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Quality System Management
Raw Material Quality Control

Up to 80% of local raw material proportion 

Ensure stable and controllable quality of incoming materials

Strictly control supplier admittance and evaluation process to select suppliers that meet the requirements of the GMP system;

Establish testing release criteria and develop key control indicators for incoming raw materials;

Batch inspection of incoming materials to check whether raw material purity, impurity limit and other indicators meet the quality requirements;

Implement online monitoring of storage conditions and store raw materials in strict accordance with requirements.

Finished product quality assurance

Ensure comprehensive performance verification of finished products and full inspection of finished products before delivery

Comprehensive testing and detection capabilities for finishing products

Physical and chemical tests: pH meter, turbidity meter, osmometer, spectrophotometer, Karl Fischer moisture meter, laser particle size analyzer, total organic carbon analyzer, etc.
Analysis and detection: HPLC, GC, microplate reader, etc.
Microbial detection: clean workbench, biological safety cabinet, PCR gel imaginer, microbial incubator, etc.
Cell detection: cell counter, CO2 shaker, CO2 incubator, bio-reactor, etc.

Lean Management & Information Management

Beijin is equipped with 5 information systems (PLM, ERP, MES, LIMS and QMS) to ensure the accuracy of material use and weighing, guarantee the authenticity, compliance and traceability of data, and help customers to meet the requirements of major quality systems.

Continuously Upgraded Multiple Quality System Certification

Lead the establishment of industrial standard on cell culture medium in China

Build the same quality system as top international medium suppliers

Construct international multiple quality systems to meet the requirements of China-Europe and China-US dual-declaration regulations, and finally realize the internationalization of culture media products

YearQuality systemDetails
2016 ISO13485:2016 The 1st culture medium company in China certified by the EU medical device authority
2021 ISO13485:2016+FDA、GMP Multiple quality systems (including ISO, FDA, and GMP)
2022 ISO13485:2016+FDA、GMP+DMF DMF (510K) filing for the Eden series of products is expected to be done in 2022 to meet regulatory requirements in European and US
Quality System Certificate

Let us contact you

We have a professional technical team to provide high quality one-stop cell culture service from process development
and optimization, medium formulation design to medium processing and manufacturing for all biopharmaceutical companies.

If you have any question, please click "Quick Message" and leave your message,  we will reply to you as soon as possible.
If anything urgent, please call (86)21-68582660-2792.

BioEngine

5F, Building 1, Lane 720, Cailun Road, Pudong, Shanghai, PRC

(86)21-68582660-2792

globalsales@bio-engine.com.cn

Work hours:9:00-17:00