Continuous processing. How to manage the technical challenge

Continuous bioprocessing

A study of the peristaltic life and pumping performance of three TPE tubing products to assess their suitability for continuous bioprocessing - white paper

The technology used in the continuous process can pose a challenge. With this white paper a comparison of the peristaltic performance of three TPE tubing materials provides powerful insights into the effectiveness of different products.

Drug manufacturers are increasingly adopting continuous bioprocessing to manufacture biologics as efficiently as possible. This is being driven by a need to reduce production costs and prices of pharmaceutical products. Furthermore, the FDA has stated its support for the implementation of continuous bioprocessing. A key consequence of continuous bioprocessing is that single-use components and assemblies must maintain integrity for process cycle times of up to 90 days.

PureWeld XL TPE tubing lasts up to 2½ times longer than its nearest competitor

For peristaltic pump tubing, there is added complexity because of the loads placed on the tubing by the pump and the resultant dynamic wear on the tubing. A peristaltic tube must deliver confidence that it will not fail within the process cycle time and that it will deliver consistent flow rate over this time.

In view of this, Watson-Marlow Fluid Technology Group (WMFTG), fluid path solutions provider of peristaltic pumps and single-use components, outlines the results of a study which makes comparisons between the peristaltic life and pumping performance of PureWeld® XL TPE tubing and two leading industry alternatives.

PureWeld XL Continuous processing white paper

Focus and outcome of this study

The study reveals noteworthy results that affirm the need for drug manufacturers to consider the peristaltic life of all tubing products used in continuous bioprocessing.

This paper details that samples of WMFTG PureWeld XL tubing tubing were compared to two leading industry alternative SEBS TPE products to assess pumping performance over time and peristaltic life.

Greater value on single-use fluid path equipment

With the increasing integration of robust single-use technologies into cGMP bioprocess, there is a greater value placed on tubing and tubing assemblies within critical fluid path. Add to this the increasing adoption of continuous bioprocessing, and the resultant process cycle times of up to 90 days, it is essential that the peristaltic tubing used delivers long pumping life.

The increasing burden of materials validation within the bioprocessing industry has driven a desire to rationalise inventory and reduce the number of fluid contact materials. To meet this need, it is advantageous for the tubing used in the bioprocess assembly to deliver high performance in terms of peristaltic life.

There is growing acceptance of SEBS TPE materials due to their compatibility with sterile welding and sealing technologies, performance and levels of purity which meet the expectations of the industry and regulators. In addition, the worldwide shortage of silicone raw materials has brought an additional focus to the implementation of TPEs.

 

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