ChargePoint Actis is an aseptic transfer system that enables isolator-level regulatory confidence in a single compact system. As a result, it has the potential to transform Annex 1-aligned facility design, reduce infrastructure costs and accelerate processing. ChargePoint Actis introduces an entirely new level of confidence in aseptic transfer, combining proven principles – isolation, rapid transfer ports, split valves and steam sterilization – into a single, compact, fully automated system. Traditionally, achieving sterility assurance at this point has required significant investment of capital, infrastructure, space and operational complexity, in order to manage a critical vulnerability where two transfer surfaces meet and separate: the ring of concern. High-grade cleanrooms, isolator barriers, laminar air flow systems and complex decontamination processes have been among the necessary compromises, until now. ChargePoint Actis is designed to bypass the ring of concern and eliminate reliance on additional infrastructure by building validated sterility assurance and both primary and secondary containment into the transfer connection itself.
Source: ChargePoint Technology
The system enables direct aseptic transfer of material through a steam-sterilisable chamber without ever exposing product to the surrounding environment. This directly addresses multiple requirements for aseptic transfer outlined in EU GMP Annex 1, including closed-transfer, penetrative sterilisation for product contact surfaces, reduced manual handling and negated first air disruption. As a result, ChargePoint Actis supports the downgrade of cleanroom classifications and eliminates reliance on transfer process isolators, delivering meaningful savings in capital, floor space and operational costs while maintaining or strengthening compliance confidence. Furthermore, a single steam in place (SIP) sterilization cycle supports multiple consecutive transfers. Combined with automated direct transfer that bypasses intermediate handling steps and manual intervention, this translates to faster and more efficient processing. — ChargePoint Technology, Liverpool, U.K.