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Countstar BioTech

Your precise and reliable analyzer in cell culture production monitoring

The Countstar BioTech combines a 5-megapixels CMOS color camera with our patented “Fixed Focus Technology” full metal optical bench to simultaneously measure cell concentration, viability, diameter distribution, average roundness, and aggregation rate in a single test cycle. Our proprietary software algorithms have been optimized for advanced and detailed cell recognition. 

 

Scope of Applications

The Countstar BioTech can be used for analyzing all kinds of mammalian cell cultures, insect cells, a wide range of cancer cells, and resuspended primary cell material in research, process development and cGMP regulated production environments.

 

Technical Features / User benefits

  • Multiple Sample Analyses on a Single Slide
    Analyze samples repeatedly and let the system calculate averages automatically to compensate inhomogeneities
  • Large Field of View
    Depending on  individual cell sizes and sample concentration, up to 2,000 cells can be analyzed in a single image
  • 5-Megapixel Color Camera
    Acquires  clear, detailed  and sharp images 
  • Analysis of Cell Aggregates
    Detects and classifies single cells even inside aggregates
  • Clear Verification of Results
    Switch inside the result view between the acquired, raw image and the sight of labelled cells
  • Accuracy and Precision
    The coefficient of variation (cv) between results of aliquots inside  the 5  chambers of a slide is < 5%
  • Harmonization of Analyzers
    An analzer-to-analyzer comparison of Countstar BioTech devices showed a coefficient of variation (cv) < 5%
  • Minimized Sample Volume
    Only 20 μL of a sample are required for one chamber fill. This allows for more frequent samplings, e.g. out of mini-bioreactor cell cultures
  • Short Test Time
    In less than 20 seconds even complex image scenarios are analyzed by our innovative algorithms
  • Low Cost, Time-Efficient, and Sustainable Consumables
    Our unique Chamber Slide layout enables a consecutive analysis of up to 5 samples in a single sequence, and reduces generation of waste significantly
  • Details
  • Technical Specifications
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Details

 

Our customized IQ/OQ/PQ validation service

We develop, on base of our standard documents, for our customers individual IQ/OQ files and support them in the verification execution, and PQ processes (by test case designs)

 

 

 

 

The Countstar BioTech software

 

 

1. Secure and Compliant Operation

Comprehensive 4-level user access management, automatic E-signatures, encryption of images and results in a secured data base, plus immutable log files allow an operation in compliance to actual cGxP guidelines.

 

 

 

2. Advanced Data Analysis

The Countstar BioTech offers advanced data analysis features, integrating Cultivation Time Charts (CTCs), overlay analysis, and direct comparative analysis of different samples.

 

 

 

3. Data Output

Various data output formats are available: MS-Excel spreadsheets, customizable PDF reports, compact JPEG images files, or direct print out templates.

 

 

 

 

4. Secure cGMP compliant data management

The data management of the Countstar BioTech complies in all aspects with the actual regulations of FDA’s 21 CFR Part 11. User-ID, analysis time stamps, parameters, and images are stored in an encrypted data format.

Technical Specifications

 

 

Technical Specifications
Data Output Concentration, Viability, Diameter, Aggregation, Roundness (Compactness)
Measurement Range 5.0 x 104 – 5.0 x 107/ml
Size Range 4 – 180 μm
Chamber Volume 20 μl
Measurement Time <20s 
Result Format JPEG/PDF/MS-Excel spreadsheet
Throughput 5 Samples / Countstar Chamber Slide

 

 

Slide Specifications
Material Poly(methyl) Methacrylate (PMMA)
Dimensions: 75 mm (w) x 25 mm (d) x 1.8 mm (h)
Chamber Depth: 190 ± 3 μm (only 1.6% deviation for high accuracy)
Chamber Volume 20 μl

 

 

Download
  • Countstar BioTech Brochure.pdf Download
  • File Download

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