increasingly busy, with lengthening lead times for equipment supply.”
Visit Horizon in Stand 735 and Optel Vision in Stand 734 at Pharmapack Europe.
--By Daphne Allen