Assignment
- With the opening of a new plant, it is necessary to introduce a manufacturing execution system that meets pharmaceutical quality requirements.
- It is essential to streamline the process of creating manufacturing records and go paperless in compliance with GMP (Good Manufacturing Practice) for pharmaceutical manufacturing.
- The MES introduced to achieve complete automation requires automatic coordination with various manufacturing equipment such as ERP and DCS (Distributed Control System).
Installed products/solutions
Manufacturing execution system for the pharmaceutical industry “Werum PAS-X MES”
Project background
Based on the vision of "Creating the future from glycerin," Sakamoto Pharmaceutical Co., Ltd.'s core business is the development, manufacture, and sale of 100% plant-based glycerin and its derivatives. The Senboku factory in Osaka functions as the company's core base for glycerin production. The factory has ISO9001, ISO14001, pharmaceutical and food additive manufacturing licenses, and the RSPO (Roundtable on Sustainable Palm Oil) supply chain certification system MB (Mass Balance) model, which guarantees sustainable palm oil production. ” certification, etc., and is stably manufacturing and supplying high-quality glycerin products. Additionally, in February 2022, the company began operating a new plant, the 2nd RG Facility, which has a production capacity of approximately 20,000 tons per year.
“What the Senboku Factory is pursuing is not only to stably produce high-quality glycerin products with excellent environmental performance, but also to increase production efficiency by making full use of digital technology and data, and ultimately to improve manufacturing efficiency. Our goal is to achieve full automation.The new plant we built with this purpose in mind is the 2nd RG facility,'' explains Yoshihiro Mine, plant manager of the Senboku Plant.
One of the systems adopted in the 2nd RG facility to improve production efficiency is the "Werum PAS-" manufacturing execution system (MES) specialized for the pharmaceutical industry, for which B-EN-G provides implementation support services. X MES” (hereinafter referred to as “PAS-X”).
Effects of introduction
- A GMP-compliant plant was completed by utilizing PAS-X, a package specialized for the pharmaceutical industry.
- Achieved automatic collection of manufacturing performance data from manufacturing equipment and paperless manufacturing records.
- Achieving automatic linkage between ERP and various manufacturing equipment and PAS-X, creating an environment where manufacturing can be started with touch operation on a tablet, and realizing manufacturing automation.
- ``Use of reliable MES'' also contributes to the audit response of the pharmaceutical company we supply to
Introduction points
- A project management officer will be appointed within the project and a system will be established to coordinate multiple participating vendors.
- Adoption of PAS-X, which has a rich track record of implementation in the pharmaceutical industry
- Support from B-EN-G, which has extensive knowledge and experience in pharmaceutical manufacturing and computerized system validation (CSV).
*Organization names, positions, numerical data, etc. in the article are as of the time of the interview. It may have changed by the time you view it. note that.
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