Tailin HTY-30X Series Microbial Filtration Stand
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | HTY-30X Series |
| Pricing | Available Upon Request |
Overview
The Tailin HTY-30X Series Microbial Filtration Stand is a precision-engineered platform designed for membrane filtration-based microbial enumeration and limit testing in pharmaceutical, biotechnology, and clinical laboratory environments. It operates on the principle of vacuum-assisted membrane filtration, where liquid samples are drawn through sterile, low-protein-binding filter membranes (typically 0.45 µm or 0.22 µm pore size) to capture viable microorganisms. Captured colonies are subsequently cultured on appropriate agar media and enumerated under controlled incubation conditions per pharmacopoeial methods (e.g., USP , EP 2.6.12, and ChP 1107). The HTY-30X series serves as the mechanical backbone of a complete microbial detection system—integrating seamlessly with standard Φ47 mm and Φ60 mm filtration assemblies, compatible pump units, and sterilizable accessories to support compendial compliance and process reproducibility.
Key Features
- Ergonomic stainless steel frame constructed from electropolished SUS316L—resistant to corrosion, chloride stress cracking, and repeated autoclaving cycles (121 °C, 30 min, saturated steam)
- Modular pump head design: detachable, tool-free replacement enables rapid configuration for single-, triple-, quadruple-, or hexa-filtration setups
- Vertical straight-tube fluid path geometry minimizes flow resistance and enhances filtration throughput compared to angled or bent configurations
- Integrated manual drain valve with positive-seal shut-off—enables controlled, drip-free sample discharge without breaking sterility or requiring secondary tubing clamps
- All-wetted components—including valves, pump heads, and sealing gaskets—designed for full-system steam sterilization (SIP) in place or disassembled for validation-grade cleaning
- Pump head compatibility with flame-sterilizable operation: supports rapid in-situ decontamination using laboratory-grade butane or propane torches (per ISO 14644-1 Class 5 cleanroom protocols)
- Interchangeable pump head options accommodate diverse filter cup geometries (e.g., reusable glass, disposable polypropylene, and low-adsorption PES membranes)
Sample Compatibility & Compliance
The HTY-30X stand accommodates standard microbiological filter membranes with diameters of Φ47 mm and Φ60 mm, including mixed cellulose ester (MCE), polyethersulfone (PES), and nylon variants. It supports aqueous, oily, and mildly viscous pharmaceutical preparations—including injectables, ophthalmic solutions, and non-sterile topical formulations—as defined in USP and ISO 11737-1. The system’s design facilitates adherence to Good Manufacturing Practice (GMP) Annex 1 requirements for aseptic processing and environmental monitoring. All contact surfaces meet FDA-compliant material certifications (ASTM F899-22 for stainless steel), and the structural integrity supports IQ/OQ/PQ validation documentation packages required for regulated facilities.
Software & Data Management
As a manually operated mechanical platform, the HTY-30X Series does not incorporate embedded electronics or digital controls. However, it is fully compatible with laboratory information management systems (LIMS) and electronic lab notebooks (ELN) when used in conjunction with validated vacuum pumps equipped with pressure sensors, runtime logging, and 21 CFR Part 11–compliant audit trails. Documentation workflows—including sterilization cycle records, filter lot traceability, and operator sign-offs—can be integrated into GxP-aligned quality management systems (QMS) via standardized SOP templates aligned with ISO/IEC 17025 and EU GMP Annex 11.
Applications
- Microbial limit testing of non-sterile pharmaceutical products per USP and Ph. Eur. 2.6.12
- Bioburden assessment of raw materials, excipients, and water-for-injection (WFI) systems
- Environmental monitoring filter analysis in Grade A/B cleanrooms
- Validation of sterilizing-grade filtration processes (e.g., pre-filtration challenge studies)
- Research-scale microbial recovery studies evaluating membrane binding efficiency and elution kinetics
- QC release testing of medical device rinse extracts and packaging leachables
FAQ
Is the HTY-30X stand suitable for use in ISO Class 5 laminar flow hoods?
Yes—the compact footprint, smooth electropolished surfaces, and absence of crevices ensure compatibility with aseptic workstation environments.
Can the entire assembly undergo autoclaving at 134 °C?
No—validation data supports only 121 °C, 30-minute saturated steam cycles. Higher temperatures may compromise elastomeric seal integrity.
Does Tailin provide installation qualification (IQ) documentation?
Yes—customized IQ/OQ protocol templates and material certification dossiers (including RoHS and REACH declarations) are available upon request.
Are replacement pump heads and valves available as spare parts?
Yes—all consumable and wear-prone components are stocked and supplied with serialized traceability for GMP audits.
Can the HTY-30X be adapted for use with Φ100 mm filters?
No—mechanical mounting and vacuum distribution are optimized exclusively for Φ47 mm and Φ60 mm configurations per current design specifications.
