Subscribe to our Newsletters !!
Climate change is very disruptive to the Amazon ra
Weigh bridges are tools which are mostly used in v
Insects that are given more attention and reverenc
Alembic Pharmaceuticals Limited appoints Mr. Manis
The importance of comparing the treatment of asthm
It is important to understand that natural remedie
Dear Readers, Welcome to the latest issue of The Magazine
When it comes to regulatory compliance, some may find the prospect of understanding and validating for MCA 21 CFR Part 11 daunting. It’s necessary to prove to regulators that your process and solutions are robust enough to meet their standards, and this will be less of a challenge if you find the right partners to support you. Hence, it is equally important to carefully consider 21 CFR Part 11 compliance solutions when choosing your lab solutions. It is important to have a closed system, where system access is controlled by the persons who are responsible for the content of the electronic records that are on the system.
Sartorius’s Cubis® II MCA is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA). The Cubis® II MCA with pharma package contains all the technical controls to support compliance with the FDA directive 21 CFR Part 11 and EU Annex 11. Full compliance can be achieved with additional procedural controls and systems for long-term data storage. The Cubis® II MCA balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. There are 45 weighing modules, 7 draft shields, and 5 software packages, including more than 60 software Apps for you to choose from.
Electronic signature, report functionality, audit trail, backup and archiving , time synchronization, electronic records, easy to use interface and web connectivity, are what you can expect from this pharma balance unit. To create a compliant weighing protocol, additional metadata must be added. Data, such as sample date and time, software version, balance ID, user ID, batch number, and so on, can be configured to include all required metadata for reliable records. Finally, the whole data set can be included in a GxP-compliant weighing report. In the print process, such values are included in the report and can be printed or exported as an electronic, signed PDF.
In case of a mistake, a user is able to mark an incorrect dataset as invalid, with an explanatory comment required before continuing . This dataset will not be deleted or hidden, but rather is displayed, together with the correct dataset, and visibly marked as invalid by crossed out text. The local user management can be configured in accordance with your password policy. User management includes predefined, non-editable roles (e.g. Administrator, Operator), but allows addition of individual roles and configuration of role rights.To ensure that you do not miss out any critical touchpoint for your compliance check, a complete compliance checklist is available to help you.
Several variables can affect the ability to weigh accurately with high-performance balances, such as the location of the balance in the lab and the environment around the balance. Lab balances, must, therefore, provide the most reliable and repeatable weighing results within that lab’s unique situation. To help maximize operational efficiency and experimental outcomes, a fully customizable laboratory balance is an ideal solution to align weighing needs with each lab’s unique demands and requirements.
The ability to pick and choose the hardware, accessories, software, and applications of a fully customizable lab balance allows researchers to meet their specific needs and situation, thus minimizing their research costs and maximizing return on investment. The Cubis® II balance, with its practical array of modular components, including hardware, software, applications, and accessories offers labs the potential to fully individualize their balance, thus enabling faster, more efficient workflows and enhanced protocol applications.
Because of its intelligent design with the ability of the optional climate monitor to detect environmental influences and the status of the balance via a dashboard, the Cubis® II series of lab balances ensures the highest level of weighing accuracy and precision even when the balance is placed in unideal locations within the lab. Almost all physical variables, such as vibration, drafts and air pressure, temperature, humidity, and static electricity, can affect weighing accuracy with high-resolution balances. Therefore, high-resolution balances must be able to operate accurately in unideal locations, and must be able to report to the user when and how the placement conditions are affecting weighing results.
With the Cubis® II, customers can choose an interface unit that actively monitors temperature, atmospheric pressure, and humidity with climate sensors and alerts users to the potential for these variables to affect their weighing results. The customizable modularity of the Cubis® II series begins with hardware; customers may choose from among 45 weighing modules, two user interfaces, and seven draft shields. Depending on a lab’s specific needs, for instance, weighing modules may be ultra-micro- or micro, semi-micro or analytical, precision, or high-capacity.
Both user interfaces allow touch-control and include essential weighing applications. The advanced user interface has the ability to run tasks with integrated QApps, which are clustered by theme in packages according to topic and are clearly structured and compact, so they are easy for Sartorius to test and validate for the customer. In addition, to help enhance productivity, efficiency, and data integrity in the lab, the advanced user interface allows communication over standard internet protocols, which helps eliminate manual data transcription errors and enhances data quality and integrity because it communicates directly with external software systems. Moreover, if customers have special needs regarding their SOPs or workflows, Sartorius developers are able to modify the software exactly to the customer’s needs.
All balance draft shields are designed to protect substances being weighed from the effects of drafts and, with ionizers installed, static electricity. Drafts and moving air will be detected by highly precise balances. The mechanical force exerted by static electricity is also detectable with analytical balances, with an increasing influence on micro- and ultramicro balances, and is the cause of instability in weighing measurements. Static elimination accessories, such as external air ionizers, can be purchased to dissipate static charges in the air around the balance.
The innovative draft shield technology of the Cubis® II balance not only protects from drafts, but has an optional accessory to eliminate static effects. This draft shield is an automatic glass draft shield that may be operated by gesture sensors, allowing the user to open the draft shield and print with specific movements of the hand over the infrared sensor. One of the Cubis® II balance’s draft shield options also includes an integrated ionizer to eliminate static charges on samples and sample containers, and a conductive coating for extra protection against electrostatic build-up, particularly that which derives from users. One of the other factors affecting accurate results is correct levelling of the balance because even being slightly off-level can introduce systematic error. The Cubis® II line of balances has a quick and easy, motorized, auto-levelling function to simplify the process of preparing the balance for use and keeping it level for the most accurate weighing results. The Cubis® II laboratory balance has a fully customizable hardware, software, and connectivity suite that will align with each lab’s unique demands and compliance requirements to help maximize operational efficiency and experimental outcomes.
The Sartorius Group is a leading international partner of the biopharmaceutical industry and the research sector. We are helping biotech scientists and engineers across the entire globe to develop and manufacture medications from the first idea to production. So more people will have access to better medicine. Ergonomics, Design and Reliability – form the cornerstone of Sartorius products. Sartorius pipettes and pipette tips raise your pipetting to a whole new level ensuring repeatable and reliable results. Enjoy the experience with Sartorius products and feel the new standard of pipetting in your hand.
