Genfarma Factory is designed with a modern manufacturing system covering solution manufacturing, filling, lyophilization, packaging, and quality control testing.
Modern factory system, equipment, and processes
Genfarma Factory is introduced as a manufacturing and quality control facility organized around key stages: solution manufacturing, filling, lyophilization, packaging, and quality control testing.
The production lines are designed with synchronization, automation, and data control capabilities throughout operation. Automatic control and monitoring systems are applied across multiple manufacturing stages, with an operational direction aligned with requirements for electronic records, electronic signatures, audit trails, and data integrity under 21 CFR Part 11 and GAMP 5.
Manufacturing Process
Solution Manufacturing
The solution manufacturing area is equipped with stainless steel 316L vessels, including 14 mobile vessels and 7 fixed vessels, with capacities ranging from 20L to 1,000L.
The vessels are designed with heating/cooling jackets and magnetic mixers to support temperature control and solution mixing during manufacturing.
The system is automatically controlled and monitored, supporting data management, electronic records, electronic signatures, audit trails, and data integrity in alignment with 21 CFR Part 11 and GAMP 5.
Filling
The filling line is designed as a synchronized system, including:
- Vial washing machine.
- Depyrogenation tunnel.
- Vial filling and stoppering machine.
The system has a maximum speed of 400 vials/minute. Vial sizes from 2R to 35R can be changed using suitable change parts.
The filling stage is operated through an automatic control and monitoring system, supporting process control and operational data management.
Lyophilization
The lyophilization area is equipped with 3 lyophilizer units, integrated with an automatic vial loading and unloading system.
Each unit has a capacity of 89,000 vials/unit.
The lyophilization process is automatically controlled and monitored, supporting data recording, electronic records, audit trails, and data integrity in alignment with 21 CFR Part 11 and GAMP 5.
Packaging
The packaging line is designed as a synchronized system, including:
- Automatic inspection machine.
- Vacuum leak test machine.
- Labelling machine.
- Cartoning machine.
- Online weighing checker.
- Case packer machine.
The system has a maximum speed of 400 vials/minute. Vial sizes can be changed using suitable change parts.
The packaging stage is automatically controlled and monitored, supporting packaging process control and operational data management.
QC Laboratory
The factory includes a QC Laboratory to support quality control testing activities in accordance with established operational procedures.
The QC Laboratory supports the inspection, monitoring, and evaluation of quality-related parameters for raw materials, intermediate products, finished products, or in-process samples, depending on the established procedures.
Operational Direction
Genfarma Factory is introduced with the following operational direction:
Scientific - Precise - Standardized
Reflected in the equipment system, manufacturing processes, and data control capabilities across each production stage.
Pioneering - High Technology - Self-reliant
Reflected in the automated manufacturing system, synchronized production lines, and equipment capacity across solution manufacturing, filling, lyophilization, and packaging.
Reliable - Transparent - Responsible
Reflected in the automatic control and monitoring systems, data recording, audit trails, electronic records, and electronic signatures.
Human-centered - For Vietnamese Health
Reflected in the direction of developing manufacturing and quality control capabilities in the biopharmaceutical field, based on technology, compliance, and professional responsibility.