Reliable OT Data at Humanwell Pharmaceutical.
Pharmaceutical manufacturing depends on precise and repeatable processes. Parameters such as temperature, pressure, machine speed, and raw material ratios can affect both product quality and regulatory compliance. An incorrect setting may compromise an entire production batch.
Yichang Humanwell Pharmaceutical uses an AMDT software solution to manage critical equipment data centrally, automate backups, and document program changes. This gives production, quality, and development teams greater control over system configurations and supports a faster recovery from equipment failures.
The challenge: Controlling critical production parameters.
Yichang Humanwell manufactures anesthetic and other controlled pharmaceutical products. Its production processes must meet strict requirements at every stage, from dosing raw materials and configuring equipment to packaging and storage.
Previously, employees configured system parameters manually and verified them through several control steps. Documenting changes required considerable effort. It was also difficult to maintain a transparent record of parameter adjustments made during production.
Humanwell needed a central solution that could protect critical equipment data, document changes, and help teams demonstrate that production systems were operating with the intended configurations.
The solution: Centralized management and automated backups.
Humanwell selected the AMDT solution in 2019 and implemented it on a new production line for freeze-dried emulsions in 2020.
The software centrally manages device programs and configurations, creates automatic backups, and records changes. This gives authorized teams access to current and previous system states without relying on manually maintained files or documentation.
When a PLC fails or a production system stops, maintenance teams can retrieve the required program data and use it to restore operations. The centrally stored versions reduce the time spent searching for suitable files and help teams return equipment to a known state.
By introducing the AMDT solution, we are minimizing the risk of PLC-failures that affect the quality of the medicines. This data management and change-software enables us resolve production stop issues and resume production as quickly as possible.
Yichang Humanwell Information Center, Responsible for research and development laboratory, quality management laboratory and all information in production
The result: Greater control over critical production data.
By centralizing equipment programs and configurations, Humanwell creates a more reliable foundation for production, quality management, and product development.
The benefits include:
- automated backups of critical equipment data,
- centralized access to current and previous versions,
- transparent documentation of program changes,
- direct comparison of production parameters,
- less manual effort for documentation and data management,
- faster access to validated process configurations,
- reliable data for restoring production equipment,
- improved traceability across regulated processes.
