Tailin FC752 Series Sterile, Single-Use, Fully Enclosed Membrane Filter Units
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | FC752 Series |
| Price | USD 0.15 (FOB) |
Overview
The Tailin FC752 Series Sterile, Single-Use, Fully Enclosed Membrane Filter Units are purpose-engineered consumables for microbial enumeration in pharmaceutical quality control laboratories. Designed exclusively for use with HTY-series intelligent microbial collectors (e.g., HTY-3000, HTY-6000), 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 collector’s calibrated air pump or vacuum manifold, test solutions—ranging from aqueous injectables to non-sterile oral suspensions—are passed through a hydrophilic membrane, retaining viable microorganisms on its surface. The fully enclosed, leak-tight architecture eliminates environmental contamination risk during handling and transfer, ensuring integrity of the sterility assurance process. Unlike open-system filters, the FC752’s integrated cup-body–membrane–cap assembly remains sealed until post-filtration membrane retrieval, directly supporting regulatory expectations for aseptic workflow continuity and documentation traceability.
Key Features
- Pre-sterilized via gamma irradiation (25–35 kGy) and supplied in double-barrier, ISO Class 5 cleanroom-packaged pouches compliant with ISO 11140-1 and AAMI ST37;
- Large-diameter (Φ75 mm) mixed cellulose ester (MCE) or nylon 66 (N66) membrane—optimized for high recovery rates (>95%) of Gram-negative bacteria (e.g., Pseudomonas aeruginosa), yeasts (e.g., Candida albicans), and molds;
- 0.45 µm nominal pore size, validated per ASTM F838-22 for bacterial retention using Brevundimonas diminuta (ATCC 19146) challenge tests;
- 150 mL maximum sample volume capacity with tapered conical filter cup geometry enabling laminar flow distribution and minimizing channeling;
- Patented support grid structure—rigid polypropylene mesh with uniform aperture distribution—provides full-surface mechanical stabilization to prevent membrane wrinkling or collapse under differential pressures up to 0.3 MPa;
- Ergonomic cup sleeve design with tactile alignment guides and rotational detents ensures rapid, tool-free attachment/detachment from HTY instrument manifolds while eliminating torque-induced membrane shear;
- Integrated membrane ejection notch—precision-molded into the cup rim—allows consistent, one-handed filter removal without tweezers or manual stretching, reducing operator variability and cross-contamination risk.
Sample Compatibility & Compliance
The FC752 series is validated for compatibility with pharmacopeial test preparations including sterile water for injection, saline diluents, buffered peptone water, and low-viscosity ophthalmic solutions. It supports both direct filtration and membrane rinse protocols per USP sterility testing requirements. All materials—including cup body, cap gasket, and membrane substrate—meet USP Class VI biological reactivity criteria and are extractables/leachables tested per ICH Q5C and Q3D guidelines. Device labeling conforms to ISO 15223-1:2021 symbols, and packaging includes lot-specific sterilization validation data, bioburden history, and endotoxin levels (<0.25 EU/mL). The system supports 21 CFR Part 11-compliant electronic batch records when paired with HTY instruments equipped with audit-trail-enabled firmware.
Software & Data Management
While the FC752 itself is a passive consumable, its integration into HTY-series platforms enables automated parameter logging—including applied pressure, filtration time, and volume processed—via RS-485 or USB-C interfaces. Instrument firmware versions ≥V4.2 generate timestamped CSV reports compatible with LIMS (e.g., LabWare, Thermo Fisher SampleManager) and support PDF export with digital signatures. Each FC752 unit bears a unique 2D DataMatrix code laser-etched on the cup base, enabling track-and-trace linkage to raw data files, QC release certificates, and stability study archives.
Applications
- Microbial limit testing of APIs, excipients, and finished dosage forms (tablets, capsules, injectables);
- Sterility testing of terminally sterilized products per USP and Ph. Eur. 2.6.1;
- Environmental monitoring filter sets for HVAC particulate and viable sampling in Grade A/B cleanrooms;
- Water system validation (PW, WFI, SWFI) per USP and EU GMP Annex 1;
- Method suitability verification for new formulations exhibiting antimicrobial activity or high particulate load.
FAQ
Are FC752 filters suitable for oily or viscous samples?
No—FC752 units are designed for aqueous or low-viscosity (<5 cP) solutions. For oils, suspensions, or viscous liquids, pre-filtration through a 1.2 µm depth filter or centrifugal clarification is required prior to FC752 use.
Can FC752 be autoclaved?
No—these units are gamma-sterilized and intended for single-use only. Autoclaving will deform the polypropylene cup and compromise membrane integrity.
What is the shelf life and storage condition?
24 months from manufacture date when stored at 15–25°C, relative humidity ≤60%, protected from UV light and ozone exposure. Do not freeze.
Is the MCE membrane compatible with R2A agar for oligotrophic organisms?
Yes—MCE exhibits superior recovery of slow-growing environmental isolates (e.g., Methylobacterium, Sphingomonas) on R2A compared to nylon, as confirmed in internal validation studies per ISO 11731-2.
Does Tailin provide filter validation reports?
Yes—lot-specific technical dossiers—including bacterial retention, extractables, endotoxin, and sterility test results—are available upon request and comply with ICH M4Q(R2) CTD Section 3.2.P.5.
