The recent move by the FDA to reclassify VHP sterilisation as an Established Category A technology is a significant development for healthcare product manufacturers seeking to adopt VHP for terminal sterilisation applications.
STERIS
VHP’s ongoing technology journey and the ever-increasing growth of innovative medical devices are well aligned for the benefit of the industry.
STERIS pioneered the development of Vaporised Hydrogen Peroxide (VHP) sterilisation and biodecontamination technology in the mid 1980’s. The first commercial VHP product launch took place in 1991 for the biodecontamination of sterility test isolators. Since then, VHP has become a widely used method for biodecontamination of cleanrooms, isolators, and material transfer. In addition, VHP is used as a sterilisation modality for reprocessing of medical devices in hospitals with increasing use in industrial sterilisation applications.
STERIS
Beginning in the early 2000’s, the medical device industry developed a demand for low temperature sterilisation of sensitive medical devices such as implants. The pharmaceutical industry joined this increasing demand for the sterilisation of packaged pre-filled syringes and other types of combination devices.
Material compatibility, temperature, and radiation sensitivity of medical device applications, including drug products in combination devices, are key considerations for stakeholders. The increase of temperature sensitive ophthalmic drug products using pre-filled syringes, electronic implants and smaller batch customised orthopaedics has created the need for a wider range of proven sterilisation modalities.
In healthcare settings, VHP sterilisers used to reprocess heat sensitive hospital instruments have paved the way since the FDA cleared its use in 2007. VHP’s healthcare track record increased attention for industrial VHP sterilisation applications. Already in 2014, chemical indicators for VHP sterilisation processes were included in ISO 11140-1: Sterilisation of health care products—Chemical indicators—Part 1: General requirements.
In 2015, the US Pharmacopoeia recognised VHP as a vapour phase sterilising agent (USP 1229.11). The acceleration of regulatory developments for VHP industrial sterilisation continued with the FDA’s 2019 Innovation Challenge. This challenge was to find new sterilisation modalities and optimise current sterilisation processes. STERIS was accepted for three applications within the program: Accelerator-Based Radiation Sterilisation, Vaporised Hydrogen Peroxide Sterilisation and Enhanced EtO Cycle Design and Processes for reducing EtO emissions.
Another important development during the past 7-8 years has been the significant efforts by several industry stakeholders in developing specific VHP sterilisation standards. The first and most significant outcome as the publication of ISO 22441:2022 - Sterilisation of health care products - Low temperature vapourised hydrogen peroxide - Requirements for the development, validation, and routine control of a sterilisation process for medical devices. In 2023, the FDA announced the recognition of ISO 22441.
A notable milestone for VHP was achieved on January 8, 2024, when the FDA announced VHP as an Established Category A sterilisation method. This puts VHP in the same category as dry heat, moist heat or steam, ethylene oxide, and radiation sterilisation modalities. Best practices in regulatory guidelines and standards are often considered through PIC/S (Pharmaceutical Inspection Co-operation Scheme) and other regulatory collaborations and can strengthen the status of VHP globally since ISO 22441 is an international consensus standard.
The next step for VHP sterilisation standards is the publication of EN 17180 - Sterilisers for medical purposes — Low temperature vaporised hydrogen peroxide sterilisers — Requirements and testing. This document is still currently in development. There is also consideration of work for the ISO 11138-6 standard for VHP biological indicators.
The industry is asking for new methods to meet the growing industry needs for sterilisation capacity. VHP sterilisation as an in-house process at the end of manufacturing line minimises packaging and transport logistics. This is especially important around heat-sensitive biological products that often require cold chain management. The utility and energy requirements are also minimal compared to other sterilisation methods. In house steam and large electricity energy use is not required for the process. VHP sterilisers come with qualified ready to use STERIS Vaprox sterilant and biological indicators conforming to ISO 11138-1. Other utilities generally include electricity, water, and compressed air.
With its proven historical efficacy, growing regulatory acceptance, high level of material compatibility, and inhouse capabilities, VHP is another viable sterilisation option to meet growing industry needs.