Tailin Biotech Reusable Fully Enclosed Membrane Filter FC50A/B Series for HTY-Series Intelligent Microbial Samplers
| Brand | Tailin Biotech |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | FC50A/B Series |
| Unit Price | USD 1.00 (ex-works) |
Overview
The Tailin Biotech Reusable Fully Enclosed Membrane Filter FC50A/B Series is a purpose-engineered consumable designed exclusively for microbial enumeration in pharmaceutical quality control laboratories operating under current Good Manufacturing Practice (cGMP) and ISO 17025-compliant environments. It functions as the core filtration module within HTY-series intelligent microbial samplers—automated, positive-pressure-driven systems that implement standardized membrane filtration per USP , EP 2.6.12, and ISO 8573-7. The device operates on the principle of pressure-assisted sterile filtration: test solutions are driven across a defined-pore membrane under controlled positive pressure, retaining viable microorganisms on the upstream surface while allowing liquid phase to pass through. Its fully enclosed architecture eliminates open handling, thereby minimizing environmental contamination risk and ensuring operator safety during aseptic processing workflows.
Key Features
- Reusable stainless-steel (FC50A) or high-performance polymer alloy (FC50B) housing engineered for ≥50 autoclave cycles (121 °C, 20 min, saturated steam), maintaining dimensional stability and leak integrity per ASTM F1800.
- Interchangeable MCE (mixed cellulose ester) or nylon 66 (N66) membranes with nominal pore size 0.45 µm or 0.22 µm—certified non-pyrogenic, low-binding, and compatible with aqueous and low-viscosity organic solvents.
- Modular design enables flexible configuration: single-, dual-, or triple-unit assemblies via standardized Luer-lock or bayonet coupling interfaces—optimized for parallel sample processing without cross-contamination.
- Integrated O-ring sealing system validated for pressure retention up to 0.3 MPa; housing geometry ensures uniform flow distribution and minimizes channeling or membrane wrinkling during filtration.
- Tool-free disassembly mechanism allows rapid filter membrane extraction post-filtration—reducing mechanical stress on the membrane and preserving colony morphology for accurate enumeration.
Sample Compatibility & Compliance
The FC50A/B series accommodates a broad range of pharmaceutical samples including injectables, ophthalmic solutions, irrigation fluids, raw material extracts, and purified water. It supports both direct filtration and membrane pre-rinsing protocols as specified in USP Sterility Tests and Ph. Eur. 2.6.1. All materials comply with USP Class VI biological reactivity requirements and EU Regulation (EC) No. 1935/2004 for food-contact polymers (applicable to FC50B). Documentation includes Certificate of Conformance, bioburden testing reports, and extractables profile summaries aligned with ICH Q5C and Q3D guidelines. The system is fully compatible with FDA 21 CFR Part 11–enabled HTY-series instruments when used with audit-trail-capable software versions.
Software & Data Management
While the FC50A/B itself is a passive hardware component, its integration into HTY-series platforms enables full traceability: each filter unit is assigned a unique identifier (e.g., batch-coded housing engraving), synchronized with instrument logs recording filtration pressure, duration, volume processed, and operator ID. Data export supports CSV and PDF formats compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Validation packages include IQ/OQ documentation templates and filter integrity test (FIT) correlation protocols using bubble point or diffusion rate methods per ASTM F838.
Applications
- Microbial limit testing of non-sterile pharmaceuticals (USP )
- Sterility testing of terminally sterilized products (USP )
- Bioburden assessment in process validation and cleaning verification studies
- Environmental monitoring filter support for compressed gas systems (ISO 8573-7)
- Method transfer and compendial equivalence studies between labs
FAQ
Can the FC50A/B be sterilized using ethylene oxide (EtO)?
No—autoclaving is the only validated sterilization method. EtO may compromise membrane integrity and introduce residual contaminants incompatible with low-bioburden applications.
Is the FC50B housing suitable for use with aggressive solvents such as acetone or DMSO?
Yes—high-molecular-weight polymer alloy construction resists swelling and stress cracking in common pharmaceutical solvents; compatibility testing data available upon request.
Does the filter require pre-wetting before use?
MCE membranes require aqueous pre-wetting; N66 membranes may be used dry or pre-wet depending on sample viscosity and filtration pressure profile.
How is filter integrity verified post-use?
Bubble point or forward flow tests must be performed immediately after filtration using calibrated instrumentation traceable to NIST standards—results recorded alongside sample metadata in the instrument log.
Are replacement O-rings and torque specifications provided?
Yes—O-ring kits (FKM or EPDM, ISO 3601-1 compliant) and installation torque charts (0.8–1.2 N·m) are included in the product manual and available from Tailin Biotech’s technical support portal.
