21 CFR Part 11 Compliance Checklist
December 20th 2023The 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.
Laboratory Balances in the Pharmaceutical Industry (Dec 2023)
December 20th 2023Pharma 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.
Use of Laboratory Balances in the Pharmaceutical Industry
December 20th 2023The 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>.
Pharmacopoeia Compliance Guide: Chapter 2.1.7 Ph.Eur. "Balances for analytical purposes"
December 20th 2023The European Pharmacopoeia's new section 2.1.7 on analytical balances was released in July 2021 and enforced from January 1, 2022. It's a mandatory standard for pharmaceuticals in Europe. Download our FAQ for compliance tips and how our Cubis® II lab balance can help.
Introduction to High Resolution Integrated Weighing
January 18th 2022Tuesday, 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
April 29th 2021*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
March 9th 2021***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 Therapies
July 22nd 2020Optimizing 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.
Data Integrity and the Next Level of Connectivity in a Modern Lab
October 29th 2019Why 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
Advanced Compliance for Use in Regulated Sectors | Cubis® II Pharma Compliant by Design
September 18th 2019The 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.