Product Overview
The STERRAD SI™ 100 System brings ASP’s proven hydrogen peroxide (H₂O₂) sterilization technology to the industrial environment. Using vaporized hydrogen peroxide (VHP), the system delivers fast, low-temperature sterilization cycles designed for heat- and moisture-sensitive semi-critical and critical medical devices.
Manufacturers can bring VHP sterilization capabilities in-house rather than relying solely on outsourced modalities such as ethylene oxide (EtO) or gamma radiation. This reduces lead times, lowers logistics costs, and ensures full process control.
Designed for seamless integration and digital traceability, this system helps manufacturers implement safe, effective, and regulatory-ready H₂O₂ sterilization or decontamination processes with confidence.
Examples of Configurable Cycle Concepts
The following examples represent potential cycle concepts that may be developed for specific applications. These cycles are provided for illustrative purposes only and are not included as standard system configurations.
DECON Cycle Processing: below 24 Minutes*
Example cycle concept intended to illustrate rapid decontamination processes with reduced hydrogen peroxide exposure profiles.
*Depending on expected log reduction.
RISTRETTO Cycle Processing: 24 Minutes*
Example cycle concept intended to demonstrate shorter exposure profiles utilizing lower hydrogen peroxide volumes and concentrations. Shorter processing durations may be considered during process development for products where minimizing thermal exposure is desirable.
*Cycle times are illustrative only and do not represent standard configurations supplied with the system.
LEGGERO Cycle Processing: 60 Minutes*
Example cycle concept illustrating lower hydrogen peroxide exposure conditions that may be evaluated when minimizing material exposure is an important process consideration.
*Cycle times are illustrative only and do not represent standard configurations supplied with the system.
CLASSICO Cycle Processing: 40 - 50 Minutes*
Example cycle concept illustrating intermediate exposure conditions. The system is capable of utilizing hydrogen peroxide concentrations up to 95%, depending on the validated process design. Such process conditions may be considered for materials with established compatibility and limited evidence of degradation following hydrogen peroxide exposure.
*Cycle times are illustrative only and do not represent standard configurations supplied with the system.
INTENSO Cycle Processing: 60 - 120 Minutes*
Example cycle concept intended to achieve increased gaseous penetration and may be considered during process development for challenging geometries, including long, narrow lumens, following appropriate validation.
*Cycle times are illustrative only and do not represent standard configurations supplied with the system.
DECON Cycle Processing: below 24 Minutes*
DECON Cycle is designed for a fast and smooth decontamination using one single injection of various volumes of 59% H₂O₂.
*Depending on expected log reduction.
RISTRETTO Cycle Processing: 24 Minutes*
RISTRETTO Cycle could be based on 2 injections of 5,4 mL of 59% H₂O₂. The short cycle duration makes it particularly suitable for heat-sensitive products, such as pre-filled syringes containing biologics, which should be kept cooled as much as possible.
*Cycle times are approximate.
LEGGERO Cycle Processing: 60 Minutes*
LEGGERO Cycle could be based on 2 injections of 1,8 mL of 59% H₂O₂. With a relatively low concentration of H₂O₂, it is mostly suitable for materials having a known degradation pathway with H₂O₂, hence requiring a minimal exposure.
*Cycle times are approximate.
CLASSICO Cycle Processing: 40-50 Minutes*
CLASSICO Cycle could be based on 2 injections of 5,4 mL of 95% H₂O₂ which represents the highest concentration possible (injections can be repeated using the same pattern). It is likely to be used only on materials with comprehensive evidence of compatibility and limited known degradation.
*Cycle times are approximate.
INTENSO Cycle Processing: 60 - 120 Minutes*
INTENSO Cycle is designed for a very high gaseous penetration and can be recommended for challenging devices having very long and thin lumens. It could be based on a multiple-injection pattern of various volumes of 59% H₂O₂.
*Cycle times are approximate.
In-House Manufacturing Integration
Move sterilization closer to production.
- Supports decentralized, in-house sterilization workflows.
- Designed for integration within existing manufacturing environments.
- Enables sterilization activities to be managed alongside manufacturing quality processes.
Digital Traceability & Process Control
Designed for connected data and process visibility.
- Automated transfer of cycle data and reports supports operational traceability and streamlined documentation.
- Optional Independent Monitoring System (IMS) provides independent data collection and one-second data logging for system validation and requalification.
- Sealed RFID-tagged hydrogen peroxide cassettes provide automatic identification, including expiration dates and lot tracking.
Sustainable, Proven Technology
Built on established vaporized hydrogen peroxide sterilization.
- Operation using standard low-temperature VHP process conditions has demonstrated approximately 70% lower annual energy consumption than steam sterilizers.1
- Use of STERRAD™ Systems instead of steam sterilizers can save an estimated 180,000 liters of water per year.1
- VHP is recognized by the FDA as an established sterilization modality for industrial sterilization applications.
- Developed in alignment with ISO 22441:2022, the recognized framework for VHP sterilization process validation.
Technical Specifications
Resources
User's Guide
The ASP IFU and User Guide reference library allows users to search by language, country and product to locate the appropriate instructions for use of ASP Products. Product literature and availability varies by country.
References
- Comparing the Environmental Impacts of STERRAD Sterilization with Competing Approaches Irvine, CA: Advanced Sterilization Products; 2016. Research Sponsored by ASP.