CertoClav 8 Vac Pro Vertical Laboratory Autoclave

Overview

The CertoClav 8 Vac Pro is a CE-marked, vertically oriented Class B small steam sterilizer engineered for precise, reproducible terminal sterilization of heat- and moisture-stable laboratory materials. Operating on the validated principles of saturated steam under pressure—per EN 13060:2022—the system delivers full vacuum-assisted air removal prior to sterilization, ensuring complete steam penetration into porous loads, hollow devices, and wrapped instruments. Its 12 L chamber accommodates standard laboratory loads including culture media, glassware, surgical tools, rubber tubing, textiles, and solid polymer components. Unlike gravity-displacement autoclaves, the 8 Vac Pro employs a multi-pulse vacuum cycle to evacuate >99% of ambient air before steam injection, enabling reliable sterilization at 121 °C or 134 °C (optional extended temperature mode) with defined F₀ values. The integrated Thomas vacuum pump and inert gas generator support controlled drying and post-cycle cooling, minimizing condensation and improving throughput consistency.

Key Features

• 7-inch high-resolution touchscreen interface with multilingual UI (English, German, French, Spanish) and real-time graphical process visualization
• Vacuum-assisted sterilization cycle architecture compliant with EN 13060 Class B requirements for porous and hollow load types
• Dual-tank water management system: independent deionized/RO water feed tank and condensate collection reservoir with level sensors and automatic shut-off
• Forced-air cooling system equipped with HEPA-grade bacterial air filter (≥99.99% @ 0.3 µm) to prevent recontamination during cooldown
• Comprehensive connectivity suite: Ethernet (LAN) for network integration, Wi-Fi for remote status monitoring, USB and CF card ports for audit-ready data export
• Nine factory-configured sterilization programs—including liquid, solid, wrapped, and porous cycles—with up to five fully customizable user-defined protocols
• Integrated thermal validation readiness: dual PT100 temperature sensors (chamber and jacket), pressure transducer, and vacuum gauge—all calibrated and traceable to national standards
• Electrical safety enclosure meeting IEC 61010-1 requirements; includes door interlock, overtemperature cutoff, and pressure relief valve

Sample Compatibility & Compliance

The 8 Vac Pro is validated for sterilizing a broad spectrum of laboratory-compatible materials: aqueous liquid media (e.g., agar, broth), dry solids (glass, stainless steel, silicone), wrapped instruments, textile packs, and hollow devices with internal lumens ≥2 mm diameter. It does not support heat-labile polymers (e.g., polystyrene Petri dishes), powders, or oil-based substances. All sterilization cycles comply with ISO 17665-1:2017 for moist heat process validation and support routine verification per EN 285 Annex D. The system’s data logging architecture satisfies FDA 21 CFR Part 11 requirements when configured with electronic signature and audit trail enabled—ideal for regulated QC/QA environments operating under GLP or GMP frameworks.

Software & Data Management

Sterilization parameters, cycle logs, alarm events, and sensor readings are timestamped and stored internally for ≥10,000 cycles. Data export via USB or CF card generates CSV or PDF reports containing cycle ID, start/stop times, temperature/pressure/vacuum profiles, and pass/fail status per phase (pre-vacuum, heating, sterilization, drying, cooling). Optional CertoClav Connect software enables centralized fleet monitoring across LAN/Wi-Fi networks, remote firmware updates, and integration with LIMS via HL7 or RESTful API. All electronic records include immutable metadata (user ID, instrument serial, calibration status) and support full traceability for internal audits or regulatory inspections.

Applications

• Routine sterilization of microbiological culture media in academic and industrial labs
• Pre-sterilization of pipette tips, centrifuge tubes, and reusable labware in core facilities
• Terminal sterilization of medical device prototypes and biocompatible components in R&D settings
• Validation support for ISO 13485-certified manufacturing processes requiring documented steam sterilization
• Teaching laboratories requiring intuitive operation, safety compliance, and curriculum-aligned cycle presets

FAQ

What is the maximum allowable load volume for the 8 Vac Pro chamber?
The 12 L chamber is rated for a maximum load of 8 L (67% fill volume), consistent with EN 13060 recommendations for optimal steam circulation and vacuum efficiency.
Does the system support automated validation runs (e.g., Bowie-Dick tests)?
Yes—dedicated Bowie-Dick and Helix test cycles are preloaded; results are logged with pass/fail determination based on thermocouple response thresholds.
Can the unit be connected to a building’s central RO water supply?
Yes—external R/O water inlet is optional and configurable via the rear panel; plumbing must conform to DIN 1988-200 standards.
Is printer output compatible with common laboratory label formats?
The integrated thermal printer supports direct cycle report printing in A6 format with QR-coded cycle IDs for rapid archival retrieval.
What maintenance intervals are recommended for the vacuum pump and filters?
Thomas vacuum pump oil requires replacement every 1,000 operating hours; bacterial air filter should be replaced quarterly or after 500 cycles, whichever occurs first.