Background
Hefei Yifan Biopharmaceutical is a high-tech pharmaceutical manufacturing enterprise focused on innovative biologics production. With RMB 1.8 billion invested in its GMP facility located in Hefei Taohua Industrial Park, the company operates a modern production base compliant with:
U.S. FDA cGMP
European Union EuGMP
China GMP for Biopharmaceutical Cleanrooms (A/B class zones)
In biologics manufacturing, time synchronization is a core compliance factor. Every production event, environmental change, and batch record must be timestamped with absolute accuracy to ensure:
Regulatory traceability
Batch consistency
Data credibility
Audit readiness
Yifan identified a need for a cleanroom-safe timing system capable of precise synchronization without particle shedding, corrosion, or electromagnetic drift.
| Challenge | Impact |
|---|---|
| Time traceability & batch records | Even small time deviations create traceability risks across MES, EMS, and BMS systems. |
| Cleanroom contamination control | Traditional clocks shed particles, trap dust, or deteriorate under alcohol/ozone sterilization. |
| Electromagnetic interference | Automated filling lines and HF equipment cause clock drift in standard electronics. |
| Regulatory compliance | Requires clean design aligned with FDA 21 CFR Part 11 and global GMP documentation standards. |
Fully sealed stainless steel enclosure with zero-gap anti-particle structure
Explosion-proof & anti-corrosion housing for A/B-class sterile zones
Certified against alcohol, hydrogen peroxide (H₂O₂), and ozone sterilization
High-brightness LED suitable for yellow-light environments (photolithography zones)
Beidou + GPS Dual-Satellite Time Source
NTP Network Time Service for Local Redundancy
4G Wireless Backup for Failover Protection
Clock accuracy maintained within ±50ms across the plant
Optional environmental data binding (temperature, humidity, pressure)
Data stream delivery via Ethernet / Wi-Fi to MES or EMS platforms
Compliant with FDA 21 CFR Part 11 electronic records requirements
Flushed embedded installation prevents dust accumulation
Remote diagnostics, fault alarms & cloud configuration
Servicing cycle extended to 5+ years, reducing annual maintenance cost by 40%
| Benefit | Outcome |
|---|---|
| Regulatory Compliance | System passed GMP audit and supported EuGMP certification. |
| Production Efficiency | Batch record consistency improved by 30%, reducing audit review time. |
| Cost Reduction | Maintenance cycle extended 5 years; OPEX reduced 40% annually. |
| Operational Accuracy | Time error controlled within ≤50ms across cleanroom environments. |
This deployment was recognized as a “Cleanroom Time Management Benchmark Case” at the China Chest Pain Center / Pharmaceutical Engineering Technology Conference.
SHUTAI has specialized in precision time-frequency system engineering for 14 years, serving medical and pharmaceutical sectors worldwide. Our technology supports cleanrooms, hospitals, automation lines, and regulated GMP environments with high-accuracy, low-maintenance synchronization systems.
Representative Clients:
Bayer • AstraZeneca • Fosun Pharma • Kelun Pharmaceutical • Asymchem • Yifan Pharmaceutical
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