Countstar Altair

Designed for daily use in cGMP regulated environments

The Countstar Altair is a bright field-based image analyzer, designed for the automated monitoring of mammalian cells, fungi and particle suspensions. Based on a full metal-designed optical bench containing a high resolution five (5) Mega Pixel CMOS color camera in combination with a top-rated 2.5 magnification lens, and integrated Fixed Focus Technology for always detailed and sharp images. The automated chamber slide mechanism allows for a consecutive analysis of up to five samples in a single sequence with its live view feature. Our proprietary image algorithms have been designed with the most advanced cell recognition techniques. The Countstar Altair will enable the user to determine precisely cell concentration, cell viability, cell diameter, the aggregation level of objects, and their roundness, based on established staining methods such as Trypan Blue exclusion.

Scope of Applications

• Process Development
• Pilot and Large Scale Manufacturing
• Quality Control

Conformity for use in cGxP environments

• E-signatures and system log files in compliance to FDA’s 21 CFR Part 11
• Four level, password-protected user management
• Encrypted data base for results and images
• Adjustable logout and shutdown feature

Overview

Process Development

Typical applications in Process Development of the Biopharma industry such as cell line selection, cell bank generation, cell storage condition-ing, product yield optimization require permanent monitoring of cell status parameters. The Countstar Altair is the optimum tool to track these aspects in a smart, fast, cost-efficient, highly accurate and validatable way. It can help to accelerate the development of industrial-scale processes significantly.

Pilot and Large-Scale Manufacturing

Consistent, multi-parameter monitoring of pilot and large-scale cell cultures is an evitable prerequisite to guarantee an optimum quality of the final products, independent of the cell themselves or their intracellular or secreted substances are in the focus of the production process. The Countstar Altair is perfectly suited for frequent batch testing in production lines, independent from the individual bioreactor volumes.

Quality Control

Cell based therapies are promising concepts for the treatment of various causes of illnesses. As the cells themselves are in the focus of the therapy, advanced quality control of their parameters is the most effective way to infuse the cells according to the pre-defined requirements. From isolation and classification of the donor cells, the monitoring of their refrigeration and transport steps, up to the proliferation and passaging of the suitable cell types, the Countstar Altair is the ideal system to test the cells at any of the listed tasks. An analyser that has its place in the quality control of upstream and downstream processing.

*All-in-one, Compact Design *

The small footprint in combination with its feasible weight makes the Countstar Altair a highly mobile analyzer, that can be shifted easily from one lab to another. With its integrated ultra-sensitive touchscreen and CPU the Countstar Altair offers the possibility to view and analyse the acquired data immediately and stores up to 150,000 measurements on its hard integrated hard disk drive.

Smart Fast and Intuitively-to-use

An intuitive software interface in combination with the pre-installed BioApps (assay template protocols) forms the basis for a comfortable and fast operation of the Countstar Altair in only three steps. Get in only 3 steps and less than 30 seconds/sample your images and results:

Step One: Stain 20µL of your cell sample

Step Two: Insert the chamber slide & select your BioApp

Step Three: Start the analysis and get images and results immediately

Accurate and Precise Results

Results are highly reproducible.

Unique Patented Fixed Focus Technology (FFT)

The Countstar Altair contains an extremely robust, full-metal made, optical bench, with our patented Fixed Focus Technology integrated. There is no need at any time for the operator of the Countstar Altair to adjust the focus manually prior to measurement.

Advanced Statistical Accuracy and Precision

Up to three regions of interest per single chamber and measurement can be selected and analyzed. This allows an additional increase in precision and accuracy. At a cell concentration of 1 x 106 cells/mL, the Countstar Altair monitors 1,305 cells in 3 regions of interest. Compared to the manual hemocytometer counts, measuring the 4 squares of the counting grid, the operator will only capture 400 objects, 3.26 times less than in a Countstar Altair.

Outstanding image results

The 5 Megapixel color camera in combination with the 2.5x objective guarantees for high resolution images. It allows the user to capture unrivaled morphological details of each single cell.

Innovative Image Recognition Algorithms

We have developed innovative Image Recognition Algorithms, that are analyzing 23 single parameters of each single object. This is the inevitable basis for a clear, differential classification of viable and dead cells.

