Can MedIntegrity’s Filter Integrity Testers Help You Meet FDA Standards?

Filter integrity testing is extremely important in pharmaceutical manufacturing. After all, product sterility and patient safety are top priorities. Filter integrity testers, also known as filter element integrity testers, use globally accepted testing methods. These tools are crucial for checking that filters used to sterilize liquids and gases are working right and are fully intact.

Role of Filter Integrity Testing in Ensuring Product Safety

When making sterile drugs, filters are a key defense against germs. A few integrity tests, like bubble point tests, pressure hold tests, diffusion flow tests, and water intrusion tests, help judge the filter’s performance. First of all, this makes sure the filters are sound. It also ensures the drug-making process is clean and sterile, which ultimately protects the safety of the people who use the medicine. This process keeps shots, biological products, and other sterile medicines free from dangerous germs.

Regulatory Expectations for Filtration Validation

Worldwide regulatory groups, like the FDA and EMA, require strict checks on filtration. Rules from the US Food and Drug Administration (FDA) and China’s Good Manufacturing Practice (GMP) state that integrity tests are a must. They are done to make sure drugs are safe and high-quality. Following these rules isn’t just the law. It is a fundamental part of Good Manufacturing Practice (GMP).

Common Methods Used in Filter Integrity Testing

Several standard methods are used to check how well filters work:

• Bubble Point Test: This test finds the biggest pore size. It does this by measuring the pressure needed for the first gas bubbles to go through a wet filter.
• Diffusion Flow Test: It checks the flow of gas through a wet membrane at a pressure below its bubble point.
• Pressure Hold Test: This test looks for leaks by seeing how much pressure is lost over time.
• Water Intrusion Test: It checks water-repellent filters by measuring how much water gets through under pressure.

These methods help make sure that only perfect filters are used. This is especially important in places where being sterile is everything.

FDA Compliance Requirements for Filter Integrity Testing

To satisfy the FDA, filter integrity testers have to follow special rules for electronic records.

Overview of FDA Guidelines and 21 CFR Part 11

21 CFR Part 11 lays out the rules for electronic records and signatures. Its purpose is to make sure electronic data in drug manufacturing is dependable and can be trusted. The testing methods meet the standards of the FDA and GMP. What’s more, they also meet the standards of the USP and EP.

Data Integrity and Electronic Records Management

Data from filter tests must be kept safe. It cannot be changed or lost. Systems need to promise:

• Accurate time-stamped records
• Secure storage
• Controlled access

This is very important for tracking things during audits or investigations.

Audit Trail and User Access Control Requirements

Besides that, 21 CFR Part 11 requires strong audit trails. Every single action must be logged. It doesn’t matter if it’s starting a test or changing a setting. The log needs to show who did it and when. Having different user levels helps stop people without permission from changing test plans or data.

Key Features of MedIntegrity’s Filter Integrity Testers

MedIntegrity offers two main models—V6.5 and V8.0. These models are made just for places that need to follow strict rules, like GMP-certified drug factories.

Comprehensive Testing Capabilities Across Models V6.5 and V8.0

Both models can do many types of tests. This is necessary for different filtering situations. They perform bubble point, diffusion flow, pressure hold, water intrusion, and ultrafiltration tests. This allows for a complete check across many uses.

Compatibility with Various Filter Types and Configurations

The tester needs to test a lot of different filters accurately. And it must give dependable results for a wide range of filters, including membrane filters, depth filters, cartridge filters, needle filters, capsule filters, ultra-filtration columns, etc.

Advanced Data Management and Audit Trail Functions

MedIntegrity testers come with built-in audit trail capabilities that follow 21 CFR Part 11 standards.

Electronic Signatures and Multi-Level User Management

People can log in with different roles, like admin, operator, or viewer. Each role has its own set of permissions. Electronic signatures make sure people are responsible for every step.

Secure Data Export and Long-Term Storage Capabilities

Test results can be safely sent out using USB or LAN connections. They stay encrypted for long-term storage, which is a major need for regulatory checks.

How MedIntegrity’s Testers Align with FDA Standards

You can see MedIntegrity’s dedication to the rules in every part of its design.

Built-in Compliance with 21 CFR Part 11 Requirements

The software setup has it all. It has full audit trails, safe login management, time-stamped logs, and data encryption. These features all line up with what the FDA wants for electronic record systems.

Enhanced Accuracy and Reliability with Digital Sensors

The accuracy of the pressure measurement should be very good, usually within a small range like ±2% of the full scale. This gives you confidence in every test result.

Support for Online and Offline Testing Environments

MedIntegrity testers are flexible. You can put them in an automated production line or use them by hand in a QC lab. Either way, they stay compliant and precise.

Advantages of Using MedIntegrity’s Filter Integrity Testers in GMP Facilities

Adding MedIntegrity solutions to GMP work brings clear benefits that go beyond just following the rules.

Improving Operational Efficiency Through Automation Features

Automatic testing means less hands-on work and more output. This is vital in busy factories where any stop in production costs a lot of money.

Enhancing Traceability and Documentation for Inspections

Documentation is made simple with built-in printers and digital export options. The built-in thermal printer gives you paper copies right away. At the same time, digital logs make remote audits or internal checks a breeze.

Reducing Risk of Human Error with Intelligent Interface Design

The simple interfaces help operators follow the right steps. This means less training is needed. So, there is less difference in how different people do the tests.

Comparison Between MedIntegrity V6.5 and V8.0 Models

While both models share the main features like multi-method testing capability and compliance features, they have some technical differences:

Key Technical Specifications and Performance Differences

Operating Systems: Single Chip vs. Optimized Linux System
The V6.5モデル has a simple embedded single-chip system. It offers basic features that are good for smaller labs. On the other hand, V8.0 uses a special Linux platform. It offers fancy customization options perfect for large-scale company use.

User Capacity, Record Storage, Interface Options, and Customization Levels
V8.0 can handle more users at once. It also has much more memory, so it can store thousands more records than the V6.5. What’s more, V8.0 has more connection choices (LAN/USB/RS232) than the V6.5. This makes it a better fit for today’s connected workplaces.

Why Choose MedIntegrity as Your Filter Integrity Tester Supplier?

Since starting in 2015, MedIntegrity U.S.A has focused on one thing: making precise testing tools just for drug companies around the world.

Proven Track Record in the Pharmaceutical Industry Since 2015

メドインテグリティ is a trusted partner for top drug makers everywhere. They have equipment in more than 40 countries.

Commitment to Innovation, Quality, and Regulatory Compliance

We help write the rules for the industry. This makes sure our products don’t just meet today’s standards—they help create the standards of tomorrow.

Global Customer Base with Customizable Solutions and Technical Support

メドインテグリティ offers complete support for every customer. This includes everything from training after setup to help with calibration and tips on keeping the equipment running well.

FAQs:

Q1: Can MedIntegrity’s filter integrity testers perform all required test types?
A: Yes. They can do bubble point, diffusion flow, pressure hold, water intrusion, and ultrafiltration tests. These cover all the main industry-standard methods that groups like the FDA or EMA require.

Q2: Are MedIntegrity’s devices compliant with FDA’s 21 CFR Part 11?
A: Yes, completely. Their systems have features like audit trails, electronic signatures, and user access controls. All of these were designed just to meet the electronic record-keeping rules in that regulation.

Q3: What kind of technical support does MedIntegrity provide post-purchase?
A: Customers get full support. This includes help with setup, information on the machine’s parts, and knowledge about upkeep and calibration. On top of that, we offer free repairs while it’s under warranty.