Holistic Serialization Solution

Transcription

1 Holistic Serialization Solution Enhanced Serialization Solution from Rockwell Automation Provides a Scalable Platform for End to End Process Integration Features and Benefits Rockwell Automation offers a holistic serialization solution that addresses challenges from Automation to MES to ERP to Cloud. The enhanced system can: Adapt to more packaging-line technologies and production management systems providing a more scalable solution Support full, turnkey, retrofit or OEM solutions with an updated Logixbased unit controller Integrate easily into existing systems with preconfigured order channels and EPCIS (Electronic Product Code Information Services) data exports Accommodate manufacturers with manual packaging lines with a pre-validated, optimized tool that supports manual serialization and aggregation workflow Utilize commercial off-the-shelf hardware and software that is modular, scalable and reusable Meet global standards and enable quicker production restarts Integrate open network and communication standards from device level (printing, vision and scanning) to the enterprise level Promote an open platform to interface with existing packaging equipment Accommodate authentication via mobile applications-no longer dependent strictly on scanners Adapt on a global scale, meeting current and future regulations The Rise of Serialization: What You Need To Know The rise of internet pharmacies. Under-regulated wholesalers and repackagers. Advances in counterfeiting technology. These are only a few of the opportunities that drug counterfeiters have seized upon to turn a profit at the expense of consumers health and manufacturers reputations. As a result, dozens of countries and regions around the world are rolling out serialization based, anti-counterfeiting regulations, including the United States, the European Union, Brazil, China and many more. Rockwell Automation has you covered. Our serialization solution is easily scalable to meet manufacturer s needs. Our serialization solution takes a holistic approach, giving both OEM s and end users a single solution to address current and upcoming regulations, product counterfeiting and product recalls for the pharmaceuticals and food and beverage industries. It can be a complete turnkey solution, from packaging to MES to ERP to Cloud or a scalable solution to where your current needs are today.

2 Advantages Regulatory Compliance Rockwell Automation serialization solution supports GS1 standard and unique device identifier. Open Architecture Based on Rockwell Automation Integrated Architecture control systems with a dedicated control network architecture to integrate line serialization equipment, the holistic serialization solution helps eliminate interoperability challenges at the shop floor and plant levels and connects seamlessly to the enterprise level and with the supply chain. It supports modular extension for any number of aggregation levels with all commissioned serialization and aggregation data that is stored in the plant s central database. Once the product ships from the plant to a warehouse, or to a downstream supply chain partner, the data transfers to the GS1 EPCIS-certified central database. Rockwell Automation recommends the Secure Azure Cloud platform from our Strategic Alliance Partner, Microsoft. Data Integration Adhering to the ISA-95 aligned data model, the solution provides segmentation of data processing and machine control, as well as serial number data generation and management. It allows end users to select their preferred OEM s and SI s. The interface to cloud-based secure storage enables central data sharing across multiple plants and a hub for supply chain partners once the product has left the facility. Data management includes a site server that is interfaced with other manufacturing and business systems. Our industry-proven Serialization Integration Gateway (SIG) supports the transfer of serialization data to thirdparty systems. Hardware Integration for Packaging Lines The solution is connected at Line Level to existing device management systems on site or a new Logix programmable automation controller (PAC) can be added to the print and verify stations with minimal impact to the machine validation. For new lines, the standard solution includes a line controller, a unit controller and HMI screens. Validation / Qualification Our global validation team has a vast range of experience in life science applications and processes. This allows them to help your quality, packaging, IT and engineering staff navigate the complexities that are related to validating a serialization application; keeping your project on track. Our validation services for serialization include: test plans, test specification, test protocols, test records, traceability matrix, risk analysis, change impact analysis and test reports. Many of our validation engineers participate actively on key professional committees staying up to date with new regulatory developments, reviews and decisions and how that progress might impact the serialization process. Production Critical Application Support Rockwell Automation 24/7/365 serialization application support services include secure remote system monitoring, periodic system health checks, customerspecific knowledgebase databases and emergency secure online system diagnostics to get the plant back in production.

3 Key Functionality Level 1 Serialization - Unit Controller Allen-Bradley (or third party PLC) is the hand of the Solution Unit Functionality Device Control Alarm Handling Unit Mode Selection According to Line Aggregation Configuration Print and Verify Module Requests Print Data Printing and Verifying Executes Product Tracking Request Children Consistency Check Trigger Ejection in case of Failure Sends Serialization and Aggregations Results IPC - User Interface Machine HMI (FTView SE Station) Starting, Stopping and Pausing the Machine Machine Status Machine Mode according to Line Aggregation Configuration Results of Print and Verify User Management Language Settings Level 2 Serialization Line Controller Allen-Bradley PLC Line Controller is the heart of the Solution Passes Configurations between Site Controller and Unit(s) Handles Synchronization between Unit(s) and Site Controller Requests and Passes Print / Serialization Data Executes Children Consistency Check Passes Parent-Child Relationships Acts as a Buffer of Contents and Results Manages the Good List between Aggregation Units

4 Level 3 - Site Server: PharmaSuite Site Server is the brain of the Solution PMC (Product Management Client) Manages Site Model Manages Serialization Master data Serial Ranges with Different Randomizers Manages Master Recipes that are defined by S88 Conform Recipes Line Aggregation Configuration: defines which units of the line are included in aggregation and which are running in Dry-Run mode Manages Packaging Orders with Serial Data Orders can be created manually or downloaded from ERP or MES systems PEC (Production Execution Client) Start and Stops the Serialization Order across the Units Allows Rework Back End Creates and Serves Serial Numbers on Demand Checks Consistence of Created EPC Data before a Packaging Order can be set to finished Mobile Client (MC) Allows Rework Interface to Line Controller PLC Passes Configuration and Synchronization Data Passes Print / Serialization Data Receive Serialization and Aggregation Results Interface to Level 4 & 5 Cloud-based Event Repository Serialization Integration Gateway (SIG) Pre-Configured Channel for Order Creation (ERP / MES Integration) Pre-Configured Channel for Commission and Aggregation EPICS data export

5 For More Information: Rockwell Automation can support your serialization projects whether it s a complete solution from end to end or working with your existing machines and system. For more information on your scalable solution, contact your Rockwell Automation sales representative or authorized partner. Or, go to: Serialization&docid=70836de446032b7247cdf88b5e81d8c1 Allen-Bradley, Integrated Architecture, LISTEN. THINK. SOLVE., Pharma Suite Site Server, and Rockwell Software are trademarks of Rockwell Automation, Inc. Trademarks not belonging to Rockwell Automation are property of their respective companies. Publication LIFESC-PP002B-EN-P April 2017 Supersedes Publication LIFESC-PP002A-EN-P October 2015 Copyright 2017 Rockwell Automation, Inc. All Rights Reserved. Printed in USA.