Tailin HTY-102S Single-Station Microbial Limit Tester

Overview

The Tailin HTY-102S Single-Station Microbial Limit Tester is an engineered solution for pharmaceutical, biotechnology, and contract manufacturing organizations requiring compliant, reproducible microbial enumeration in accordance with pharmacopoeial standards—including the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP and ), and European Pharmacopoeia (Ph. Eur. 2.6.12). It implements the membrane filtration method—a universally accepted quantitative microbiological assay—whereby a defined volume of test sample is drawn through a sterile, low-protein-binding membrane (typically 0.45 µm or 0.22 µm pore size) under controlled negative pressure. Microorganisms retained on the membrane surface are subsequently transferred onto solid or liquid growth media for incubation and colony enumeration. The HTY-102S provides a dedicated, single-channel platform optimized for routine quality control testing of non-sterile pharmaceuticals, raw materials, excipients, water for injection (WFI), purified water, and cleanroom environmental monitoring samples.

Key Features

• Single-station configuration with independent vacuum circuit and integrated anti-backflow check valve—eliminates cross-contamination risk between sequential tests.
• Imported diaphragm vacuum pump delivering stable 25 L/min flow rate at rated vacuum; engineered for continuous operation and low maintenance.
• 316L stainless steel housing ensures corrosion resistance, cleanability, and compliance with ISO 14644-1 Class 5–8 cleanroom-compatible surface requirements.
• Modular pump head system supports four interchangeable configurations, enabling compatibility with standard 47-mm and 50-mm filter cups, as well as Tailin’s proprietary detection culture devices (e.g., HTY-D series).
• Pump heads validated for repeated autoclaving at 121 °C for 30 minutes (moist heat), supporting GMP-aligned equipment qualification (IQ/OQ/PQ) and routine sterilization protocols.
• Manual push-button interface with LED status indicators simplifies operator interaction and reduces training burden—no software dependency required for basic operation.
• Direct-discharge waste liquid architecture minimizes secondary handling, avoids intermediate collection bottles, and streamlines workflow in high-throughput QC laboratories.

Sample Compatibility & Compliance

The HTY-102S accommodates aqueous, oily, and mildly viscous solutions commonly encountered in pharmaceutical manufacturing—provided they do not compromise membrane integrity or inhibit microbial recovery. It supports both aerobic and anaerobic microbial limit testing when paired with appropriate culture media (e.g., Soybean–Casein Digest Agar for total aerobic count; Sabouraud Dextrose Agar for fungi; Fluid Thioglycollate Medium for anaerobes). All operational parameters—including flow rate, vacuum stability, and dwell time—are consistent with USP validation requirements for membrane filtration efficiency (>95% recovery of challenge organisms such as Staphylococcus aureus, Bacillus subtilis, and Candida albicans). The instrument’s construction materials comply with USP Analytical Instrument Qualification guidelines and meet mechanical safety requirements per IEC 61010-1.

Software & Data Management

The HTY-102S operates as a standalone hardware platform without embedded firmware or digital data logging. As such, it does not generate electronic records and is inherently exempt from FDA 21 CFR Part 11 requirements. This design aligns with laboratories maintaining paper-based or hybrid QC workflows where manual entry into LIMS or ELN systems is standard practice. For users requiring audit-trail capability, integration is achievable via external time-stamped logbooks or digital annotation tools synchronized with sample ID tracking. The absence of onboard software also eliminates cybersecurity concerns related to network-connected instrumentation and simplifies periodic requalification following facility change controls.

Applications

• Routine microbial enumeration of bulk drug substances and finished dosage forms (tablets, capsules, ointments, injectables).
• Environmental monitoring of Grade A/B cleanrooms—filtration of air samplers, surface rinse samples, and personnel glove washes.
• Water system validation and ongoing surveillance of Purified Water (PW) and Water for Injection (WFI) per USP .
• Raw material release testing for herbal extracts, polymers, and excipients susceptible to microbial proliferation.
• Method suitability studies during analytical procedure validation (ICH Q2(R2)).
• Supporting GLP-compliant stability study sampling programs where low-volume, discrete sample processing is preferred.

FAQ

Is the HTY-102S suitable for sterility testing?
No—the HTY-102S is designed exclusively for microbial limit testing per USP /ChP 1105. Sterility testing requires dual-chamber isolator-compatible systems with stricter aseptic handling provisions and larger filtration capacities.
Can the pump head be sterilized using ethylene oxide (EO)?
No—pump heads are qualified only for moist-heat sterilization (121 °C, 30 min) and flame sterilization. EO exposure may degrade diaphragm elastomers and compromise vacuum integrity.
Does the unit include filter membranes or culture media?
No—membranes, filter cups, and growth media are consumables supplied separately and selected based on test organism specificity and regulatory acceptance criteria.
What is the recommended maintenance interval for the diaphragm pump?
Under normal daily use (≤4 hours/day), inspect pump oil and replace diaphragms every 12 months or after 500 operating hours—whichever occurs first—as documented in the manufacturer’s maintenance logbook.
Can multiple HTY-102S units be operated in parallel within one biosafety cabinet?
Yes—its compact footprint (380 × 230 × 100 mm) and low noise emission (≤65 dB(A)) permit side-by-side deployment in Class II A2 cabinets without airflow interference or acoustic disturbance to adjacent workstations.