Tuttnauer T-LAB-V60/V85 Vertical Steam Sterilizer

Overview

The Tuttnauer T-LAB-V60/V85 Vertical Steam Sterilizer is an engineered solution for reliable, repeatable moist-heat sterilization in academic, clinical, and industrial laboratory environments. Built under OEM partnership with Zealway Instruments and distributed exclusively in mainland China, this series leverages Tuttnauer’s globally recognized sterilization architecture—adapted for local regulatory alignment and operational robustness. The unit operates on the fundamental principle of saturated steam under pressure, achieving microbial inactivation through thermal denaturation of proteins and nucleic acids. Validated to meet ISO 17665-1:2017 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices), it supports gravity displacement and pre-vacuum cycle types, enabling effective air removal and uniform heat penetration across heterogeneous loads—including wrapped instruments, porous materials, liquids in vented containers, and solid non-porous items.

Key Features

• Vertical chamber design optimizes floor space utilization while maintaining ergonomic access and safe steam discharge pathways.
• 5-inch full-color touchscreen interface provides intuitive navigation, real-time parameter monitoring, and graphical cycle progress visualization.
• Dual mobile PT100 temperature sensors ensure high-fidelity measurement at multiple points within the chamber—critical for temperature uniformity verification per EN 285:2015 Annex C.
• Hinged lid with multi-point mechanical locking system guarantees secure sealing integrity during pressurization; interlocked safety mechanisms prevent lid opening until chamber pressure drops below 0.02 MPa.
• Integrated programmable controller supports customizable cycle profiles—including liquid, solid, and wrapped instrument modes—with adjustable exposure time, drying duration, and exhaust rate.
• Chamber construction uses 304 stainless steel with electropolished interior surface (Ra ≤ 0.8 µm), minimizing biofilm retention and facilitating cleaning validation per ISO 15883-1.

Sample Compatibility & Compliance

The T-LAB-V60/V85 accommodates a broad range of load configurations: glassware (flasks, pipettes, Petri dishes), metal surgical tools, rubber stoppers, textile packs, and aqueous solutions up to 5 L per container (with appropriate venting). It complies with national mandatory standards GB 8599–2008 (Large Steam Sterilizers for Medical Use) and meets essential requirements of the Medical Device Regulation (MDR 2017/745) when used as a Class IIa auxiliary device. Cycle documentation includes timestamped records of chamber temperature, pressure, and phase duration—supporting GLP/GMP traceability and audit readiness. Optional Ethernet or RS485 interfaces enable integration into centralized lab management systems for electronic record retention aligned with FDA 21 CFR Part 11 requirements.

Software & Data Management

The embedded control firmware logs all sterilization cycles automatically, storing ≥10,000 cycle records with metadata (operator ID, cycle type, start/end timestamps, alarm events). Data export is supported via USB flash drive in CSV format for offline analysis or LIMS ingestion. Optional PC-based software (Zealway SteriLog™) enables advanced reporting—including trend analysis of sterilization lethality (F₀ values), calibration history tracking, and preventive maintenance scheduling based on cumulative operating hours. Audit trails are immutable and include user authentication logs, satisfying ISO 13485:2016 clause 7.5.10 on record control.

Applications

This sterilizer serves core functions across biosafety level 1–2 laboratories: preparation of sterile media and reagents; decontamination of contaminated waste prior to disposal; sterilization of reusable labware in teaching and research facilities; and processing of quality control samples in pharmaceutical QC labs. Its dual-volume configuration (60 L and 85 L) allows scalability—from small university departments to mid-sized contract testing organizations—without compromising cycle consistency or validation stability. Routine use supports compliance with CLSI M29-A4, USP , and WHO TRS No. 992 Annex 2 for steam sterilization of heat-stable products.

FAQ

What standards does the T-LAB-V60/V85 comply with for medical device sterilization?
It conforms to GB 8599–2008, ISO 17665-1:2017, and EN 285:2015 for large steam sterilizers, and its design supports validation per ISO 11134 for industrial applications.
Can the unit sterilize liquids without boil-over or container rupture?
Yes—liquid cycles incorporate slow heating, controlled exhaust, and post-sterilization cooling phases calibrated to minimize thermal shock and pressure differentials in sealed or vented vessels.
Is third-party IQ/OQ/PQ validation support available?
Zealway provides documented validation protocols and on-site support from certified field service engineers trained to ISTA and AAMI ST79 guidelines.
How often does the temperature sensor require recalibration?
Annual recalibration is recommended; dual-sensor redundancy allows in-situ verification using NIST-traceable dry-block calibrators without system downtime.
Does the system support remote monitoring or alarm notification?
With optional network module, email/SMS alerts for critical faults (e.g., door seal failure, temperature deviation >±1.5 °C) can be configured via SMTP or Modbus TCP integration.