Высокопроизводительный биореактор для роста клеток и биофармацевтические препараты совместимые с GMP
- Категория: >>>
- Поставщик: Shanghai Ritai Medicine Equipment Project Co. Ltd.
Сохранить в закладки 1601272499395:
Описание и отзывы
Характеристики
Product Description
Fibra disk bioreactor
Fibra disk bioreactor, also known as basket bioreactor, is applied to anchorage dependent cell culture of animal cell, insect cell, etc.. Successful cases of this product include vero cell of rabies vaccine, vero cell of IPV, MDCK cell of bird flu, BSR cell of rabies vaccine of veterinary use, CHO cell of EPO, vero cell of nephritic syndrome, vero cell of swine fever, vero cell of BVDV, diploid cells of rabies vaccine.
The stainless steel bioreactor adopts modular design and is customized according to user's requirements. It is capable of CIP, SIP, auto-lift of lid, cold point monitor of sterilization, data storage and remote monitor, etc. When cultured in fixed-fluidized bed, cells enter polyester disc, eliminate damage from impeller's shear force and reduce the foam influence from gas sparger, which makes cells stay in a relative static state and prevent cells from shedding easily. Long maintenance time greatly increases harvesting and decreases the DNA content of host cell in harvest solution.
Company Profile
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
Automatic polishing and welding
Manual welding
Continuous laser welding
Product warehouse
Assembly workshop
Certifications
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.
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.
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.
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.
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.
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