Systec H-Series 2D Dual-Door Wall-Mounted Steam Sterilizer
| Brand | Systec |
|---|---|
| Origin | Germany |
| Model | H-Series 2D |
| Sterilizer Type | Vertical, Dual-Door, Wall-Pass-Through |
| Power Supply (HX-65 to HX-200) | 380–400 V, 50/60 Hz, 3-phase 5-wire (L1/L2/L3/N/PE), 16 A |
| Power Supply (HX-210 to HX-1580) | 380–400 V, 50/60 Hz, 3-phase 5-wire (L1/L2/L3/N/PE), 32 A |
| Compliance | EN 285, EN 13060, ISO 17665-1, PED 2014/68/EU, AD 2000-Merkblatt W2 |
| Configuration | Fully customizable voltage options available upon request |
| Vendor Status | Authorized Distributor (non-manufacturer) |
Overview
The Systec H-Series 2D Dual-Door Wall-Mounted Steam Sterilizer is a CE-marked, Class B medical device sterilizer engineered for high-integrity terminal sterilization of heat-stable instruments, glassware, media, and porous loads in research laboratories, pharmaceutical QC labs, and clinical facilities. Designed in accordance with EN 285 (large steam sterilizers) and EN 13060 (small steam sterilizers), the H-Series employs saturated steam under pressure as the sterilizing agent, delivering validated lethality (F0 ≥ 12 min) across all load configurations. Its dual-door, wall-pass-through architecture enables strict separation of clean and contaminated zones—critical for ISO 13485-certified environments and GMP-compliant manufacturing suites. The sterilizer operates via a microprocessor-controlled cycle manager with real-time monitoring of chamber temperature, pressure, steam quality, and vacuum integrity, ensuring full traceability and process repeatability.
Key Features
- Dual independent access doors with interlocked mechanical and electronic safety systems preventing simultaneous opening; door seals certified to DIN 58953-4 for steam-tight integrity
- Full-cycle vacuum-assisted air removal (pre-vacuum and post-sterilization drying) compliant with EN 13060 Annex C for porous load processing
- Chamber constructed from electropolished AISI 316L stainless steel with Ra ≤ 0.4 µm surface finish, meeting USP requirements for non-pyrogenic surfaces
- Integrated steam generator with automatic water level control and conductivity-based feedwater monitoring; optional connection to central pure steam supply
- Real-time validation-ready interface supporting thermocouple (PT100) and pressure transducer inputs per EN 285 Annex D
- Comprehensive safety architecture including overtemperature cut-off, overpressure relief valves (TÜV-certified), door lock verification sensors, and emergency steam venting
Sample Compatibility & Compliance
The H-Series accommodates a broad spectrum of laboratory materials: wrapped and unwrapped surgical instruments, stainless-steel trays, PETG and polycarbonate containers, agar plates, liquid media in sealed bottles (up to 5 L), and textile packs. Load configurations are validated per ISO 17665-1 using biological indicators (Geobacillus stearothermophilus spores) and chemical integrators. All models meet PED 2014/68/EU for pressure equipment and carry AD 2000-Merkblatt W2 certification for vessel design. Optional IQ/OQ/PQ documentation packages align with FDA 21 CFR Part 11 and EU Annex 15 requirements for computerized system validation.
Software & Data Management
Equipped with Systec’s SteriControl™ v4.2 firmware, the sterilizer provides audit-trail-enabled cycle logging with timestamped records of all critical parameters (T, P, time, vacuum depth, steam flow). Data export is supported via USB 2.0 and Ethernet (TCP/IP) to LIMS or MES platforms. Cycle reports include F0 calculation, Bowie-Dick test results, and leak rate verification—all formatted to GLP/GMP record retention standards. Optional 21 CFR Part 11 compliance module adds electronic signatures, role-based user access control, and immutable data archiving.
Applications
- Terminal sterilization of reusable labware in university core facilities and contract research organizations (CROs)
- Media preparation and depyrogenation support in biopharmaceutical upstream process development
- Decontamination of biohazardous waste prior to autoclave disposal in BSL-2 and BSL-3 containment labs
- Validation of sterilization processes for ISO 13485 medical device manufacturers
- Support of ASTM E535 and USP sterile processing workflows in compounding pharmacies
FAQ
What regulatory standards does the H-Series comply with?
EN 285, EN 13060, ISO 17665-1, PED 2014/68/EU, AD 2000-Merkblatt W2, and optionally FDA 21 CFR Part 11 when equipped with the compliance software module.
Can the sterilizer be integrated into a building management system (BMS)?
Yes—via Modbus TCP or optional Profibus DP interface, enabling remote status monitoring, alarm forwarding, and cycle start/stop commands under defined security protocols.
Is on-site IQ/OQ validation support available?
Systec-certified validation engineers provide turnkey installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) services—including protocol development, execution, and final report generation aligned with ISO/IEC 17025.
What maintenance intervals are recommended?
Daily: Chamber seal inspection and door gasket cleaning; Quarterly: Vacuum pump oil change and steam trap testing; Annually: Full calibration of PT100 sensors and pressure transducers by an accredited metrology lab.
Are custom voltage configurations supported beyond standard 380–400 V?
Yes—custom electrical configurations (e.g., 208 V, 480 V, or 600 V 3-phase) are available upon engineering review and require lead-time adjustment; all variants retain full EN 61000-6-2/6-4 EMC compliance.
