A Cancer Research facility in Hertfordshire, UK is among a growing number of clinical trial sites that have adopted asepticSU single-use fluid path technology from Watson-Marlow Fluid Technology Group.
Used with two Flexicon FP50 automated filling and stoppering machines, asepticSU has helped the Biotherapeutics Development Unit (BDU) at South Mimms to eliminate the need for cleaning validation and simplify traceability of applied product contact components.
The BDU is a modern, MHRA licensed, GMP-compliant, 2,000m² facility that is engaged in the process development and production of novel Investigational Medicinal Products (IMPs) for Phase I clinical trials sponsored by Cancer Research UK.
'Put simply, we’re a clinical trial supply unit within the charity, and we have our own filling lines in a sterile environment,' said Deputy Production Manager, John Emerson.
asepticSU is 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. Single-use technology simplifies the validation process, making it a preferred solution over traditional hard piped systems with piston pumps that require complex cleaning validation.
Emerson said the firm has benefited in a number of ways from the inherent design characteristics of the asepticSU.
'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 asepticSU we were either performing manual pipetting or using external resources.'
Single-use technology is transforming the way filling lines are used, ensuring that 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 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 asepticSU unit.
'We order using a single part number, which simplifies inventory management, and the system arrives pre-configured so we are ready to go,' added Emerson. 'Everything is fully integrated with standard connections, so set-up time is virtually zero.'
At the heart of asepticSU 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 filling accuracy of ±0.5% is achievable on volumes higher than 1ml, thereby preventing costly overfilling.
'We fill vials between 2 and 50ml, although 5ml is probably our most common size,' Emerson. 'A batch is usually 5 or 10 litres, which means filling 1,000 or 2,000 5ml vials. It’s important we don’t overfill.'
