Tailin HTY-303G Microbial Limit Tester

Overview

The Tailin HTY-303G Microbial Limit Tester is a precision-engineered, triple-channel membrane filtration system designed for quantitative microbial enumeration in pharmaceutical, biotechnology, and clinical laboratory environments. It operates on the principle of vacuum-assisted membrane filtration—applying controlled negative pressure via integrated diaphragm pumps to draw liquid samples through sterile, low-protein-binding filter 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 transferred onto solid growth media for incubation and colony-forming unit (CFU) enumeration. Unlike conventional setups requiring external vacuum sources and separate filtration flasks, the HTY-303G integrates all critical fluid-handling components—including dual diaphragm pumps, sealed tubing pathways, and valve-controlled inlet manifolds—into a compact, self-contained stainless-steel chassis. This architecture eliminates intermediate connections prone to leakage or contamination, thereby enhancing procedural reproducibility and reducing operator-dependent variability.

Key Features

• Triple independent filtration channels, each equipped with a high-integrity imported ball valve for precise manual flow regulation—enabling simultaneous multi-sample processing or isolated single-channel operation without cross-contamination.
• Dual high-efficiency diaphragm liquid pumps delivering ≥1.2 L/min total flow capacity under nominal load, engineered for stable performance across extended duty cycles and compatible with aqueous, buffered, and mildly viscous pharmaceutical preparations.
• 304L stainless-steel housing with electropolished finish, offering superior corrosion resistance, cleanability, and compliance with ISO 14644-1 Class 7 (ISO Class 10,000) cleanroom-compatible surface requirements.
• Ergonomic dual-color LED status indicators (green/red) paired with tactile push-button controls provide unambiguous real-time feedback on pump activation, channel engagement, and system readiness—reducing training burden and operational error rates.
• Rapid-deploy pump head design: fully detachable without tools; validated for steam sterilization at 121 °C for 15–20 minutes (per ISO 17665-1), and compatible with open-flame sterilization using handheld gas torches for immediate re-use between sequential batches.
• Universal filter cup compatibility—including F47, F47B, F60, and S60 series—supports flexible method adaptation across USP , , EP 2.6.12, and ChP 1105 regulatory workflows without hardware modification.

Sample Compatibility & Compliance

The HTY-303G accommodates a broad range of non-viscous to moderately viscous liquid matrices commonly encountered in quality control laboratories: sterile injectables, ophthalmic solutions, oral suspensions, buffer solutions, purified water (PW), and water-for-injection (WFI). Its pressure-balanced filtration path ensures consistent flow dynamics even with low-tension or surfactant-containing formulations. The system conforms to core regulatory expectations for microbial limit testing equipment, including mechanical integrity verification per ASTM E2928-13 (Standard Guide for Validation of Membrane Filtration Methods), structural traceability per ISO 9001:2015, and material biocompatibility aligned with USP and . While not intrinsically compliant with FDA 21 CFR Part 11, its operational simplicity and deterministic manual control pathway facilitate straightforward validation documentation under GLP and GMP frameworks—particularly where electronic audit trails are managed externally via lab information management systems (LIMS).

Software & Data Management

The HTY-303G is a hardware-only platform with no embedded microprocessor or digital interface. All operation is manually initiated and monitored via physical controls—intentionally eliminating firmware dependencies, cybersecurity vulnerabilities, and software qualification overhead. This analog architecture aligns with Annex 11 (EU GMP) principles for “low-risk” equipment used in non-critical process steps, allowing laboratories to focus validation efforts on procedural controls, filter integrity testing (e.g., bubble point or diffusion tests), and environmental monitoring rather than code-level verification. Raw data (e.g., filtration time, observed CFUs, filter lot numbers) are recorded manually in bound logbooks or structured Excel templates compliant with ALCOA+ data integrity criteria. For labs implementing digital workflows, the device integrates seamlessly with third-party LIMS or ELN platforms via standard operating procedure (SOP)-driven entry protocols.

Applications

• Pharmaceutical QC: Routine microbial enumeration of final drug products per USP and EP 2.6.12.
• Water system validation: Testing of PW, WFI, and clean steam condensate in accordance with pharmacopoeial water specifications.
• Raw material release: Screening of excipients, solvents, and packaging component rinsates.
• Environmental monitoring support: Processing of settle plates, contact plates, and air sampler membranes when pre-filter concentration is required.
• Bioburden assessment in early-phase bioprocess development, especially for harvest streams and purification intermediates prior to sterile filtration.

FAQ

Is the HTY-303G suitable for sterility testing?
No—it is specifically designed for microbial limit testing (quantitative enumeration), not sterility testing (qualitative presence/absence). Sterility testing requires stricter aseptic handling, larger filtration volumes, and different regulatory validation criteria (e.g., USP ).

Can the system be used with 0.22 µm filters for mycoplasma detection?
Yes—provided the filter membrane and cup assembly are certified for mycoplasma retention and validated for the specific matrix; however, mycoplasma enumeration typically requires specialized enrichment and detection methods beyond standard membrane filtration.

Does the device require calibration?
No formal calibration is mandated per pharmacopoeial guidelines for membrane filtration apparatuses; however, periodic verification of pump flow rate (using calibrated volumetric flask and stopwatch) and valve leak integrity is recommended as part of routine preventive maintenance.

What is the expected service life of the diaphragm pumps?
Under typical pharmaceutical QC usage (≤4 hours/day, 5 days/week), the dual diaphragm pumps demonstrate ≥18 months of reliable operation before scheduled replacement—consistent with manufacturer-recommended maintenance intervals and supported by documented mean time between failures (MTBF) data from field deployments.