Serialize with the help of contract packagers

Contract packagers are building in flexibility to handle the needs of a diverse group of pharmaceutical customers.

As pharmaceutical manufacturers around the world ready their operations and products for item-level serialization, another group of companies is getting ready, too: contract packagers. Known for their flexible operations and customizable menu of packaging support, these contractors have been increasingly serving as an extension of pharma companies’ operations (or in some cases, as their only source of production). And with pharmaceutical serialization activities scaling up, contract packagers are seeing even more demand for their help.

“While some of our clients are well on their way, many others are just at the ground floor and looking for guidance,” Ian Parsonage, director of global serialization, for Packaging Coordinators Inc. (PCI; pciservices.com), tells PMP News. “We expect a groundswell of activity in the market for serialization support because there is still such a lag in preparedness from entirety of pharmaceutical and biotech companies looking to meet the pending track and trace obligations. Many of these companies do not appreciate the impact to their resources in getting prepared for the serialization effort, with data management, artwork impact, documentation, logistical needs, etc.”

PCI has offered serialization services for many years, so Parsonage says that the company “is well positioned to support customers both for consultative support as well as having the operational flexibility globally to provide a solution to their needs. We believe the market will rely heavily on expert contract packagers to help meet the requirements and are ready to assist.”

Contract packager Reed-Lane (www.ReedLane.com) recently completed a dedicated Serialization Suite at the company’s Wayne, NJ, facility for supporting track-and-trace services down to the unit level. Line installation was completed in July 2014, and validation activity is underway. “We will be validating the full capabilities of the serialized line for system function and accuracy of the audit trail and batch record,” Richard Wrocklage, director of package development for Reed-Lane, tells PMP News. “We have selected four operational scenarios to test the line capabilities in validation.”

Most pharmaceutical manufacturers are looking to serialize at the saleable-unit level. “Most markets and their regulatory requirements call for serialized codes on the saleable unit, be it a bottle, carton, etc.,” says Parsonage. “Conceptually, you could apply serialized codes down to the unit dose for blister packaging, pouches, or single-use injectables, for example. For the established and emerging markets we are currently supplying, the demand has been primarily for the saleable unit and the associated tertiary packaging. Most companies are seeing value in aggregating their data from the saleable unit to the tertiary packaging and then to case and pallet, despite the fact that many of the country-specific legislations do not mandate that requirement at this stage.”

Reed-Lane has invested in a carton serialization line targeting products in which the unit of sale to the pharmacist is a carton, explains Wrocklage. “The carton can be distributed directly to the end user or could contain multiple cartons, wallet cards, blister packages, bottles, or ampoules for distribution as individual units by the pharmacist,” he says.

In terms of what markets are driving activity, PCI is seeing requests from drug manufacturers asking for programs to support the future U.S. requirements as well as for other markets outside the United States. “We have clients who are actively initiating serialization programs for U.S. supplies ahead of the requirement, and others who are initiating their serialization supplies for those markets who have 2015 requirements, for example, South Korea, Brazil, and China,” explains Parsonage. “It is interesting how some of the emerging markets have been effective in implementing serialization requirements ahead of the United States and European Union. It really benefits those companies with global supply, enabling them to get started with serialization at a manageable scale. Having international operations has allowed us to get a broad view of the global market for serialization and ensure we have a consistent solution for each individual market need and client.”

While Wrocklage says that Reed-Lane’s “customers have mostly indicated their need for U.S. requirements, some have inquired about our ability for markets outside the United States. This is why we feel having a flexible line that can offer full aggregation is important.”

PCI’S APPROACH
PCI is employing the Xyntek/Antares solution for its Enterprise Serialization system across its network of sites in North America and Europe, which entails both data management as well as the integrated line equipment for data application, verification, and data capture, explains Parsonage. “One of the key selling features for us was the simplified integration of the data interphase and enterprise IT integration as well as the proven line-level technologies. It provides us a seamless interaction with our global ERP platform and order processes as well as operational batch processing.

