Qualification Certificate
The company has obtained ASME U Stamp, NBBI certificate, PED certificate, ISO9001 Quality Management System certificate, as well as over 50 patent certificates.
Customized services
Why Choose BAILUN
Qualification Certificate
The company has obtained ASME U Stamp, NBBI certificate, PED certificate, ISO9001 Quality Management System certificate, as well as over 50 patent certificates.
Qualification Certificate
The company has obtained ASME U Stamp, NBBI certificate, PED certificate, ISO9001 Quality Management System certificate, as well as over 50 patent certificates.
Qualification Certificate
The company has obtained ASME U Stamp, NBBI certificate, PED certificate, ISO9001 Quality Management System certificate, as well as over 50 patent certificates.
Customer Case
BAILUN BIO BLBIO 10KL yeast fermentation plant with upstream and downstream
20KL GMP standard workshop provided by BAILUN BO blbio
500L 5000L bioreactor system for Drug Substance provided by BAILUN bio blbio
Drug Substance Manufacturing workshop provided by BAILUNBIO BLBIO
how to cooperate
Please read our service process below.
1.1 Provide URS
Customers provide User Requirement Specification (URS), including operational needs, performance criteria, and regulatory compliance.
1.2 Factory layout plan
Taking into account workflow optimization, space utilization, and safety standards, develop a layout plan for the production facility.
1.3 Equipment plan
Outline the equipment selection, including specifications, delivery time, and installation requirements.
1.4 Instrumentation & Control
Define the required instrumentation and control systems to ensure seamless integration with the overall process.
1.5 Budget
Prepare a comprehensive budget plan covering all aspects of the project.
2.1 PFD and P&ID design
Design process flow diagrams (PFD) and piping and instrumentation diagrams (P&ID) to include all major equipment, process lines, and control loops.
2.2 Layout design plan
Develop an optimal layout design for the project, considering spatial requirements, workflow efficiency, and safety considerations.
2.3 Equipment specifications
Provide detailed specifications for the equipment, including agitation systems, sterilization units, sensors, and control systems.
2.4 Bill of materials
Compile a list of all materials required for the project, including raw materials, components, and consumables.
2.5 Validation plan
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.
3.1 Project execution manual
Develop a comprehensive manual outlining the overall execution plan, including project scope, roles and responsibilities, schedule, and quality standards.
3.2 Detailed drawing documentation
Detail the foundational drawings and documents (including: parameter tables, P&ID, 3D design drawings, construction drawings, etc.)
3.3 Design document review
Conduct a comprehensive review of the design documents to ensure compliance with engineering standards, safety regulations, and client requirements.
3.4 Spare parts procurement
Initiate the procurement process for the required project spare parts to ensure timely delivery.
3.5 Quality management
Establish a robust quality management system to ensure that the required spare parts meet high standards.
4.1 Equipment production
Manufacture core equipment according to design specifications, with quality checks and inspections during the production process.
4.2 Assembly test
Assemble the components into a complete system unit and subject it to comprehensive testing to ensure the proper functioning of all components.
4.3 Test report
Compile the test results and findings into a testing report.
4.4 Packing & Delivery
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 Installation
Install the bioreactor on-site by technical personnel. Perform final tuning of the equipment at the installation site.
5.1 Verification
Provide certification services for compliance with GMP requirements such as FDA, EU, TGA.
5.2 Maintenance manual
The compilation of equipment operation and maintenance manuals, as well as a troubleshooting guide for common faults.
5.3 Operational training
Provide training for employees of client companies on equipment operation as well as emergency response procedures.
5.4 Return visit
Post-project evaluation and customer feedback, continued support and assistance.
5.5 Maintenance
Provide maintenance and spare parts, as well as remote or on-site maintenance.
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.)
Partners
Point Of Concentration
BAILUN Bio focuses on the biopharmaceutical and bioengineering industries, and its production services include: R&D, design, manufacturing and verification of high-standard sanitary containers and modular process equipment;
Learn more from our FAQ
Do you have overseas installation service?
Answer:
Yes. We have.
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How is the MOQ?
Answer:
1 unit.
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Do you accept customize or OEM?
Answer:
Yes.
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Are you Manufacturer of Trade company
Answer:
We are manufacture.
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