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.
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The STERIS VHP® LTS-V Low Temperature Sterilizer 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 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.
Your product integrity – The VHP LTS-V Low Temperature Sterilizer technology is a low temperature, surface sterilization solution which preserves your product integrity while achieving 6-log microbial reduction. 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 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.
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 per ISO 14937 standard 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.
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 automated systems by a supplier. Adherence to this management system by the supplier provides both the system and sufficient documentary records to enable the complete system to be accepted and validated by the user. GAMP 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.
The unit 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.
The control system software does not contain ‘dead’ code. ‘Dead’ code is defined by GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008 Appendix D4: Guideline for Management, Development and Review of Software, paragraph 3.1.6; Removal of Dead Code.
21 CFR Part 11 Statement
STERIS develops, documents, and enforces policies and procedures that ensure the security of electronic records and signatures according to 21 CFR Part 11. Together with our Customers, STERIS will help implement and enforce Part 11-compliant solutions involving validation, audit trails, and security of our computer systems.
Certificates of manufacture/analysis for consumable products by product ID and lot number. (Adobe® Acrobat® Reader required)