Sartorius Cubis® II Premium Balances

For safe product development and manufacturing;

Completeness and accuracy of data are important. Violation of data integrity can have serious implications for human health and safety. In recent years, the number of data integrity violations in the pharmaceutical industry has increased significantly. More than 65% of all FDA Warning Letters in 2017 addressed data governance and data integrity deficiencies. For this reason, many companies are turning to integrated IT solutions such as ELN, LIMS, SDMS or SCADA systems to manage data operations and ensure data integrity throughout the laboratory workflow. A complete solution can only be obtained if it is fully integrated into a computerized system to help prevent errors arising from laboratory equipment, manual data processing, or failure to comply with Standard Operating Procedures (SOP) or instructions. The problem of integrating laboratory equipment into a computerized system is the absence of an industrial standard that meets all compatibility requirements with a plug-and-play interface as an alternative to an external middleware application. Another point is inconsistent usage when transitioning from a computerized system to laboratory equipment in a laboratory workflow. This is confusing for these users and carries potential risk. Abbott Informatics and Sartorius developed a solution that facilitates the integration of Sartorius Cubis®II into STARLIMS and provided users with customized comprehensive laboratory workflows with plug-and-play connections recognized IT standards and adequate protection against data integrity issues.

Sartorius Cubis

The first laboratory balance with a fully modular design; Cubis allows you to combine the display and control unit, weighing module, data interface module and more of your choice. Sartorius Cubis balances allow you to create a customized profile for your specific application requirements with special user-specific design, without needing to use a laptop. By integrating data into your software infrastructure, it provides full control over your weighing process. Specialized laboratory balances have become a criterion for use in regulated sectors with the highest requirements, such as pharmaceutical laboratories. Abbott Informatics is a subsidiary of Abbott Laboratories and is a leading provider of laboratory information management solutions with over 1000 installations in more than 45 countries. Abbott Informatics' STARLIMS increases the reliability of laboratory sampling processes, supports compliance with global regulatory requirements and industry standards, and provides comprehensive reporting, tracking and analysis capabilities.

STARLIMS

The user-server responsible side is well designed and flexible. The client side runs in a standard web browser and the server side consists of a scalable and extensible application and database server. Communication between client and server is provided via standard web service messaging over Hypertext Transfer Protocol (HTTP) or optionally Secure HTTP (HTTPS) for a more protected environment. Each Cubis balance is an independent unit that can communicate with STARLIMS via REST Web Services without any additional middleware between them. With a standard device interface, another Cubis balance can be quickly connected to STARLIMS without complex configuration efforts or additional software licenses. A handheld scanner that can read and verify sample identification labels and can read different types of matrix codes can be connected directly to Cubis®II. By running QApps on Cubis®II; customer-specific embedded applications can be used that extend standard weighing functions by guiding the user step by step through a specific process and implementing related workflows. A QApp application was developed that ensures seamless integration of a laboratory workflow to connect to Cubis®II balance. This QApp application can be customized to meet customer SOPs up to 100%. Another advantage of these small embedded applications is low validation effort. Instead of complex PC software, only the application itself needs to be validated, which significantly reduces costs and risks for the end customer.

Creating Workflow

As an example for integration, a typical laboratory workflow for differential weighing applications, e.g. loss on drying. The process begins in STARLIMS where samples are created and assigned to an analytical method and a specific Cubis®II balance. Samples will be labeled with a barcode containing the sample ID from STARLIMS to track them throughout the entire process. After the job is created in STARLIMS, it is transferred to the balance. The user logs into Cubis®II with personal credentials and scans a sample with the barcode reader. The balance directly verifies that the scanned sample is included in the sample list and that the logged-in user is permitted to work with this sample; otherwise, an error message will be received and the job will not be performed. The user is guided step by step through the weighing process on the balance's display. This provides protection against incorrect operation, misuse or violation of weighing-related SOPs. This step can be fully customized according to the customer's needs for additional functions such as sample ionization. Finally, Cubis®II sends the weighing result to STARLIMS along with all required metadata. STARLIMS automatically calculates the difference between initial and remaining weights and stores the raw data securely. STARLIMS offers many options to document and evaluate results and monitor the progress of the sample or batch throughout the process.

Calibration Monitoring

In addition to the differential weighing application, a calibration routine has also been implemented. Regular calibration is required to ensure the balance performs within its own technical specifications. This task can be created directly from STARLIMS on the Cubis®II balance. In doing so, a job is sent to the balance with specific calibration weights. The user is guided step by step through the calibration workflow and Cubis®II balance automatically evaluates the results and sends them back to STARLIMS. With STARLIMS, an "out of service" status can be assigned to the balance with defined events such as the expiration of regular maintenance intervals. The user can only use the balance for measurements when an authorized person performs the calibration and sets the equipment status to "In Service". This important function ensures that weighing operations are only performed on a released balance. In laboratories in regulated fields, the reliability of data is essential. By fully integrating Cubis®II into STARLIMS, you can successfully reduce data integrity issues and increase the degree of automation with this solution. The WHO data integrity guide states that data integrity risks are higher when processes are performed manually or paper-based. The solution outlined minimizes manual data entry. The weighing process does not include a manual data entry step. Sample identification is performed via barcode and results are automatically transmitted to STARLIMS. Thus, the likelihood of transmission errors or data loss from paper-based records is significantly reduced. The complete integrated solution comprising Cubis®II balance and STARLIMS provides full compliance with cGMP and cGCP regulations. The Cubis II balance is designed to cover all aspects of ALCOA principles, FDA, PIC/S and MHRA guidelines. Cubis®II balances produce data with all required metadata and immediately transfer this data to STARLIMS designed for automatic data collection and long-term data storage. If someone logs in using a shared user account, it is not recorded which user was responsible for creating or modifying a data record. This later results in a violation of data integrity. This can be prevented by using personalized accounts supported by Cubis®II and STARLIMS. The two systems' users are synchronized and user rights are created that prevent unauthorized users from beginning weighing. Failure to follow SOPs is frequently criticized by the FDA. This can be prevented through seamless integration of Cubis®II with STARLIMS. Without any breaks between STARLIMS and Cubis®II, the user is guided step by step throughout the entire weighing process. This ensures compliance with SOPs and business rules. Laboratory information management system (LIMS) is becoming increasingly important in GMP areas for creating secure data integrity and implementing faster applications. Through direct device integration with LIMS, it eliminates the possibility of errors caused by manual records, operator downtime, and data redundancy. Sartorius, a provider of STARLIMS, a LIMS solution at world standards, and Abbott Informatics have developed a comprehensive computerized solution for the integration of Sartorius Cubis®II premium laboratory balances into STARLIMS covering all cGMP/cGLP applications.