Automated solutions to optimize production and shorten product launch times

Finding the best solution

Roche has more than 10 years of successful cooperation with Rockwell Automation Propack Data. Based on these successful cooperation and system evaluations, Roche Nicholas SA decided to select the most suitable automation solution for them – Propack Data PMX MENSTM for upgrading and extending its existing Manufacturing Execution System (MES). This decision was made after their comprehensive assessment of MES suppliers worldwide. The key reason they chose Rockwell Automation is: Propack Data PMXTM is a full-featured tool that covers the entire range of drugs from the material receipt process to the final product. The production cycle, and the company can get a pre-verified system from a single supplier. In this project, its core goals are: to optimize production, shorten the time for the products to be put on the market, and to fulfill the requirements of various regulations.

Roche Nicholas is a subsidiary of the Roche Group in France and is currently designated as a strategic production base of the Roche Group. It is positioned as a “high-output, high-operativity factory”. However, the current site-level MES system is a customized non-standard MES. The system was installed 10 years ago. It is not only backward in technology, but it is also nearing the end of its service life. There is a lack of coherence and consistency among the various parts, and its operating and maintenance costs are getting higher and higher. More importantly, the technology of 10 years ago could not meet the urgent need of Roche to implement the production strategy into the workshop system. This requires Roche Nicholas to find an effective solution to replace non-standard MES.

With the new integrated integrated system, Roche hopes to achieve a higher goal: to use automation to assist in production planning, management and tracking during the production process. This project covers Y2000 and GMP procedures and version control, configuration configuration access, and audit trail. In addition, it also plans interfaces with SAP R/3 and other existing production systems.

Solution successfully implemented

After submitting the overall requirements, Roche collaborated with Propack Data experts to formulate the specific framework concept of the project. The entire project is divided into two phases, starting from April 2001 and ending in November 2002.

The first phase is the project start-up phase. The Rockwell Automation Propack Data expert develops the overall project plan according to the requirements of Roche, and then proceeds to prepare further documents, such as specific procedures, system test reports and acceptance reports. These documents are: The foundation for the subsequent step-by-step implementation of the project and the verification of the system components. Roche achieved the following functions at this stage: With the support of the IT department, the interface with the SAP system was completed; with the Propack Data PMX Recipe MESTM system, the version control of the pharmaceutical formulation and shop floor master data was performed; using Propack Data PMX The Schedule MESTM system supports SAP R/3 "rough capacity planning" for the entire production chain (from weighing to packaging). After the "Function and Specification (FTS)", including the confirmation of the entire software system, was approved, the first phase of the work was announced.

The second phase of the main work is to achieve the functions related to process processing, including the following functional modules:

1. Adopt Propack Data PMX Warehouse MESTM system to complete logistics management and warehouse control, integrate with a warehouse automation system that implements transportation, storage and abandonment through a set of interfaces;
2. Use Propack Data PMX Dispense MESTM system to complete the weighing and dispensing work;
3. Use Propack Data PMX Dispense MESTM system to complete the evaluation of production data, create batch processing documents, and monitor production instruction execution and production lines through interfaces with on-site automation control systems and visual interfaces;
4. Deviation processing;
5. Meet the GMP requirements of the logistics control (MFC).

Throughout the project implementation process, Propack Data's engineers worked closely with Roche's employees to carefully consider the state of the existing system and the state of the planning system, thereby developing the most suitable automation solution for Roche. In addition to providing technical solutions and verification services, Propack Data engineers also provide Roche with continuous field services including: knowledge transfer, technical guidance, training for key users, and data migration. Prior to the start of the entire system in November 2002, Propack Data engineers performed precise system testing and acceptance procedures to ensure the successful operation of the entire system.

Since running on November 12, 2002, Roche Gaillard's Propack Data PMX MESTM system has never experienced a major failure. Mr. Robert Fretz, the MES project leadership committee of Roche Group and its global MES system manager said: “The Roche Group is very satisfied with the project. The new system has greatly accelerated our workflow!” Mr. Michel Doucet, product manager of Roche Gaillard Praised: "This system is much more convenient than previous systems in terms of user access rights, production planning, and operational tracking. In addition, these further enhanced system functions, consistent procedures, and continued improvement None of the possibilities will increase the cost of IT."

Source: Industry Packaging Solutions