CertoClav 8B Pro Benchtop Medical-Grade B-Class Steam Sterilizer

Overview

The CertoClav 8B Pro is a compact, fully integrated benchtop steam sterilizer engineered to meet the stringent requirements of EN 13060 for B-class medical device reprocessing. Unlike gravity-displacement sterilizers, the 8B Pro employs a pre-vacuum and post-vacuum cycle architecture—leveraging an integrated THOMAS diaphragm vacuum pump—to ensure complete air removal from lumened and porous loads prior to steam penetration. This validated vacuum-assisted process enables reliable sterilization of complex instruments including dental handpieces, endoscopes accessories, and wrapped surgical kits, in accordance with ISO 17665-1 and EU MDR Annex I essential requirements. With a maximum operating temperature of 134 °C at 0.145 MPa (21 psi), the unit achieves a minimum F₀ value of 3 minutes under standard B-cycle conditions, ensuring microbiological lethality against Geobacillus stearothermophilus spores (D₁₂₁ = 1.5 min). Its all-in-one design eliminates the need for external water supply or drainage connections, incorporating both fresh water reservoir and sealed wastewater tank—ideal for laboratories, dental clinics, and small-scale medical facilities where infrastructure flexibility is critical.

Key Features

• Benchtop footprint (56 × 44 × 36 cm) with 8 L chamber volume—optimized for space-constrained environments without compromising load capacity
• Pre- and post-vacuum cycles driven by a maintenance-free THOMAS diaphragm pump, delivering stable vacuum levels ≤10 mbar for consistent air removal
• Integrated bacterial air filter (0.2 µm pore size) on exhaust line to prevent environmental contamination during vacuum and drying phases
• Nine programmable sterilization cycles—including standardized B-cycle (EN 13060), liquid cycle, and user-defined profiles—with password-protected parameter adjustment
• Forced-air cooling system enabling rapid post-cycle cooldown (<15 min to <45 °C surface temperature), reducing turnaround time between batches
• Compliance-ready architecture: full audit trail logging, cycle signature storage, and optional thermal printer interface for real-time hardcopy output per cycle
• Electrical safety enclosure rated to IEC 61010-1; dual redundant temperature and pressure sensors with automatic fault detection and lockout

Sample Compatibility & Compliance

The 8B Pro accommodates a broad range of reusable medical devices and laboratory tools within its 17 × 32 cm cylindrical chamber, supporting both unwrapped and double-wrapped instrument sets up to 300 mm in length. Compatible load configurations include stainless steel trays (supplied), silicone tubing, glassware, and polymer-based components rated for repeated autoclaving. All cycles are developed and validated per EN 13060:2014+A2:2021, with documentation traceable to CE Certificate No. 1023. The system supports GLP/GMP-aligned operation through configurable user access levels, electronic signature capability (when paired with compliant software), and data export via USB for integration into LIMS or quality management systems. It satisfies key regulatory prerequisites for Class Ir and Class IIa medical device reprocessing under EU MDR 2017/745.

Software & Data Management

The embedded control firmware provides intuitive touchscreen navigation with multilingual UI (English, German, French, Spanish). Each sterilization cycle records timestamped metadata—including chamber temperature, pressure, vacuum depth, dwell times, and sensor diagnostics—stored internally for ≥1000 cycles. Data export is supported via USB 2.0 port in CSV format, preserving ISO/IEC 17025-compliant traceability. Optional PC software (CertoSoft v4.x) enables remote monitoring, cycle report generation, and trend analysis of thermal performance over time. For regulated environments, the system supports FDA 21 CFR Part 11 compliance when configured with electronic signatures, audit trail activation, and role-based access control—ensuring integrity of sterilization records during internal audits or regulatory inspections.

Applications

• Dental practices: sterilization of handpieces, burs, mirrors, and impression trays
• Research laboratories: decontamination of pipette tips, centrifuge rotors, and reusable cell culture vessels
• Small animal facilities: preparation of surgical instruments and cage accessories under ALAC guidelines
• Clinical trial sites: processing of investigational device components requiring documented sterility assurance
• Medical device distributors: validation support for field service technicians performing on-site reprocessing verification

FAQ

What does “B-Class” mean in the context of steam sterilization?
B-Class refers to sterilizers capable of processing all load types defined in EN 13060—including porous loads, hollow instruments with lumens ≥2 mm in diameter and ≥1.5 m in length, and wrapped items—using a vacuum-assisted cycle sequence.
Is external plumbing required for operation?
No. The 8B Pro operates autonomously with built-in fresh water reservoir and sealed wastewater tank; only electrical connection (220–240 V AC) is needed.
Can cycle data be exported for quality documentation?
Yes—via USB interface in CSV format, including full thermobaric profiles, operator ID, and cycle pass/fail status.
Does the unit comply with FDA or ISO standards for medical device reprocessing?
It conforms to EN 13060 (equivalent to ISO 17665-1 for steam sterilization processes) and carries CE marking under MDD 93/42/EEC and MDR 2017/745; FDA clearance is not applicable as it is marketed in the EU under notified body oversight.
What maintenance is required for the integrated vacuum pump?
The THOMAS diaphragm pump is oil-free and requires no routine lubrication; annual inspection of pump membranes and filters is recommended per CertoClav’s service schedule.