Single-use consumables

March 20, 2024

Bubble point test: Purpose & Procedure

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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.

March 20, 2024

Annex 1: All you need to know

michael-muehlegger
Michael Mühlegger

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.

March 13, 2024

Annex 1 and the PUPSIT requirement

Khalil Essani - Single Use Support
Khalil Essani

Annex 1 and PUPSIT meant significant changes in the pharmaceutical sector. In this article, we will illustrate the focus areas of Annex 1 and will discuss main aspects of PUPSIT.

March 13, 2024

Overview of filter integrity testing methods

Khalil Essani - Single Use Support
Khalil Essani

There are various approaches to validate the integrity of sterile filters, as is required by several regulatory frameworks. We will cover some of the most common methods in this article.

March 5, 2024

Single-use bag manufacturers: the major players

micheal-eder
Michael Eder

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!

July 14, 2023

Interview: Considerations for Sterilization of single-use assemblies

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David Seifert

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.

June 13, 2023

Navigating GMP Annex 1: How Single-Use Assemblies will Comply

1640281789974
David Seifert

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.

March 14, 2023

Primary and secondary packaging of drug substances

Claus Exenberger - Single Use Support
Claus Exenberger

Throughout the manufacturing process of drug substances, the liquids must be transferred frequently, such as during the upstream and downstream processing. Safe packaging of large volume substances is of high necessity in each step. Protection is ensured by appropriate primary and secondary packaging. This article will provide an overview of the different types of primary and secondary packaging materials, which are used specifically for safe handling of drug substance. 

February 28, 2023

Shipping pharmaceutical liquids and its challenges

Claus Exenberger - Single Use Support
Claus Exenberger

The global distribution of pharmaceuticals is complex and demanding, requiring precise handling and storage of sensitive products. With the rise of personalized medicine and the increasing globalization of the industry, the need for safe and efficient shipping and supply chain has never been more important.

December 20, 2022

Upstream processing with single-use systems

bernhard-schlichtner
Bernhard Schlichtner

The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasingly employing single-use bioreactors, titers, filtration and other components, especially during upstream.

December 19, 2022

Downstream processing with single-use systems

bernhard-schlichtner
Bernhard Schlichtner

One would think that a sector like the fast-paced biomanufacturing industry could not get any faster. Yet, increased speed-to-market and ever more efficient manufacturing continue to drive product and process development. This is why single-use technologies have become increasingly popular. Read more about single-use systems for downstream processing in this article. 

October 12, 2022

Mission completed – and now? How RoSS® Shell is to be recycled

Claus Exenberger - Single Use Support
Claus Exenberger

Once they have fulfilled their purpose to protect valuable biologics, the question for our RoSS containers arises: What now? This is why we summarized information on the recycling of our containers for single use bags in this article.