ChuanYi CYW-600S Stainless Steel Membrane Filtration System for Microbial Limit Testing

Overview

The ChuanYi CYW-600S is a precision-engineered, three-channel membrane filtration system designed for standardized microbial limit testing in compliance with pharmacopoeial methods—including USP <61>, EP 2.6.12, and ChP 1105. It operates on the principle of vacuum-assisted sterile filtration: liquid samples are drawn through pre-sterilized 47 mm or 50 mm pore-rated membranes (typically 0.45 µm or 0.22 µm), capturing viable microorganisms on the filter surface for subsequent enumeration via colony-forming unit (CFU) counting after transfer to solid growth media. Unlike traditional gravity-based or manual suction systems, the CYW-600S integrates an oil-free diaphragm vacuum pump with independent channel control, enabling simultaneous, parallel filtration of up to three samples under identical pressure and flow conditions—critical for inter-sample reproducibility and regulatory audit readiness.

Key Features

• Compact, integrated benchtop design minimizes footprint within ISO Class 5 laminar flow hoods—ideal for space-constrained QC laboratories.
• Pre-sterilized, pyrogen-free polycarbonate or glass fiber membranes eliminate endotoxin carryover and reduce bioburden introduction during setup.
• Lip-seal filtration cups require no clamps or O-rings; engineered sealing geometry ensures leak-free operation and uniform microbial retention across the entire membrane surface.
• Three independently controllable filtration channels allow flexible sample sequencing—e.g., test sample, positive control, and negative control—without cross-contamination risk.
• Reusable filtration cups fabricated from ASTM F86-compliant 304 stainless steel; all wetted parts are fully disassemblable, autoclavable (121°C, 20 min), and free of welded joints to prevent biofilm entrapment.
• Oil-free vacuum pump delivers stable negative pressure (–80 kPa typical) with acoustic noise ≤52 dB(A), suitable for continuous operation in shared lab environments.
• Electropolished 304 SS housing with mirror-finish surface resists corrosion and facilitates validated cleaning protocols using ethanol, sodium hypochlorite, or quaternary ammonium disinfectants.
• Flame-sterilizable filtration heads enable rapid in-situ decontamination between sequential runs—essential for high-throughput environmental monitoring or sterility testing workflows.
• Low-center-of-gravity base with dual ergonomic handles ensures mechanical stability even when collection bottles are filled to capacity (up to 1 L per channel).

Sample Compatibility & Compliance

The CYW-600S supports a broad range of aqueous and low-viscosity pharmaceutical, cosmetic, and food-grade samples—including purified water, WFI, buffer solutions, ophthalmic preparations, oral suspensions, and non-ionic surfactant formulations. Compatible membrane types include mixed cellulose ester (MCE), polyethersulfone (PES), and nylon—each certified for low extractables and high recovery of Gram-positive/negative bacteria, yeasts, molds, and spores. The system meets ISO 13408-1 (aseptic processing), ISO 11737-1 (microbial enumeration), and FDA 21 CFR Part 11 requirements when paired with validated electronic logbooks. All stainless-steel components conform to ASTM A240/A240M specifications, and surface roughness (Ra ≤ 0.8 µm) complies with ASME BPE-2022 hygienic design criteria.

Software & Data Management

While the CYW-600S operates as a hardware-only platform (no embedded microprocessor), it is fully compatible with laboratory information management systems (LIMS) and electronic lab notebooks (ELN) via standardized digital log templates. Each filtration run generates traceable metadata—including operator ID, date/time stamp, sample ID, membrane lot number, vacuum duration, and final filtrate volume—which can be manually entered or imported via CSV into compliant documentation workflows. Optional accessories include calibrated digital timers with GLP audit trails and barcode-scanned membrane tracking kits to support 21 CFR Part 11-compliant electronic signatures and change control records.

Applications

• Pharmaceutical quality control: microbial enumeration of raw materials, excipients, and finished dosage forms per USP <61> and ChP 1105.
• Sterility testing of injectables and implants using membrane filtration followed by incubation in fluid thioglycollate medium (FTM) or soybean-casein digest medium (SCDM).
• Environmental monitoring of cleanrooms and isolators—filtering large-volume air or surface rinse samples for total viable count (TVC) assessment.
• Bioburden testing in medical device manufacturing per ISO 11737-1, including rinse extraction of catheters, syringes, and implantable components.
• Water system validation: quantification of aerobic mesophilic microorganisms in purified water (PW), water for injection (WFI), and clean steam condensate.
• Microbial challenge studies for filter validation, including bacterial retention testing with Brevundimonas diminuta (ATCC 19146) and Serratia marcescens (ATCC 13883).

FAQ

What membrane diameters and pore sizes are supported?

The system accommodates standard 47 mm and 50 mm diameter membranes with pore sizes ranging from 0.1 µm to 0.45 µm, depending on target microorganism size and sample particulate load.

Can the filtration cups be autoclaved repeatedly without degradation?

Yes—304 stainless steel cups and support grids withstand ≥500 autoclave cycles at 121°C/20 min without dimensional drift or surface pitting, as verified per ASTM E2917 accelerated aging tests.

How is system performance verified before routine use?

A daily system suitability test is performed using 100 mL of purified water per channel; filtration time must fall within 1–5 minutes at ambient temperature. Deviations trigger root-cause investigation per SOP-MFT-003 (leak check, membrane integrity, pump calibration).

Is the vacuum pump serviceable on-site?

The diaphragm pump features modular construction with user-replaceable valves and diaphragms; full maintenance kits and torque-spec calibration tools are supplied with each unit.

Does the system support integration with automated colony counters?

Yes—the standardized 50 mm membrane format is compatible with major automated colony imaging platforms (e.g., ProtoCOL 3, iQ-Scan, Scan® 500), enabling seamless digital CFU enumeration and report generation.