NüVE NC 23B / NC 32S Benchtop Steam Sterilizer

Overview

The NüVE NC 23B and NC 32S are CE-marked, benchtop steam sterilizers engineered for precision, traceability, and regulatory compliance in clinical, dental, veterinary, cosmetic, and laboratory settings. Designed and manufactured in Turkey under strict adherence to the European standard EN 13060:2021+A2:2023, these units operate on saturated steam under pressure—leveraging gravity displacement or vacuum-assisted air removal to achieve microbial inactivation through thermal denaturation of proteins and nucleic acids. The NC 23B is certified as a B-class sterilizer, capable of processing all load types—including wrapped and unwrapped solid, porous, and hollow A-type instruments—while the NC 32S meets S-class requirements, optimized for unwrapped porous loads, small hollow B-type devices, and multi-layered packaged items. Both models integrate a robust AISI 304 stainless steel chamber, PED 2014/68/EU–certified pressure vessel design, and dual-temperature capability (121 °C and 134 °C) to accommodate diverse bioburden profiles and material tolerances.

Key Features

• Compliance-certified operation per EN 13060:2021+A2:2023 for B- and S-class applications, validated for routine use in GLP- and GMP-aligned environments
• N-Smart™ microprocessor control system with real-time parameter monitoring, graphical time-series visualization, and password-protected access levels
• Integrated self-diagnostic architecture delivering fault codes, cycle history diagnostics, and proactive maintenance alerts (e.g., gasket replacement, HEPA filter service)
• Dual-vacuum capability: NC 23B performs Bowie & Dick, Helix, and vacuum leak tests; NC 32S supports Bowie & Dick and vacuum integrity verification
• Extensive data retention: stores full-cycle logs (500 cycles) and summary records (29,500 cycles), exportable via USB flash drive for audit readiness
• Multi-channel connectivity: Wi-Fi-enabled remote monitoring via N-Mobile™ mobile application, Ethernet-based internet access through NuveCloser™ PC software, and optional AlerText™ SMS alerting
• Safety-critical hardware: overpressure relief valves, lid interlock mechanism, automatic door lock during pressurized phases, and red-alert visual/audio signaling upon anomaly detection
• Configurable cycle library: five pre-programmed sterilization protocols (e.g., General, Rapid, Prion, Sensitive Load, Flash) plus two user-defined programs and one dedicated drying phase

Sample Compatibility & Compliance

The NC 23B accommodates a broad spectrum of medical and laboratory instrumentation: wrapped surgical kits, lumened endoscopes (A-type), textile packs, glassware, and polymer-based tools. Its B-class classification ensures validation compatibility with ISO 17665-1 and EN ISO 11134 for steam sterilization process development. The NC 32S, designated S-class, is intended for non-wrapped porous items (e.g., dental handpieces, fiber-optic cables), small-diameter hollow devices (≤2 mm internal diameter, ≤1.5 m length), and single- or double-layer sealed pouches. Both sterilizers conform to the Pressure Equipment Directive (PED 2014/68/EU), carry CE marking for Class IIa medical devices under MDR 2017/745, and support traceability requirements aligned with FDA 21 CFR Part 11 when paired with NuveCloser™ audit-trail functionality.

Software & Data Management

Data integrity and regulatory traceability are embedded at the system level. The N-Smart™ interface maintains an immutable chronological record of every cycle—including start/end timestamps, temperature/pressure profiles, vacuum stages, dwell times, and alarm events. All logs are timestamped, user-attributed, and stored with checksum validation. Exported USB files comply with CSV and PDF formats suitable for inclusion in quality management systems (QMS). With optional NuveCloser™ software, administrators can configure remote access, schedule automated report generation, assign role-based permissions, and generate electronic signatures compliant with ALCOA+ principles. Email notifications (up to five recipients) and AlerText™ SMS delivery ensure immediate awareness of critical events—supporting continuous operational oversight without physical presence.

Applications

• Dental clinics: sterilization of handpieces, burs, mirrors, and impression trays
• Veterinary practices: processing of surgical instruments, biopsy forceps, and reusable endoscopic components
• Research laboratories: decontamination of glassware, pipette tips, media bottles, and biohazard waste containers
• Cosmetic and aesthetic centers: validation-compliant treatment of dermarollers, tweezers, and electrology probes
• Small-scale hospitals and outpatient facilities: batch processing of low-volume instrument sets under ISO 13485–aligned workflows

FAQ

What is the difference between B-class and S-class sterilization according to EN 13060?
B-class sterilizers remove air from all load types—including porous and hollow items—using a vacuum pump before steam injection, enabling penetration into complex geometries. S-class units are designed for simpler, non-wrapped porous loads and do not require full air removal from hollow devices.
Can the NC 23B/NC 32S be validated for routine use in a regulated environment?
Yes—both models provide documented cycle parameters, digital log export, and configurable audit trails compatible with IQ/OQ/PQ protocols and ISO 17665-1 validation frameworks.
Is the chamber material resistant to corrosion from repeated steam exposure and cleaning agents?
The chamber is constructed from AISI 304 stainless steel, offering high resistance to chloride-induced pitting and steam condensate corrosion under normal operating and maintenance conditions.
How does the vacuum system contribute to sterilization efficacy?
Vacuum-assisted air removal ensures uniform steam saturation within porous and lumened loads, eliminating cold spots and guaranteeing thermal lethality across heterogeneous item configurations.
What documentation is provided for regulatory submissions?
NüVE supplies EU Declaration of Conformity, EN 13060 test reports, PED 2014/68/EU assessment documentation, and technical files supporting MDR 2017/745 compliance—all available upon request with device-specific serial number referencing.