David Seifert

Among the possible filter integrity testing methods, the bubble point test belongs to the most frequent ones. Therefore, this article will describe the process along with its applications, benefits and limitations, and its automation.

In an interview with single-use systems expert David Seifert, he compares sterilization methods and shares insights, benefits and outlooks in the field of single-use sterilization technology.

GMP Annex 1 significantly impacts the use of single-use assemblies in fluid management processes within the biopharmaceutical industry. It requires manufacturers and stakeholders to adopt a risk-based approach, implement proper controls, and ensure the integrity and sterility of single-use systems.

Single-use systems are looking ahead a bright future – but what is it that manufacturers need to consider before the switch? Learn more about it in this article!

Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. While extractables and leachables both describe foreign matter that can lead to contamination of highly valuable drug products, it is important to understand their characterization but also the difference between the two.

PUPSIT will contribute to simplifying not only integrity testing and validation but manufacturing processes in general, while keeping in line with current good manufacturing processes and any standards and guidelines defined by major authorities such as FDA and EMA. Read all about it!

An overview of manufacturers and its brands of single-use tubings for biopharmaceutical fluid management.

Are you switching your operation to single-use tubing assemblies? In the following, we show you more about the separate components that single-use tubing assemblies and manifolds are made up of and their specific functions.