Tailin Biotech Microbial Detection Membrane Filters
| Brand | Tailin Biotech |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | OEM/ODM Manufacturer |
| Product Category | Domestic (China-Made) |
| Model | Microbial Detection Membrane Filter |
| Pricing | Available Upon Request |
Overview
Tailin Biotech Microbial Detection Membrane Filters are precision-engineered polymeric filtration membranes designed for quantitative microbial enumeration in pharmaceutical, biotechnology, food & beverage, and environmental quality control laboratories. These filters operate on the principle of membrane filtration—a standardized method defined in pharmacopoeial compendia (USP , EP 2.6.12, JP 4.07) and regulatory guidelines (FDA Aseptic Processing Guidance, ISO 11737-1)—where test samples are vacuum- or pressure-driven through a sterile, low-binding membrane surface. Microorganisms retained on the membrane surface are then transferred onto solid culture media for colony-forming unit (CFU) enumeration. Tailin’s filters are validated for compatibility with standard microbiological testing workflows, including sterility testing, microbial limit testing, and water bioburden assessment.
Key Features
- Consistent pore geometry and narrow pore size distribution—ensuring high reproducibility in microbial retention across batches.
- Optimized porosity and low hydraulic resistance—enabling rapid filtration of viscous or particulate-laden samples without premature clogging.
- Enhanced hydrophilicity via surface-modified polymer chemistry—facilitating uniform wetting, improved nutrient diffusion, and robust colony development during incubation.
- High microbial recovery efficiency (>95% for common indicator organisms including Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans under validated conditions).
- Available in multiple base materials—including mixed cellulose ester (MCE), nylon, and polyethersulfone (PES)—each selected for specific chemical compatibility, protein binding characteristics, and sterilization stability.
- Standard diameters: 25 mm, 47 mm, and 142 mm; custom circular formats available upon request to match proprietary or legacy filtration manifolds.
Sample Compatibility & Compliance
Tailin membrane filters are compatible with aqueous solutions, buffered saline, isotonic diluents, and low-concentration organic solvents commonly used in microbial testing protocols. They support both vacuum-assisted and positive-pressure filtration systems, including widely deployed platforms such as Millipore® Sterivex™, Sartorius™ Minisart®, and Thermo Fisher Nalgene™ filtration assemblies. All filters undergo pre-sterilization by gamma irradiation (25–35 kGy) and are supplied double-bagged in ISO Class 7 cleanroom environments. Certificate of Analysis (CoA) and Certificate of Conformance (CoC) accompany each lot, documenting endotoxin levels (<0.25 EU/mL), bioburden limits (<1 CFU/filter), and sterility validation per ISO 11137. Filters comply with requirements for GLP/GMP-regulated environments and support audit readiness for FDA 21 CFR Part 11–aligned data integrity frameworks when integrated with compliant filtration workstations.
Software & Data Management
As consumables, Tailin Microbial Detection Membrane Filters do not incorporate embedded electronics or firmware. However, they are fully interoperable with digital microbiology workflow systems—including LIMS-integrated filtration tracking modules (e.g., LabVantage, STARLIMS), electronic lab notebooks (ELNs), and automated colony counters (e.g., Synbiosis ProtoCOL, iQ-CELL). Batch-specific traceability is maintained via serialized lot numbers printed on primary packaging, enabling full chain-of-custody documentation from filter issuance to final report generation. Integration with electronic batch records ensures alignment with Annex 11 and ALCOA+ principles for data reliability and long-term archival.
Applications
- Pharmaceutical sterile product sterility testing (USP )
- Non-sterile product microbial limit testing (USP and )
- Bioburden monitoring of purified water and water-for-injection (WFI)
- Environmental monitoring of cleanroom surfaces and compressed gases
- Microbial enumeration in cosmetics, dietary supplements, and medical device rinsates
- Validation studies for filtration process suitability and extractables/leachables screening
FAQ
Are Tailin membrane filters certified for use in regulated GMP environments?
Yes—each production lot is manufactured under ISO 13485–certified quality management systems and supports compliance with ICH Q5A, USP general chapters, and regional regulatory expectations for microbial testing consumables.
Can I request validation support documents for my internal qualification protocol?
Tailin provides comprehensive technical dossiers—including material safety data, extractables profiles, and microbiological performance data—for inclusion in user qualification packages.
Do you offer non-standard pore sizes or composite membranes?
Custom pore sizes (e.g., 0.1 µm, 0.45 µm, 0.8 µm), specialty coatings (e.g., low-protein-binding PES), and multi-layer configurations are available under NDA-supported development programs.
What is the shelf life and recommended storage condition?
Unopened filters retain full performance for 36 months when stored at 15–25°C in dry, dark conditions; avoid exposure to ozone, UV radiation, or high-humidity environments.
