Automation Industry Association

Authorities are placing increasingly strict demands on the safety of pharmaceutical products. This also includes full manufacturing documentation in which all packaging elements are identified automatically and the packaging process is documented in detail. The strict regulations also necessitate the integration of packaging machines into “track & trace” systems. The correctness of the packaging and package inserts must be documented, while at the same time the correctness and legibility of the product codes printed on the packaging must be ensured because they identify the individual products and therefore serve as a key component of the required proof of quality.

Integrating the functions necessary to meet these specifications into the packaging automation system has many advantages. A packaging solution using this system can be validated easily and quickly. Integration also offers the advantages of fast engineering, rapid commissioning, good serviceability, and efficient diagnosis. The quality status and position of every product on the packaging line can be traced at any time, and master track & trace systems on the IT level are supplied directly with quality data.

Requirements for the packaging lines:

• Reliable automatic identification of all materials used (auto ID)
• Protection of every quality-relevant process step by downstream inspections (e.g., optical seal and label control with machine vision)
• Data flow clocked through every station, which assigns the quality characteristics recorded in the process to every product in a fail-safe procedure (“validated shift register”)

The continuous tracing of the manufacturing process requires automatic identification of all packaging components and ensuring a correct process execution by using machine vision components.

Auto ID minimizes risks:

Using auto ID in pharmaceutical packaging lines provides positive confirmation that the right packaging materials, package inserts, and leaflets have been used. At the same time, auto ID provides the relation between the individual product and the corresponding quality data set recorded in the process. This is a prerequisite for the reliable ejection of defective products and is also provable. In a packaging line protected against manual intervention, auto ID prevents defective products from getting into the transport packaging and therefore onto the market. Every detail of the quality of the delivered products can be positively confirmed.

Data matrix or RFID?

Packaging components, package inserts, and leaflets are usually detected automatically by means of bar codes or data matrix codes, but the direct interpretation of text and graphics in printed material is also possible with machine vision technologies. The labeling of pharmaceutical products with an electronic pedigree is already being discussed in some US states.

Data matrix codes are applied to solid and flexible materials at an extremely low cost by various printing methods. The data matrix code can be fully reconstructed even when up to 25 percent of the code area is illegible. Data matrix codes are therefore increasingly preferred to other methods for the labeling of materials and packaging components. However, whether the product code is printed directly on the packaging by using a data matrix code or stored on an radio-frequency identification (RFID) tag on the packaging depends, above all, on the requirements of the target market. So it may be necessary to equip packaging lines with both data matrix and RFID technologies. This also makes the production more flexible. With RFID, in-house logistical processes and distribution benefit from the rapid bulk acquisition of all the information about a delivery. The possibility of saving all the data required for logistical control directly on the transport medium also calls for the use of rewritable RFID tags, at least on circulating transport units.

Integration offers many benefits:

No matter what labeling methods are used, the results of process monitoring by auto ID are used directly for machine control and for supplying the input for product tracking. Process monitoring, track & trace, and packaging automation go hand in hand. For cost-effective, high-performance, and reliable packaging solutions with auto ID, the sensors, automation system, and user software of the packaging line must interact as an integrated, easy-to-maintain total system. Standardized system technology that includes sensor technology, SCADA, and enterprise resource planning (ERP) links and efficiently supports modular machine concepts is a basic prerequisite for this.

Several companies have been providing RFID and machine vision solutions for industrial applications in many fields for more than 25 years. A unique portfolio containing RFID, data matrix code reading systems, and machine vision, as well as control, drive, visualization, process control, and manufacturing execution systems is available and integrable into a consistent, universal system. This reduces both the complexity of the creation of new packaging machines with auto ID, optical process monitoring, and track & trace functionality and the expense of retrofitting existing packaging lines already automated with control and motion systems.

In the engineering system, the sensors are configured as intelligent I/O devices, and the details of communication on the field level and for horizontal and vertical integration are controlled by system functions of engineering systems. The direct integration of all process monitoring functions increases the performance of the entire system by using short, direct communication paths; this performance increase is immediately noticeable in high-throughput production.

Individual solutions with standard software:

High reliability, short implementation times, and low validation expense are promised by packaging automation solutions comprising pretested standard software. An example of the plug & play-capable automation of single stations and entire packaging lines is the Optimized Packaging Line concept. With standardized and easily adaptable motion-control systems, these automation solutions also meet the requirements of 21 CFR Part 11. They are based on international standards such as OMAC and Profinet and ensure harmonization of interfaces and machine operation. Software libraries are available for all important packaging jobs, including handling. They include all the necessary machine functions, from communication and operation to validated shift registers.

Guenter Lanzer, Lars Jahn