SAFE SERIALISATION LABELLING AUTOMATION MODULAR SOFTWARE TRACK&TRACE for process-safe serialisation, aggregation and track and trace

To implement existing and future statutory provisions within the EU and globally, b+b Automationsund Steuerungstechnik GmbH has developed intelligent concepts for process-safe and efficient serialisation of packaging. The central element behind these concepts is a modular software architecture that is tailored to the needs of pharmaceutical manufacturers, re-importers and contract packagers and can be adapted at any time to future requirements. These concepts are used for managing production lines or sites, adapting to new coding and aggregation requirements or expanding the equipment fleet....

What is serialisation? ■ Application of unique serial numbers to sales units / bundles / cartons / pallets ■ Checking and recording of the applied data / serial numbers ■ Saving, managing and forwarding / reporting of the serial numbers for subsequent track and trace Important information about serial numbers ■ Simple ascending numbers (counter) are no longer standard for serial numbers because they are easy to counterfeit. They are still only used for pallet numbers (NVE/SSCC). Instead, serial numbers now comprise random digits (0-9) and letters (A-Z), commonly with 10 to 20 places. 8. b+b trace...

2. An overview of b+b trace serialisation software b+b Site Server bb-trace software structure Basic software (always required): ▪ Central server service + database Management software / order preparation ▪ b+b Work Order Label module Production software: manual checking / recording of printed product labels per scanner ▪ b+b Storage List Module Production software: manuel distribution of inspected product labels to storage location via scanner ▪ b+b Packing List Module Production software: recording of product labels in dispatch (during the preparation of shipping crates), printing of pack lists...

3. b+b trace serialisation software – Packages 4. b+b trace serialisation software – BASIC package b+b trace serialisation software is made up of various modules. Not every customer requires every module. The individual modules are configured as required by b+b depending on their purpose. The basic package for contract manufacturers and folding box manufactures in the pharmaceutical sector: Below are some typical software packages that can be supplemented or modified in accordance with customer requirements: Simple creation of orders and their serial numbers Printing and checking in the system...

5. b+b trace serialisation software – STANDARD package 6. b+b trace serialisation software – RE-IMPORTER package The standard package for manufacturers of pharmaceutical products: The full package for pharmaceutical re-importers enables: Creating orders and their serial numbers Recording and checking of purchased ‘raw materials’ Printing and checking in the system or manually Creating ‘finished goods’ orders and their serial numbers Storage documentation (optional) Printing and checking in the system or manually Shipping documentation (optional) Shipping documentation Reporting numbers to authority...

7. b+b trace serialisation software – AGGREGATION package 8.1 b+b trace serialisation software – Details about the modules The serialisation package for the agrochemical industry and all other sectors that require serialised identification at all aggregation levels: ▪ Creating/importing article master data and orders (not from a single batch) and their serial numbers at all aggregation levels Printing and checking in automated production lines or on manual workbenches Transferring the serial number hierarchy to the clients AGGREGATION modules: b+b Site Manager (expanded order/article management)...

Central management software for the data contained in the b+b Site Server database. It can be used on any Windows PC in the network without being installed and enables: ■ Management of own users / user groups ■ Management of Site Server settings ■ Management of the audit trail (21 CFR Part 11) ■ Management of reports / report printing ■ Management of customer and reporting master data ■ Management of product data ■ Management of orders (creation, change, line allocation) ■ Management of reports / export of serial numbers ■ Decommissioning of serial numbers (in case of loss, theft, destruction,...

8.3 b+b Work Order Label Module Additional modules (pharmaceutical) Software to rapidly generate pharmaceutical serialisation orders in production. The following pharmaceutical-specific data must be entered or recorded by a handheld scanner. ■ Order number ■ Article number (German PPN and/or international GTIN) ■ Batch number (LOT) ■ Expiry date (EXP) ■ Order size (number of serial numbers) ■ Optional: internal batch number, internal article number, customer number The b+b Work Order Label Module automatically generates or imports the serial numbers required for the order. ■ Optional: immediate...

8.5 b+b Storage List Module 8.6 b+b Packing List Module Optional software for production: Software for shipping: Records serialised product labels by handheld scanner during packaging. Additional modules (pharmaceutical) Assigns serialised products by handheld scanner to a warehouse list / pallet number (simple aggregation for internal warehouse management) Transfers the recorded numbers and the assigned warehouse list to the b+b Site Server (database) Additional modules (pharmaceutical) Prints the warehouse list / pallet label on a Windows printer b+b Storage List Module Transfers the recorded...

For the HMI system PC (for example, HSF for folding boxes or LSS or LSS-V for finished products). Software for incoming goods: Additional modules (pharmaceutical) Additional modules (pharmaceutical re-importer) Order selection (list with production orders from the b+b Site Server) Prints via an inkjet system Transfers the recorded numbers and the warehouse location to the b+b Site Server (database) Checks with a Cognex camera Optional: automatic verification query to the EU reporting system Deactivates incorrect codes with a handheld scanner Special feature: b+b Line Manager software has an integrated...