HJ MT-2000B Sterile Filtration and Microbial Collection System

Overview

The HJ MT-2000B Sterile Filtration and Microbial Collection System is a compact, CE-compliant laboratory instrument engineered for membrane filtration-based microbial recovery in regulated pharmaceutical and biotechnology environments. It operates on the principle of controlled peristaltic pressure-driven filtration—applying calibrated, non-invasive mechanical force to draw liquid samples through sterile, single-use 47 mm membrane filters (0.22 µm or 0.45 µm pore size) housed within closed, pre-sterilized filtration assemblies. This method isolates viable microorganisms quantitatively on the filter surface while preserving sterility integrity throughout the process. Designed specifically for compliance with pharmacopoeial methods—including USP , EP 2.6.1, and JP 4.06—the MT-2000B supports both sterility testing and microbial enumeration workflows without compromising aseptic technique or operator safety.

Key Features

• Electropolished ASTM A240 Type 304 stainless steel housing: seamless, crevice-free construction ensures cleanability, corrosion resistance, and compatibility with common disinfectants (e.g., 70% IPA, hydrogen peroxide vapor).
• Low-noise, high-torque brushless motor drive: delivers consistent rotational output at ≤50 dB(A), minimizing acoustic interference in laminar flow hoods and ISO Class 5/7 cleanrooms.
• Interlocked peristaltic pump head: automatically halts operation upon lid opening—meeting IEC 61000-6-2 functional safety requirements for laboratory equipment.
• Continuously variable speed control (0–300 ±5 rpm) with pause memory: enables precise adjustment for viscous or particulate-laden samples; retains last-set speed after power cycle.
• IP67-rated footswitch with 24 V DC low-voltage actuation: eliminates electrical hazard risk in wet environments and complies with IEC 60335-1 insulation requirements.
• Hermetically sealed port interfaces and electropolished internal pathways: prevent cross-contamination and microbial ingress into instrument internals during extended use.
• Modular drain tray system: supports either fixed-position spill containment or 360° rotary integration for flexible benchtop configuration.
• Field-upgradable sample recovery bracket: allows retrieval of valuable test articles post-filtration—critical for high-cost biologics, cell therapies, or investigational drug substances.

Sample Compatibility & Compliance

The MT-2000B is validated for use with commercially available 47 mm sterile filtration assemblies conforming to ISO 8573-1 (compressed air purity) and ISO 13408-1 (aseptic processing). It accommodates aqueous, oily, and mildly viscous pharmaceuticals—including purified water, water for injection (WFI), large-volume parenterals (LVPs), ophthalmic solutions, and sterile excipients—without requiring system recalibration. All wetted components are non-pyrogenic and extractables-tested per USP and . The device meets mechanical safety requirements under EN 61010-1:2010 and supports audit-ready documentation for FDA 21 CFR Part 11–compliant software integration (when paired with optional data logging modules). Routine maintenance follows ISO/IEC 17025-aligned procedures for calibration traceability to NIST standards.

Software & Data Management

While the MT-2000B operates as a standalone hardware platform, its analog control architecture includes standardized 0–5 V DC and RS-232 outputs for integration with third-party LIMS or ELN systems. Optional firmware upgrades enable time-stamped event logging (pump start/stop, speed changes, interlock triggers) with GLP/GMP-compliant audit trails. All operational parameters—including total runtime, cumulative filter pressure differential (via external transducer), and footswitch activation count—are exportable as CSV files for QC review and regulatory submission. No embedded operating system or cloud connectivity is present, ensuring deterministic real-time performance and eliminating cybersecurity vulnerabilities inherent in networked lab devices.

Applications

• Pharmaceutical manufacturing: sterility testing of WFI, bulk drug substances, final container fills, and lyophilized products per USP and Ph. Eur. 2.6.1.
• Biologics and cell therapy: recovery of low-biomass microbes from monoclonal antibodies, viral vectors, and CAR-T formulations using 0.22 µm filtration.
• Medical device sterilization validation: extraction fluid analysis for ISO 11737-1 bioburden assessment.
• Food and beverage quality control: aerobic plate count (APC) and coliform screening in ready-to-eat products.
• Environmental monitoring: microbial load quantification in HVAC condensate, cleanroom wipe extracts, and compressed gas systems.

FAQ

Is the MT-2000B compatible with all commercially available 47 mm sterile filtration assemblies?
Yes—it accepts standard 47 mm membrane cassettes from major suppliers (e.g., Pall, Sartorius, Merck Millipore), provided they utilize luer-lock or bayonet-style connectors.
Does the instrument require annual calibration certification?
Per ISO/IEC 17025 guidance, speed accuracy (±5 rpm) and motor torque consistency should be verified semiannually using NIST-traceable tachometry and load-cell instrumentation.
Can the MT-2000B be used in an ISO Class 5 laminar flow hood?
Yes—its compact footprint (26 × 26 cm), low heat dissipation (<60 W), and absence of internal fans make it suitable for placement inside unidirectional airflow workstations.
What is the expected service life of the peristaltic tubing under continuous GMP operation?
With daily use (8 h/day, 5 days/week), fluoropolymer-reinforced silicone tubing demonstrates ≥6 months functional integrity when operated below 250 rpm and cleaned with 70% ethanol between runs.
Is there a documented IQ/OQ protocol available for this model?
HJ provides a vendor-validated qualification template aligned with ASTM E2500-13, including installation checks (voltage stability, grounding resistance), operational tests (speed linearity, interlock response time), and performance verification using reference suspensions of Bacillus subtilis spores.