The FDA's recent reclassification of Vaporised Hydrogen Peroxide (VHP) sterilisation as an Established Category A technology marks a significant milestone for healthcare product manufacturers looking to adopt VHP for terminal sterilisation applications. STERIS, the pioneer of VHP technology in the mid-1980s, initiated commercial VHP product launches in 1991, leading to its widespread use in biodecontamination of cleanrooms, isolators, and material transfer, as well as in the sterilisation of medical devices in hospitals and industrial settings. The increasing demand for low temperature sterilisation of sensitive medical devices like implants and pre-filled syringes has driven the industry to explore a wider range of sterilisation modalities, with VHP emerging as a key solution. The FDA's recognition of VHP as an Established Category A sterilisation method, alongside other traditional modalities, reflects its growing regulatory acceptance and industry importance. VHP's compatibility with various materials, minimal energy requirements, and in-house capabilities make it an attractive option for meeting the industry's growing sterilisation needs. The ongoing efforts to develop specific VHP sterilisation standards and regulatory collaborations are further strengthening VHP's global status. With VHP's historical efficacy and alignment with industry requirements, it stands out as a reliable sterilisation technology for the future.