Pharmaceutical packaging departments striving for continuous innovation must keep up with healthcare trends, regulatory compliance requirements and the latest efficient production processes. All of which are being covered at the now-open Interphex show (Apr. 21-23; New York).

On the production side, pharmaceutical packaging operations have seen the benefits of real-time decision making enabled by new machine intelligence such as the Internet of Things and remote monitoring. At the Rockwell Automation Center for The Connected Enterprise, industry experts are presenting related educational and technical sessions throughout the show, free to all show visitors.

Dave Sharpe, global industry director for consumer packaged goods (CPG), at industrial automation and information leader Rockwell Automation, tells us how pharmaceutical packaging operations can benefit from today’s integrated controls and smart packaging automation technologies.

What new smart technologies are available for pharmaceutical packaging operations?

Sharpe: Pharmaceutical packaging innovators are following initiatives like the Smart Manufacturing Leadership Coalition, Industrie 4.0 and China’s Manufacturing Intelligence 2025—but many don’t yet have a clear strategy in place to operationalize these initiatives.

Success today requires greater process knowledge—the kind locked deep inside production systems. Accessing that data and converting it into useful information can yield tremendous benefits.

But information alone isn’t enough. Cross-departmental activity between plant-floor and front-office systems has become particularly necessary in the life sciences industry, as tracking and reporting has evolved from a nice-to-have to a must-have. We refer to this as The Connected Enterprise. It’s the creation of a unified control and information system architecture to harness production intelligence and improve operations across the product life cycle—from formulation to factory.

For example, Rockwell Automation has introduced its new holistic serialization solution to help manufacturers comply with new regulations and produce a number of business benefits beyond compliance, such as a strong and more efficient supply chain.

The holistic serialization solution, powered by Rockwell Software PharmaSuite Manufacturing Execution System (MES), is fully integrated across all enterprise and control system levels of the ISA-95 data model. The solution leverages the Microsoft Azure cloud-computing platform and services, and seamlessly connects and shares data. Data is shared between the plant floor, the enterprise, supply-chain partners and the retail point of sale—and potentially, right to the customer.

The common serialization data thread, which provides real-time visibility to a company’s products and customers, can increase the efficiency and productivity of all departments in The Connected Enterprise, from manufacturing, quality and finance to supply chain, logistics and marketing.

How are these smart technologies improving manufacturing and packaging operations for pharmaceutical companies?

Sharpe: Serialization processes introduce new complexities to existing packing lines that have the potential to negatively impact throughput.

The application, authentication and aggregation of serialized data to products at multiple levels of packaging must be managed in a consistent, centralized fashion to maintain the integrity of the data. Serialized data connectivity to packaging machinery, printers, labelers, vision systems and barcode scanners must leverage open communication standards and protocols, such as EtherNet/IP to insure consistent, globally supportable system deployments. The packaging line serialized data must be integrated seamlessly with a plant’s serialization site server, business planning and logistics systems and ultimately to the supply-chain, track-and-trace serialization data event repository.

When serialization is implemented for regulatory compliance reasons, all of these serialization data levels become production critical assets. If they go down, production stops. Pharmaceutical manufacturers need a solution that is easy to maintain and support. This makes “black-box” solutions or those with custom code less desirable.

Pharmaceutical manufacturers should instead consider basing their system on a modular and scalable off-the-shelf control and information platform that can be easily integrated into their existing lines. Specifically by tapping a software platform that also offers MES and electronic batch recording (EBR) capabilities, a serialization system can help address global serialization requirements, including necessary data capabilities and high-speed device management of serialization components—all while minimizing production interruptions or validation burdens.

Original equipment manufacturers (OEMs) serving the life sciences market can also differentiate their machines, with serialization-ready machines, running the PharmaSuite AOI (Add-On Instructions).

Why is now the right time to invest in these smart technologies?

Sharpe: Proliferation of dangerous counterfeit medication is a global concern. Impending regulations across markets will require pharmaceutical, medical device and consumer packaged goods manufacturers to trace products down to the individual saleable unit across the supply chain. These include the European Union’s Falsified Medicines Directive, the United States’ Drug Supply Chain Security Act and China’s electronic drug supervision code requirement.

However, early adopters are learning that a comprehensive and holistic serialization system can also deliver reverse-logistics benefits, more accurate and efficient recalls and provide valuable data for improved forecasting and more customer-specific marketing programs.

How can these smart technologies be best retrofitted into existing packaging lines?

Sharpe: For packaging operations, pharmaceutical manufacturers have the task of trying to fully incorporate the serialization system into an existing control architecture than can include legacy equipment, multiple different device vendors, networks, protocols and proprietary platforms. A serialization solution must also be compatible with all package types and country-specific unique identification (UID) formatting requirements to ensure compliance and uninterrupted product changeovers. It should also support seamless integration of serialization components, such as high-speed printers and vision-inspection cameras.

The holistic serialization solution from Rockwell Automation is technology agnostic. Because it is based on the PharmaSuite MES offering, it sits above the control system. It is designed for interoperability between the plant-floor and enterprise systems. In addition, by using an ISA88 aligned data model, an open architecture platform, open network and communication standards, and commercial off-the-shelf PLC technology, interoperability challenges with existing packaging machinery, printer and vision systems are minimized.