Tailin HTY-302G Triple-Channel Microbial Limit Tester

Overview

The Tailin HTY-302G Triple-Channel Microbial Limit Tester is an engineered solution for quantitative microbial enumeration in pharmaceutical, biotechnology, and medical device manufacturing environments. Designed in strict accordance with the Chinese Pharmacopoeia (ChP) Volume IV General Chapter 1105 (Microbiological Examination of Nonsterile Products) and aligned with ISO 8573-7 (compressed air microbiology), USP and , and EP 2.6.12, the instrument implements the membrane filtration method—a gold-standard technique for recovering low-concentration microorganisms from large-volume liquid samples. Its triple-channel architecture enables parallel processing of up to three independent samples per run, significantly improving throughput without compromising sterility integrity. Each channel operates via a dedicated high-efficiency diaphragm pump with an integrated non-return valve, ensuring unidirectional fluid flow and eliminating backflow contamination risk during vacuum-assisted filtration. The system supports both standard 47 mm and 50 mm filter cup configurations, as well as proprietary sterile microbiological test chambers compatible with pour-plate or membrane-transfer culture workflows.

Key Features

• Triple independent filtration channels with individual manual push-button controls and real-time status indicator LEDs for operational transparency.
• Modular pump head design—four interchangeable pump head variants available to accommodate diverse filter cup geometries and regulatory-compliant consumables (e.g., sterilized polyethersulfone (PES) or mixed cellulose ester (MCE) membranes).
• 316L stainless steel housing conforming to ASTM A240 specifications, providing corrosion resistance, cleanability, and compatibility with routine CIP/SIP protocols in regulated facilities.
• Integrated diaphragm pump rated for continuous duty at 1200 mL/min flow rate, eliminating need for external vacuum traps or collection flasks—enabling direct waste discharge into laboratory drainage systems equipped with appropriate containment.
• Pump heads validated for autoclaving at 121 °C for 30 minutes (wet heat) and compatible with rapid on-site flame sterilization using calibrated butane torches—supporting aseptic reconfiguration between batches.
• Noise emission ≤60 dB(A) under full-load conditions, meeting ISO 7779 and ANSI S12.2 requirements for low-noise laboratory instrumentation.

Sample Compatibility & Compliance

The HTY-302G accommodates aqueous, oily, and mildly viscous nonsterile preparations—including injectables, ophthalmic solutions, oral suspensions, topical creams (after appropriate dilution or solvent extraction), and purified water/WSF samples. It complies with pharmacopeial requirements for filter membrane pore size (typically 0.45 µm or 0.22 µm), minimum recovery efficiency (>70% per ChP/USP), and procedural validation documentation (e.g., growth promotion testing, negative control verification, and method suitability assessment). All wetted surfaces are non-leaching and extractables-tested per USP . The unit’s mechanical design meets IEC 61010-1 safety standards for laboratory electrical equipment and supports GLP/GMP-aligned recordkeeping when used with controlled logbooks and instrument usage registers.

Software & Data Management

As a manually operated platform, the HTY-302G does not incorporate embedded software or digital data logging. However, its deterministic mechanical operation—combined with standardized filter cup labeling, batch-specific run sheets, and traceable consumable lot tracking—facilitates full audit trail generation in compliance with FDA 21 CFR Part 11 Annex 11 principles when integrated into paper-based or LIMS-linked quality management systems. Users may pair the instrument with validated electronic notebooks (e.g., LabArchives, Benchling) or structured Excel templates to capture sample ID, operator, date/time, filter type, volume filtered, incubation parameters, and colony count results—ensuring data integrity, reviewer approval workflows, and long-term archival per ALCOA+ criteria.

Applications

• Microbial limit testing of raw materials, excipients, and finished dosage forms per ChP, USP, EP, and JP monographs.
• Environmental monitoring support—filtration of rinse waters from cleanroom surfaces, HVAC condensate, and compressed gas streams.
• Water system validation (PW, WFI, and purified steam condensate) per EU GMP Annex 1 and WHO TRS 970.
• Bioburden assessment of medical devices prior to sterilization (ISO 11737-1).
• Process validation studies requiring replicate filtration runs under identical operational parameters.

FAQ

Can the HTY-302G be used for sterility testing?
No—the HTY-302G is designed exclusively for microbial limit testing (quantitative enumeration), not sterility testing (presence/absence), which requires different filtration volumes, membrane types, and incubation durations per USP and ChP 1101.
Is the instrument compatible with 0.22 µm filters for mycoplasma detection?
Yes—provided the selected filter cup and membrane assembly are certified for mycoplasma retention and validated for the target matrix; however, mycoplasma-specific assay validation remains the user’s responsibility.
Does the unit meet FDA or EU regulatory expectations for equipment qualification?
Yes—the HTY-302G supports IQ/OQ execution through documented mechanical verification (flow rate calibration, leak testing, pump performance checks) and can be included in PQ protocols alongside media growth promotion and recovery studies.
What maintenance intervals are recommended?
Diaphragm pump inspection every 500 operating hours; pump head sterilization validation annually or after 100 autoclave cycles; visual inspection of O-rings and check valves before each use.
Are consumables supplied with regulatory documentation (CoA, CoC, extractables data)?
Tailin-certified filter cups and membranes are supplied with lot-specific Certificates of Analysis and Conformance; full extractables reports available upon request for GMP-regulated users.