Tailin FC502 Series Sterile, Single-Use, Fully Enclosed Membrane Filtration Units
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | FC502 Series |
| Price | USD 0.15 (FOB) |
Overview
The Tailin FC502 Series Sterile, Single-Use, Fully Enclosed Membrane Filtration Units are purpose-engineered consumables for microbial enumeration in pharmaceutical and biotechnology quality control laboratories. Designed exclusively for use with HTY-series intelligent microbial collection systems (e.g., HTY-601, HTY-701, HTY-801), these units implement the standardized membrane filtration method per USP , EP 2.6.12, and ISO 8573-7. Under controlled positive-pressure filtration driven by the integrated peristaltic or diaphragm pump of the host instrument, test solutions pass through a defined-pore membrane; microorganisms—including bacteria, yeasts, and molds—are quantitatively retained on the upstream surface. The fully enclosed architecture eliminates open handling, thereby preventing environmental contamination and ensuring assay integrity throughout filtration, rinsing, and membrane transfer. This design directly supports compliance with current Good Manufacturing Practice (cGMP) requirements for sterility assurance and data reliability in non-sterile product testing.
Key Features
- Fully enclosed, single-use configuration ensures batch-to-batch consistency and eliminates cross-contamination risk between samples.
- Proprietary cup sleeve design—patented in CN210904723U—enables rapid, tool-free disassembly while minimizing mechanical stress on the membrane during removal.
- Reinforced polycarbonate cup body rated for sustained operating pressures up to 0.3 MPa (43.5 psi), supporting efficient filtration of viscous or particulate-laden pharmaceutical suspensions and ophthalmic solutions.
- Integrated membrane ejection notch at the cup rim facilitates clean, tear-free retrieval of the filter disc without forceps contact—critical for preserving colony morphology during subsequent membrane transfer.
- High-recovery performance validated per USP using standard challenge organisms (e.g., Bacillus subtilis, Candida albicans, Aspergillus niger) across diverse formulation matrices including buffered saline, isotonic glucose, and low-viscosity suspensions.
Sample Compatibility & Compliance
The FC502 Series is compatible with aqueous, oily, and mildly organic solvent-based preparations commonly encountered in pharmaceutical QC, including injectables, oral liquids, topical creams (after appropriate dilution), and raw material extracts. It meets ISO 11737-1:2018 requirements for bioburden estimation and supports validation protocols aligned with FDA Guidance for Industry: Sterility Testing of Drug Substances and Products (2022). All units undergo terminal ethylene oxide (EO) sterilization and are supplied in double-barrier, peel-open packaging with full sterility assurance (SAL ≤ 10⁻⁶). Each lot includes a Certificate of Conformance listing EO residual levels (< 10 ppm), endotoxin content (< 0.25 EU/mL), and bioburden test results.
Software & Data Management
While the FC502 units themselves are passive consumables, their integration into HTY-series instruments enables full digital traceability when paired with compliant software platforms. HTY instruments equipped with firmware v3.2+ support 21 CFR Part 11-compliant audit trails—including user login, filtration time stamp, pressure profile logging, and operator ID linkage—when connected to LIMS or ELN systems via RS232/USB. Filter unit lot numbers are manually or barcode-scanned into the system prior to run initiation, ensuring chain-of-custody documentation for regulatory submissions and internal GLP audits.
Applications
- Microbial limit testing of non-sterile pharmaceuticals per USP and JP 4.07.
- Bioburden monitoring of process water (PW, WFI), excipients, and active pharmaceutical ingredients (APIs).
- Environmental monitoring sample processing (e.g., compressed gas, HVAC filter eluates).
- Validation of sterilization processes where membrane filtration serves as the recovery method for biological indicators.
- QC release testing of herbal extracts, nutraceuticals, and cosmetics under ISO 17516 and CPSC guidelines.
FAQ
Are FC502 units compatible with non-HTY brand filtration systems?
No. Mechanical interface dimensions, pressure port alignment, and cup seating geometry are proprietary to HTY-series instruments. Interchangeability with other brands is not validated and may compromise seal integrity or filtration efficiency.
What is the shelf life and recommended storage condition?
36 months from date of manufacture when stored unopened at 15–25°C and relative humidity ≤ 60%. Avoid direct sunlight and exposure to ozone-generating equipment.
Can FC502 units be used for sterility testing per USP ?
No. These units are designed and validated solely for microbial limits testing. Sterility testing requires different filter housing configurations, larger membrane surface areas, and alternative validation criteria per USP and ISO 13409.
Is the MCE membrane pre-wetted or supplied dry?
All FC502 units ship with dry, sterile MCE or Nylon 66 membranes. Pre-wetting is performed automatically by the HTY instrument’s priming cycle prior to sample introduction.
Do you provide technical documentation for regulatory filing?
Yes. Tailin provides a comprehensive Technical Dossier upon request, including materials of construction (USP Class VI), extractables profiling (per USP ), EO sterilization validation summary, and microbial retention test reports per ASTM F838-22.
