Case Study - Reducing Product Loss | Process-independence

Claus Exenberger - Single Use Support

Claus Exenberger

August 22, 2022

Table of contents

Show

When CDMOs plan to expand their production capacities based on single-use technologies, it is tempting to either implement existing spare platform systems or simply "copy paste" used equipment - especially for greenfield facilities. However, it is also a great opportunity to install platform systems that help optimize process operations. CDMOs must strike a balance between limiting the Total Cost of Ownership and the building a process-efficient manufacturing facility

Single Use Support assisted a global CDMO in expanding its manufacturing facility that had already previously implemented RoSS technology.  In this case study, siloed platform systems for filling, freezing and ultra-cold storage of pharmaceuticals in single-use bags with high dependency on single suppliers were identified as the biggest cost drivers.  

Find out how you can save capital expenses thanks to modular and vendor-independent process solutions and operating expenses thanks to increased process speed at various scales with reduced product loss. Gain process-independence to unleash efficiency manufacturing processes.

Case Study - Reducing Product Loss | Process-independence

With the implementation of RoSS® shells, a multinational CDMO has been able to standardize its fluid management process thanks to the protective shell’s bag-independence, and regardless of size and type of single-use bag used. RoSS – abbreviation for "robust storage and shipping”: • helps to streamline the liquid transfer process and • optimizes each full cold chain management process by enabling full flexibility.1 The CDMO has now planned an extension of their manufacturing site and is searching
Claus Exenberger - Single Use Support

Claus Exenberger

Product Line Management

Claus Exenberger is Product Line Manager at Single Use Support. As product owner of the RoSS shell, the secondary packaging of single-use bags, Claus and his team develops further non-sterile products to advance handling of single-use bags for the biopharmaceutical industry. With his working experience of 5+ years at Single Use Support he is expert in the protection of all available single-use bioprocess containers. His proximity to customers helps connect his process-oriented approach with the technical development of products.

More from Claus Exenberger

Monoclonal Antibodies

Safe handling of monoclonal antibodies: Best practices

Monoclonal antibodies bring along some special requirements in terms of safe handling. In this article, we will discover what these requirements are, and how they can be met.

Claus Exenberger - Single Use Support

Claus Exenberger

February 7, 2024

Single-use Technology

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 - Single Use Support

Claus Exenberger

March 14, 2023

Read more about Single-use Consumables

Single-use Consumables

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.

1640281789974

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-muehlegger

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 - Single Use Support

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 - Single Use Support

Khalil Essani

March 13, 2024