Track &Trace. Advanced serialization and aggregation

Transcription

1 Track &Trace Solutions Advanced serialization and aggregation

2 2 Seidenader

3 Track&Trace Solutions How to reduce today s market risks? Product Loss Risk of losing good products through unnecessary recalls and on the way through the distribution chain. Pharmaceutical companies and governments worldwide are promoting serialization to make pharmaceutical products traceable and to reduce today s market risks. This is why track & trace solutions are being integrated into new and existing packaging lines. Counterfeiting Manufacturing of fake replicas of a genuine branded product and distribution under the original brand name. Gray Marketing Unauthorized distribution of branded products. Risks Loss of revenue, profit and brand equity and the risk of potential lawsuits. Requirements for track & trace solutions Seamless integration into existing lines must be possible Additional features such as tamper evident seal must be supported Upgradeable for aggregation at additional packaging levels Track & trace solutions must be proven and stable Services and improvements must be guaranteed to meet current and future requirements Adaptation to specific requirements must be possible Implementation time must be as short as possible Seidenader 3

4 Seidenader Track&Trace Solutions allow serialization for the pharmaceutical industry at each aggregation level in the product packaging process: From the smallest saleable unit (item) through bundles and cases to pallets, Seidenader offers secure traceability solutions to provide transparency throughout the packaging process, with a high level of safety for pharmaceutical products and patients. We offer inline and stand-alone machine and software solutions as well as the integration into 3rd party systems at each secondary packaging level. Using serialization with 1D/2D coding including human readable text, our solution supports anti-counterfeiting initiatives and ensures product authentication in order to avoid product mix-up. Furthermore, Seidenader Track&Trace Solutions guarantee conformity with legal and country-specific regulations today and tomorrow. 4 Seidenader

5 Track&Trace Solutions More solution less complexity Make your packaging process comply with worldwide legislations. For many years Seidenader Track&Trace Solutions have been successfully supporting CMO, small-, mid-sized and global pharmaceutical companies, with local and large-scale multi-site rollouts. This expert know-how is readily available in the modular software solution integrated in our product. Transparency and traceability through the whole packaging process Your benefits Tried-and-tested solutions are combined into standard products Version-controlled software products Reliable state-of-the-art software solutions Same HMI look & feel throughout all Seidenader Track&Trace Solutions products Freedom to implement specific requirements with minimal effort Fast project implementation on customer s site Integration into new or existing packaging lines Inline or stand-alone serialization solutions Upgradeable solution in order to fulfill future requirements Continuous development and product innovation Seamless integration into ERP/MES environment (e.g. WERUM, SAP) Seidenader 5

6 Advanced serialization and aggregation Seidenader Track&Trace Solutions combine product transport with coding and verification by Seidenader vision technology. In conjunction with our software products conformity with worldwide legal requirements is guaranteed. Our Track&Trace Solutions for item, bundle, case or pallet serialization and aggregation can be integrated inline or used as stand-alone solution. Seidenader Track&Trace Solutions fulfill the high quality standards in the pharmaceutical industry and are compliant with FDA s Title 21 CFR Part 11, cgmp and GAMP requirements. 6 Seidenader

7 Track&Trace Solutions Transport (at item level) 4 Label application Advanced servo-driven flighted conveyor belts for precise guidance during product coding for best print results Compact servo-driven top/bottom conveyor system for effective transport of the complete product range Vignette label applicator for top and side label application Tamper evident label application on the flaps of the folding boxes to guarantee the closure of the products 2 PRINT Market leading inkjet and laser printing technology for an optimal print result 3 Identification and verification Seidenader vision technology verifies the presence, readability, correctness and quality of the online printed data Integration of 3rd party vision solutions (e.g. Cognex) for local requirements Reject (at item level) Pneumatic reject for smooth and damage free product sorting Servo-driven reject for heavy boxes and high-speed sorting Checkweigher (at item level) Integrated checkweigher for leaflet presence and foreign objects check Seidenader 7

8 Track&Trace Solutions 1 2 Item Expert Bundle Expert Multi Line Manager Coding Verification Identification and read-in Coding Verification Line Controller 3 4 The modular approach Seidenader s new Track&Trace Solutions-Software is modular in design. An individual solution is built according to customer needs for the relevant jobs (serialization, aggregation, rework and production data capture). 80% of the requirements in a normal project can be met by the modular standard software. The remaining 20% can be covered by automated and manual configuration. 8 Seidenader

9 Case Expert Pallet Expert Identification and read-in Coding Verification Identification and read-in Coding Verification 5 6 The following software products are available to provide this solution: 1 Multi Line Manager Global serial number management Global interface with MES/ERP Global recipe management Global batch management and information Global user management Global report management Global line administration and information 2 Line Controller Central batch management and information for the respective line Distribution of batch data to all aggregation levels of the respective line Central information collection for all aggregation levels of the respective line (lot information, error messages, diagnostics messages, and more) 3 Item Expert Coding of the single saleable unit: Print of serial number and batch information (lot number, expiry date, etc.) Verification of the printed data Serialization 4 Bundle Expert Scanning of the code (serial number) of the single saleable units Serialization of the bundle Aggregation 5 Case Expert Scanning of the code (serial number) of the bundle or single saleable units Serialization of the case Aggregation 6 Pallet Expert Scanning of the code (serial number) of the bundles/ cases Serialization of the pallet Aggregation Seidenader 9

10 Seidenader Services Tailored to Your Needs Seidenader Customer Support Our Customer Support Team is available during business hours to help you with urgent questions you may have about your Seidenader machine or any other technical issues. 24/7 support is also available as an additional option. Seidenader After Sales Services Maintenance, spare part orders or retrofit requests your direct contact is a designated customer support team to coordinate all your inquiries regarding our comprehensive range of after sales services. Seidenader Academy Reduce your installation time to a minimum by taking advantage of customized training sessions for integrators and users of our products from the basics to the tips & tricks to run your machine in the most efficient way. Seidenader Qualification Support Profit from our validation support package and minimize validation and start-up time. Our specialists develop test plans and qualification protocols and provide support during execution. Seidenader Seidenader Maschinenbau GmbH Lilienthalstr Markt Schwaben Germany T F info@seidenader.de