Sartorius

Articles by Sartorius

The Cubis®️ II balance, equipped with a pharma package, provides technical features for regulatory compliance in pharmaceutical quality control. Complete compliance requires extra procedural controls and data storage systems. Our checklist highlights key regulatory details and shows how Cubis®️ II facilitates full pharma compliance.

Pharma companies must comply with pharmacopeia regulations, like the USP for the US and Ph.Eur. for Europe, to market drugs. The USP has long had a chapter on lab balances, while the Ph.Eur. introduced a similar mandatory chapter in January 2022. Our infographic compares lab balance rules in both pharmacopeias, noting their differences.

The European Pharmacopoeia's new Chapter 2.1.7 on analytical balances was published on July 1, 2021, and became mandatory for pharma companies in Europe from January 1, 2022. It outlines calibration and performance standards for balances. Our white paper compares this with USP Chapters <41> and <1251>.

Introduction to High Resolution Integrated Weighing

Tuesday, 1/18/22 at 11am EST | 8am PST | 5pm CET | 4pm GMT In this presentation we look at the products available to support projects where high resolution weight determination is essential. We will also explain what is important when designing a system that requires an integrated weighing solution and the various factors that can influence the performance and final results.

Strategies for Intensified Bioprocessing: From Seed Train to High Cell Density Clarification

*Thursday April 29, 2021 at 2pm EDT | 1pm CDT | 11am PDT* Interested in achieving an efficient and automated seed train in upstream processing? Do you have challenges in high cell density clarification using traditional hybrid approaches? Register now to find out how to overcome these challenges by applying process intensification, advanced process analytical technology and single-use centrifugation.

Compliance, Data Integrity and Software-based Workflow Guidance in Today’s Lab

***Live: Tuesday, March 9, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET*** Review what needs to be put in place to ensure data integrity and compliance and minimize the risk for your organization. Learn how today´s state-of-the-art laboratory balance Cubis II from Sartorius provides all the technical features needed to automate processes to ensure pharma compliance and offers digital workflow support for trusted and error-free process. ** On demand available after final airing until March 9, 2022.***

Optimizing the Manufacture of Cell and Gene TherapiesDescription: Cell and gene therapies are an emerging field that is seeing rapid growth. The manufacture of these advanced therapy products is not yet fully optimized, however, and still carries risks and challenges to process quality, scale up and efficiency. This ebook on Optimizing the Manufacture of Cell and Gene Therapies discusses strategies to making these cell or gene therapy products a success.

-Higher integrity assurance is needed for single-use systems -An integrity-testing strategy may be required to meet regulatory expectations -New scientific and technological approaches offer stronger integrity

Why is laboratory data integrity a hot topic for bio/pharma companies and regulators? Get insights on challenges and solutions in the paperless laboratory in this webcast. Live: Tuesday, Oct. 29, 2019 at 11am EDT | 8am PDT| 3pm GMT| 4pm CET On demand available after airing until Oct. 29, 2020 Register free

The Cubis® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7” display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.

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