“One other key benefit to the Antares system was the diversity of coding technologies that can be employed,” he continues. “We can utilize the appropriate coding mechanism for the application, which may include traditional ink-jet, covert UV ink-jet, or laser technologies. They offer a robust platform for the subsequent vision verification and data capture for commissioning codes and aggregation to tertiary packaging and palletization.”

PCI’s system can be changed over quickly. “This was a critical element of our product selection,” says Parsonage. “Our operations are fundamentally built on flexibility, and we have to meet the divergent needs of our broad range of customers and applications. One of the key benefits our serialization platform is the ability to utilize the technology across many different product configurations and customer needs. We have a system that allows personnel to very quickly change from one program to another. The system can achieve this in less than one minute, which then positions the remaining changeover as consistent with our normal processes. In addition, we have invested in stand-alone ‘flex lines’ that enable us to apply serialization to prepacked medicines, providing a simplified solution for clients who may be struggling to adopt serialization in their own packaging operations. These flex lines can work between a wide range of package sizes, from ‘matchbox to shoebox,’ and are capable of printing on multiple faces of the package simultaneously, and our changeovers are a matter of minutes.”

Parsonage says that all aspects of PCI’s serialization approach have been fully validated, “both equipment and data programming/exchange, including roughly a dozen modules within the Antares product. Each serialization packaging line is then validated, along with the specific configurations for each product or family of products. Lastly, the interface between PCI and each of our customers is then validated to confirm a robust and secure data transfer exchange.”

For handling that data, PCI sought a solution that enabled a flexible approach. “Some clients are very prescriptive about the data they provide to us and how they want it delivered back,” he explains. “Others might look for PCI to manage their data and rely on our expertise in how they structure their systems.”

The company’s model supports the addition of additional capacity across sites both in traditional primary and secondary packaging equipment as well as the global serialization technology platform. “Having best-in-class technologies at each site and consistency in our technology across our site network allows us to maintain supply continuity for our clients as they address supply challenges like serialization and global supply,” says Parsonage. “We aim to provide the leading customer experience and work to ensure that is a consistent experience at every site.”

REED-LANE’S APPROACH
Reed-Lane chose an Optel Vision TrackSafe system. “We initially contacted six potential vendors for a serialized solution,” explains Wrocklage. “Optel was selected for its approach to manufacturing of the system, the capability/flexibility of the proposed solution, and the track record that Optel has with a serialized solution for the upcoming requirements for the pharmaceutical industry. We have a previous relationship with Optel, with several inspection systems successfully installed and supported. Optel’s plan to expand support structure to meet industry demand for serialization gave us the confidence this direction would position us to support our customers for years to come.”

Reed-Lane’s line can be used to serialize individual cartons; aggregate cartons to cases; aggregate cartons to bundles; aggregate bundles to cases; aggregate cases to pallets; or rework previously serialized items according to customer needs. “The Carton Serialization Line can function as a stand-alone tertiary operation, it can be duplicated as such, or can be integrated with an automatic cartoner or into an existing line,” Wrocklage adds.

He adds that system set-up “is not complicated, with each Pharmaproof station initiated as needed through the Line Master central controller. Once the stations are initiated, user guided recipes for the individual stations can be configured in under 30 minutes. Configured recipes can be selected from a menu and loaded with a single touch screen selection and the mechanical settings are metered and can be set in under 30 minutes.

For handling product identification data between Reed-Lane and pharmaceutical manufacturers, the contract packager is currently working with HTML files and has plans to move to a cloud-based solution for transmission of files, Wrocklage says.

Reed-Lane’s next line(s) to adopt serialization will be solid-dose bottle filling line(s). “We don’t foresee the immediate need to serialize individual blisters or sachets, and we’re not sure the engineering has been done to support these applications. Blisters are always packaged in cartons, which would be the unit of sale which would be serialized,” he says.

Reed-Lane is currently working with its existing customers to schedule pilots for products that it currently packages and has been in communication with existing and prospective customers concerning their upcoming needs, Wrocklage says.