In pharmaceutical laboratories, ensuring the integrity of sterilizing filters is a foundational part of maintaining product safety and compliance with regulatory standards. A Filter Integrity Tester is a precision analytical device used to verify that filter elements — such as pleated cartridges, capsule filters, and membrane assemblies — are intact and capable of performing as intended before and after sterilization processes. Tailin Bioengineering’s suite of filter integrity testers provides advanced, automated solutions that support multiple industry‑standard test methods and help pharmaceutical labs ensure reliable filtration performance.
What Is a Tailin Filter Integrity Tester?
Overview of Tailin’s Solution
Tailin’s Filter Integrity Testers include models like the HTY‑FT100, HTY‑FT223, and HTY‑FT224 — all designed to evaluate filter performance non‑destructively using highly accurate pressure and flow measurement technology. These instruments are widely used in pharmaceutical manufacturing, biotechnology, and other sectors where sterile filtration is essential.
Key Features of Tailin Filter Integrity Testers
Versatile Testing Methods
Tailin testers support a variety of standard integrity test modes:
- Bubble Point Test — Determines the largest pore size and detects pinholes or defects.
- Forward Flow Test — Measures liquid or gas flow through the pre‑wetted filter to assess permeability.
- Water Intrusion Test — Detects flow when water is forced through the filter, indicating pore integrity.
- Pressure Hold Test — Monitors pressure decay over time to ensure no leaks are present.
- Combined test modes further enhance detection reliability.
These multiple testing methods provide comprehensive assurance that a filter can effectively perform its sterilizing or clarifying role in lab processes.
Intelligent Design and Ease of Use
These testers are equipped with:
- A large color touchscreen and Windows‑based interface for intuitive control.
- Fast, fully automated testing sequences with minimal operator input required.
- Built‑in printers or optional connectivity such as OPC‑UA and Modbus TCP for data communication.
- Robust data security features including multi‑level user access control, audit trails, and encryption — essential for GMP and 21 CFR Part 11 compliance.
Reliable Performance and Data Management
Tailin instruments offer high‑precision sensing and responsive control systems to deliver fast, accurate results. Test data storage, graphical reporting, and secure data traceability help labs maintain thorough records and support audit readiness.
Compliance with Regulatory Standards
In the regulated world of pharmaceutical production, compliance with guidelines and standards is critical:
- Tailin Filter Integrity Testers are designed in accordance with GAMP principles and comply with 21 CFR Part 11 requirements for electronic records and audit trails.
- The instruments support full validation protocols (IQ, OQ, PQ), making them suitable for use in sterile processing and quality control workflows.
Compliance with global pharmaceutical standards ensures that integrity testing not only meets internal quality objectives but also satisfies regulatory inspections and audits.
Applications in Pharma and Beyond
Quality Control in Pharmaceutical Manufacturing
Filter integrity testing plays a crucial role in ensuring sterile filtration systems perform correctly in:
- Pharmaceutical liquid preparation systems
- Sterile drug production lines
- Radiopharmaceutical and biologics manufacturing
- Disposable filtration systems (PUPSIT)
Using Tailin’s integrity testers, labs can confirm filter performance before use and verify integrity after critical processing steps, reducing the risk of contamination and product recalls.
Broader Industry Uses
While primarily used in pharma, Tailin testers are also applicable in fields such as:
- Food and beverage filtration testing
- Municipal water quality monitoring
- Biotechnology and research environments
This versatility makes them valuable across sectors that require precise filtration control.
Choosing the Right Tailin Integrity Tester for Your Lab
HTY‑FT100: Cost‑Effective Performance
- Designed for labs needing reliable basic integrity testing.
- Offers key test modes with a user‑friendly interface and strong data compliance features.
HTY‑FT223: Advanced and Fully Compliant
- Ideal for labs requiring 21 CFR Part 11 compliance and comprehensive validation support.
- Features a graphical touchscreen, fast test cycles, and enhanced data handling.
HTY‑FT224: Enhanced Connectivity and Print Support
- Offers upgraded interface and printing capabilities with customizable data output options.
- Suitable for high‑volume testing environments.
In modern pharmaceutical laboratories, filter integrity testing is fundamental to ensuring product quality, safety, and regulatory compliance. Tailin Filter Integrity Testers blend advanced sensor technology, automated workflows, and robust data management to deliver reliable filtration performance assessment. Whether ensuring sterile manufacturing or supporting broader filtration verification needs, Tailin’s solutions help labs operate with confidence and precision.
As the life science industry continues to evolve, Tailin is
well positioned to play a leading role in shaping the future. By investing in
innovation, expanding its international presence, and strengthening
collaboration with global partners, Tailin continues to create value for
customers and society alike.
To learn more about Tailin’s products and solutions, visit our website. For inquiries, contact +86-571-8658-9087
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View Source:- Tailin Filter Integrity Tester: Ensuring Reliable Filtration in Pharma Labs
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