AdvantaPure, the sanitary products division of US-based NewAge Industries, offers the AdvantaPass wall pass-through technology for transferring critical fluids during pharmaceutical and biopharmaceutical production. The system combines single-use tubing and isolation chamber assemblies with in-wall, permanent stainless steel components to eliminate cleaning validations associated with cleanroom protocols.
The company, based in Southampton, PA, says AdvantaPass is the first system of its kind to offer complete isolation between manufacturing environments when transferring multiple lines of fluid through a single wall portal. It conveys fluids without having to move bins and totes, thereby removing the risk of breakage, spillage and lost pharmaceutical product associated with bin transfer.
The technology offers a practical, safe, secure and easy way to move large volumes of liquids from one room to another while maintaining separate atmospheres and minimising the risk of cross contamination, the company says.
Tony Butler, AdvantaPure's Manager of Single-Use Systems, says the system is unique in two ways. First, it incorporates single-use disposable fluid transfer and isolation barrier components, thus eliminating cleaning validation issues between product transfer processes. Second, it can handle multiple fluid transfer lines without compromising the isolation barrier.
'Other pass-through systems can only manage one line at a time, when correctly installed, without jeopardising the barrier,' he says.
The system's other advantages include:
- Cost savings over other pass-through methods that involve multiple moving parts and frequent maintenance;
- Design flexibility – suitable for new construction or existing facilities;
- Customisable to accommodate multiple tubing ports, environmental purge ports, and cleanroom wall thicknesses including floor-to-ceiling conveyance;
- Time, labour and expense savings compared with the sterilisation and validation requirements of traditional hard piping transfer systems;
- Quick and easy assembly and disassembly;
- A choice of single-use components in platinum-cured silicone or AdvantaFlex biopharmaceutical grade TPE.
AdvantaPass offers optional purge ports to further reduce the chance of cross contamination between viral-active and non-viral-active suites. It incorporates BPE-compliant hygienic union clamps and is supplied in nominal sizes up to 6in diameter with larger sizes available on request.
Butler says the permanent components are machined from solid stainless steel, and the single-use tubing, seals and gaskets provide quick changeovers.
'It is a customised system using standardised parts that provides an uncompromised safety barrier between cleanrooms,' he says.
AdvantaPure will show the AdvantaPass technology at this week's Interphex show in New York, from 18–20 March.