The STERIS VHP™ LTS-V Low Temperature Sterilizer is an exciting technology breakthrough, allowing
pharmaceutical/biopharmaceutical and medical device manufacturers to sterilize temperature and/or
radiation-sensitive devices as packaged, finished goods on-site.
The sterilizer product line chambers range from small 850-liter volume chambers to full production-size
9000-liter chambers with loading cart systems. STERIS VHP LTS-V Low Temperature Sterilizers operate
under deep vacuum, enable fast production turnaround time, apply independent process monitoring as
a standard feature and conform to the latest overall industry standards and regulations.
How the VHP LTS-V Low Temperature Sterilizer works
The STERIS VHP LTS-V Low Temperature Sterilizer 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 VHP LTS-V Low Temperature Sterilizer has configurable cycles, chambers sizes, accessories and optional features to adapt to your demanding production environment and process.
Why the VHP LTS-V Low Temperature Sterilizer
- Your product integrity – The VHP LTS-V Low Temperature Sterilizer technology is a low temperature, surface sterilization solution which preserves your product integrity with a sterility assurance level of SAL 10-6. The VHP LTS-V Low Temperature Sterilizer 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 cGMP, cGAMP, 21 CFR Part 11 requirements, EU Annex 1, and EU Annex 11.
- 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.
Process Validation Services
A new service being offered by STERIS is to be able to provide full process validation and required laboratory services related from feasibility testing to validation for the pharmaceutical and medical device industry. This way STERIS can provide valuable help to our Customers as an expert validation service offering, that is highly important in meeting regulatory requirements and implementing VHP sterilization process to the medical device or drug delivery device manufacturing process.
GAMP Statement
STERIS follows GAMP 5, a risk-based approach to compliant GxP computerized systems.
GAMP 5 is built around a Risk-Based Management System for the development, supply and maintenance
of vendor-supplied automated systems. Adherence to this GAMP 5 by the vendor provides both the
system and sufficient documentation to enable the complete system to be accepted and validated by the
user. GAMP 5 provides documented evidence and a high degree of assurance that the specific process will
consistently produce a product meeting its pre-determined specifications and quality attributes.
LTS-V sterilizers and all standard options are built according to GAMP 5 guidelines.
Special features will be designed and assembled in compliance with GAMP 5, but the GxP risk assessment
of the Customer-specified features will remain the responsibility of the specifying party.
STERIS’s control system software does not contain ‘dead’ code.
21 CFR Part 11 Statement
STERIS develops, documents and enforces policies and procedures that ensure the security of electronic
records and signatures per 21 CFR Part 11. Together with our Customers, STERIS will help to implement
and enforce Part 11-compliant solutions involving validation, audit trails and security of our computer
systems. The base LTS-V sterilizer system includes electronic records, electronic signatures, electronic
batch reports and audit trails. See controls description for complete details.