Sterile Consumables

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.

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!

In order to comply with the versatile requirements of today’s market, flexibility and the option to customize are key whilst maintaining availability and short lead times. This is true for many areas, not least when it comes to the ever-growing number of single-use technologies utilized in the biopharmaceutical industry, be it for research and development or small- and large scale production.

Single-use technologies, which reduce the risk of cross-contamination of high-quality bulk drug substances, are becoming increasingly popular in the pharmaceutical industry. You can find out the reason for this in the blog post!
 

The advanced platforms of the newest generation of single use bags are generally compatible with a variety of bag brands and volumes. One of these platforms is Single Use Support’s RoSS®, which offers the benefit of not only being bag agnostic but also highly flexible thanks to its modular design. Learn more about the biggest player in the industry!

The big names in the pharmaceutical industry are increasingly switching from immobile systems based on bulky stainless steel tankers to scalable single-use filtration systems. But why is this so?

Annex 1 is a fundamental framework for the production of sterile medicinal goods. This article will provide an overview of the concept, its history, contents, challenges, and perspectives.