Since 1870, Sartorius has been on the cutting edge of weighing technology and innovation. In 1970, the company created the world’s first electronic balance, and in 1994 the first monolithic weight cell in 1994. Fast forward to 2009 and the Cubis® II, the first fully configurable balance series, was introduced. And within a few years, a high-capacity micro balance was added with 60 million divisions, which was the highest resolution laboratory balance on the market at the time. Today, Sartorius’ Cubis II platform offers a completely configurable, high-performance portfolio of both laboratory-weighing hardware and software for scientists in R&D and analytical laboratories.
Ensuring Data Integrity and Compliance
The pharmaceutical industry is faced with many challenges, and one of the biggest challenges is data integrity. In fact, 65% of all warning letters issued by the FDA in 2017 were related to data integrity issues—from not documenting batch-related activities and backdating of data to transferring data incorrectly or an insufficient audit trail(1) .
To address these issues, Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles are incorporated into the Cubis II balance, offering a full form of compliance to adhere to all necessary data integrity regulations. With a pharmaceutical package, the Cubis II offers users all of the technical controls necessary to support compliance with common regulations such as FDA’s (21 CFR Part 11) and EU’s (Annex 11). These controls include audit trail, safe data transfer, backups, time synchronization, e-signatures, access control and user management, and alibi memory.
The audit trail is essentially a tamper-protected timestamp electronic log file that allows reconstruction of events related to the creation, modification, or deletion of records. Data can easily be displayed, filtered, recorded, and exported in various ways. Additionally, the system can automatically execute time-controlled actions for backups. Users are able to upload data onto a file share or export the data to other systems. Archiving is also easily done within full compliance.
The system enables the protection of electronic records from any sort of manipulation by saving all files together with a calculated MD5 checksum, which is stored in the audit trail files or in a separate MD5 file. An accurate timestamp is essential for trusting records. The Cubis II balance supports automatic time synchronization via a network time protocol (NTP).
Electronic signatures can be used to sign the final report via the electronic signature feature for all weighing processes. The combination of both the username and a password is fully compliant with (21 CFR Part 11).
Additionally, the Cubis II balance provides two options for complete user management with access control: A local user management that can be configured in accordance with your password policy, or the password rules for (21 CFR Part 11) compliance can easily be implemented by integrating the system into your company’s own domain to allow for a single sign-on. And in this case, the company-defined password rules are implemented automatically.
From Hardware to Software
Beyond compliance, the Cubis II platform has fully customizable hardware, software, and connectivity solutions. From the weighing module standpoint, there are up to 46 different weighing modules that can best fit user parameters and preferences. Additionally, there are seven different models of draft shields to choose from. Depending on balance type and needs, there are unique features to support a range of balance performance and designs. Users can choose between an advanced and an essential user interface display based on what is being weighed as well as the applications and requirements.
Software benefits include flexibility and modularity, cost effectiveness, and a future-proof nature. There are more than 60 optional software applications that are clustered into four different QApp packages organized according to the applications and functions necessary in the laboratory. Users only need to select the QApps software necessary for their workflows and can pick and choose between different packages to fulfill specific demands. Packages come preinstalled on the balance with the option to add more later, and once the software is purchased and installed, free updates or upgrades are included with every balance in the Cubis II portfolio for the lifetime of the product.
Intelligence in the Laboratory
To put the advantages of the Cubis II balance platform into perspective, here are a few practical examples using the automatic motorized leveling function, gesture control, climate monitoring, status center notification, and stabilization time to aid the performance of measuring samples and weighing them in a pharmaceutical or medical-device environment.
The automatic motorized leveling function is a convenient feature that avoids the burdensome process of repeatedly having to prepare the balance. This is especially beneficial for applications in which hazardous samples might be employed in a fume hood. The user does not have to worry about leveling the balance because it is done automatically.
Gesture control enables users to automatically have the balance recognize up to four different gestures that can be used and positioned near the balance directly in the flow of motion at their workspace via the gesture sensor. This feature allows users to open and close the automatic draft shield or start the ionizer and other functions, enabling users to work conveniently and efficiently within their workspace. This is especially helpful when working in a hands-free environment where samples are simultaneously manipulated and weighed.
The built-in climate sensor monitors all influencing variables, including temperature, pressure, and humidity. This is critically important when trying to achieve highly accurate results in a pharmaceutical or medical-device setting.
Status center notification allows users to see all balance information and environmental conditions at a glance. Functions such as calibration, leveling, temperature and humidity settings, air pressure, and service functions are all centralized into one dashboard. In the event of a warning alert, a detailed help message is sent, and support is available immediately so that the problem can be identified and corrected.
When a major manufacturer in the stent industry compared results from the Cubis II balance against results from another manufacturer, they noticed they were getting 20% faster performance with the Cubis II balance system because of faster stabilization times. The Cubis II helped improve this medical-device manufacturer’s laboratory testing efficiency, especially when they worked with larger quantities of solutions, standards, and materials.
The Sartorius Cubis II balance platform combines customization and compliance to support pharmaceutical laboratory-weighing applications, allowing users to align with their unique demands—from compliance requirements to maximizing operational efficiencies and experimental outcomes.
(1) FDA, “Warning Letters 2017,” www.fda.gov/drugs/warning-let tersand-notice-violation-letters-pharmaceutical-companies/warning-letters-2017