中文
Tender Hall 
Resource CenterEPC for Biopharmaceutical
BusinessEPC for Biopharmaceutical
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Service introduction
Tianjushi Group has many qualifications such as Class A design in chemical, petrochemical and pharmaceutical industry, Class A design in construction industry, Class A general contract for mechanical and electrical installation engineering construction, and Class A general contract for construction engineering construction. Adhering to the concept of "quality comes from design", Tianjushi Group is deeply focusing on areas such as biopharmaceuticals, medical devices and laboratories. The business unit is dedicated to providing biopharmaceutical companies with one-stop general contracting solutions including professional consulting, designing, purchasing, construction and GMP regulation services.
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Business Scope
- Engineering consultation
- Engineering design
- Mechanical and Electrical Installation Engineering
- Architectural Engineering
- GMP Plant Structure
- Clean Room Ventilation System
- CleanPiping
- Commissioning
- Test
- Validation
- Process Automation
- Utility automation
- Factory Informationization
- Electrical equipment handover test
- Preventive test of electrical equipment
Expert Team
The design team not only has many years of work experience in major domestic medical design institutes, but also has many years of experience in internationally renowned engineering companies, and has cooperated with engineering companies in the United States, Europe, and Australia.
The core members of the team have more than 20 years of experience in the medical design industry, including technical consulting, engineering, design, project management and other fields. The team has design experience in international engineering projects and has participated in many large-scale pharmaceutical projects.
Advantage of Service
Provide professional one stop service from consulting, design, procurement, construction to GMP consulting
Insight into customer needs, understanding of production processes, starting from GMP compliance, focusing on energy conservation, environmental protection and intelligent manufacturing, meeting customer needs from the initial design stage of the project to the implementation process of the project, and focusing on the guarantee of customer's plan, investment and progress
The Biopharmaceutical Business Unit of Tianjushi provides delivery documents in accordance with international standards and national regulations
In the conceptual design and basic design phases, documents such as mass balance & PFD, staff scheduling, public engineering consumption table, room list, bill of quantity and validation compliance
In the detailing phase, 3D modelling will be designed with BIM, providing drawings meeting construction requirements
cGMP Audits
FDA Review Meetings
URS and Risk Assessment
Validation Master Plans
Protocol Generation and Execution
Cleaning/Sanitization,and Sterilisation Validation
Typical Case
With a global engineering perspective, it has participated in and led the construction of nearly 100 pharmaceutical factory facilities that meet the requirements of China's new version of GMP, FDA and EMA. It has already had industry representative cases in macromolecular biological drugs and high-activity products, especially in the fields of new biological agents such as monoclonal antibodies, vaccines, insulin, cell therapy and gene therapy.The implementation of the project adopts the international project management mode to provide the owner with advanced project management.