JINTENG DV-3 Microbial Limit Tester (Triple-Station, Stainless Steel Frame)

Overview

The JINTENG DV-3 Microbial Limit Tester is a triple-station, semi-automatic membrane filtration system engineered for precise, reproducible microbial enumeration in regulated life science environments. It operates on the principle of quantitative membrane filtration—where liquid samples are drawn under controlled negative pressure through sterile, low-protein-binding filter membranes (typically 0.45 µm or 0.22 µm pore size), retaining viable microorganisms on the membrane surface. This method aligns with internationally recognized pharmacopoeial standards including USP , EP 2.6.12, and ISO 8573-7 for non-sterile product testing. The DV-3’s rigid 316L stainless steel frame ensures structural integrity during repeated autoclaving (up to 180°C), eliminating carryover risk and supporting aseptic processing in cleanroom-grade laboratories. Its modular architecture allows parallel processing of up to three independent samples without cross-contamination, significantly reducing hands-on time compared to single-station systems.

Key Features

• Triple independent filtration stations with individual stainless steel control valves—enabling selective activation, real-time flow monitoring, and process isolation.
• 316L stainless steel support frame with low-center-of-gravity design—resists tipping even when fully loaded with 250 mL filter cups and full collection bottles.
• Precision-engineered sanitary clamping system—ensures leak-tight sealing between filter cup, filtration head, and base manifold using FDA-compliant silicone gaskets.
• Pre-sterilized, pyrogen-free polycarbonate or polypropylene filter cups (100 mL and 250 mL variants)—supplied gamma-irradiated, ready-to-use, minimizing operator handling and environmental contamination.
• Integrated vacuum port interface compatible with standard diaphragm vacuum pumps (e.g., KNF N860.3FT.18 or equivalent)—supports stable vacuum levels from –0.08 to –0.095 MPa, ensuring consistent filtration rates across viscosity ranges.
• Patented adjustable collection bottle valve assembly—provides simultaneous functions of fluid direction control, flow cutoff, throttling, and backflow prevention without compromising vacuum stability.

Sample Compatibility & Compliance

The DV-3 accommodates a broad spectrum of aqueous and low-viscosity non-aggressive matrices—including purified water, WFI, saline solutions, pharmaceutical suspensions, food extracts, and chemical process streams—provided they do not exceed pH 2–12 and lack suspended solids >50 µm. All wetted components comply with USP Class VI biocompatibility requirements. The system supports validation per ASTM E2921-21 (Standard Guide for Validation of Membrane Filtration Methods) and facilitates audit-ready documentation when paired with qualified vacuum pumps and calibrated timers. Its construction meets ASME BPE-2021 surface finish specifications (Ra ≤ 0.8 µm) for hygienic process equipment, making it suitable for GMP manufacturing environments subject to FDA or EMA inspection.

Software & Data Management

While the DV-3 operates as a hardware platform without embedded electronics, its workflow integrates seamlessly into digital quality management ecosystems. When used with time-stamped vacuum pump controllers (e.g., Vacuubrand PC-300 series with RS485 output) and validated electronic lab notebooks (ELNs), it supports ALCOA+ data integrity principles. Operators may log filtration start/stop times, vacuum pressure readings, membrane lot numbers, and incubation conditions manually or via barcode-scanned entries—enabling full traceability per 21 CFR Part 11 requirements when deployed with appropriate access controls and audit trail configuration. JINTENG provides IQ/OQ documentation templates aligned with Annex 15 and ISO/IEC 17025 for installation and operational qualification.

Applications

• Pharmaceutical QC labs performing microbial limits testing on APIs, excipients, and finished dosage forms per USP and .
• Biotechnology facilities conducting environmental monitoring of purified water systems (PW, WFI) per EU GMP Annex 1 and WHO TRS 970.
• Food safety laboratories validating shelf-life studies and raw material screening per ISO 4833-1 and AOAC Official Methods.
• CDC and public health reference labs executing standardized water microbiology assays (e.g., heterotrophic plate count, coliform detection).
• Contract testing organizations requiring scalable, auditable filtration capacity across multiple client projects without revalidation overhead.

FAQ

Is the DV-3 compliant with current pharmacopoeial standards for microbial enumeration?
Yes—the system implements the membrane filtration method as described in USP , EP 2.6.12, and JP 4.05, and is routinely employed in labs undergoing FDA pre-approval inspections.
Can the stainless steel frame be sterilized in a steam autoclave?
Yes—316L stainless steel construction permits repeated autoclaving at 121°C for 30 minutes or dry heat sterilization at 180°C for 60 minutes without dimensional deformation or surface degradation.
What vacuum pump specifications are recommended for optimal performance?
A diaphragm pump with ultimate vacuum ≥ –0.095 MPa, flow rate ≥ 25 L/min at –0.08 MPa, and oil-free operation is required; compatibility with aggressive solvents is not supported.
Are replacement filter cups and membranes supplied by JINTENG certified sterile?
All filter cups are gamma-irradiated (25 kGy) and provided with CoA confirming sterility, endotoxin levels <0.25 EU/mL, and membrane integrity test results.
Does the DV-3 include built-in pressure monitoring or digital controls?
No—it is a mechanical filtration platform; vacuum pressure and timing must be monitored externally using calibrated gauges and timers to meet GLP/GMP documentation requirements.