JTONE ZW-2008 Stainless Steel Enclosed Membrane Filtration Bacterial Collection Instrument

Overview

The JTONE ZW-2008 Stainless Steel Enclosed Membrane Filtration Bacterial Collection Instrument is a precision-engineered, laboratory-grade sterility and microbial limit testing system designed in strict accordance with international pharmacopeial standards. It operates on the principle of pressure-driven, positive-flow membrane filtration—utilizing controlled peristaltic pumping to deliver test samples uniformly across sterile, low-protein-binding filter membranes (0.22 µm, 0.45 µm, or 0.8 µm pore size). This enables quantitative retention of viable microorganisms—including bacteria, yeasts, and molds—on the membrane surface while removing inhibitory substances via sequential rinsing. The instrument supports both reusable and single-use closed-system filtration assemblies, ensuring full containment throughout sample processing, filtration, membrane transfer, and subsequent incubation. Its architecture meets the physical and operational requirements for aseptic handling under Grade A/B environments as defined by EU GMP Annex 1 and FDA Aseptic Processing Guidance.

Key Features

• AISI 304 stainless steel enclosure—corrosion-resistant, non-porous, and compliant with cleanroom-compatible surface finish standards (Ra ≤ 0.8 µm); compact footprint (35 cm height) optimizes bench space in QC laboratories.
• Phase-controlled speed regulation system—enables precise, stepless adjustment from 0 to 240 rpm, eliminating torque drop at low speeds and supporting consistent flow delivery for viscous or particulate-laden samples (e.g., antibiotic suspensions, lipid emulsions).
• High-efficiency worm-gear reduction motor—engineered for ultra-low acoustic emission (<52 dB(A)) and zero rotational inertia, minimizing vibration-induced membrane shear and ensuring mechanical stability during extended filtration cycles.
• Dual-safety circuit architecture—integrates optical position sensing and electromagnetic load monitoring to trigger immediate power cutoff upon abnormal pressure buildup, tubing occlusion, or door interlock disengagement.
• Universal consumable interface—mechanically and dimensionally compatible with ISO-standardized 47 mm and 50 mm filtration cups, including those conforming to DIN 1986-100, ASTM D5197, and Chinese Pharmacopoeia Chapter 1105/1106 mounting configurations.
• Energy-efficient operation—120 W nominal power draw with thermal management system ensuring continuous duty cycle performance without derating at ambient temperatures up to 30 °C.

Sample Compatibility & Compliance

The ZW-2008 is validated for use with injectables, ophthalmic solutions, lyophilized powders, large-volume parenterals (LVPs), sterile water for injection (WFI), purified water, oral liquids, and medical device eluates. It supports both direct inoculation and membrane transfer workflows per USP <71> Sterility Tests and USP <61> Microbial Limits Tests. All filtration protocols align with mandatory documentation requirements for GLP and GMP audits—including electronic audit trails when integrated with compliant LIMS or ELN platforms. The system satisfies data integrity criteria under FDA 21 CFR Part 11 when paired with validated software controls, and its mechanical design facilitates routine cleaning validation (swab recovery ≥ 95% for common residues).

Software & Data Management

While the ZW-2008 operates as a standalone hardware platform, its analog speed control interface includes RS-232 and optional USB-to-serial output for integration into centralized laboratory automation systems. When connected to JTONE’s optional PC-based DataLog Pro v3.2 (validated for IQ/OQ/PQ), users gain timestamped event logging—including start/stop times, speed setpoints, total runtime, and safety fault codes—with export to CSV or PDF for regulatory submission. All logs include operator ID fields and digital signature support to fulfill ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Sterility testing of final container closures (vials, syringes, IV bags) per USP <71> and EP 2.6.1.
• Microbial enumeration and objectionable organism detection in purified water, WFI, and clean steam condensate per USP <1231>.
• Bioburden assessment of raw materials, excipients, and process intermediates in API manufacturing.
• Validation of sterilization processes (e.g., autoclave efficacy, filter integrity) using challenge organisms (B. subtilis, P. diminuta).
• Environmental monitoring support—filtration of air sampling impinger fluids or surface rinse extracts.
• Non-pharma applications: microbial load analysis in beverage concentrates, cosmetic preservative efficacy testing (PET), and biotech cell culture harvest clarification screening.

FAQ

What filter membrane pore sizes are supported?
The ZW-2008 is compatible with standard 0.22 µm (sterility testing), 0.45 µm (microbial limits), and 0.8 µm (high-particulate or rapid screening) hydrophilic or hydrophobic membranes meeting ASTM E2904 and ISO 8573-7 specifications.
Is the instrument suitable for viscous samples such as ointments or suspensions?
Yes—its high-torque worm-gear drive and wide speed range (0–240 rpm) enable controlled filtration of samples with dynamic viscosities up to 250 cP when used with appropriately sized inlet tubing and pre-filter adapters.
Does the ZW-2008 meet FDA 21 CFR Part 11 requirements?
The base unit is Part 11–ready when operated with validated third-party data acquisition software; full compliance requires documented risk assessment, access controls, electronic signatures, and audit trail review procedures per organizational SOP.
Can reusable filtration assemblies be autoclaved in place?
No—reusable cups must be disassembled, cleaned, and sterilized separately per manufacturer instructions; the ZW-2008 housing itself is not autoclavable but is designed for repeated surface disinfection with 70% IPA or hydrogen peroxide vapor.
What maintenance intervals are recommended?
Peristaltic pump tubing should be replaced every 500 operating hours or after 100 sterilization cycles; gear lubrication is factory-sealed and requires no user servicing over the rated 10,000-hour service life.