Pharmaceutical and Biopharmaceutical manufacturers have many good reasons to implement track and trace technology within manufacturing and packaging processes. Serialization allows manufacturers to ensure the integrity of their product and compliance with emerging pedigree laws. Designed primarily as a response to the increase of counterfeit pharmaceuticals, pedigree and e-pedigree laws (for electronic documentation) require manufacturers to show the complete life cycle of the drugs they distribute, from the manufacturing process through the end-of-line packaging.
Unit level tracking methods have been in place for years. Lot/Expiration codes are ubiquitous on a wide variety of products. But recent changes to the law have shifted the focus to implementing track and trace systems with case packers and palletizers. This can present a number of challenges to pharmaceutical manufacturers, so selecting a qualified packaging machinery supplier to work with the track and trace system supplier is vital. Pharmaceutical companies already invest heavily in capital equipment for manufacturing and packaging. By integrating track and trace serialization technology with automated end-of-line packaging machinery, pharmaceutical manufacturers can meet pedigree requirements and maintain their levels of productivity in a single robust solution.
Many serialization equipment providers include automatic vision inspection machines for 100% verification of pharma products in the production process, ensuring they meet the highest quality standards and cGMP regulations.
Coding systems support serialization efforts. DPSS Lasers showed the ultraviolet laser coding system marking bottle bottoms with up to four lines of text or bar code. Mounted below the conveyor, the coder produces a permanent mark, without ink, debris or fumes, at rates up to 300 containers per minute.
Another ultraviolet laser coder, the 7810 model, is designed especially for marking high-density polyethylene (HDPE) bottles. The system can generate print as small as 4-point. 3340 Pharmaline carbon dioxide laser coding system. It prints up to four lines of text and barcodes (2D and linear) and offers processing speeds capable of generating serialized codes. A 600-mm marking window makes it possible for one coder to handle what previously required two units. Three wave lengths and different power settings and focal distances enable coding on labels, cartons, and virtually any packaging substrate except HDPE.
The simplest application for track and trace systems is the pick-and-place inspection of products. Whether the product is an aggregation or an individual carton or bottle, a properly programmed robotic cell with well-designed end-of-arm tool (EOAT) can pick the object, pass it in front of a vision inspection system or a barcode scanner and place it in a bin or on a conveyor, depending on whether the product is rejected or passed downstream for further packaging.
Robotic inspection works well in applications that require an aggregation to be verified after individual products have been bundled, and aggregation scanning equipment cannot be integrated into an existing machine. The stand-alone robotic system can pick the bundle and move it under or over a scanning device. The system allows for rescanning the bundle in the event of a read error. The scanning device can also verify the count, the bottle or carton status and create a list of each item in the bundle. The robot places rejected bundles in a reject bin to be reworked or discarded.
Robotic systems can be used in an end-to-end packaging line to help track the first product in all the way to the finished pallet, ensuring the integrity of every product, every case, and every pallet throughout the production process. For example, a packaging line for pharmaceutical bottles begins as each filled and closed bottle is marked with a unique serial number, which may be printed on the label, on the bottle or on an RFID. In a cartoning application, sensors verify the code as each bottle enters the cartoner infeed, which may be robotically loaded. After the carton and any required leaflets are loaded, cameras and/or sensors verify the carton contents before it is sealed and labeled.
Robotic palletizers also integrate easily with track and trace systems. Prior to palletizing, labeled cases are verified at the case infeed conveyor. The system either presents the label to the barcode reader or a barcode reader positioned on the conveyor can read the label before the case is picked. In either scenario, incorrect cases can be rejected for rework. Robots can also be programmed to position the case label so that it can be seen and scanned at pallet’s final location.
Robotic palletizers can be integrated directly with track and trace case packers to create a complete end-to-end system. High speed case packers integrated with stand-alone robotic pallet cells can handle up to 20-25 cases per minute using two robots, one to case pack and one to palletize. Track and trace packaging lines requiring lower speeds, between 5-6 cases per minute, can incorporate case packing and palletizing with a single robot to create a very compact track and trace packaging solution.
Labelers and scanners are also integrated with robotic palletizers. Fully loaded pallets are also labeled using RFID tags, bar codes or readable codes to fully verify the contents of the pallet.
Benefits of serialization includes it encodes packages with expiration date, lot code, serial number, GTIN, and a 2D matrix code and a GSI-Data Matrix symbol, it is used to track products for anti-counterfeiting efforts, Provides regulatory compliance, Track and trace capability throughout the supply chain, Consumer protection & Brand protection.