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Kuhner Insight Software

For convenient control of Kuhner shakers and orbital bioreactor systems with GMP options

The user-friendly Kuhner Insight software was developed for data logging, calibration, programming, and control of Kuhner shakers. With Kuhner Insight, it is possible to log process data from up to eight shakers or orbitally shaken bioreactor systems simultaneously.

The software is logically structured and easy to use. It ensures the continuous recording and storage of process parameters such as shaking speed, temperature, humidity, and CO₂ concentration. In addition, process data such as dissolved oxygen and pH can also be recorded and displayed for orbital bioreactors. Furthermore, all user interactions with the shaker are recorded in an audit trail.

For easy monitoring of experiments, all process data can be clearly displayed in customizable charts and printed. The setpoints for the various process parameters can either be programmed and executed automatically or set and changed manually via the control panels for shaking speed, temperature, etc.

In the user management section of the Kuhner Insight software, up to 255 different users can be created and assigned to freely definable groups with different access rights.

Kuhner Insight also handles the calibration of shakers and orbitally shaken bioreactors. This enables the user to generate corresponding test reports, which is particularly important for IQ-OQ (Installation Qualification and Operational Qualification) documentation.

Kuhner Insight – in a nutshell

Control

Manual operation
Programming of setpoints and recipes
Integrated calibration functions
Control of control parameters
Alarm settings

Data acquisition

Recording of all process-relevant data
Graphical data display and analysis
Audit trail: Traceability of data
Data export

User Management

Organization of users into freely selectable groups
Up to 255 different users possible
Highly flexible access rights management

Shaker/PC Connection

CAN-USB
CAN-Ethernet

GMP Options

Alarms with acknowledgment /
confirmation system
Protection against data loss
Auto save: no data loss
Auto logoff for users (system switches to
viewer mode)
Automatic batch process
Batch report: information about
the current process
Audit trail for batches, user, and system settings
Locked mode to ensure data integrity for all process and system data

The Kuhner Insight software connects to shakers and bioreactors either directly via a USB/CAN interface or via a network (CAN/Ethernet interface). When working under GMP conditions, the software can also be operated via a touchscreen that is built directly into the shaker or the control unit of the orbital bioreactor.

Benefits of Kuhner Insight Software

Very easy integration into process validations Ensuring data integrity through the use of a proprietary data format for storing process data and system settings.

Automatic generation of batch reports (PDF/printout and electronic record)

Prevention of unauthorized data access (system security).

Integrated calibration functions and related reporting

GMP Version

Kuhner Insight supports all key requirements for working under GMP/GLP. The functions and features necessary for computer system validation and operation in accordance with 21 CFR Part 11 and EU GMP Annex 11 requirements are integrated into the software. With Kuhner Insight, it is possible to execute batch processes automatically or via external process management systems, enabling integration into automated manufacturing environments. The software’s built-in safeguards against data loss ensure continuous and seamless operation of processes along with their data logging. Every alarm triggered by a deviation during the process is recorded and must be acknowledged by the user, depending on the settings.

All user rights can be defined with a high degree of flexibility, either in freely definable user groups or on an individual basis. An audit trail for all relevant events and interventions is implemented and can be made available in a prepared format for review during inspections.

Equipment Qualification

GMP-compliant equipment qualification is supported by the provision of standardized or customized qualification protocols (FAT/SAT/IQ/OQ). The execution of these protocols by our highly qualified and certified service staff is documented in accordance with GMP. The qualification covers all aspects of our machines (software, interfaces, machines). In addition to the qualification protocols, the comprehensive documentation includes, among other things, all required material and test certificates, manuals, and data sheets.

IQ-OQ Documentation

IQ-OQ (Installation Qualification and Operational Qualification) is a device qualification process conducted in accordance with GMP guidelines. Naturally, Kuhner also offers the service of performing IQ-OQ on-site at the customer’s location.