Glove Integrity Tester HTY-GIT01

The Ultimate Guide to Glove Integrity Tester HTY-GIT01: Ensuring Precision and Compliance

In environments requiring strict contamination control, glove integrity and leak testing are essential. The HTY-GIT01 Glove Integrity Tester stands out as a reliable solution for verifying the safety of gloves and sleeves used in aseptic isolators and Restricted Access Barrier Systems (RABS). This guide explores its features, benefits, technical parameters, and applications, providing a comprehensive understanding of how this device supports compliance and operational efficiency.

What is a Glove Integrity Tester?

A glove integrity tester is a specialized device used to detect leaks in gloves and sleeves installed in aseptic isolators or RABS. Ensuring glove integrity is crucial in pharmaceutical, biotech, and laboratory environments where contamination can compromise product safety or lead to regulatory non-compliance.

The HTY-GIT01 Glove Integrity Tester employs advanced pressure decay technology, delivering fast, reliable, and precise testing that aligns with global standards like ISO 14644-7 and 21 CFR Part 11 compliance.

Key Features of the HTY-GIT01 Glove Integrity Tester

1. In Situ Leak Testing
   • Allows leak detection without removing gloves or sleeves.
   • Reduces downtime and enhances efficiency.
     
     
2. Automation and Control
   • Fully automated processes managed by Siemens PLC control.
   • Supports compliance with cGAMP guidelines.
     
     
3. Cleanroom Compatibility
   • Constructed from stainless steel, ensuring durability and compatibility with cleanroom environments.
     
     
4. Regulatory Compliance
   • Meets stringent regulatory standards, including ISO 14644-7 and 21 CFR Part 11.
   • Features built-in data logging and a stylus printer for documentation.
     
     
5. Flexible Air Supply Options
   • Operates with clean compressed air or nitrogen, providing versatility for various facilities.
     
     
6. Customizable Glove Ports
   • Supports standard Ø255mm round ports with options for customization.

Technical Specifications of the HTY-GIT01

How the Glove Integrity Tester HTY-GIT01 Works

1. Setup and Calibration
   • Connect the tester to the glove or sleeve port.
   • Calibrate to the required pressure and parameters.
     
     
2. Pressure Decay Method
   • The tester introduces a controlled amount of air or nitrogen.
   • Monitors for pressure decay, identifying leaks if pressure drops beyond acceptable limits.
     
     
3. Results and Reporting
   • The integrated stylus printer generates test results.
   • Digital records support compliance with regulatory standards.

Applications of the HTY-GIT01 Glove Integrity Tester

1. Pharmaceutical Manufacturing

• Ensures the sterility of gloves and sleeves in isolators used for drug production.

2. Biotechnology

• Validates glove integrity in RABS, ensuring product safety during sensitive processes.

3. Research Laboratories

• Verifies leak resistance in laboratory gloves to prevent contamination during experiments.

4. Medical Device Manufacturing

• Maintains contamination-free environments during the production of critical devices.

5. Regulatory Compliance Testing

• Supports routine testing required by GMP and FDA guidelines.

Advantages of Using the HTY-GIT01 Glove Integrity Tester

1. Enhanced Safety

   • Prevents contamination by ensuring glove and sleeve integrity.

2. Time and Cost Efficiency

   • Reduces downtime with in situ testing, improving operational flow.

3. Regulatory Confidence

   • Aligns with international standards, ensuring compliance during audits.

4. Precision and Reliability

   • Advanced technology delivers accurate and repeatable results.

5. Customizability

   • Adapts to various glove port sizes and facility requirements.

Why Choose the HTY-GIT01 Glove Integrity Tester?

The HTY-GIT01 is designed for industries where sterility and precision are non-negotiable. With its robust features, regulatory compliance, and ease of use, it’s an indispensable tool for maintaining contamination-free operations.

FAQs About Glove Integrity Testers

1. What is the purpose of a glove integrity tester?
A glove integrity tester ensures that gloves and sleeves in isolators and RABS are free from leaks, maintaining sterility and preventing contamination.

2. How does the pressure decay method work?
The pressure decay method introduces air or nitrogen into the gloves, monitoring for pressure drops that indicate leaks.

3. How often should gloves be tested?
Glove integrity should be tested before and after use, as required by GMP guidelines.

4. Can the HTY-GIT01 accommodate different glove port sizes?
Yes, the HTY-GIT01 supports customization for various glove port sizes.

5. Is the HTY-GIT01 compliant with regulatory standards?
Absolutely. It complies with ISO 14644-7 and 21 CFR Part 11, ensuring adherence to global regulations.

6. What is the test duration for the HTY-GIT01?
Tests typically take between 5 and 8 minutes, depending on the parameters.