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How to integrate single-use technologies with traditional stainless steel equipment

By John Boehm Bioprocessing Business Unit Manager Colder Products Company

Introduction

The incorporation of disposable components into bioprocessing systems provides operational and safety advantages. Therefore, an important question in the industry today is how to integrate single-use technologies with traditional stainless steel equipment. Choosing the correct connection technology can help ease a manufacturer’s transition from stainless to disposables.

Disposable systems - a definitive trend in the industry?

Single-use systems have been used in the biopharm industry for more than a decade. However, over the last few years, their acceptance and growth has truly accelerated. While disposables once focused primarily on lower cost media, the use of single-use systems has spread throughout the production process and even downstream into final fill operations.

Key advantages driving the trend toward disposables.

Single-use systems increase productivity through the reduction of system downtime associated with cleaning and cleaning validation. Reducing downtime of key processes allows manufacturers to increase output while also decreasing time to market. Flexibility is strategically important as processors strive to increase operational efficiency and prepare facilities for production of new drugs. Unlike fixed piping systems, disposable systems enable quick modification of the media transfer process between existing processing equipment. The implementation of single-use technologies can increase production capacity at an existing facility where traditional fixed systems would require costly facility expansion. Risk management continues to be a fundamental concern in the bioprocessing industry; the integration of single-use systems minimizes the risk of cross-contamination. Media contamination can lead to expensive reprocessing activities or the complete loss of a valuable batch of product. Contamination concerns are magnified as companies conduct more multi-product manufacturing within single facilities. Disposable systems reduce operational expenses as well as capital costs. Labor, chemical, water, and utility expenses are decreased due to diminished requirements for cleaning or cleaning validation. Capital investment for new construction can also be lowered due to reduced equipment and floor space requirements, thus improving ROI.

Important criteria for bioprocessing connections

There are three primary criteria for bioprocessing connections: reliability, compatibility and flexibility. Reliability is critical as manufacturers expect secure, leak-free connections to protect them from potential product contamination or loss. Materials used in the connectors must be compatible with a manufacturer’s varying process requirements. Materials must meet stringent biocompatibility requirements to address concerns associated with leachables and extractables. Media, chemical and temperature compatibility along with sterilization requirements help determine which materials are suitable for a given application. Flexibility is a final key aspect of selecting the appropriate connection. The advancement of single-use technologies brings the challenge of connecting all the various elements together - bags, filters, tubing assemblies, process equipment, etc. Therefore, the availability of a broad range of connection solutions of differing sizes and termination options means the evolving needs of the industry can more easily be addressed.

The future of single-use systems

As more manufacturers capitalize on the advantages of single-use systems, the integration of these systems will increase accordingly. Small and large companies alike are utilizing single-use systems to reduce the time required to design, build and commission new production facilities. At the same time, existing facilities are being retrofitted to incorporate disposable systems. The result will be increased productivity, minimized risk, added flexibility and reduced operating costs. The innovation of connection, bag, tubing and filter technologies will further stimulate the growing acceptance of these single-use systems.