The quest for sterility assurance: A new approach to isolator decontamination

Published: 12-Apr-2024

One of the more challenging, essential aspects of planning for an isolated fill-finish operation is determining the approach to decontamination

Sterility assurance is a top priority, and ensuring a selected method meets regulatory thresholds is vital. Just as important to the overall goal of timely, effective, and safe parenteral drug delivery is the manufacturing process itself. As the need for fragile, highly targeted products grows, the time it takes for a treatment to reach a patient is an area pharmaceutical manufacturing professionals must continue to improve on and optimise for. The volatility and innovation experienced industry-wide over the past five years have necessitated that the drug development process become more streamlined, safer, and more resilient. Fill finish professionals are constantly keeping an eye out for where the next innovative trend will lead to, and where the next big improvement in sterility or contamination control strategies will occur.

AST shares: "One of the key areas of customer experience that we wanted to explore in our new isolator design was an improved, operation-friendly decontamination strategy. Were there aspects of decontamination protocols that were considered a “given” that could be challenged What if effective decontamination could be completely reimagined?

Conventional Decontamination Methods

Common approaches to isolator decontamination methods typically utilise high concentrations of hydrogen peroxide with additional factors that vary across application. Dwell time, exact strength of concentration (starting at 35 percent at least), form, and distribution mechanism can all differ. And with any choice of application, a number of practical points have to be considered: Do you have to optimise your process with features like heat to speed up aeration? If utilising wet application, do you oversaturate to ensure a high kill but risk leaving harmful residue How do you deal with the potential of pooling or uneven application? In both dry and wet applications, how long does the outgassing process take in order for the machine to be operated safely?

And how do all these variables fit together in the context of production? What’s the total downtime of the machine in operation?

In most settings, the routine length of a completed decontamination cycle, where the isolator is fully aerated and ready to operate, is at least three hours—a clear mark we knew could be improved upon.

Establishing a True One-Hour Cycle Time

With this solution, AST wanted to speak to more than just “decontamination time,” which is often cited around the industry for isolator performance. While decontamination is necessary to account for, simply citing the duration of one aspect of the decon cycle paints an incomplete picture, especially in cases where outgassing can last for over 24 hours. More accurately and more relevant to the operator is describing the full cycle within a manufacturing context, from initiating the decontamination protocol to the fill line returning to a ready-to-run state. And here was the key dilemma to be solved: Could we ensure sterility assurance while optimising machine uptime?

The answer was “Yes.” Thanks to our partnership with the team at CURIS System, AST implemented an innovative new vapour-only hydrogen peroxide system within the isolator.

By introducing low-concentration Vapor Phase Hydrogen Peroxide, our new isolator achieves greater than a 6-log sporicidal reduction and Grade A / ISO 14644 class 5 operations with CURIS’s patented Pulse™ technology, which maintains an optimal, non-hazardous concentration of VPHP throughout the decontamination process.

The notion that an isolator must use corrosive and hazardous levels of hydrogen peroxide to maintain sterility assurance is no longer scientifically accurate. This groundbreaking method of decontamination opens up new levels of flexibility and time-to-market possibilities, all of which are demonstrable within an isolated fill finish setting. Starting with a true 60-minute cycle time, from initiation to resuming operation, this solution includes:

Isolator and Fill Line Integrity

  • The AST Isolator will be a closed loop system with no optimisation necessary to speed up aeration (like heat) and no pressure or outside air introduced into the isolator.
  • Low-Concentration VPHP has minimal impact on sensitive instrumentation and will allow for expanded scope of material compatibility for fill-finish processing.
  • Utilises a true vapour for dry application and prevents condensation
  • Annex 1 compliant

Customer-Centred Solutions

  • Non-hazmat, and easy to ship and store
  • Locally made and serviced, backed by AST’s robust aftermarket services
  • Fully automated cycles for repeatability,
  • Fully integrated into the ASTView for seamless, intuitive HMI operations and 21 CFR 11 documentation requirements.

With this new decontamination technology, AST is excited to offer our life science industry partners a forward-looking, flexible solution, designed to meet the current and future demands of sterile parenteral drug manufacturing. Learn how AST can provide your organisation with the next generation of high-quality isolator technology – contact our experts today."

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