BOXUN BXM-85EI Vertical Steam Autoclave

Overview

The BOXUN BXM-85EI Vertical Steam Autoclave is an ISO-compliant, Class B (EN 13060) laboratory-grade steam sterilizer engineered for reproducible, traceable, and validation-ready thermal decontamination of heat-stable materials. It operates on saturated steam under positive pressure, leveraging the well-established principle that microbial inactivation—particularly of bacterial spores such as Bacillus stearothermophilus—is governed by temperature, exposure time, and steam quality (i.e., absence of non-condensable gases). Designed for routine sterilization of culture media, glassware, surgical instruments, labware, and regulated biohazard waste, the BXM-85EI integrates process control logic aligned with international standards including ISO 17665-1 (Moist Heat Sterilization), ASTM E535 (Sterilization Cycle Validation), and USP (Bacterial Endotoxins Test) preparation requirements.

Key Features

• PMMA-I microprocessor-based control system with a 7-inch capacitive touchscreen interface enabling real-time visualization of chamber temperature, pressure, elapsed time, phase progression, and dynamic status diagrams
• Eight pre-programmed cycles (e.g., liquid, solid, wrapped/unwrapped load, waste) plus six user-definable protocols supporting custom ramp-hold-cool profiles
• Positive-pressure pulse air removal with six-stage programmable air evacuation—critical for achieving >99.9% air displacement prior to sterilization, ensuring uniform steam penetration in porous or hollow loads
• Six-level adjustable post-cycle depressurization rate to prevent boil-over of liquids and minimize thermal shock to sensitive media
• Three-tiered access control (Engineer / Administrator / Operator) compliant with GLP/GMP documentation integrity requirements and audit trail readiness
• Integrated rapid cooling system combining forced-air convection, secondary water cooling, and an internal condenser—reducing post-cycle cooldown time by up to 40% versus passive cooling units
• Full thermal insulation with anti-scald housing design, ergonomic handwheel door mechanism, and automatic lid interlock verification at closure
• 100-hour delayed start scheduling and altitude-compensated boiling point adjustment (for installations above 500 m elevation)

Sample Compatibility & Compliance

The BXM-85EI accommodates standard autoclave-compatible loads including agar-based and broth media, stainless-steel and aluminum instruments, borosilicate glassware, polypropylene containers, and regulated biomedical waste in leak-proof bags. Its 85 L chamber (Ø400 × 725 mm) supports dual 370 × 285 mm baskets for vertical stacking. All operational parameters—including temperature uniformity (±0.5 °C), pressure stability (0.22 MPa working / 0.38 MPa design), and thermal recovery time—are validated per EN 285 Annex C and meet FDA 21 CFR Part 11 data integrity prerequisites when paired with optional printer and probe modules. Optional 0.2 µm high-temperature/pressure-rated exhaust filters enable safe containment of aerosolized biological agents during venting.

Software & Data Management

The embedded PMMA-I OS logs all critical process variables (temperature, pressure, time, cycle ID, operator ID) with timestamped records stored internally and exportable via USB. When equipped with the optional thermal printer (SPR-TH series), it generates tamper-evident hardcopy reports containing date/time stamps, temperature-time curves, F₀ calculations (when used with calibrated sample temperature sensors), and cycle pass/fail indicators. The RS-485 interfaces support integration into centralized laboratory information management systems (LIMS) or building automation platforms. Audit trails are retained for ≥12 months and comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Routine sterilization of microbiological growth media in academic, clinical, and industrial labs
• Preparation of sterile reagents and buffers under cGMP conditions
• Decontamination of sharps, pipette tips, and reusable lab tools in biosafety level 2 (BSL-2) facilities
• Validation studies requiring precise F₀-based lethality quantification (with optional probe kit)
• Regulatory submissions requiring documented thermal process consistency (e.g., ISO 13485 medical device manufacturing)
• High-altitude field laboratories where atmospheric pressure compensation is essential

FAQ

What sterilization standards does the BXM-85EI conform to?
It meets EN 13060 Class B requirements for small steam sterilizers and supports validation protocols aligned with ISO 17665-1 and ASTM E535.
Can the BXM-85EI be validated for GMP use?
Yes—when configured with optional temperature probes, printer, and audit-trail-enabled software, it satisfies FDA 21 CFR Part 11 and EU Annex 11 data integrity criteria.
Is the chamber volume suitable for full-size media bottles?
The Ø400 mm diameter and 725 mm height accommodate standard 2 L and 5 L media bottles vertically stacked in two baskets.
Does the unit support IQ/OQ/PQ documentation packages?
BOXUN provides standardized qualification templates (including test protocols, acceptance criteria, and blank record forms) upon request for installation, operational, and performance qualification.
What safety certifications does the BXM-85EI hold?
It carries CE marking (2014/34/EU ATEX not applicable; covered under Machinery Directive 2006/42/EC and PED 2014/68/EU), and complies with IEC 61010-1 for laboratory electrical safety.