The future is gloveless for biopharma aseptic filling
Vanrx was recently featured in the leading international publication Cleanroom Technology for redesigning the aseptic filling process with our gloveless isolator technology.
Cleanroom Technology: The Future is Gloveless for Biopharma Aseptic Filling
This article explains how the future of aseptic filling is shifting away from glove ports / conventional isolators and focusing on gloveless isolators, such as Vanrx Aseptic Filling Workcells. The built-in flexibility and aseptic assurance provided by these new aseptic filling technologies are a global solution for changing pharmaceutical market demands.
There are two key design parameters of a gloveless isolator. First, the sources of interventions through glove ports are designed out of the machines. If there are no conveyors, vibratory bowls, star wheels and other moving parts, at least 95% of the possible interventions no longer exist. Designing these parts out simplifies the interior of the isolator, boosting decontamination speed and effectiveness. Vibratory bowls and conveyors are particle generators, so their removal reduces the risk of particle introduction into the drug product.
Second, containers and closures are never handled individually and are only handled by robots. This concept was learned from semiconductor manufacturing, which uses a front-opening unified pod (FOUP) to move wafers between machines. In an aseptic filling workcell, the FOUP’s equivalent is pre-sterilised, nested ready-to-use (RTU) containers and closures. Handling nests of containers significantly reduces the possibility of an intervention and eliminates particles from glass-to-glass contact.