What are the key features of Cubis® II that support compliance with global regulatory standards such as 21 CFR Part 11?
The Cubis II balance, integrated with the Pharma software package, provides essential technical controls and features to facilitate 21 CFR Part 11 compliance. This comprehensive software package includes key functionalities such as user management, audit trail, and electronic signatures, ensuring standalone compliance without the necessity of installing middleware. For more information, refer to the Cubis II 21CFR Part 11 checklist.
In what ways does the minimum sample weight capability of Cubis® II contribute to reducing experimental error and cost?
Most importantly, the minimum sample weight was assessed not only at low preloads but also with the customary glassware employed for weighing minute sample quantities, mirroring the standard use case for ultra-high resolution balances.
These findings, detailed in a published applicate note, illustrate that the new Cubis II balances exhibit superior performance in measuring small minimum sample weights, even when heavy tare vessels are utilized.
As a user, your objectives include a) accurately weighing the smallest possible amounts of precious samples and b) directly weighing them into glassware such as volumetric flasks, to circumvent sample transfer, thereby mitigating the risk of sample loss.
How does the Cubis® II Ultra-High Resolution balance ensure precision in everyday conditions, like changes in temperature, humidity, and air pressure?
These balances ensure precision through its advanced features. The 4th generation monolithic weighing system, coupled with built-in intelligent adaptive systems and ionizing technology, collaboratively mitigates common influences such as draft, vibration, temperature and humidity fluctuations, and static charges.
Through its unique engineering, the balance achieves exceptional precision and rapid stabilization times, thereby facilitating highly repeatable and accurate measurements, making it a dependable instrument in analytical laboratories.
How does the Cubis® II Ultra-High Resolution balance address electrostatic charges, and what is the role of ionizing technology and strategically positioned ionizing nozzles?
The balance is equipped with state-of-the-art ionizing technology, a feature designed to neutralize and eliminate electrostatic charges present in the environment. This technology plays a crucial role in preventing the interference of electrostatic forces with the accuracy of weight measurements, thanks to the strategically positioned ionizing nozzles, which ensure complete coverage of the weighing chamber.
These nozzles effectively neutralize electrostatic charges across the entire balance, guaranteeing accurate and stable readings and enhancing the efficiency and reliability of the weighing process.
What key pain points with cleaning and maintenance do the Cubis® II Ultra-High Resolution balances address? How does the Cleaning QApp software simplify both routine and advanced cleaning procedures, and how does it integrate with standard operating procedures (SOPs)?
The Cubis® II Ultra-High Resolution balances aim to simplify and enhance the cleaning and maintenance processes, with the Cleaning QApp providing step-by-step instructions for both daily and advanced cleaning along with tool-free assembly and disassembly.
Cleaning can now seamlessly integrate with standard operating procedures (SOPs) commonly followed in laboratories, enhancing compliance standards and becoming an integral part of the audit trail, facilitated by the Cleaning QAPP. The tool-free assembly and disassembly design of the balances, especially for hard-to-reach areas, streamline the cleaning process, alleviating concerns regarding time-consuming maintenance routines.
Moreover, our High-Capacity Micro Balance comes with a comprehensive cleaning kit comprising all essential tools, thereby enhancing the cleaning process. For Semi-Micro balance users, the kit is available as an optional accessory for purchase.
In what ways does the Cubis® II Ultra-High Resolution balance offer flexibility in terms of customization options with hardware and software, even after purchase?
These balances distinguish themselves with their unique capability for post-purchase hardware and software upgrades, which is one of a kind in the market. Users have the flexibility to upgrade hardware components such as ionizers, draft shields, and additional hardware integrations.
Similarly, the software solutions can be customized to specific application workflows and upgraded to specialized software packages as required. With the Ultra-High Resolution balances, users can rest assured of investment security and relevance, adapting seamlessly to evolving laboratory demands.
What are the benefits of the Ingenix Suite in terms of connectivity and digital data management for laboratory needs?
The Ingenix Suite optimizes laboratory operations, providing cost savings through the elimination of middleware services, and ensures compliance with regulatory standards, like 21 CFR part 11, EU Annex 11.
With a streamlined licensing process, particularly with the Cubis® II QApp's one-time license, it simplifies administrative tasks. The suite enables seamless connectivity to ELN|LIMS systems, facilitating the transfer and management of weighing data.
Advanced connectivity features enhance digital data management, ensuring efficient organization, accessibility, and traceability. The Ingenix Suite offers a holistic solution, combining cost-effectiveness, compliance, efficiency, and connectivity for modern laboratory data management.
About the Interviewee, Holger Densow
Holger Densow studied biology at the University of Bielefeld, Germany and finished his Doctorate in 2005. Then he was working as sales representative for 2,5 years for a German Biotech company and in 2008 switched to another company to manage lab instruments as product manager. Since 2016 he is working as Product Manager at Sartorius and He is taking care of Software Solutions for Lab Balances.
