Saves biologics manufacturers time and money with the on-site hydrogen peroxide sterilization of pre-filled syringes and delivery devices containing temperature and/or radiation sensitive drug products.
The STERIS VHP® LTS-V Low Temperature System is an exciting technology breakthrough, which allows biologics manufacturers to sterilize pre-filled syringes and other temperature sensitive parenteral devices on premise, avoiding the time and expense of off-site sterilization services and/or reducing the need for class 100 processing space.
The STERIS VHP® LTS-V combines the STERIS proprietary low temperature sterilization and vacuum chamber technologies to create a system capable of sterilization of a variety of loads. Temperature, humidity, pressure, H202 concentration and time are all tightly controlled throughout each cycle phase to ensure repeatability with required surfaces sterilization efficacy. The LTS-V has configurable cycles, chambers sizes, accessories and optional features to adapt to your demanding production environment and process.
Your product integrity – The STERIS VHP® LTS-V technology is a low temperature, surface sterilization solution which preserves your product integrity while achieving 6-log microbial reduction. The LTS-V is the perfect on-site system for your temperature, radiation and/or humidity sensitive drug products.
Testing and Validation support – Systems are fully tested during our factory qualification under production like conditions. From feasibility studies to validation support, STERIS supports you through the process of developing a validated production cycle.
Compliance – Systems are designed, manufactured, tested and documented according to the latest global standards and practices to facilitate compliance with GMP, cGMP, GAMP 5 and 21 CFR Part 11 requirements.
Productivity – Reliable equipment design, process control and control system ensure repeatable and validatable low temperature sterilization cycle for your sensitive products.
Flexibility – Systems are designed for different/demanding applications with cycle versatility to accommodate varying load types and a full range of loading, transfer and other auxiliary equipment.
Certificates of manufacture/analysis for consumable products by product ID and lot number. (Adobe® Acrobat® Reader required)