Watson-Marlow Fluid Technology Group – WMArchitect

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end-user partnership

Watson-Marlow Fluid Technology Group – WMArchitect

WMArchitect is a flexible range of single-use solutions designed to streamline bioprocessing. It is the only single-use solution on the market designed to work synergistically. This fully flexible range is available from a single supplier, designed to safeguard the product and reduce regulatory burden. 

The range includes solutions for upstream, downstream and fill-finish applications. As well as a comprehensive selection of standard, ready-to-use assemblies, any assembly can also be fully customisable incorporating a wide range of components for the application’s specific requirements. Each assembly uses an open architecture model to allow full flexibility and compatibility with existing fluid-contact materials and is supported with rigorous validation studies and tailored regulatory compliance packages.  

WMArchitect streamlines the use of single-use fluid path technology at a UK based cancer research facility. It was installed to support their fill/finish operations which is a GMP-compliant facility engaged in the production of Investigational Medicinal Products (IMPs) for phase I clinical trials. 

WMArchitect is used alongside two Flexicon FP50 automated filling and stoppering machines to facilitate the seamless use of single-use fluid paths, eliminating the need for cleaning validation and simplifying traceability of product contact components. This technology ensures that the liquid being filled does not come into contact with mechanical parts, permanent pipework, or the external environment, reducing contamination risks and simplifying the validation process. 

Sterility and GMP compliance are essential for safety and regulatory approval. All WMArchitect single-use solutions are manufactured, pre-assembled and packaged in Class 7 cleanrooms and quality is assured with 10-6 SAL. Lot traceability of each component facilitates regulatory compliance. The system is installed in a sterile, GMP-compliant environment and is integral to the efficient, contamination-free filling of pharmaceutical products.

The success of the partnership between WMArchitect and the cancer research facility has been quantified through several key operational improvements, including eliminating the need for cleaning validation, simplifying traceability, and reducing contamination risk. These benefits have contributed to a more streamlined and cost-effective process, helping the customer meet stringent GMP standards while producing Investigational Medicinal Products (IMPs) for phase I clinical trials sponsored by Cancer Research UK. The technology’s ability to guarantee sterility and filling accuracy (±0.5%) for vials ranging from 2 to 50ml has exceeded expectations, particularly in preventing costly overfilling during production.

The customer adopted the fill/finish system due to its ease of use, reduced setup times, and simplified inventory management. Prior to using this system, the customer was performing manual pipetting or relying on external resources, which was more labour-intensive and prone to errors. The system was chosen specifically because it eliminates the need for traditional cleaning and sterilisation steps associated with mechanical filling systems. The single-use technology simplifies the validation process by providing pre-sterilised components and ensuring contamination-free filling in a sterile environment, making it a perfect fit for the customers’ operations.

The trial site chose this system to enhance efficiency, reduce risk, and support the critical needs of drug development for biopharmaceuticals.

“Thanks to the adoption of fill/finish we have benefited in a number of ways from its the inherent design characteristics. As the liquid being filled is not in contact with any mechanical parts, permanent pipework or the external environment, there is no risk of cross contamination. In terms of traceability, all of the documentation is provided with the validation pack from Watson-Marlow, which makes our job much simpler. Before we had fill/finish we were either performing manual pipetting or using external resources.” -  customer testimonial