The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world - in Europe and Asia in particular - disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks.
How can companies manage this transformation with the greatest degree of success while also minimalizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation and provides business benefits beyond compliance.
FOUR LEVELS OF TECHNOLOGY
There are four main levels of technology involved in the delivery of an effective serialization solution:
• Level 1: The Device Level - Includes line level systems such as printers, scanners, cameras, code readers
• Level 2: Line Level Control Systems - Includes software that controls data, serial number management and aggregation of data across all Layer 1 devices on a specific packaging line. These real-time controls and software supervise, monitor and control the physical processes, human-machine interface (HMI) and data acquisition.
• Level 3: Site Level Software and Hardware - Includes software systems that send and receive information to multiple Level 2 systems within each site and that connect to Level 4 software, which is often hosted outside the company firewall, or in the cloud. There is typically one Level 3 system for each packaging facility. These systems manage production workflow to serialize the desired products: Master data such as customer, product and work order information are generally managed in this layer and distributed out to Level 2 systems in a one-to-many distribution model. Centralized configuration at Level 3 provides an enhanced level of governance and robustness in today’s fast-changing environment.
• Level 4: Business Logistics Systems - Level 4 encompasses the software that manages connectivity to the greater pharmaceutical company and connects all Level 3 site level systems across all sites. Level 4 Electronic Product Code Information Service (EPCIS) systems typically interface with Enterprise Resource Planning (ERP) systems along with other track-and-trace related systems in order to provide comprehensive use of serialized and operational data. Level 4 systems manage the business-related activities of the manufacturing operation, such as establishing the basic plant production schedule, material use, shipping and inventory levels.
The most effective and comprehensive serialization solutions will support the requirements of all levels of technology, connecting challenges at the shop floor and plant levels with the enterprise level.
IMPORTANCE OF LEVEL 3 APPLICATIONS
There is no denying the importance of Level 3 applications for serialization solutions - the software that resides at the manufacturing or packaging plant site level above the packaging lines and machines/devices (Levels 1 and 2), and below Level 4 enterprise applications.
ISA-95.00.01-2010 is an international standard for the development by global manufacturers of an automated interface between enterprise and control systems (Levels 3 and 4). It is meant to be applied in all industries and all sorts of processes, such as batch, continuous and repetitive processes.
The goals of the standard are to increase uniformity and consistency of interface terminology, and to reduce the effort associated with implementing new product offerings so that enterprise and control systems can easily integrate and smoothly interoperate.
While there are no definitions for serialization in ISA-95 for objects, attributes, interfaces, etc., the overall architecture and concepts can be leveraged in designing and implementing serialization systems.
As defined by ISA-99.01.01, implementation of a Level 3 system above all Level 2 systems is a critical element in securing corporate infrastructure through a conduit and zoning model, where a zone is defined as a grouping of logical or physical assets that share common security requirements, and conduits are defined as a logical grouping of communication channels connecting two or more zones. As most serialization systems are implemented in response to counterfeiting or brand protection programs, it should seem obvious that following best practices security guidelines would be a basic requirement.
One of the primary goals of Level 3 applications is the provision of critical isolation of automation and production devices from enterprise applications at Level 4.
This separation provides:
• Network traffic management and security
• System access management and control