Assuring sterility, traceability, and quality for your single-use fluid handling

Introduction

One of the major trends in pharmaceutical manufacturing over the last decade has been the replacement of traditional, reusable cleanable components by single-use disposable alternatives. This transition has been possible due to the development of a wider range of single-use products for both upstream and downstream processing as well as for formulation and filling.

The increasing scope and availability of single-use technology has also presented the opportunity to design and assemble multi-component manifolds and systems that can offer benefits such as elimination of in process cleaning and steam sterilization, faster processing times, more flexible manufacturing and lower risk of operator error. Most importantly, single-use pre-sterilized systems can also offer potentially a higher level of sterility assurance and a lower risk of product contamination by eliminating some of the operational procedures of traditional processing. The importance of this benefit was highlighted by the FDA’s product recalls in 2015 where 78% of recalls were attributed to lack of sterility assurance or to contamination of the drug product, with the primary reason being failure to follow written procedures.

A key requirement for multi-component, single-use sterile systems is the need to make safe and secure connections between the various manifolds and attachments using a sterile connector – and without the need for aseptic handling under laminar airflow in classified environments. In this publication, we describe the approach to the design, development and validation of a new sterile connector, the Pall Kleenpak® Presto Sterile Connector, with a unique design and manufacturing procedure that ensures the robustness and full traceability of every connector. The contribution of this feature to the integrity assurance of single-use systems is discussed as well as other properties of the connector that facilitate the management of sterile connections.