Genphon GF-WSW-3 Microbial Limit Tester (Sterile Filtration Apparatus)

Overview

The Genphon GF-WSW-3 Microbial Limit Tester is a precision-engineered, stainless-steel-based membrane filtration system designed for quantitative microbial enumeration in pharmaceutical, biotechnology, food & beverage, cosmetics, and environmental water testing laboratories. It operates on the standardized membrane filtration principle defined in pharmacopoeial methods—including USP <61>, EP 2.6.12, and ChP 1105—where liquid samples are drawn under controlled negative pressure through sterile, low-protein-binding microporous membranes (typically 0.45 µm or 0.22 µm pore size). Microorganisms present in the sample are retained on the membrane surface, which is then aseptically transferred onto solid growth media for incubation and colony-forming unit (CFU) enumeration. The GF-WSW-3 supports both single- and multi-sample parallel processing, ensuring compliance with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) requirements for sterility assurance and quality control workflows.

Key Features

• Robust 316L stainless-steel construction for corrosion resistance, cleanability, and long-term durability in regulated environments.
• Modular filtration head design—available in 1-, 3-, or 6-head configurations—enabling flexible throughput scaling without cross-contamination risk.
• Interchangeable filter cups with standard Φ47 mm or Φ50 mm membrane compatibility and an effective filtration area of 40 mm diameter.
• Standard cup capacity of 150 mL; optional 250 mL cups accommodate larger-volume samples such as raw water or bulk process streams.
• Detachable, autoclavable filtration assemblies compliant with ISO 13485 and FDA 21 CFR Part 11–ready validation protocols when integrated with documented SOPs.
• Flame-sterilizable components for rapid field decontamination during emergency or non-autoclave settings.
• Optimized fluid dynamics enabling consistent 100 mL filtration in ≤15 seconds (with membrane installed), minimizing operator variability and improving assay reproducibility.

Sample Compatibility & Compliance

The GF-WSW-3 accommodates a broad range of aqueous and low-viscosity liquid matrices, including purified water, water for injection (WFI), saline solutions, oral suspensions, ophthalmic preparations, cosmetic toners, soft drink concentrates, and environmental water samples (e.g., surface, drinking, and wastewater). Its design conforms to the physical and procedural constraints outlined in ISO 8573-7 (compressed air microbiology), ASTM D4410 (microbial analysis of water), and EU GMP Annex 1 (sterile product manufacturing). All wetted surfaces meet USP Class VI biocompatibility standards. Filter membrane compatibility includes mixed cellulose ester (MCE), nylon, PVDF, and PES—allowing method adaptation per organism recovery requirements (e.g., Pseudomonas aeruginosa recovery on nylon vs. Bacillus subtilis on MCE).

Software & Data Management

As a hardware-only filtration platform, the GF-WSW-3 does not incorporate embedded software or digital controls. It is intentionally designed as a manually operated, analog-compatible instrument to ensure operational transparency, reduce validation burden, and support audit-ready paper-based or LIMS-integrated recordkeeping. When deployed in regulated facilities, users typically pair it with electronic lab notebooks (ELNs) or validated LIMS modules that capture lot numbers, operator ID, filtration time, membrane type, incubation conditions, and CFU counts—all traceable to 21 CFR Part 11–compliant audit trails. Calibration and performance qualification (PQ) documentation—including flow rate verification, leak testing, and sterility confirmation—are maintained per ICH Q5A and WHO Technical Report Series No. 961 guidelines.

Applications

• Pharmaceutical QC labs performing microbial limit tests on excipients, APIs, final dosage forms (capsules, tablets, injectables), and purified water systems.
• Contract testing organizations (CTOs) conducting outsourced compendial testing for clients under ISO/IEC 17025 accreditation.
• Food safety laboratories validating shelf-life studies and verifying pathogen absence in beverages and bottled waters.
• Cosmetic manufacturers fulfilling ASEAN Cosmetic Directive (ACD) and EC Regulation 1223/2009 microbiological specifications.
• Public health institutions performing routine surveillance of municipal water supplies and recreational water bodies per WHO Guidelines for Drinking-water Quality.

FAQ

Is the GF-WSW-3 compatible with vacuum pumps from third-party manufacturers?
Yes—the system uses standard 8–10 mm ID vacuum tubing and accepts external pumps delivering ≥60 kPa vacuum pressure and ≥25 L/min free-air flow.
Can filtration heads be sterilized in a steam autoclave?
Yes—entire filtration assemblies (including cups, funnels, and gaskets) are rated for repeated cycles at 121°C, 103 kPa (15 psi), 30 minutes, per ISO 17665-1.
What regulatory documentation is provided with the instrument?
Each unit ships with a Factory Acceptance Test (FAT) report, material certification (316L SS), and a traceable serial-numbered calibration certificate for filtration rate verification.
Does Genphon offer IQ/OQ/PQ protocol templates?
Yes—validated installation, operational, and performance qualification templates aligned with ASTM E2500 and EU GMP Annex 15 are available upon request for qualified customers.
Are replacement parts (gaskets, clamps, funnels) available separately?
Yes—all consumable and wear components are stocked and supplied with full part-number traceability and CoA documentation.