Located in Shanghai’s Xinzhuang Industrial Zone, the company operates GMP-certified plant and equipment. Thanks to its R&D platforms for biological extraction, micro-organism fermentation and chemical synthesis, Shanghai Techwell Biopharmaceutical is able to independently research and develop a wide range of challenging APIs.
Its main products include human chorionic gonadotropin (HCG), human menopausal gonadotropin (HMG), follicle stimulating hormone (FSH), prostaglandins, antifungals and intermediates. The company’s biochemical and fermentation series products enjoy a strong reputation in both domestic and foreign markets.
The challenge
Shanghai Techwell Biopharmaceutical implemented the Kaye LabWatch LT Continuous Monitoring System to regulate plant temperature and humidity levels in accordance with Good Manufacturing Practices for pharmaceutical products. The Kaye LabWatch system’s temperature and humidity sensors allow facility personnel to monitor and control critical environmental conditions to ensure safe, compliant pharmaceutical production.
In addition, Kaye LabWatch system’s monitoring, alarming and data collection capabilities enhance the efficiency of plant air conditioning systems, helping Shanghai Techwell Biopharmaceutical to conform to central government initiatives for ecofriendly and energy saving operations.
If plant temperature or humidity levels were to deviate from acceptable standards, Shanghai Techwell Biopharmaceutical would be forced to scrap work in process, resulting in delayed shipments to customers, significant financial losses and potential reputation damage.
What’s more, energy efficiency could be compromised — driving up costs and causing adverse environmental impact. Given these high-stakes risks, the company needed a way to keep its Kaye LabWatch system up and running — all the time — for energy efficient production under the proper environmental conditions.
The solution
After evaluating a number of high availability solutions, Shanghai Techwell Biopharmaceutical selected the Stratus ftServer system, a fully integrated, continuously available hardware and software solution that’s ideal for running business-critical manufacturing operations and control applications.
The Kaye LabWatch system runs on a single ftServer 2800 system located in the company’s Tian Wei Station data centre.
Leveraging state-of-the art Intel Xeon processor technology, ftServer provides continuous application availability with advanced lockstep technology and real-time management and monitoring. The ftServer system is made up of two identical customer replaceable units (CRUs) — each with its own processors, memory and storage.
Patented lockstep processing ensures that no transactions are lost — even in the event of a hardware component failure — and multipath I/O failover protects against data corruption. All redundant components and subsystems are packaged as a single unit, simplifying ongoing system management and reducing software licensing fees.
Given the need for continuous processing in the high-cost and strictly regulated pharmaceutical manufacturing environment, ease of serviceability was also a key selection criterion. The ftServer system is designed for serviceability with hot-swappable CRUs that can be removed without powering down the system and replaced without using special tools.
The CRUs are automatically resynchronised when reinserted and the system continues to run without interruption.
When Shanghai Techwell Biopharmaceutical factored in acquisition, deployment, management and unplanned downtime costs, it became clear that ftServer was the best choice for achieving continuous availability, high reliability and simplified operation and management for the lowest total cost of ownership.
The results
Since deploying the ftServer system, Shanghai Techwell Biopharmaceutical has achieved continuous availability of its Kaye LabWatch system, allowing the company to produce high-quality APIs and pharmaceutical intermediates — without interruption — in optimal environmental conditions.
The ftServer 2800 system’s smaller footprint and low energy consumption meet the firm’s ecofriendly standards as well as government mandates for energy efficient operations.
In addition, the ftServer system was remarkably easy to deploy — with no ISV application modifications or failover scripts required — enabling the company to achieve faster time to value. Automated self-monitoring, self-diagnosing,and alerting capabilities simplify ongoing management for significant time and cost savings.
Combining high reliability, energy efficiency and ease of operation, the ftServer system has enabled Shanghai Techwell Biopharmaceutical to achieve continuously stable operation of its temperature and humidity monitoring system for always-on pharmaceutical manufacturing that meets the highest quality and safety standards.