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Engineering Operations
Engineering Operation
Factory Design and Construction
We provide comprehensive and compliant design and engineering construction, taking into account factors such as budget, civil works, processes, environment, and safety regulations to deliver reasonable and standardized designs (including feasibility study, conceptual design, basic design, and detailed design) and construction.
Traditional factory construction model
Modular Construction
Procurement and Validation of Production Facilities and Equipment
Choose facilities and equipment that are economical, practical, and well-suited to the products.
Select appropriate equipment based on layout, product characteristics, process flow, and capacity to meet production volume, quality, safety, and regulatory requirements.
Value-Added Services
Integrate regulatory compliance strategies into the design, ensuring rational allocation of resources under the premise of compliance. Provide reasonable recommendations or planning for the establishment of the Quality Management System (QMS).
Provide technical support for production processes
Ensure the best solution is developed
Ensure product quality while achieving optimal production efficiency.
Biological Facility Case
Based on the QbD approach and in alignment with regulatory requirements from CFDA, FDA, and the EU, process characteristics and compliance strategies are integrated into the design. This ensures regulatory conformity while enabling rational resource allocation, avoiding unnecessary pursuit of overly stringent standards, and ultimately fulfilling the needs of customers and stakeholders more effectively.
Our company has extensive experience in the design of specialized production lines, including those for highly potent small molecule drugs, antibody biologics, and insulin. Specific case studies are available for reference.
