Tokyo, Japan - October 23, 2020
Yokogawa Electric Corporation (TOKYO: 6841) announces the October 23 global release of the OpreX™ Environmental Monitoring System for the pharmaceutical and medical device industries. The new product is a data collection and recording system that records and manages environmental data such as temperature, humidity, and room differential pressure in pharmaceutical and medical device manufacturing, testing, and storage areas. This system makes use of Yokogawa paperless recorders that comply with Good Manufacturing Practice (GMP*1), Quality Management System (QMS*2), and other regulatory requirements and are installed at multiple locations around a plant. The new system reduces risk and aids pharmaceutical and medical device manufacturers in the performance of strict and efficient environment monitoring that ensures compliance with the various regulations and guidelines on operations at manufacturing sites.
In manufacturing, testing, and storage areas at pharmaceutical and medical device plants, the recording and management of environmental data such as temperature, humidity, differential room pressure, and particle count must be done in compliance with GMP, QMS, and other regulations that seek to ensure the correctness, comprehensiveness, completeness, and secure storage of this data*3. To streamline the management of environmental data measured at multiple locations in a factory, a unified approach is needed. Although data acquisition and storage could be performed by a general-purpose monitoring and control system, such a system would need to be configured to comply with regulatory requirements of various industries. Such a system would also have risk management problems because the data would be collected directly from sensors, and thus any kind of failure, such as power failure, sensor malfunctioning, or recorder capacity exhaustion could affect a broader scope of data. To address such issues, Yokogawa has developed the OpreX Environmental Monitoring System for the pharmaceutical and medical device industries.
This system consists of Yokogawa paperless recorders*4, a data server, and monitoring PCs.
Pharmaceutical and medical device industries
*1 Standards for production and quality management of the manufacturing of safe and effective pharmaceuticals. Each country sets its own regulations and guidelines.
*2 Standards for production and quality management of the manufacturing of safe medical devices and pharmaceuticals for in-vitro diagnostics. As with GMP, each country sets its own regulations and guidelines, including Japan's QMS ministerial ordinance on production management and quality management standards for medical devices. In addition, the ISO 13485 standard is applied internationally.
*3 The Ordinance for Enforcement of the Pharmaceutical Affairs Act specifies how documents on test results should be prepared. It requires test results that raise doubts about effectiveness and safety to be thoroughly examined and documented in a complete and comprehensive manner and requires the keeping of records that contain supporting information.
*4 GX10, GX20, GP10, GP20, and GM10 recorders in Yokogawa's OpreX Data Acquisition family are equipped with an optional security function that complies with the FDA's 21 CFR Part 11 regulations on electronic records and signatures and the ER/ES guidelines of Japan's Ministry of Health, Labour and Welfare
*5 Inspection work that is conducted when introducing computerized systems to make sure that there is no problem with hardware/software development, design, commissioning, operation, availability, etc.
*6 Based on GAMP®5: Risk-Based Approach to GxP Computerized Systems, it is the latest version of the Good Automated Manufacturing Practice (GAMP) standard on CSV procedures published by the International Society for Pharmaceutical Engineering, Inc. (ISPE).
OpreX is the comprehensive brand for Yokogawa's industrial automation (IA) and control business. The OpreX name stands for excellence in the technologies and solutions that Yokogawa cultivates through the co-creation of value with its customers, and encompasses the entire range of Yokogawa's IA products, services, and solutions. This brand comprises the following five categories: OpreX Transformation, OpreX Control, OpreX Measurement, OpreX Execution, and OpreX Lifecycle. The OpreX Environmental Monitoring System is part of the OpreX Data Acquisition product lineup, which is placed under the OpreX Measurement category. The OpreX Measurement category includes field equipment and systems for highly precise measurement, data collection, and analysis.
With this brand, Yokogawa will deliver integrated solutions that address specific needs and support its customers in their efforts to transform and grow their businesses.
Founded in 1915, Yokogawa engages in broad-ranging activities in the areas of measurement, control, and information. The industrial automation business provides vital products, services, and solutions to a diverse range of process industries including oil, chemicals, natural gas, power, iron and steel, and pulp and paper. With the life innovation business, the company aims to radically improve productivity across the pharmaceutical and food industry value chains. The test & measurement, aviation, and other businesses continue to provide essential instruments and equipment with industry-leading precision and reliability. Yokogawa co-innovates with its customers through a global network of 114 companies spanning 62 countries, generating US$3.7 billion in sales in FY2019. For more information, please visit www.yokogawa.com.
The names of corporations, organizations, products, services and logos herein are either registered trademarks or trademarks of Yokogawa Electric Corporation or their respective holders.
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