Tuttnauer 5075ELV & 3870ELV Vertical Steam Sterilizers (Imported, Manufactured in Israel by Zealway)

Overview

The Tuttnauer 5075ELV and 3870ELV vertical steam sterilizers are fully automated, CE-marked Class B vacuum-assisted autoclaves engineered for precision, safety, and regulatory compliance in demanding laboratory, pharmaceutical, and clinical environments. Built under OEM partnership with Zealway Instruments and manufactured in Israel, these units implement saturated steam under pressure as the primary sterilant—operating on the fundamental principle that microbial inactivation (including spores of *Geobacillus stearothermophilus*) is achieved through sustained exposure to thermally stable, moisture-saturated conditions at defined temperature–time–pressure profiles. With maximum operating parameters of 138 °C and 0.42 MPa, they exceed standard 121 °C/15 psi cycles and support extended sterilization protocols required for heat-stable liquids, porous loads, and wrapped instruments. Their vertical configuration optimizes footprint efficiency while maintaining full compliance with international sterilization validation standards—including ISO 17665-1 (moist heat sterilization), EN 285 (large steam sterilizers), and relevant clauses of USP and EU Annex 1.

Key Features

• Fully automatic water fill and drain system eliminates manual intervention and prevents steam discharge into lab drains—reducing corrosion risk and eliminating residual odors in controlled environments such as cleanrooms and biosafety labs.
• Vacuum-assisted air removal ensures complete steam penetration into hollow devices, lumens, and wrapped instrument packs—critical for achieving sterility assurance level (SAL) of 10⁻⁶.
• Intuitive color TFT touchscreen controller with optional bilingual (English/Chinese) interface supports one-touch execution of up to 30 pre-programmed cycles—including liquid, solid, wrapped, unwrapped, and porous load profiles.
• Real-time monitoring of chamber temperature, jacket pressure, vacuum level, cycle phase, and fault diagnostics displayed continuously during operation.
• Integrated electronic log stores the last 200 complete sterilization cycles—including start/end timestamps, setpoints, actual process values, alarms, and operator ID—with export capability via USB 2.0 port.
• Remote diagnostic port enables secure, encrypted technician access for firmware updates, parameter verification, and root-cause analysis—minimizing downtime and supporting preventive maintenance planning.

Sample Compatibility & Compliance

These sterilizers accommodate a broad spectrum of laboratory and production materials: aqueous liquids (e.g., culture media, buffers), glassware (including narrow-neck flasks and pipettes), stainless steel instruments, textiles, filtration membranes, and biohazardous waste in approved containment bags. The 5075ELV (31 L chamber) and 3870ELV (160 L chamber) models are validated for use with both gravity-displacement and vacuum-pulse cycles per EN 285 Annex A. All programmable cycles adhere to the biological indicator challenge requirements of ISO 11138-3 and ISO 11138-4. Data integrity features—including user authentication, electronic signatures, audit trail logging, and tamper-proof cycle records—support compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and GLP documentation requirements.

Software & Data Management

The embedded controller runs a deterministic real-time OS with non-volatile memory for persistent parameter storage and cycle history. Each sterilization record includes timestamped sensor data (temperature ±0.5 °C, pressure ±0.01 MPa), phase transition markers (pre-vacuum, heating, sterilization hold, exhaust, drying), and event-triggered alerts. USB exports generate CSV-formatted files compatible with LIMS integration or external QA review. Optional software packages provide advanced reporting (trend charts, deviation analysis, statistical process control), batch release documentation, and automated PDF certificate generation—fully traceable to individual cycle IDs and operator credentials.

Applications

• Preparation and sterilization of microbiological growth media and reagents in QC/QA laboratories.
• Terminal sterilization of reusable surgical instruments, endoscopes, and dental handpieces in central sterile supply departments (CSSD).
• Decontamination of biohazardous waste prior to incineration or landfill disposal under BSL-2/3 containment protocols.
• Validation of sterilization processes for medical device manufacturers seeking ISO 13485 certification.
• Routine sterilization of glassware, plastic consumables, and filtration assemblies in pharmaceutical R&D and bioprocessing facilities.

FAQ

What validation documentation is supplied with the unit?
Each unit ships with Factory Acceptance Test (FAT) reports, IQ/OQ protocol templates aligned with ISO 13485 and EN 285, and calibration certificates for integrated PT100 sensors and pressure transducers.
Can the sterilizer be integrated into a building management system (BMS)?
Yes—via optional 4–20 mA analog outputs and Modbus RTU over RS-485, enabling remote status monitoring and alarm relay signaling.
Is routine maintenance supported locally outside Israel?
Zealway-certified service partners provide annual PM, leak testing, vacuum validation, and chamber integrity verification in accordance with EN 285 Clause 9.2 across APAC, EMEA, and North America.
Does the controller support multi-level user permissions?
Yes—administrator, operator, and reviewer roles with password protection and session timeout; all critical actions require dual authorization.
How is cycle reproducibility ensured across repeated runs?
Through closed-loop PID control of jacket and chamber temperatures, dynamic vacuum calibration before each cycle, and real-time compensation for ambient humidity and line voltage fluctuations.