Single-use Consumables

Explore our extensive articles on single-use consumables, covering a wide range of topics to enhance your knowledge and practices. Read about different types of consumables, best practices for their use, and comparisons of solutions from various companies. Our content delves into the latest trends and innovations, providing valuable insights for applications in mRNA & LNP handling, cell & gene therapy, and vaccine development. Stay informed and make better decisions with our expert analysis and comprehensive guides on single-use consumables.

All articles about Single-use Consumables

RoSS.FILL Bag_Product Photo_Single Use Support-16

Bubble point test: Purpose & Procedure

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.

David Seifert

March 20, 2024

Single-use Consumables

Annex 1: All you need to know

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.

Michael Mühlegger

March 20, 2024

Single-use Consumables

Annex 1 and the PUPSIT requirement

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.

Khalil Essani

March 13, 2024

Single-use Consumables

Overview of filter integrity testing methods

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.

Khalil Essani

March 13, 2024

Single-use bag manufacturers biopharmaceutical market Single Use Support

Single-use Consumables

Single-use bag manufacturers: the major players

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!

Michael Eder

March 5, 2024

IRIS Single-Use Assmeblies_Production Kufstein-29

Single-use Consumables

Interview: Considerations for Sterilization of single-use assemblies

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.

David Seifert

July 14, 2023

IRIS Single-Use Assmeblies_Production Kufstein-9

Single-use Consumables

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

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.

David Seifert

June 13, 2023

Single-use Consumables

Primary and secondary packaging of drug substances

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.

Claus Exenberger

March 14, 2023

Single-use Consumables

Shipping pharmaceutical liquids and its challenges

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.

Claus Exenberger

February 28, 2023

Single-use Consumables

Upstream processing with single-use systems

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.

Daniel Tischler

December 20, 2022

Single-use technology in downstream processing

Single-use Consumables

Downstream processing with single-use systems

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.

Daniel Tischler

December 19, 2022

Frozen single use bag in RoSS shell single use bag protection

Single-use Consumables

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

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.

Claus Exenberger

October 12, 2022

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Recommended Downloads

E-Book

eBook: Filling Gaps in Managing Large Volumes of Biologics

Aseptic aliquotation and cryopreservation of drug substances are crucial process steps in bioprocessing. Even though they’re not in the spotlight of biomanufacturing. In drug development and drug delivery, biologics must be transferred at numerous occasions. Along the journey of monoclonal antibodies, vaccines and more, the drug substance passes lots of process steps where liquid transfer is required. This is relevant for the transitions between upstream processing, downstream processing and fill & finish, but also within these manufacturing milestones. The market of fluid & cold chain management has great growth potential and is on its way to professionalization and industrialization. To meet the challenges of manufacturing drug substances, Single Use Support helps manufacturers and CDMOs to advance their fluid & cold chain management process to achieve a secure and efficient process for liquids on the basis of single-use bags.

E-Book

Whitepaper: Scalable Freezing & Thawing of Pharmaceutical Bulk

The process of freezing can lead to a denaturation of the protein. In fact, parts of the protein solution will always show less activity based on the stress the protein is exposed to during freezing and thawing. It is therefore important to optimize the freezing and thawing process in order to minimize activity loss. A key parameter for this process is the freezing or thawing rate.

RoSS.FILL CGT Small Volumne_Product Photo-3-min

E-Book

App Note: Enhancing Flexibility & Accuracy With Single Use Support and Sonotec

Enhancing Process Flexibility and Filling Accuracy With Automated Filling. For low volume dispensing at a commercial scale, accuracy and repeatability are essential. To achieve a filling accuracy range of even less than ± 1 mL with the RoSS.FILL platform, Single Use Support decided to implement SONOTEC‘s SONOFLOW CO.55 V3.0 ultrasonic flow meters. Hence, RoSS.FILL users benefit from advanced process safety, flexibility, and scalability with accurate and airless volume dosing.