RAPID STERILITY TESTING OF CELL AND GENE THERAPIES

calScreener+™ Sterility

The calScreener+™ Sterility System, based on biocalorimetry, offers a new standard in speed and sensitivity for sterility testing of cell and gene therapies. With its seamless, easy workflow, it delivers rapid and reliable growth-based detection of living microorganisms. This enables release testing in as little as three days—or even less with further optimization. This is a fraction of the time required by compendial methods, accelerating product release and manufacturing workflows, and bringing life-saving therapies to patients faster.

DEDICATED TO STERILITY TESTING OF ADVANCED THERAPIES

The calScreener+ Sterility system advances growth-based contamination testing through real-time detection of metabolic heat.

It is optimized for rapid sterility testing at two temperatures simultaneously, in alignment with regulatory guidelines. The system includes two calScreener+ units, one configured for measurement at 20-25 °C and one at 30-35 °C. Each calScreener+™ unit comprises a multichannel biocalorimeter, a main thermostat, an external thermostat and the calView™ software for instrument control and data acquisition.

OPTIMIZED THOUGHPUT, COMPLIANCE ASSURED

Samples are loaded into single-use sterile glass vials and tested in the calScreener+™ units, which are capable of processing up to 32 individual samples simultaneously. The testing system includes a sample handling kit, complete with sample and loading plates and vial preparation tools. Disposable sterile glass vials with growth media are the sole consumables needed—no reagents are required for operation.

The system supports compliance with global regulatory requirements, including 21 CFR Part 11 and IQ/OQ validation protocols for EP- and FDA-regulated environments.

ENGINEERED FOR ACCURACY AND RELIABILITY

Each biocalorimeter features 48 independent isothermal channels equipped with high-performance, Peltier-based heat flow detectors. The detection system is designed without integrated moving parts, ensuring long term reliability and minimizing the risk of downtime.

The sensors are extremely sensitive, capturing even the smallest amounts of metabolic heat from living microorganisms (LOD < 5 CFU), even in small-volume samples. Unlike other growth-based sterility testing systems that rely on multiple secondary measurements, the calScreener+ delivers a true, more direct, rapid microbial detection method.

CALVIAL™ - PRECISION SAMPLING

With a volume range from 500 µL down to just 50 µL, the sterile single-use glass calVial is optimized for sterility testing of sensitive, high-value advanced therapies where every drop matters.

Vials are delivered sterilized and closed with an aluminum cap and rubber septum. The closed vials are not fully sealed, allowing easy injection of media and samples through the septum without the risk of overpressure. Once the sample has been injected, the vial can be fully sealed using an electric crimping tool.

CALPLATE™ FOR SEAMLESS SAMPLE LOADING

The calPlate™ is optimized for precise loading of sample vials into the calScreener+™ system, enabling accurate and highly sensitive detection of microbial contamination. The 48-well layout allows parallel loading of 32 test samples, with 2×8 outer reference wells ensuring stability and uniform measurement precision across the plate.

CALORIMETRIC REFERENCES

To ensure accurate measurements, each sample is paired with a calorimetric reference. These references are made of inert material with calorimetric properties matched to the sample. The system includes a full set (48) of reference samples, which can also be used as placeholders for any unused sample positions.

calView™

The calView™ software interface streamlines the entire workflow—from sample entry to result reporting. It allows real-time monitoring of all measurements and offers flexible data visualization, from full experiment overviews to individual sample curves.

Once the experiment is complete, positive/negative results are provided automatically, and detailed reports including data from multiple experiments can be generated or exported for further analysis.

The system supports 21 CFR Part 11 data integrity requirements with audit logs, user roles, and secure electronic documentation.

SREAMLINED WORKFLOW

The calScreener+ supports sterility testing workflows aligned with regulatory guideline principle of sterility testing 1% of the batch, offering precise detection with minimal sample input. Samples are directly inoculated into vials containing growth media, which are then loaded into the calScreener™ unit, where continuous phenotypic readout detects microbial activity and provides final positive/negative results in less than 3 days.

No filtration
No reagents
No lysing