Tailin HTY-300 Triple-Station Microbial Filtration Stand

Overview

The Tailin HTY-300 Triple-Station Microbial Filtration Stand is an engineered component of a regulated membrane filtration system for quantitative microbial enumeration in pharmaceutical, biotechnology, and clinical laboratory environments. It operates on the principle of vacuum-assisted membrane filtration—where liquid samples are drawn under controlled negative pressure through a sterile, low-protein-binding 47 mm diameter filter membrane (e.g., mixed cellulose ester or polycarbonate). Microorganisms present in the sample are physically retained on the upstream surface of the membrane, while the filtrate passes through. The membrane is then aseptically transferred to an appropriate solid or liquid growth medium and incubated under defined conditions (e.g., 30–35 °C for aerobic bacteria, 20–25 °C for molds/yeasts) to allow colony formation. This method conforms to compendial standards including USP , EP 2.6.12, and ISO 8573-7 for non-sterile product testing and environmental monitoring.

Key Features

• Triple independent filtration stations enable parallel processing of up to three samples without cross-contamination risk—critical for batch release testing and comparative studies.
• Fixed-position pump heads are constructed from autoclavable 316 stainless steel and engineered for long-term mechanical stability during repeated wet-heat sterilization cycles (121 °C, 15–20 min, 100 kPa).
• Each station features manual valve control for precise flow regulation and endpoint detection; no electronic actuators or software dependencies ensure operational reliability in GMP cleanrooms.
• Integrated structural design supports seamless compatibility with standard F47 and F47-R250 microbiological filter cups—ensuring consistent sealing force and uniform membrane compression across all three channels.
• Pump head surfaces are optimized for rapid decontamination via handheld flame sterilization (e.g., using a butane micro-torch), minimizing downtime between runs in high-throughput QC labs.
• Compact footprint (37 × 12.5 × 10.5 cm) allows placement within biosafety cabinets or laminar flow hoods without obstructing workflow ergonomics.

Sample Compatibility & Compliance

The HTY-300 stand is validated for use with aqueous, oily, and low-viscosity suspensions commonly encountered in pharmaceutical manufacturing—including purified water, WFI, buffer solutions, ophthalmic preparations, and non-sterile oral suspensions. It supports both qualitative presence/absence testing and quantitative limit testing per pharmacopoeial requirements. When paired with a compliant vacuum source (e.g., Tailin’s dedicated microbial vacuum pump with oil-free diaphragm technology), the system meets ISO 13408-1 sterility assurance principles and supports audit readiness for FDA 21 CFR Part 11–aligned documentation workflows when integrated with validated electronic lab notebooks (ELNs). All wetted components comply with USP Class VI biocompatibility and EU Directive 2002/72/EC for food-contact materials.

Software & Data Management

As a hardware-only filtration platform, the HTY-300 does not incorporate embedded firmware or onboard data logging. Its design intentionally avoids digital dependency to maintain regulatory flexibility and reduce validation burden. Users record operational parameters—including filtration time, vacuum level (measured externally), membrane lot number, incubation conditions, and colony counts—in paper-based or electronic batch records aligned with GLP/GMP Annex 11 and ALCOA+ data integrity principles. Integration with LIMS or ELN systems occurs at the procedural level, not the device level—ensuring full traceability without proprietary lock-in.

Applications

• Microbial limit testing of raw materials, excipients, and finished dosage forms per USP and JP 4.06.
• Environmental monitoring of Grade A/B cleanroom surfaces and compressed gases per ISO 14644 and EU GMP Annex 1.
• Water system validation (PW, WFI, SW) in accordance with ASTM D4199 and pharmacopoeial water quality specifications.
• Bioburden assessment prior to terminal sterilization of medical devices (ISO 11737-1).
• Method suitability verification for antimicrobial preservative efficacy testing (USP ).

FAQ

Can the HTY-300 be sterilized in an autoclave?

Yes—the entire unit, including pump heads and support frame, is rated for full-cycle autoclaving at 121 °C, 100 kPa for 15–20 minutes. Verify load configuration to ensure steam penetration and avoid shadowing.
Is it compatible with nitrocellulose or PVDF membranes?

It supports any 47 mm diameter membrane with standard support ring geometry; however, low-binding membranes (e.g., PVDF) require pre-wetting and careful handling to prevent drying artifacts during transfer.
Does it require calibration?

No routine calibration is required, as it is a passive mechanical assembly. Verification of uniform filtration performance across stations should be conducted during initial qualification and after major maintenance per IQ/OQ protocols.
What vacuum pressure range is recommended for optimal filtration?

Typical operating range is –40 to –80 kPa, depending on sample viscosity and membrane pore size. Excessive vacuum may cause membrane rupture or non-uniform retention; always validate pressure settings with representative product matrices.
Can it be used for sterility testing?

No—the HTY-300 is designed for microbial limit testing only. Sterility testing requires a separate, dedicated system meeting USP requirements, including larger-volume filtration capacity and stricter aseptic handling provisions.