Microbial Limit Tester for Pharmaceutical Water Testing

Product Introduction

Pharmaceutical water systems — including purified water and water for injection — require rigorous microbial limit testing to comply with pharmacopeial standards such as ChP, USP, and EP. The membrane filtration method is the prescribed technique, yet laboratories frequently encounter challenges: maintaining consistent filtration rates across operators, preventing cross-contamination between consecutive test samples, and ensuring that the equipment itself does not introduce variability into the test results.

The HM-WX3B microbial limit tester from HM Instruments addresses these industry pain points with a design philosophy centered on operational simplicity and result reliability. The three-channel configuration allows simultaneous processing of three water samples, while individual mechanical rotary knob control for each channel provides immediate on-off operation without navigating through menus or programming steps. The built-in diaphragm pump generates stable negative pressure with minimal noise, and the direct drainage system eliminates filtrate collection bottles that require cleaning between test runs — a common source of cross-contamination risk. The L304 stainless steel shell withstands repeated disinfection cycles with alcohol-based and quaternary ammonium compounds, supporting the surface hygiene standards mandated by GMP-regulated environments. Filter heads are compatible with flame sterilization, enabling rapid decontamination between consecutive test cycles. For pharmaceutical quality control laboratories performing daily water system monitoring, the HM-WX3B delivers the consistent performance needed to maintain testing schedules and meet regulatory expectations.

Applications

• Pharmaceutical purified water testing — Membrane filtration for total aerobic microbial count per ChP and USP 61 requirements in pharmaceutical manufacturing facilities
• Water for injection testing — Microbial limit examination of WFI samples from distillation and reverse osmosis systems per GMP guidelines
• Medical device production water — Verification of microbial quality in process water used for device cleaning and rinsing operations
• Food and beverage quality control — Membrane filtration-based microbiological analysis of bottled water, juice, beer, and dairy products
• Drinking water surveillance — Bacterial count and pathogen screening for municipal and facility drinking water supplies per GB 5749
• Cosmetic water-phase testing — Microbial enumeration in water-based cosmetic formulations per ISO 17516

Key Features & Advantages

1. Three independent filtration channels with dedicated mechanical rotary knobs provide immediate, intuitive control without menu navigation.
2. Built-in diaphragm pump delivers stable vacuum generation with low noise, eliminating dependence on external vacuum sources or central vacuum systems.
3. Direct drainage design discharges filtered liquid immediately, removing the need for collection bottles and their associated cleaning validation requirements.
4. L304 stainless steel shell with brushed finish withstands routine disinfection and resists corrosion from common laboratory cleaning agents.
5. Anti-backflow protection mechanism prevents liquid reverse flow, safeguarding test integrity against operator error.
6. Flame sterilization-compatible filter heads allow rapid decontamination between consecutive test runs, minimizing cross-contamination risk.
7. Compatible with disposable Ø47mm / 100 mL filter cups for single-use convenience, or reusable Ø47mm / Ø50mm stainless steel filter cups for cost-sensitive applications.
8. Modular filter unit design enables quick disassembly for thorough cleaning, autoclave sterilization, and routine maintenance.
9. Compact 363 x 238 x 202 mm footprint integrates into standard laminar flow cabinets and biological safety cabinets used in aseptic testing environments.
10. 6.0 kg lightweight construction facilitates bench repositioning and installation in laboratories with limited space.
11. 19W low power consumption reduces operating costs for continuous daily testing operations.
12. ISO 9001 certified quality management ensures consistent instrument performance and traceable manufacturing processes.

Technical Specifications

FAQ

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