【虹科方案】虹科 elproMONITOR 有線溫濕度監測系統 – 醫療器械與 GMP 合規解決方案 - 虹科電子有限公司

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[Hongke Solutions] elproMONITOR Wired Monitoring System: Helping Medical Device Companies Achieve Compliance in Production and Storage Environments

With the rapid development of the medical device industry and the continuous tightening of regulatory standards, ensuring that production and storage environments comply with industry regulations has become a core challenge for companies. For medical device manufacturers, key parameters in the production environment—such as temperature and humidity—must be continuously monitored to maintain stable environmental conditions while meeting requirements for data integrity, traceability, and quality management systems.

Against this complex backdrop, Yipai Sheng Medical Device Manufacturing (Changzhou) Co., Ltd. has chosen to introduceelproMONITOR Wired Automatic Temperature and Humidity Monitoring System, to effectively meet strict and complex environmental control requirements.

01 Customer Profile

As a leading global developer and manufacturer of self-injection and infusion systems, Ypsomed, based in Switzerland, is internationally renowned for its diabetes solutions. Its client portfolio includes well-known companies such as AstraZeneca, Bristol-Myers Squibb, Pfizer, Roche, Genentech, and Dongbao. Ypsomed Medical Devices Manufacturing (Changzhou) Co., Ltd., located in the Life and Health Industry Park of the Changzhou High-Tech Zone, is the company’s key production base in the Asia-Pacific region. With a total investment exceeding 40 million euros, the company primarily engages in the research, development, production, and assembly of medical injection pens and related needle products.

As the Changzhou plant moves toward full automation, large-scale manufacturing, and the Industrial 4.0 smart factory model, the company urgently needs to establish a stable and reliable environmental monitoring system to continuously manage various key environmental parameters throughout the production process.

02 Needs and Challenges

Driven by the trends of “Smart Manufacturing” and “Industry 4.0,” Yipai Medical Device Manufacturing (Changzhou) Co., Ltd. has set stricter requirements for production environment control and data monitoring. Its environmental monitoring system must meet the following core requirements:

Continuous Temperature and Humidity Monitoring and Compliance Requirements The production of medical devices must comply with GMP(Good Manufacturing Practice for Pharmaceutical Products),FDA 21 CFR Part 11 ...and other international standards to ensure that temperature and humidity in cleanrooms and assembly workshops remain highly stable.
Smart Alarms and Real-Time Response Mechanisms The system must be equipped with fully automated monitoring capabilities that trigger immediate alarms when temperature and humidity exceed preset ranges, ensuring that the relevant personnel can take timely corrective actions to prevent environmental fluctuations from affecting product quality.
Data Integrity and Traceability The environmental monitoring system must comply with FDA 21 CFR Part 11 Standards that ensure the authenticity, integrity, and traceability of data. Monitoring data should include features such as tamper-proofing and audit trails, and should support real-time data collection and storage.

03 Solutions

Hongke elproMONITOR Wired Automatic Temperature and Humidity Monitoring System

elproMONITOR Software The elproMONITOR software integrates seamlessly into users’ existing IT infrastructure and databases and is suitable for monitoring hundreds to thousands of measurement points. The software is primarily used to manage measurement data, alarm messages, and monitoring reports, and provides an intuitive, user-friendly interface that helps users quickly grasp environmental conditions, address anomalies, and perform compliance verification. Through a digital data management model, enterprises can effectively reduce manual record-keeping and significantly improve the reliability and traceability of environmental monitoring data.
The Six Major Modules Monitored by ECOLOG-PRO

04 System Advantages

1. Compliance and Safety

Comply with GMP,GLP,GAMP5,FDA 21 CFR Part 11,Annex 11 up to HACCP Standard.
Enables fully automated data monitoring, control, report generation, data archiving, and anomaly alerts.
Identify potential problems early to prevent product damage and property loss.

2. High Quality and Cost-Effectiveness

Equipped with high-precision, highly stable measurement equipment and software.
A Swiss-engineered system with a low total cost of ownership (TCO) that comprehensively covers R&D, production, and storage facilities.
We provide professional technical support and maintenance services, and can offer customized solutions based on your needs.

3. Efficient office work and increased productivity

With convenient setup and remote access features, it makes it easy to comply with various regulatory audits.
With robust user management, automated notifications, and report generation capabilities, it is suitable for facilities of all sizes.
Comprehensively record all key environmental parameters to fully implement digital and paperless management.

4. Comprehensive Temperature Monitoring Solutions

furnish GxP Consulting and Validation ServicesThe
We provide professional, compliance-driven project and calibration services.
It is global Top 50 Pharmaceutical CompaniesA Trusted Partner.

05 Customer Reviews

With its precise data collection, real-time alerts, and reliable data management capabilities, Hongke’s elproMONITOR Wired Automatic Temperature and Humidity Monitoring System has successfully helped Yipai Sheng achieve automated data collection, centralized management, and anomaly response for its production environment, significantly improving environmental monitoring efficiency and data reliability.

"We are very satisfied with the actual performance of the elpro wired monitoring system in our factory. The installation process went extremely smoothly, and the system is easy to operate and offers comprehensive functionality. In particular, it provides robust support for real-time temperature and humidity monitoring and data logging, enabling us to maintain full control over the production environment throughout the entire process. The system’s alarm function is highly responsive, helping us identify and resolve potential environmental issues immediately, thereby effectively ensuring the quality and safety of every batch of medical devices.”

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