CytScop? Pro automatic intelligent cell analyzer uses trypan blue staining exclusion method and AOPI double fluorescent staining method to determine the cell viability. It is equipped with bright field and fluorescent large-field microscopic optical systems and disposable microfluidic consumables. The system is designed with high-precision cell recognition algorithms, combined with a fully automatic and high-throughput operating mode, it can achieve accurate, stable, efficient, economical and standard process analysis of cell counts and viability in the field of biopharmaceuticals.
Product features
? Fully automatic: dispensing samples, loading consumables, dyeing, photographing, analyzing and cleaning;
? Microfluidic consumables: innovation, precision and high efficiency;
? Intelligent algorithm: adapt to various cell types, accurate and anti-interference;
? High throughput: 24-sample trays, single sample detection time <2 min, continuous measurement;
? Dual fluorescence imaging system: wide field of view, high contrast;
? Multiple dyeing modes meet different application requirements;
? Compliant with 21CFR Part 11 requirements;
? Comply with ALCOA+ principles for data integrity;
? IQ/OQ verification procedures meeting GMP requirements.
Data Integrity and Compliance
CytScop? Pro automatic intelligent cell analyzer software is designed to monitor the cell counting & viability of cell culture process for biopharmaceutical applications, which is in compliance with the requirements of the US Food and Drug Administration (FDA) on electronic records and electronic signatures (21 CFR Part 11) and data integrity guidelines (ALCOA+), and also compliance with Good Practice (GxP) regulations for the entire process of analytical instrument qualification. By enabling the security options in the software, the system will automatically authorize users to adjust the following configurations to achieve compliance.
? Audit trial
? User authorization management
? Log file
? IQ/OQ validation
? Electronic signature function
? Instrument quality control
? User security login
? Standard beads
Flexible, innovative, and easy-to-use
? Easy-to-install consumable package
? Convenient data export
? Various data formats
Meet clean room requirements
? No external PC or monitor required
? Smooth and easy-to-clean surface, without dead ends
? Resistant to VHP
Stable and reliable data
? High repeatability≤5%
? High accuracy ±6%, R2>0.99
? Data consistency CV≤7%
? When the density is 2x106 cells/mL and above, the difference in the average sample density results between instruments will not exceed 10%, with a confidence level of 95%.
Case study
Data analysis
Item | Specification | Result |
Ability to optimize analysis parameters | Yes | Improve accuracy and ensure method consistency |
Density range | 5 x 104 - 1.5 x 107 cells/mL | Reduce sample dilution |
Counting accuracy | ≤5% error compared to coulter counter test @ ≥2 x 106 cells/mL | Accurate and reliable results |
Count repeatability | Sample repeatability CV≤±5% @ ≥2 x 106 cells/mL | Stable and reliable results |
Diameter range | 5-60 μm | Meet testing needs of samples of different sizes |
Roundness measurement | Yes | Helps identify debris in samples |
Performance parameters
Features | Specification | Result |
Autosampler | 24-position autosampler cycle loading, fully automatic sample preparation | Walkaway during runtime |
Allow to select counting mode | Trypan blue staining mode and AOPI staining mode | Meet different sample counting accuracy requirements |
Dye pre-embedded consumables | Yes | No additional reagents or buffers required |
Comply with 21CFR part 11 requirements | Yes | Meet GMP requirements |
Sample volume | 200 μL | Meet testing needs of small-scale cell culture |
Analysis duration | 2 min | Save time, increase throughput |
Sample mixing times | Adjustable | Optimize depending on cell type, ensures accuracy of the results |
Default cell analysis parameters | Yes | Easy to use with standard methods |
Technical parameters
Item | Parameter |
Optical sensor | 630w CMOS Array |
Brightfield channel | Yes |
Fluorescence channel | EM1: 535 nm; EM2: 595 nm |
Operating system | Win10 64-bit |
Power requirements | 110-230V/AC, 50/60Hz |
Screen | 12.1 inch |
Hard drive capacity | 500G |
Working temperature | 10-40℃ |
Working humidity | 20-80 |
Weight | 22 kg |
Dimension | L x D x H: 54 x 38 x 43 cm |
Ordering information of system
Part name | Model |
Automatic Intelligent Cell Analyzer (dual fluorescence) | CA01 |
Automatic Intelligent Cell Analyzer (bright field) | CA02 |
Ordering Information of accessories and consumables
Part name | Model |
TB microfluidic chip | MC01 |
AOPI microfluidic chip | MC02 |
System calibration chip | MC03 |
Starter kit | TK01 |
2M density control 2e6 cells/ml | MB01 |
4M density control 4e6 cells/ml | MB02 |
10M density control 10e6 cells/ml | MB03 |
* The above products are for industrial and scientific research only, not for diagnosis.
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