Chuanyu Instruments ZW-2008 Smart Microbial Filtration and Collection System

Overview

The Chuanyu Instruments ZW-2008 Smart Microbial Filtration and Collection System is a precision-engineered, single-use, closed-system apparatus designed for sterility testing and microbial limit testing in regulated pharmaceutical, biotechnology, medical device, and food safety laboratories. It operates on the principle of vacuum-assisted, positive-pressure-driven membrane filtration—leveraging peristaltic pumping to draw liquid samples across sterile, low-protein-binding microporous membranes (0.22 µm or 0.45 µm pore size, 47 mm diameter). The system ensures complete physical separation of microorganisms from the test sample while maintaining aseptic integrity throughout filtration, membrane rinsing, and subsequent culture medium infusion. Its fully enclosed architecture eliminates open handling, minimizing contamination risk and supporting compliance with pharmacopoeial methods including USP <71>, EP 2.6.1, and JP 4.07. The unit is not a standalone incubator but serves as a critical pre-culture preparation platform—integrated into end-to-end sterility workflows where sample integrity, operator reproducibility, and audit-ready documentation are mandatory.

Key Features

• Grade 304 stainless steel enclosure: Electropolished ASTM A240 304 stainless steel housing with seamless, crevice-free geometry—engineered to withstand repeated sterilant exposure (e.g., 70% isopropanol, hydrogen peroxide vapor) and comply with ISO 14644-1 Class 5 cleanroom surface requirements.
• Four-step fixed-speed peristaltic drive: Pre-calibrated rotational settings at 40, 60, 160, and 240 rpm—optimized for volumetric throughput consistency across diverse sample types (e.g., large-volume parenterals, lyophilized reconstitutes, viscous ophthalmic solutions) without manual speed tuning.
• Modular, removable waste trough: Ergonomically contoured stainless steel collection tray with radial drainage slope—prevents residual fluid retention and biofilm formation; compatible with autoclaving (121 °C, 20 min).
• Universal bottle-holding cradle: Adjustable, form-fitting support structure accommodating standard 100 mL to 2000 mL vented or non-vented containers—eliminates mechanical slippage and reduces risk of accidental disconnection during filtration.
• Radial bayonet-style tubing interface: Patented circular coupling mechanism enabling rapid, tool-free connection of silicone peristaltic tubing—reduces tubing compression damage and ensures repeatable seal integrity over >500 cycles.
• Integrated footswitch and tactile toggle switch: Dual-mode actuation supports hands-free operation during gowning or glove use; front-panel controls minimize panel penetrations to preserve surface hygiene and simplify decontamination.
• Ergonomic lever clamp: Biomechanically optimized handle design delivering uniform clamping force across the full length of the pump head—ensuring consistent occlusion pressure and extended tubing service life.

Sample Compatibility & Compliance

The ZW-2008 supports filtration of aqueous and low-viscosity non-aqueous pharmaceutical preparations—including purified water, water for injection (WFI), large-volume parenterals (LVPs), small-volume parenterals (SVPs), lyophilized powders (post-reconstitution), ophthalmic solutions, and medical device eluates. It is validated for use with commercially available, gamma-irradiated, sterile, pyrogen-free filtration assemblies compliant with ISO 8536-4 (infusion containers) and ISO 11140-1 (sterilization indicators). The system meets structural and operational requirements referenced in FDA Guidance for Industry: Sterility Testing of Drug Substances and Products (2022), EU GMP Annex 1 (2022 revision), and WHO Technical Report Series No. 961, Annex 2. While the instrument itself does not generate electronic records, its mechanical repeatability and traceable operating parameters (speed setting, runtime, filter lot) support GLP/GMP-aligned manual logbook entries and 21 CFR Part 11-compliant data capture when integrated with external digital workflow systems.

Software & Data Management

The ZW-2008 is a hardware-only, analog-controlled system with no embedded firmware, touchscreen interface, or internal memory. All operational parameters are set manually via physical dials and switches. This design intentionally avoids software qualification burdens—making it suitable for environments where regulatory validation of embedded code would require extensive IQ/OQ/PQ protocols. Process data (e.g., start/stop time, selected speed, filter batch number, operator ID) must be recorded externally using paper-based logs or LIMS-integrated electronic notebooks. The absence of network connectivity or USB ports eliminates cybersecurity risks and aligns with ICH Q9 quality risk management principles for low-complexity, high-reliability instrumentation.

Applications

• Sterility testing of final drug products per USP <71>, Ph. Eur. 2.6.1, and JP 4.07—particularly for membrane-retained organisms (e.g., Pseudomonas diminuta, Bacillus subtilis) following filtration, washing, and transfer into fluid thioglycollate medium (FTM) or soybean–casein digest medium (SCDM).
• Microbial enumeration of purified water and WFI per USP <61> and EP 2.6.12—enabling quantitative recovery of aerobic mesophiles, Pseudomonas, and molds/yeasts on R2A or TSA membranes.
• Bioburden assessment of medical devices—including syringes, IV sets, catheters, and surgical implants—per ISO 11737-1:2018, using extraction and filtration methodologies.
• Environmental monitoring support—processing settle plates, air samplers, and surface swab rinsates in cleanroom qualification studies.
• Process validation activities involving filter challenge studies, extractables/leachables sample preparation, and stability-indicating method development.

FAQ

Does the ZW-2008 meet ISO 13485 or FDA 21 CFR Part 11 requirements?
The ZW-2008 is a mechanical filtration device with no electronic data generation or storage capability. It does not fall under the scope of Part 11, nor does it require ISO 13485 certification as a standalone instrument. However, its design supports compliance when used within a certified quality management system.
Can the system accommodate 0.1 µm filters?
No—the ZW-2008 is validated exclusively for 47 mm diameter membranes with nominal pore sizes of 0.22 µm and 0.45 µm, as specified in pharmacopoeial sterility test methods.
Is the peristaltic pump head autoclavable?
The pump head assembly is not autoclavable; only the stainless steel housing, waste trough, and bottle cradle are rated for steam sterilization. Tubing and disposable filter housings are single-use and non-sterilizable.
What maintenance is required?
Routine cleaning with 70% IPA or approved sporicidal agents; periodic inspection of tubing elasticity and occlusion alignment; replacement of silicone tubing every 200–300 operating hours or per manufacturer’s recommendation.
Is technical support available outside mainland China?
Yes—Chuanyu Instruments provides remote application support and calibration guidance through authorized international distributors, with documentation available in English, German, and Japanese.