Pilot & Industrial Scale cGMP Compliant Suspension Cell Bioreactor with CIP/SIP for Mammalian Cell Culture & Vaccine Production

Product Description

Product Description
Product Overview
CIP Station
CIP station is a set of independent process module. Its working mode is usually passive mode. Shanghai RITAI supplies single, double or multiple tanks structure in fixed or mobile type according clients' process. In addition, it is capable of heating, feeding acid or base agent, etc.
The cleaning process adopts full-automatic methods. Clients is able to adjust formula flexibly to satisfy different requirement of process through HMI and graphical display. In addition, clients is able to adjust process parameters such as cleaning time, pressure, flow rate, temperature, etc. It is capable of automatic preparation of agent and automatic check of cleaning effect. All operations will be recorded, which facilitates system authentication.
CIP Station Details
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Company Profile
Shanghai Ritai Facilities
With more than 25 years of industry experience, Shanghai Ritai focuses on providing comprehensive modular engineering services in the fields of biopharmaceuticals, bioengineering and life sciences. This includes all aspects from design to manufacturing to installation and commissioning, ensuring that our services meet the cGMP standards set by SFDA, FDA, WHO and the European Union, and providing complete verification support. In addition, we provide customers with design, manufacturing, installation, commissioning, training and after-sales services that comply with GB, ASME, PED and other standards and specifications. The products are produced in strict accordance with GMP and FDA requirements, and the quality indicators have reached the international advanced level. Performance, appearance, Both longevity and service enjoy a good reputation in the market.
Production workshop
Production workshop
Automatic polishing and welding
Automatic polishing and welding
Manual welding
Manual welding
Continuous laser welding
Continuous laser welding
Product warehouse
Product warehouse
Assembly workshop
Assembly workshop
Certifications
Certifications and Compliance
Our Advantages
Validation Service
Ritai team members have rich pharmaceutical validation & consulting background, and have good knowledge of domestic and international GMP and rich practical experience, with strong ability to provide GMP (FDA, EU , TGA, CFDA) required validation service.
Validation Service Overview
The verification services we provide include but are not limited to:
VMP: Validation Master Plan OQ: Operation Qualification
21 CFR Part 11 Assessment PQ: Performance Qualification
GXP Impact Assessment RTM: Requirements Traceability Matrix
SIA: System Impact Assessment Deviation Analysis
CCA: Critical component Assessment RA: Risk Assessment
URS Compiling Clean Validation
FAT: Factory Acceptance Testing CSV: Computer System Validation
SAT: Site Acceptance Testing Analysis method validation
DQ: Design Qualification Process Validation
IQ: Installation Qualification VMR: Validation Summary Report
R&D Center
The company boasts a cell culture technology research center, offering comprehensive services from cell culturing and preservation to bioreactor validation, including optimization of culture conditions and support for large-scale cultivation techniques.
R&D Center
Customer Case
As an industry leader, we have not only successfully delivered projects to more than 30 countries around the world and established a good industry reputation, but also have a high-quality professional team composed of project managers, design engineers, verification experts and operating technicians . This team continues to introduce advanced industry concepts and cutting-edge technologies, and is committed to providing core equipment, process systems, engineering solutions, modular factories and digital operation services for the life sciences and biopharmaceutical industries. Through these efforts, Shanghai Ritai ensures that it can meet the changing needs of customers and continues to promote innovative development in the industry.
Customer Case Worldwide
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To learn more about cases and solutions, please contact the sales account manager.
Packing & Delivery
Strict packing process to ensure the safety and completeness of the goods. We are experienced in the whole packing and shipping process, and we will be responsible for any damage made during shipping and send clients replacements for free.
Packaging and Shipping
Frequently Asked Questions
What types of CIP stations does Shanghai Ritai offer?
Shanghai Ritai supplies single, double, or multiple tanks structures in either fixed or mobile configurations based on specific process requirements.
How does the CIP station system control the cleaning process?
The system utilizes fully automatic methods managed via HMI and graphical display, allowing flexible formula adjustment, precise control over time, pressure, flow rate, and temperature, alongside comprehensive audit trail recording.
Which industry standards and guidelines do your products comply with?
All equipment and services comply with cGMP standards regulated by SFDA, FDA, WHO, and the European Union, along with international engineering specifications such as GB, ASME, and PED.
What comprehensive validation services do you support?
Validation services include VMP, DQ, IQ, OQ, PQ, FAT, SAT, 21 CFR Part 11 assessment, CSV (Computer System Validation), risk assessments, and cleaning validation documentation.
What warranty policy applies to shipping and transport damages?
We handle the entire packing and delivery protocol with high-grade protective packaging. In the event of any damage incurred during shipping, we take full responsibility and provide free replacement parts or equipment.

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