Easy adaptation, easy customization due to flexible software architecture and BioApps concept

The BioApps based assay test menu is a comfortable and easy-to oper-ate feature to customize the daily routine tests on a Countstar Altair to the individual characteristics of cell lines and their culture conditions. Cell Type settings can be tested and adapted in an Edit Mode, new BioApps can be added to the analyzer software by simple USB up-load, or copied to other analyzers. For higher convenience, our core facility for image recognition can also design new BioApps on the base of acquired image data for the customer free of charge.

Overview of Acquired Images, Data, and Histograms at a Glance

The resulting view of the Countstar Altair gives prompt access to all images acquired during a measurement, displays all analysed data and generated histograms. By a simple finger touch, the operator can switch from view to view, activating or de-activating the labeling mode.

Overview of data

Diameter Distribution Histogram

Data Management

The Countstar Rigel system uses a built-in database with a sophisticated and ergonomic design. It gives the operators maximum flexibility in regards to the data storage while ensuring safe and traceable handling of results and images.

Data Storage

With 500GB of hard disc drives, stores up to 160,000 complete sets of experimental data including images

Data Export

Choices for data output include PDF, MS-Excel, and JPEG files. All of which are easily exported using the included USB2.0 & 3.0 external ports

BioApp/Project Based Data Management

New experiment data are sorted in the database by their BioApp Project name. Consecutive experiments of a project will be linked to their folders automatically, allowing a fast and secure retrieval.

Easy Retrieval

Data can be selected by experiment or protocol name, analysis date, or keywords. All acquired data can be reviewed, re-analyzed, printed, and exported in various formats.

FDA 21 CFR Part11

Meet modern pharmaceutical and manufacturing cGMP requirements

The Countstar Altair is designed to meet modern pharmaceutical and manufacturing cGMP requirements. The software complies with 21 CFR part 11. Key features include tamper-resistant software, user access management, and electronic records and signatures that provide for a secure audit trail. IQ/OQ service and PQ support from Countstar technical specialists are also available to provide.

User Login

Four-level user access management

E-Signatures and Log Files

Upgradable validation service (IQ/OQ) and Standard Particle Suspensions

When implementing the Altair in a regulated environment, our IQ/OQ/PQ support starts early – we will meet with you if needed prior to the qualification execution.

Countstar provides the necessary verification documentation to qualify the CountstarAltair for performing process development and production tasks in cGMP related environments.

Our QA department has established a comprehensive infrastructure in-house to comply with cGAMP (Good Automation Manufacturing Practice) guidelines for manufacturing analyzers, starting from the instrument and software design process through the final factory acceptance tests for systems and consumables. We guarantee a successful verification (IQ, OQ) on-site, and we will assist in the PQ process.

Instrument Stability Test(IST)

Countstar has established a comprehensive validation plan for testing the stability and accuracy of Altair measurements in order to guarantee precise and reproducible measurement data is captured daily.

Our proprietary IST monitoring program (Instrument Stability Test) is your assurance that our instruments will meet the standards required in cGMP-regulated environments. The IST will prove and, if necessary, re-calibrate the instrument in a defined cycle of time to guarantee the results measured by the CountstarAltair remain accurate and stable during the entire life cycle of use.

Density Standard Beads

• Used to re-calibrate the accuracy and precision of concentration measurements to verify the quality of everyday measurements.
• It is also a mandatory tool for the harmonization and comparison between several CountstarAltair instruments and samples.
• 3 different standard of Density Standard Beads are available: 5 x 105/ml、2 x 106/ml、4 x 106/ml.

Viability Standard Beads

• Used to simulate various levels of cell-containing samples.
• Verifies the accuracy and reproducibility of live / dead labelling. Proves the comparability between different CountstarAltair instruments and samples.
• 3 different standard of Viability Standard Beads are available: 50%、75%、100%.

Diameter Standard Beads

• Used to re-calibrate the diameter analysis of objects.
• Proves the accuracy and stability of this analysis feature. Demonstrates the comparability of results between different CountstarAltair instruments and samples.
• 2 different standard of Diameter Standard Beads is available: 8 μm and 20 μm.