Systec H-Series Cabinet Sterilizer
| Brand | Systec |
|---|---|
| Origin | Germany |
| Model | H-Series |
| Type | Vertical Autoclave |
| Voltage Options | 380–400 V, 50/60 Hz, 3-phase 5-wire (with neutral and earth) |
| Current Rating | 16 A (HX-65 to HX-200) |
| Configuration | Freestanding cabinet-style sterilizer with customizable voltage input |
Overview
The Systec H-Series Cabinet Sterilizer is a CE-marked, Class B vacuum-assisted steam sterilizer engineered for laboratories requiring full compliance with EN 13060:2021 and ISO 17665-1. Designed and manufactured in Germany, this vertical autoclave employs saturated steam under pressure as the primary sterilizing agent, utilizing a pre-vacuum phase to remove air from porous loads and ensure uniform heat penetration. The system supports all standard sterilization cycles—including unwrapped instruments, wrapped goods, porous loads, and liquid media—with precise control over temperature, pressure, time, and vacuum depth. Its robust stainless-steel chamber (AISI 316L), integrated steam generator, and dual-sensor pressure/temperature monitoring architecture provide high reproducibility across repeated cycles. Unlike basic gravity-displacement units, the H-Series incorporates a validated vacuum pump and steam-jacketed chamber design to eliminate cold spots and guarantee sterility assurance levels (SAL) of ≤10⁻⁶ for critical applications.
Key Features
- CE-certified Class B autoclave compliant with EN 13060:2021, EN 61000-6-3 (EMC), and EN 61000-6-2 (immunity)
- Vacuum-assisted cycle technology enabling reliable sterilization of hollow, porous, and multi-layered loads
- Stainless-steel chamber (AISI 316L) with double-wall insulation and steam jacket for thermal stability and energy efficiency
- Integrated programmable controller with password-protected user levels (operator, technician, administrator)
- Real-time cycle documentation with timestamped event logging (phase transitions, temperature, pressure, vacuum level)
- Optional Ethernet or RS232 interface for integration into laboratory information management systems (LIMS)
- Modular design supporting field-upgradable options: print module, USB data export, remote diagnostics, and enhanced validation packages
- Compliance-ready architecture supporting IQ/OQ/PQ documentation templates aligned with ISO 13485 and FDA 21 CFR Part 11 requirements
Sample Compatibility & Compliance
The H-Series accommodates a broad spectrum of laboratory materials including surgical instruments, glassware, pipette tips, culture media (in sealed containers), textile packs, and polymer-based devices. Chamber volumes range from 65 L (HX-65) to 1580 L (HX-1580), with standardized internal dimensions optimized for ISO-standard sterilization trays (e.g., DIN 58953-2). All models are validated per EN ISO 11140-1 for biological indicator performance and support routine use of Class 5 chemical integrators and Class 6 emulating indicators. The system meets GLP/GMP environmental monitoring prerequisites and includes audit-trail functionality for traceability—essential for regulated environments such as pharmaceutical QC labs, clinical microbiology departments, and medical device manufacturing facilities.
Software & Data Management
Systec’s proprietary sterilization software provides intuitive cycle configuration, real-time graphical display of process parameters, and automated report generation in PDF or CSV format. Each cycle record contains digital signatures, operator ID, chamber serial number, and calibration status metadata. Data integrity is maintained via non-volatile memory with battery-backed clock and write-protected storage. Optional firmware upgrades enable expanded protocol libraries—including USP , ISO 17665-2 liquid sterilization curves, and custom ramp-hold-cool profiles. For laboratories operating under FDA 21 CFR Part 11, the system supports electronic signatures, role-based access control, and immutable audit logs that meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Terminal sterilization of reusable surgical and diagnostic instruments in hospital central sterile supply departments (CSSD)
- Preparation of sterile culture media and buffers in academic and industrial microbiology laboratories
- Validation of sterilization processes for ISO 13485-certified medical device manufacturers
- Decontamination of biohazardous waste in BSL-2 and BSL-3 containment facilities
- Research-grade sterilization of 3D-printed polymer scaffolds and implantable biomaterials
- Quality control testing of sterilization packaging integrity (e.g., Tyvek® pouches, medical-grade paper wraps)
FAQ
What sterilization standards does the Systec H-Series comply with?
It conforms to EN 13060:2021 (small steam sterilizers), EN ISO 17665-1 (moist heat sterilization), and supports validation against ISO 11134, ISO 11135, and USP .
Can the H-Series be integrated into a facility’s building management system (BMS)?
Yes—via optional Modbus TCP or BACnet/IP gateways, enabling remote status monitoring, alarm notification, and energy consumption tracking.
Is third-party validation support available?
Systec collaborates with certified validation partners to deliver IQ/OQ/PQ protocols, test scripts, and final reports meeting local regulatory expectations.
What maintenance intervals are recommended?
Chamber seal inspection every 6 months; vacuum pump oil change annually; full preventive maintenance (including sensor calibration and door gasket replacement) every 24 months.
Does the system support automatic cycle verification using biological indicators?
Yes—integrated BI holders and compatible cycle programs allow routine use of Geobacillus stearothermophilus spore strips (e.g., ATCC 7953) with automated pass/fail interpretation based on incubation results.
