Case FAQ

Q: What are the specific manifestations of the system in terms of energy conservation and consumption reduction? How long is the investment return cycle approximately?

The system adopts ultra-low pressure infiltration filtration technology, saving 22% energy and over 50000 yuan in annual electricity bills. At the same time, the stable current and pressure control technology effectively reduces membrane loss, prolongs the membrane replacement cycle by 35%, and ensures that EDI modules are replaceable for 10 years. Overall, the investment return cycle is about 2.5 years, and the benefits throughout the entire lifecycle are significant.

Q: Is the operation of a high flow system with a capacity of 3000L/H complicated? How much manpower is required for daily maintenance?

The equipment adopts fully automatic operation, one click start stop, and the operation is extremely simple. The intelligent system can automatically record operational data and remind consumables to be replaced, greatly reducing the burden of manual inspection and recording. At present, Shengxiang Biotechnology only requires one part-time operation and maintenance personnel for regular data analysis and preventive maintenance.

Q: Can this system pass FDA and CE certification? Is the verification file complete?

Yes. We provide a complete set of GMP validation documents, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and all validation data are complete and standardized. The Shengxiang Biotechnology Changsha headquarters project has passed multiple domestic and international certifications such as NMPA, FDA, CE, etc. in one go, fully meeting global market access requirements.

Question 1

How does the system ensure stability in daily production? Will the water quality fluctuate, especially before and after the disinfection cycle?

Accepted Answer

We specifically simulate the actual production mode during the performance confirmation phase to verify the stability of water quality under daily operation and disinfection cycles. The system adopts circulating constant pressure water supply technology and fully automatic disinfection program to ensure stable water quality before and after disinfection, as well as during peak and off peak periods, fully meeting the requirements of continuous production.

Question 2

The new GMP R&D and production center has high requirements for verification documents. Can your company provide complete verification materials?

Accepted Answer

Yes. We start with User Requirements Specification (URS) and provide a complete set of validation documents, including Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure that the system successfully passes GMP certification. The Sano Biotechnology project has passed GMP validation in one go.

Question 3

As a biosensing technology enterprise, what are the special requirements for the quality of purified water by Sano Biotechnology? Can this system meet the requirements?

Accepted Answer

The production of biosensors is extremely sensitive to impurities such as ions, microorganisms, and organic matter in water, requiring highly pure water quality. The system's water production resistivity remains stable at 18.25M Ω .cm@25 ℃， TOC＜5ppb， Microorganisms<1cfu/ml, comprehensively superior to pharmacopoeia standards, fully meeting the stringent requirements of biosensing technology research and production for water quality, ensuring product detection accuracy.

Question 4

What are the specific manifestations of the system in terms of energy conservation and consumption reduction? How long is the investment return cycle approximately?

Accepted Answer

The system adopts ultra-low pressure infiltration filtration technology, saving 22% energy and over 50000 yuan in annual electricity bills. At the same time, the stable current and pressure control technology effectively reduces membrane loss, prolongs the membrane replacement cycle by 35%, and ensures that EDI modules are replaceable for 10 years. Overall, the investment return cycle is about 2.5 years, and the benefits throughout the entire lifecycle are significant.

Question 5

Is the operation of a high flow system with a capacity of 3000L/H complicated? How much manpower is required for daily maintenance?

Accepted Answer

The equipment adopts fully automatic operation, one click start stop, and the operation is extremely simple. The intelligent system can automatically record operational data and remind consumables to be replaced, greatly reducing the burden of manual inspection and recording. At present, Shengxiang Biotechnology only requires one part-time operation and maintenance personnel for regular data analysis and preventive maintenance.

Question 6

Can this system pass FDA and CE certification? Is the verification file complete?

Accepted Answer

Yes. We provide a complete set of GMP validation documents, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and all validation data are complete and standardized. The Shengxiang Biotechnology Changsha headquarters project has passed multiple domestic and international certifications such as NMPA, FDA, CE, etc. in one go, fully meeting global market access requirements.