Dedicated to sterility testing
The calScreener+™ Sterility system is optimized for rapid sterility testing at two temperatures simultaneously to comply with regulatory guidelines. As such, it consists of two calScreener+, one configured for measurement at 20-25 °C and one at 30-35 °C. Each calScreener+™ unit comprises a multicalorimeter unit, a main thermostat, an external thermostat and the calView software for instrument control and data acquisition.
Optimised throughput and easy to use
Samples, loaded into single-use sterile glass vials with a volume of <500 µL, are placed into the calScreener+™. Each instrument can process up to 32 individual samples simultaneously, optimising throughput.
The Sterility testing system includes a Sample Handling Kit, complete with sample and loading plates, an automatic crimping tool, scissors, and a tweezer.
The only consumables required for sterility testing are disposable sterile glass vials.
For laboratories needing regulatory compliance, the calScreener+™ offers a calView™ software module, supporting 21 CFR Part 11 compliance and IQ/OQ protocols, ensuring adherence to FDA regulations.
calPlate™ for glass vials
The calPlate™ for glass vials is a sample plate optimised for loading the disposable glass vials into the calScreener+™ with high precision and highly sensitive biocalorimetric measurements. The 48-well sample plate format provides fast sample loading of up to 32 samples simultaneously and with 2×8 positions used as a calorimetric reference for increased sensitivity and performance.
calVial™ - glass vials
Glass Vial
The capped, single-use sterile glass vial has a sample volume capacity of less than 500 µL. Each vial comes closed with aluminum caps with a rubber septum. The closed vials are not fully sealed, allowing for 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 automatic electric crimping tool.
Each package contains four heat-sterilized vials, which are packed in either a single-layered or triple-layered bags.
Calorimetric references
Inert reference sample
To ensure accurate measurements, each sample is paired with a calorimetric reference. The calorimeter reference should be completely inert with similar calorimetric properties as the sample. The system includes a full set (48) of these inert reference samples that also can be used as dummies for any unused sample positions.
calView™
The state-of-the-art calView™ 2.0 software is designed to give you complete control over your calorimetric experiments, providing built-in analysis and reporting capabilities. calView™ provides both instrument control and data acquisition, allowing you to manage your experimental setup. You can input detailed sample information and display real-time data in a variety of formats to suit your analysis needs.
This powerful software offers a comprehensive view, enabling you to monitor all test graphs simultaneously or zoom in for a close-up examination of individual test results. Once the experiment is complete, you can generate detailed reports that include data from multiple experiments, or export the results for further analysis.
In addition, calView™ can be integrated with a 21 CFR Part 11 compliant software module, providing robust support for electronic records and signatures. This module enables users to enforce access restrictions, define user roles, and ensure secure tracking of analysis and instrument events, ensuring compliance with regulatory standards
