WMArchitect single-use assemblies eliminate cleaning validation

A cancer research organisation in the United Kingdom is among many clinical trial sites that have adopted WMArchitect fill/finish single-use fluid path technology from WMFTS (fill/finish assemblies). Used in conjunction with two Flexicon FP50 automated filling and stoppering machines, fill/finish assemblies have helped a research facility to eliminate the need for cleaning validation and simplify traceability of applied product contact components.

The clinical trial supply unit of the leading cancer research organisation is an MHRA licensed, fully GMP-compliant, 2000 m² facility that is engaged in the process development and production of novel Investigational Medicinal Products (IMPs) for phase I clinical trials. By adopting single-use assemblies from WMFTS the clinical trial supply unit has benefitted from disposable, single-use technology such as fill/finish.

Lower risk

Fill/finish assemblies are a sterile, single-use fluid path perfected for aseptic filling. Used in combination with Flexicon filling machines it helps eliminate the risk of contamination in high-purity filling applications. Importantly, single-use technology simplifies the validation process, making it the preferred solution over traditional hard-piped systems with piston pumps that require complex cleaning validation.

“Thanks to the adoption of fill/finish assemblies we have benefited in a number of ways from its the inherent design characteristics,” a spokesperson for the clinical trial supply unit said. “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 assemblies we were either performing manual pipetting or using external resources.”

Single-use technology transforms the way filling lines are used, ensuring systems are kept clean and free from contamination. In fact, sterility is guaranteed as all parts are double-bagged and pre-sterilised using a validated gamma irradiation process. This eliminates the need for costly laminar air flow assembly areas, autoclaves and labour for the on-site assembly and sterilisation of filling accessories. Once the filling process is complete, users simply remove the fill/finish assembly unit.

Quick and easy

At the heart of fill/finish assemblies is Watson-Marlow’s Accusil platinum-cured silicone tubing, the only silicone tubing optimised for Flexicon fillers. Engineered specifically for post-irradiation dispensing stability and manufactured in ISO 14644-1 Class 7 cleanroom conditions under tight tolerances, Accusil is also post-cured for lowest extractables and features laser etched lot data. Importantly, the tubing helps ensure superior filling accuracy of ±0.5% is achievable on volumes higher than 1 ml, thereby preventing costly overfilling.

A spokesperson for the clinical trial supply unit added: “We order using a single part number, which simplifies inventory management, and the system arrives pre-configured so we are ready to go. Everything is fully integrated with standard connections, so set-up time is virtually zero.

“We fill vials between 2 and 50 ml, although 5 ml is probably our most common size. A batch is usually 5 or 10 litres, which means filling 1000 or 2000 5 ml vials. It’s important we don’t overfill.”

Learn more about Fill/finish single-use assemblies