Tailin HTY-102 Single-Station Microbial Limit Tester

Overview

The Tailin HTY-102 Single-Station Microbial Limit Tester is a precision-engineered filtration-based instrument designed explicitly for quantitative microbial enumeration in compliance with pharmacopoeial standards—including the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP <61> and <62>), European Pharmacopoeia (Ph. Eur. 2.6.12), and Japanese Pharmacopoeia (JP). It implements the membrane filtration method—a gold-standard technique for low-bioburden samples such as sterile pharmaceuticals, ophthalmic solutions, injectables, and purified water systems. The HTY-102 operates on a controlled vacuum principle: a high-efficiency diaphragm pump generates consistent negative pressure across a sterile, hydrophilic or hydrophobic membrane (typically 0.45 µm or 0.22 µm pore size), enabling rapid and uniform passage of the test solution while retaining viable microorganisms on the filter surface. Subsequent transfer of the membrane onto appropriate solid culture media (e.g., Soybean–Casein Digest Agar or Tryptic Soy Agar) allows colony-forming unit (CFU) development under defined incubation conditions. Its compact footprint, direct-drain architecture, and absence of intermediate vacuum flasks reduce contamination risk and simplify workflow validation.

Key Features

• Single-station configuration optimized for routine QC laboratories requiring dedicated, non-shared microbial testing stations.
• High-reliability diaphragm pump delivering stable 1200 mL/min flow rate under load—engineered for extended duty cycles without thermal drift or performance degradation.
• Modular pump head system supporting four interchangeable configurations, each compatible with industry-standard filtration assemblies including 47-mm reusable stainless-steel filter holders, disposable polypropylene filter cups (e.g., Millipore-style), and pre-sterilized microbiological test kits (e.g., Pall Envirochek™ or Sartorius Minisart® NML).
• Pump heads constructed from autoclavable materials (validated for ≥30 cycles at 121 °C, 15 psi, 15 min) and capable of rapid in-situ flame sterilization using a laboratory-grade butane torch—enabling same-day re-use across multiple sample batches without cross-contamination.
• Integrated one-way check valve within each pump head prevents backflow during power interruption or filter clogging, maintaining sterility integrity and eliminating false-positive risk from media reflux.
• Front-panel manual push-button control with dual-color status indicator (green = operational, red = overpressure or blockage alert) ensures intuitive operation without software dependency—ideal for GLP environments where simplicity and audit readiness are critical.
• 316L stainless steel chassis provides corrosion resistance against disinfectants (e.g., 70% ethanol, hydrogen peroxide vapor), acids, and saline solutions, ensuring long-term structural integrity in cleanroom and ISO Class 5/7 settings.

Sample Compatibility & Compliance

The HTY-102 supports filtration of aqueous, oily, and mildly viscous preparations up to 100 mL volume per run. Compatible sample types include purified water, water for injection (WFI), buffer solutions, liquid APIs, ointments (after emulsification), and lyophilized product reconstitutes. All wetted components meet USP Class VI biocompatibility requirements. The instrument’s design facilitates full traceability per FDA 21 CFR Part 11 when integrated into validated laboratory information management systems (LIMS)—though standalone use requires documented operator training, equipment logbooks, and periodic performance qualification (PQ) per ISO/IEC 17025. Routine maintenance includes pump diaphragm replacement every 12 months (or after 500 hr cumulative runtime) and quarterly verification of flow consistency and vacuum stability.

Software & Data Management

The HTY-102 is a hardware-only platform with no embedded firmware or digital interface—deliberately architected to eliminate cybersecurity vulnerabilities, software validation burdens, and obsolescence risks associated with embedded operating systems. All operational parameters (sample ID, filtration time, membrane lot number, incubation date, analyst ID) are recorded manually in bound, page-numbered lab notebooks or electronic records compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). When used in GMP environments, it integrates seamlessly with LIMS via barcode-scanned consumable labels and structured Excel-based reporting templates aligned with Annex 11 expectations.

Applications

• Microbial limit testing of non-sterile pharmaceutical dosage forms (tablets, capsules, topical creams) per ChP General Chapter 1105.
• Bioburden assessment of component raw materials prior to sterilization process validation.
• Environmental monitoring support—filtration of settle plates rinse fluids or compressed gas condensates.
• Water system surveillance: routine sampling of distribution loops, storage tanks, and point-of-use outlets.
• Educational use in university pharmacology and microbiology labs for teaching membrane filtration methodology and regulatory science fundamentals.

FAQ

Is the HTY-102 compliant with USP <61> and <62>?

Yes—the instrument enables execution of the membrane filtration method as described in USP chapters, provided users follow validated procedures for filter selection, rinsing, and media suitability testing.
Can the pump head be sterilized in an autoclave?

Yes—pump heads are rated for repeated autoclaving at 121 °C, 15 psi, for 15 minutes; validation documentation (including material certificates and cycle mapping reports) is supplied with each unit.
Does the device require a vacuum flask or collection bottle?

No—it features a direct-drain design that discharges filtrate into a floor drain or waste container, eliminating secondary containment and reducing setup time.
What is the expected service life of the diaphragm pump?

Under normal QC lab usage (≤4 hrs/day, 5 days/week), the pump maintains ±5% flow accuracy for ≥10,000 operating hours; preventive replacement is recommended annually or after 500 operational hours, whichever occurs first.
How is cross-contamination prevented between samples?

Through three redundant safeguards: (1) autoclavable or flame-sterilizable pump heads, (2) integrated check valves preventing reverse flow, and (3) disposable filtration membranes and filter cups certified for single-use sterility.