STERIS’s VHP® LTS-V Low Temperature Sterilizer has recently received another FDA approval for a Customer application. The STERIS VHP® LTS-V Low Temperature Sterilizer has continued to be a proven, regulatory acceptable, and a reliable method for low temperature sterilization, fulfilling ISO 14937 requirements.
Our Vaporized Hydrogen Peroxide (VHP) dry process sterilization technology and proprietary Vaprox Hydrogen Sterilants are designed to support biotechnology, pharmaceutical and medical device manufacturing and related industries low temperature applications through our sterilization and biodecontamination systems. The dry process doesn’t leave behind any harmful or potentially damaging condensation or toxic residue on surfaces -- providing a wide range of material compatibility.
This patented breakthrough technology allows i.e. ophthalmic and biologics manufacturers to sterilize pre-filled syringes and other temperature sensitive parenteral injection devices, as well as other medical devices onsite, avoiding off-site sterilization time and expenses and logistic risks. The STERIS VHP LTS-V technology is also designed, manufactured, tested and documented in accordance with the latest global regulatory compliance requirements for cGMP, cGAMP as well as enabling 21 CFR Part 11 compliance for electronic data reporting for sterilization batches and audit trail.
The comprehensive product application feasibility testing, cycle development and ISO 14937 process validation services provide a straight forward pathway for the development process to become a validated product application for industrial manufacturing use.
With the continual FDA approvals on our low temperature sterilization solutions, our VHP equipment is the most effective and efficient solution for your facility and applications.
For more information or to speak to our team about our VHP solutions, please contact us here.