Tailin HTY-305SP Triple-Channel Microbial Limit Tester

Overview

The Tailin HTY-305SP Triple-Channel Microbial Limit Tester is an engineered solution designed in strict accordance with the microbial enumeration and limit testing requirements specified in the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP , ), and European Pharmacopoeia (Ph. Eur. 2.6.12). It implements the standardized membrane filtration method — a gravimetric and quantitative microbiological assay technique wherein test samples are drawn through sterile, low-protein-binding, hydrophilic microporous membranes (typically 0.45 µm or 0.22 µm pore size) under controlled vacuum. Microorganisms present in the sample are retained on the membrane surface, which is then transferred onto appropriate solid culture media (e.g., Soybean–Casein Digest Agar or Tryptic Soy Agar) and incubated under defined conditions to allow colony formation. Colony-forming units (CFUs) are enumerated visually or via automated colony counters, enabling quantitative assessment of bioburden in pharmaceuticals, raw materials, excipients, medical devices, and purified water systems.

Key Features

• Triple-channel independent operation enables simultaneous processing of three distinct samples — ideal for comparative testing, parallel validation runs, or multi-batch screening without cross-contamination risk.
• Imported high-efficiency diaphragm pump delivers stable, pulse-free vacuum with consistent flow rate (1500 mL/min nominal) across all channels, ensuring uniform filtration kinetics and minimizing membrane clogging.
• Integrated Steam-in-Place (SIP) sterilization system supports fully automated, programmable cycles (temperature, duration, pressure ramp) compliant with GMP Annex 1 and ISO 13408-1 for aseptic process equipment qualification.
• Four configurable pump head options accommodate diverse filter configurations: standard 47 mm funnel assemblies, 50 mL or 100 mL sterile filtration cups, and Ph. Eur.-compliant rapid detection chambers — each rated for repeated autoclaving at 121 °C for ≥30 minutes.
• 316L stainless steel chassis meets ASTM A240 specifications for corrosion resistance, cleanability, and compatibility with CIP/SIP protocols; surface finish Ra ≤ 0.8 µm for reduced biofilm adhesion.
• Intelligent touch interface with real-time status feedback includes dedicated SIP progress indicators, individual channel runtime presets, and audible/visual alerts for end-of-cycle, overpressure, or membrane breach events.

Sample Compatibility & Compliance

The HTY-305SP supports aqueous, oily, and low-viscosity suspensions within ISO 11737-1-defined bioburden ranges (1–10³ CFU per unit dose). It is validated for use with commercially available sterile filtration consumables conforming to ISO 8549 and USP . The instrument’s design satisfies core regulatory expectations for microbial limit testing equipment under FDA 21 CFR Part 11 (when paired with compliant LIMS integration), EU GMP Annex 11 (data integrity), and WHO Technical Report Series No. 961 (sterile product manufacturing). All wetted surfaces are non-leaching and extractables-tested per USP . Documentation packages include IQ/OQ protocols aligned with ASTM E2500-13 and vendor-supplied calibration certificates traceable to NIM (National Institute of Metrology, China).

Software & Data Management

While the HTY-305SP operates as a standalone hardware platform, its embedded firmware logs timestamped operational records — including start/stop times, SIP cycle parameters, pump runtime per channel, and fault codes — stored internally for ≥10,000 events. Optional RS-232 or USB-C interface enables export of CSV-formatted audit trails compatible with laboratory information management systems (LIMS) and electronic batch record (EBR) platforms. When integrated into a validated environment, these data streams support ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) required for GLP/GMP audits.

Applications

• Pharmaceutical final product release testing (sterile and non-sterile dosage forms)
• Raw material and excipient bioburden verification per ICH Q5C
• Purified water and water-for-injection (WFI) system monitoring per USP
• Medical device packaging integrity challenge studies
• Environmental monitoring program (EMP) sample processing in cleanrooms
• Process validation support for aseptic filling lines and depyrogenation tunnels

FAQ

Is the HTY-305SP compliant with USP and for microbial enumeration and absence-of-pathogen testing?
Yes — its membrane filtration architecture, flow control precision, and sterility assurance features meet method suitability and procedural validation requirements outlined in both chapters.
Can the pump heads be sterilized using dry heat or ethylene oxide?
No — only moist heat (autoclaving at 121 °C, 15 psi, ≥30 min) is validated for pump head sterilization; alternative methods may compromise diaphragm integrity or seal performance.
Does the instrument support 0.22 µm filtration for mycoplasma detection?
Yes — when used with certified 0.22 µm filters and appropriate culture media (e.g., PPLO agar), the HTY-305SP fulfills the filtration step in compendial mycoplasma testing protocols.
What is the maximum allowable sample volume per channel?
The recommended upper limit is 1000 mL per channel under standard operating conditions; higher volumes require pre-filtration or dilution to maintain membrane integrity and avoid breakthrough.
Is third-party IQ/OQ support available from Tailin?
Yes — Tailin provides vendor-qualified IQ/OQ documentation templates and on-site protocol execution services upon request, aligned with ISO/IEC 17025 and ASTM E2500-13 guidelines.