Advanced Aseptic Filling: How Single-Use Isolator Technology Transforms Pharmaceutical Manufacturing
In the dynamic landscape of pharmaceutical manufacturing, the integration of innovative technologies is pivotal for driving progress. One such breakthrough is the adoption of single-use isolator technology, revolutionising aseptic filling processes.
Since 2019, GTP Bioways has been at the forefront of this revolution, offering comprehensive drug substance manufacturing, formulation & aseptic filling services powered by a state-of-the-art single-use isolator technology. Our 700-square-metre cGMP manufacturing unit, built in compliance with European and global drug manufacturing requirements, underscores our commitment to excellence.
In this article, we explore the convergence of regulatory imperative and technological innovation within the realm of aseptic filling, focusing on the transformative impact of single-use isolator systems.
Regulatory requirements and innovation in aseptic filling
Some would have been satisfied with a conventional production line meeting the prerequisites of sterile manufacturing in a simple, tried-and-tested way; fixed-isolator sterile drug production lines have been known and accepted for now over 30 years. However, advancement in manufacturer technology have transformed the aseptic filling landscape.
Today, achieving aseptic requirements no longer necessitates the addition of surface bio-decontamination systems as supplementary equipment. An expert in vaporised hydrogen peroxide processing is often no longer needed for the qualification and validation of decontamination cycles in isolator environments, as each manufacturer has a proven solution that comes with its equipment and is fully integrated into the isolators. Regulatory requirements are no longer an obstacle to implementing single-use isolators, which are now seen as the future of aseptic filling as they help reach levels of sterility assurance that classic clean rooms don’t.
Unlike classic clean rooms, isolators enable unparalleled levels of sterility assurance. For instance, while some labs endeavour to validate a 3-log reduction of G. stearothermophilus in class A/B environments, where human presence is accepted near critical zones, single-use isolators facilitate reductions exceeding 6-log or even 12-log. This underscores the paradox within the pharmaceutical industry: the necessity to validate extreme levels of sterility in non-hazardous environments.
How an isolator in an aseptic filling line addresses all GMP constraints
To date, isolator technology is therefore the best technical solution for aseptic product filling in a GMP environment with all the constraints it brings. Even though the new Annex 1 of the GMP guidelines gives a prominent place to the use and management of single-use isolator, it does not explicitly emphasise the advantages of this technology over other manufacturing methods, likely to maintain increasingly high levels of requirements against the risks of contamination.
There is therefore a need for innovative uses of these isolators that can respond to all regulatory requirements. The introduction of single-use isolator technology represents a significant advancement in aseptic filling processes within the pharmaceutical industry. While some may argue that regulatory requirements stifle innovation, the development and integration of single-use isolator systems demonstrate how manufacturers can adapt and thrive within these constraints.
GTP Bioways’ drug product manufacturing suite exemplifies this adaptability, providing sterile drug manufacturing and aseptic filling services for innovative therapies. By embracing single-use isolator technology, we have not only met stringent regulatory standards but also surpassed traditional clean room environments in terms of sterility assurance.
