The abundance of different regulations regarding traceability in different countries doesn’t scare the industry; after all, pharmaceutical manufacturers are quite used to ensuring compliance with extremely diverse requirements in their different export regions. The fact that the U.S. dictates the e-pedigree, Italy the Bollino, and Turkey, the ITS system (Ilac Takip Sistemi), etc., doesn’t imply an exceptional level of complexity for pharmaceutical professionals.

The companies have set up suitable projects for the Track & Trace. The requisites for the secure management of individual codes at the plant level are given, since pharmaceutical manufacturers already have validated structures for data management. There is usually a connection from the PPS (Production Planning System) to the production planning level. For the most part, vertical integration of the MES Manufacturing Execution System carries forward to the process level.

The serial numbers for serialisation are usually generated by the PPS or directly via the packaging line’s system control.

Track & Trace with conventional technology

How is serialisation or Track & Trace then conventionally integrated to the packaging line? The smallest product unit, such as tamper-proof primary packaging, reaches the system, is separated and then given an identification number. A camera verifies the correct labelling.

Once the product moves from an accumulating conveyor to the next process step, such as packing in the shipping box, it first needs to be repositioned so that cameras can read the identification number. If the system was packed the primary packages in shipping boxes, this step must be verified again with a camera.

The information for the Track & Trace is collected over and over again. Each individual, separately running process step requires a control with corresponding components, such as cameras or checkweighers.

For an error-free Track & Trace function, the system has to guarantee interaction and communication between all components. The devices are often sourced from different manufacturers and contain their own software package. This represents a challenge for the set-up as well as the subsequent operation.

Track & Trace with the TLM technology: the basics

From the outset, TLM pharmaceutical systems have more direct access to process and traceability data. There are no stand-alone solutions. Schubert’s VMS Packaging Machine Controller integrates all functions of the packaging process for serialised pharmaceutical final packaging. From the acquisition of the products through to the pallet with finished products. All automation components, such as robots, scanners, cameras and printers communicate with the VMS.

The Transmodule can convey the products through the entire system. There are no routes between two line segments along which theproducts travel in an undefined condition.

The Transmodule can be localised at any time as a single-axis, rail-based robot (100% position control). As a result, this also applies to the products being conveyed by the Transmodule. If, for example, a robot picks up serialised cartons from the Transmodule to place them in the shipping box, the information is available as to what numbers identify the cartons which are being packed in this specific shipping box. The information doesn’t have to be recorded and communicated first by a camera system.

The benefits:

• Aggregation in real time in one system: VMS incorporates complete product tracking
• No components with separate operating software, no interface issues; all printers, cameras, etc. receive data directly from the line management system or VMS system
• Fewer individual components for tracking; simplified qualification
• Consistent documentation
• Unitary user interface

Schubert-Pharma configures the packaging line with perfectly matched TLM standard components, such as the VMS controller, robotics, the Vision System and electronics in conjunction with a Track & Trace solution entirely customised to the user. All technologies have been developed by Schubert and proven in practice over several years.