Cubis® – 高度な製薬コンプライアンス (APC)
電子天びんCubis®シリーズを設計するにあたり、ザルトリウスは特に規制された分野でのお客様のニーズに注目しました。その結果、Cubis®は、ソフトウェア、ハードウェア、サービスパッケージ全体を含む多くの機能性を備えたひょう量機器となり、医薬品環境で使用するための特別な資格を保有しています。この天びんは、互換性やトレーサビリティといった規制上の必須要件を満たすためのすべての強力な機能と、ひょう量プロセス全体を通してユーザーを直接サポートする生産性向上のための機能を兼ね備えています。
Compatibility and Traceability
Thanks to its high-grade materials featuring a sleek and structure-free finish, Cubis® is fast and easy to clean for thorough results.
The Audit Trail function logs important changes to the balance. In this way, any errors or other non-conforming items can be quickly traced to the source.
A built-in Alibi memory ensures traceable transfer of legal-for-trade weighing data to your PC.
We asked an independent institute known for its strict vigilance to test and evaluate the suitability of a representative sample of many Cubis® series balances for use in GLP environments. These balances were equipped with an MSA display and control unit for testing. The outcome: the suitability of Cubis® for use in these environments was unconditionally certified.
A representative sample of many Cubis® series balances with an MSA display and control unit had to pass risk analysis testing according to the proactive method of FMEA (Failure Modes and Effects Analysis) as the basis for a GLP suitability review and cleaning validation. The results of this analysis are available on request.
Balance Monitoring
Q-Level enables you to have your balance automatically leveled by motors at the touch of a key. In the process, Cubis® checks whether the balance is perfectly level and will immediately alert you whenever the balance has to be re-leveled (automatic messaging only on models with a capacity of < 6.2 kg and a readability of > 0.001 mg). Q-Level combines novel sensors and the most advanced display technology, making it easier and faster for you to level the balance accurately. Cubis®, along with MSA or MSU display and control units, offers interactive prompting to guide you during manual leveling. While Q-Level is active, the display will show you all the information you need: the position of the air bubble as well as text prompts, or icons on MSE, so you know which leveling foot to turn in which direction.
You can choose to have the isoCAL function perform fully automatic calibration and adjustment after a factory preset or user-definable interval has elapsed. In addition, when a factory preset or user-definable temperature difference is exceeded, isoCAL will automatically trigger calibration and adjustment again.
So-called linearity errors occur when there are any deviations from the theoretical linear slope of a balance's characteristic curve. Optimal linearization is required in order for your balance to meet its high accuracy criteria. That's why Cubis® eliminates these errors by automatically performing linearization.
Cubis® lets you determine the standard deviation right where your balance is installed so you can check the repeatability of your weighing results: just one touch of a key is all it takes. This convenient reproTEST feature enables you to quickly determine whether the balance's environment is suitable so your balance will consistently deliver optimal and reliable weight measurements.
Process Monitoring
Management of user profile names and passwords provides tamper-proof security.
Cubis® provides alert messages and reminder functions with user-definable action hierarchy for leveling, minimum sample weight – i.e., the desired smallest net weight – and calibration | adjustment.
During a weighing process, Cubis® monitors compliance of the starting point of its operating range with USP requirements. Once Cubis® has determined the starting point of an operating range, it will alert you whenever a value goes below this lowest point and will identify any unacceptable weights recorded or transferred.
Following internationally recognized DakkS calibration by the Sartorius Services unit, the characteristic curve of the measurement uncertainty can be read into the software of your Cubis®. As a result, you can choose between having the absolute or relative measurement uncertainty as well as the process accuracy displayed for every weight measured.
The Task Management function enables you to define application workflows in your Cubis®. After you have configured a task workflow, you and your other operators will be guided interactively through your weighing process. Information not relevant to this process will be hidden to ensure error-free operation and to let you concentrate fully on the essentials of the task at hand.