Introducing ChargePoint Actis™: the system that reimagines aseptic transfer for the Annex 1 era

In aseptic pharmaceutical manufacturing, the transfer of material into and out of the aseptic core is consistently identified as one of the most critical risk points in any process, including by EU GMP Annex 1 and similar regulations. Achieving sterility assurance and regulatory confidence at this point has traditionally required manufacturers to compromise on cost and operational efficiency.

We’re changing that dynamic with the launch of ChargePoint Actis™.

ChargePoint Actis™ is a new category of aseptic transfer system that delivers, for the first time, isolator-level regulatory confidence with the efficiency and footprint of a rapid transfer device. Read on to discover how – and what becomes possible when you can achieve confidence in every transfer.

The cost of confidence at the transfer point

Every aseptic transfer depends on a make-and-break connection. Two surfaces come together, material moves and the connection separates, all within seconds. In that window, several risks converge: airflow disruption over the critical zone, residual bioburden on contact surfaces, operator technique and interventions, and the ring of concern at the outer sealing surfaces.

What is the ring of concern?

At every make-and-break connection, when two surfaces that have been exposed to the external environment come together, they create a ring-shaped interface of potential contamination risk at the outer sealing surfaces: the ring of concern. This is a potential contamination bridge between the non-sterile outer environment and the internal sterile or Grade A zone.

Historically, managing these risks to protect product quality, regulatory compliance and patient safety has meant building layers of infrastructure and protocols around the transfer point. High-grade cleanrooms, transfer isolators, laminar airflow plenums and complex manual decontamination cycles are some of the most common, all of which require manufacturers to compromise on cost, space and efficiency. And even then, a degree of product exposure at the connection must still be accepted.

ChargePoint Actis™ takes a new approach.

Three proven principles. One aseptic transfer system.

ChargePoint Actis™ brings together the best of three trusted approaches in a fundamentally new way:

• The barrier integrity of an isolator
• The direct transfer efficiency of a Split Butterfly Valve (SBV)
• The proven sealing of a Rapid Transfer Port (RTP)

The result is a single, direct transfer system that integrates validated sterility assurance and double containment directly into the transfer connection itself, rather than relying on layers of surrounding infrastructure.

Inside ChargePoint Actis™, the critical transfer surfaces are enclosed within a fully steam-sterilised chamber, with a transfer path that bypasses the ring of concern entirely. This ensures that two sterile interfaces come together at the make-and-break connection, surfaces that have only ever been exposed to a penetrative sterilisation process, never to the external environment.

What ChargePoint Actis™ makes possible

With sterility assurance built directly into the aseptic transfer system, the benefits of ChargePoint Actis™ extend far beyond the connection, supporting:

• The downgrade of cleanroom classifications and removed reliance on transfer process isolators, delivering meaningful savings in capital, floor space and operational costs while maintaining, and in many cases strengthening, the level of compliance confidence.
• Multiple consecutive transfers from one steam in place (SIP) sterilisation cycle, removing handling steps and manual intervention, translating to faster and more efficient processing.
• Improved protection for operators handling potent compounds, reducing risk of cross-contamination and reliance on manual cleaning (and the risks thereof) and personal protective equipment (PPE).

Our customers are not only solving for today, they are building processes and facilities that will also need to accommodate pharmaceutical products and regulatory expectations of tomorrow. ChargePoint Actis™ is designed to meet both challenges. The double containment and compact, modular design support agile manufacturing that can adapt to shifting processes and increasingly potent compounds. All while providing a robust, repeatable and reliable compliance foundation needed today and in the future.” – Christian Dunne, Director of Global Corporate Business Development