CytScop® Pro Automatic Intelligent Cell Analyzer

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.

• 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.

3.Advantages

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%.

4.Specification