Biobay Bio is a full-platform, one-stop CDMO covering the entire CMC lifecycle of biologic drugs. The company operates multiple advanced technology platforms, including:
Microbial fermentation
Mammalian cell culture
Gene and cell therapy
XDC technologies
GMP manufacturing line engineering and customization
Supported by its proprietary PanFlex® engineering technology, Biobay Bio has built:
The world’s largest single-vessel 30,000 L stainless-steel bioreactor production line for mammalian cell culture
A 30,000 L high-cooling-capacity fermenter enabling ultra-high cell-density microbial fermentation
Founded in Boston, USA, in 2014, Biobay Bio now operates two global R&D centers and three GMP manufacturing facilities.
P01 GMP plant established in Shanghai in 2019
P02 GMP plant established in 2021
P03 GMP plant established in 2023
Two additional ultra-large GMP facilities (P04 and P05) have been launched and are scheduled to come online within the next 3–7 years.
As a leading biopharmaceutical CDMO, Biobay Bio operates high-grade GMP cleanrooms where time management plays a critical role in regulatory compliance, data integrity, and operational efficiency.
GMP & Regulatory Compliance
Regulations such as China GMP, FDA 21 CFR Part 11, and EU GMP Annex 11 require accurate, reliable timestamps for production, testing, and equipment operations, ensuring traceability and data integrity under ALCOA+ principles.
Cleanroom Compatibility
Clock devices must meet cleanroom classifications (Grade C, Grade B / Grade A background), featuring corrosion-resistant materials, dust-free surfaces, seamless structures, and flush or embedded installation to avoid contamination risks.
Unified Time Accuracy
Logs and records across different cleanroom functions—upstream processing, fill & finish, QC testing, and environmental monitoring—must remain highly synchronized to prevent audit findings.
High Reliability & Minimal Maintenance
Cleanroom maintenance is costly and restricted. Time systems must operate 24/7 with minimal intervention, eliminating frequent manual calibration.
Audit Readiness
Time displays must be clear and intuitive, with verifiable satellite-based time sources to support audit inspections.
To meet Biobay Bio’s stringent requirements, Changsha Tianqiong Electronics (Shutai®) delivered a cleanroom-specific embedded satellite-synchronized clock solution, deployed throughout GMP clean areas at the Shanghai facility.
Flush-mounted / embedded installation perfectly aligned with color steel panel walls
Seamless, gap-free structure with no hygiene dead zones
Smooth surfaces resistant to corrosion and compatible with standard cleanroom cleaning and disinfection procedures
Fully compliant with GMP cleanroom design principles
Clocks are powered via PoE and connected to the Shutai NTP Time Management Server
Time source synchronized through BeiDou/GPS dual-mode satellite signals
Ensures millisecond-level synchronization accuracy across all cleanroom areas and connected systems
Industrial-grade components with wide operating temperature tolerance
Built-in OCXO (Oven-Controlled Crystal Oscillator)
Maintains ultra-high time accuracy even during temporary satellite signal loss
Daily drift far exceeds GMP requirements, significantly reducing dependency on external signals
Supports 7×24 continuous, failure-free operation
High-brightness LED or LCD displays
Clearly shows HH:MM:SS and YYYY-MM-DD
Readable under cleanroom lighting conditions
Clean, regulation-compliant display format without unnecessary information
Fully automatic synchronization eliminates manual calibration
Prevents contamination risks associated with personnel entering cleanrooms for clock adjustment
Satellite time source is traceable and auditable, providing objective evidence for inspections
Full GMP Compliance
Accurate, unified timestamps across all cleanroom operations support ALCOA+ data integrity requirements and withstand regulatory audits.
Zero Manual Calibration
Automated synchronization eliminates human error and reduces cleanroom access frequency.
High System Reliability
Stable 24/7 operation meets the demands of continuous biopharmaceutical manufacturing.
Improved Audit Readiness
Clear displays and traceable satellite time sources simplify audit verification.
Scalable for Future Expansion
The solution supports Biobay Bio's rapid capacity growth and upcoming GMP facilities.
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