Important Notice: In order to efficiently obtain solutions, you must have a sufficient understanding of your product’s process. You need to provide a User Requirement Specification (URS) or a similar process description document. We will design the Process Flow Diagram (PFD) based on the URS or process description document provided by the client.
(If a URS cannot be provided, you can also request a template from the account manager for completion.)

Please read our service process below.

1. Preliminary discussion

1.1 Customers provide User Requirement Specification (URS), including operational needs, performance criteria, and regulatory compliance.
1.2 Taking into account workflow optimization, space utilization, and safety standards, develop a layout plan for the production facility.
1.3 Outline the equipment selection, including specifications, delivery time, and installation requirements.
1.4 Define the required instrumentation and control systems to ensure seamless integration with the overall process.
1.5 Prepare a comprehensive budget plan covering all aspects of the project.

2. Foundation design

2.1 Design process flow diagrams (PFD) and piping and instrumentation diagrams (P&ID) to include all major equipment, process lines, and control loops.
2.2 Develop an optimal layout design for the project, considering spatial requirements, workflow efficiency, and safety considerations.
2.3 Provide detailed specifications for the equipment, including agitation systems, sterilization units, sensors, and control systems.
2.4 Compile a list of all materials required for the project, including raw materials, components, and consumables.
2.5 Develop a validation plan outlining the procedures and protocols for validating the performance, quality, and compliance of the project, ensuring it meets regulatory and operational requirements.

3. Detailed design

3.1 Develop a comprehensive manual outlining the overall execution plan, including project scope, roles and responsibilities, schedule, and quality standards.
3.2 Detail the foundational drawings and documents (including: parameter tables, P&ID, 3D design drawings, construction drawings, etc.)
3.3 Conduct a comprehensive review of the design documents to ensure compliance with engineering standards, safety regulations, and client requirements.
3.4 Initiate the procurement process for the required project spare parts to ensure timely delivery.
3.5 Establish a robust quality management system to ensure that the required spare parts meet high standards.

4. Production and installation

4.1 Manufacture core equipment according to design specifications, with quality checks and inspections during the production process.
4.2 Assemble the components into a complete system unit and subject it to comprehensive testing to ensure the proper functioning of all components.
4.3 Compile the test results and findings into a testing report.
4.4 Strict packaging processes to ensure the safety of the goods. We take responsibility for any damage incurred during transportation and will provide free replacements to the customer.
4.5 Install the bioreactor on-site by technical personnel. Perform final tuning of the equipment at the installation site.

5. Project delivery

5.1 Provide certification services for compliance with GMP requirements such as FDA, EU, TGA.
5.2 The compilation of equipment operation and maintenance manuals, as well as a troubleshooting guide for common faults.
5.3 Provide training for employees of client companies on equipment operation as well as emergency response procedures.
5.4 Post-project evaluation and customer feedback, continued support and assistance.
5.5 Provide maintenance and spare parts, as well as remote or on-site maintenance.