Tailin HTY-306G Six-Station Manual Microbial Limit Tester
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | OEM Manufacturer |
| Region | Domestic (China) |
| Model | HTY-306G |
| Pricing | Upon Request |
Overview
The Tailin HTY-306G Six-Station Manual Microbial Limit Tester is a dedicated membrane filtration system engineered for quantitative microbial enumeration in pharmaceutical, biotechnology, and healthcare product testing. Designed in strict accordance with the Chinese Pharmacopoeia (ChP) General Chapter 1105 “Microbiological Examination of Nonsterile Products” and aligned with international principles outlined in USP , EP 2.6.12, and ISO 8573-7, the HTY-306G implements standardized vacuum-driven filtration to isolate microorganisms from liquid or soluble solid samples onto sterile, low-protein-binding filter membranes. Following filtration, membranes are transferred to appropriate agar media and incubated under controlled conditions to enable colony formation and subsequent enumeration—supporting compliance with microbial limit testing requirements for raw materials, excipients, finished dosage forms, and purified water systems.
Key Features
- Six independent filtration stations with fully manual operation—each station equipped with a dedicated high-efficiency diaphragm pump (rated flow: 1200 mL/min at nominal vacuum), enabling parallel processing without cross-contamination risk.
- Modular pump head design compatible with four interchangeable pump head configurations, allowing seamless integration with industry-standard 47 mm or 50 mm diameter filter holders—including stainless steel, polycarbonate, and disposable pre-sterilized filtration assemblies.
- Pump heads constructed from autoclavable 316L stainless steel (not 304L; verified per ASTM A240), validated for repeated wet-heat sterilization at 121 °C for 30 minutes (per ISO 17665-1), and optionally flame-sterilizable between runs using a laboratory-grade Bunsen burner or infrared microflame device.
- Integrated unidirectional check valves within each pump head prevent backflow during filtration cessation or pressure fluctuations—critical for maintaining sterility integrity and eliminating carryover contamination.
- Front-panel dual-color LED indicators (green/red) and tactile push-button switches provide immediate visual and operational feedback for each station—supporting intuitive workflow execution in GMP environments where glove-compatible interfaces are essential.
- Direct drainage architecture eliminates the need for external vacuum flasks or intermediate collection vessels; features an enlarged discharge port (Ø12 mm) for rapid, drip-free effluent evacuation into standard laboratory waste containers.
- Compact footprint (660 × 220 × 100 mm) and low acoustic emission (≤60 dB(A) under load) ensure compatibility with laminar flow hoods, isolators, and shared QC laboratory spaces.
Sample Compatibility & Compliance
The HTY-306G supports filtration of aqueous solutions, buffered saline, isotonic diluents, and low-viscosity suspensions commonly used in pharmacopeial microbial testing—including soybean-casein digest broth (SCDB), fluid thioglycollate medium (FTM), and R2A agar preparations. It accommodates filters with pore sizes of 0.22 µm (for bacterial retention) and 0.45 µm (for total aerobic microbial count), compliant with ISO 8573-7 Annex A recommendations. All wetted surfaces contact only USP Class VI-certified elastomers and electropolished stainless steel, meeting extractables/leachables criteria for pharmaceutical use. The instrument’s mechanical design conforms to IEC 61010-1 safety standards for laboratory electrical equipment and supports audit readiness for GLP and GDP-aligned quality systems.
Software & Data Management
As a manually operated, non-automated filtration platform, the HTY-306G does not incorporate embedded software or digital data logging. Its design intentionally omits electronic controls to minimize validation burden, reduce calibration dependencies, and maximize operational robustness in regulated settings. Users maintain full traceability through paper-based or LIMS-integrated batch records documenting filtration duration, membrane lot numbers, operator ID, environmental monitoring data (e.g., hood certification status), and incubation parameters—fully compatible with FDA 21 CFR Part 11–compliant documentation practices when paired with qualified electronic record systems.
Applications
- Quantitative microbial limit testing of nonsterile pharmaceuticals (tablets, capsules, ointments, syrups) per ChP, USP, and EP requirements.
- Environmental monitoring sample processing (e.g., purified water, WFI, compressed gases via impinger or membrane capture).
- Raw material and excipient bioburden assessment prior to formulation.
- Validation support for sterilization processes, including filter integrity testing preparation (pre-use/post-use).
- Educational and research laboratories requiring reproducible, low-cost membrane filtration infrastructure.
FAQ
Is the HTY-306G compliant with USP & EP microbial testing methods?
Yes—the instrument enables execution of USP , , and EP 2.6.12 membrane filtration procedures when used with pharmacopeia-specified filters, media, and incubation conditions.
Can pump heads be sterilized in an autoclave?
Yes—pump heads are rated for repeated autoclaving at 121 °C, 103 kPa (15 psi) for 30 minutes; validation documentation is available upon request.
Does the unit require a separate vacuum source?
No—it integrates six independent diaphragm pumps and operates directly from AC 220 V / 50 Hz mains power (30 W total consumption).
What filter diameters and pore sizes are supported?
Standard 47 mm and 50 mm filters with 0.22 µm or 0.45 µm pore ratings; compatibility confirmed with Millipore, Pall, Sartorius, and domestic certified suppliers.
Is maintenance documentation provided?
Yes—users receive a printed Operation & Maintenance Manual, calibration guidance for flow verification, and a Certificate of Conformance indicating material traceability and electrical safety compliance.
