RAVONA IGT-200 Standalone Glove Tester:
At RAVONA, we understand the critical need for ensuring glove integrity in high-risk environments where containment and aseptic conditions are paramount. Our IGT-200 Standalone Glove Tester is an advanced, self-contained device designed to perform integrity testing for gloves used in aseptic isolators, containment isolators, and RABS systems. This ensures that gloves remain leak-free, maintaining both operator safety and the sterility or containment of sensitive materials.
The IGT-200 is a crucial tool in verifying that gloves used in these critical systems are fully functional and intact, safeguarding operators while preventing contamination or exposure to hazardous materials.
What is the RAVONA IGT-200 Standalone Glove Tester?
The IGT-200 Standalone Glove Tester is a state-of-the-art testing unit designed to verify the integrity of gloves used in aseptic isolators, containment isolators, and RABS systems. The device conducts rigorous leak testing to ensure that the gloves, which provide a critical barrier between operators and potent or hazardous materials, are free from defects and leaks.
By simulating real-world conditions, the IGT-200 applies controlled pressure to the gloves, ensuring they maintain their seal and integrity throughout their use in critical containment and aseptic environments.
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Why Choose the RAVONA IGT-200 Standalone Glove Tester?
Reliable Leak Detection: The IGT-200 is engineered for high-precision leak detection, ensuring that even the smallest defects in glove integrity, including holes as small as 50 µm, are identified before they can compromise safety or sterility.
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Regulatory Compliance
With CFR 21 Part 11, ISO, FDA, and cGMP compliance, the IGT-200 helps ensure that glove integrity tests meet the required industry standards, supporting your facility’s quality assurance and regulatory compliance efforts.
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Efficiency and Time Savings
The automated testing system eliminates the need for manual inspections, providing faster results and reducing downtime in your operations.
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Customizable and Flexible
The IGT-200 can be adapted to various glove ports types, (as well as non-RAVONA glove ports).
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Complete Data Management
With RFID integration, active directory, and internal report generation, the IGT-200 provides enhanced data tracking, security, and compliance. The PDF report generation allows for easy record-keeping and sharing.
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Regulatory Compliance
RAVONA’s aseptic isolators meet global regulatory standards, including FDA, cGMP, and ISO certifications for aseptic processing and aseptic product handling.
We Comply with the Following Standards and Guidelines
Benefit from optimal glove integrity, and maximum peace of mind.
RAVONA IGT-200 Standalone Glove Tester
Key Features of the RAVONA IGT-200 Standalone Glove Tester
Glove Integrity and Leak Testing: The IGT-200 is designed to perform comprehensive leak detection on gloves used in aseptic isolators, containment isolators, and RABS systems. It applies controlled pressure to each glove and detects any weaknesses or leaks, including holes as small as 50 microns. This ensures that gloves remain fully sealed, protecting both operators and the materials being handled from potential contamination or exposure.
Automated and High-Precision Testing: The tester automates the integrity testing process, applying precise pressure to each glove to monitor for any leaks. If a glove fails to maintain pressure or shows signs of leakage, the system provides immediate alerts. This automation enhances testing efficiency and ensures reliable, repeatable results, minimizing human error during the testing procedure.
Detection of Holes as Small as 50 Microns: The IGT-200 is capable of detecting even microscopic holes in gloves, with sensitivity to holes 50 microns and above. This ensures that even the smallest defects that could compromise operator safety or aseptic conditions are detected before they can cause harm.
Real-Time Feedback and Detailed Reporting: The IGT-200 provides real-time feedback on the performance of the gloves, allowing operators to immediately see if the gloves are intact or leaking. It generates comprehensive reports after each test, including data on the test parameters, the glove’s performance, and any detected leaks, providing full documentation for compliance and quality assurance.
Customizable Test Parameters: The IGT-200 allows for customizable test settings, accommodating various glove types, sizes, and materials used in aseptic and containment systems. Operators can adjust test parameters based on specific operational requirements, ensuring the tester fits a variety of applications.
User-Friendly Interface: With its intuitive interface, the IGT-200 is easy for operators to set up, run tests, and interpret results. Whether for routine maintenance or specialized testing, the device simplifies the process, saving time and improving efficiency.
Durable and Reliable Design: The IGT-200 is built with high-quality materials to withstand rigorous testing environments. It is designed for long-lasting performance and consistent accuracy across multiple cycles of glove integrity testing.
Compliance with Regulatory Standards: The IGT-200 meets FDA, ISO, and cGMP compliance, ensuring that glove integrity tests meet the required industry standards, supporting your facility’s quality assurance and regulatory compliance efforts.
RFID Integration: The IGT-200 is equipped with RFID tags, allowing for seamless tracking and management of gloves used in testing. This feature ensures that each glove’s identity is recorded, enhancing the traceability and documentation of testing activities.
Internal Report Generation: The IGT-200 comes with built-in report generation capabilities, automatically creating test reports after each glove test. These reports include detailed information such as test results, glove performance data, and any issues detected during the testing process.
Active Directory Integration: The IGT-200 is designed for integration with Active Directory, allowing for streamlined user access management. This ensures that only authorized personnel can operate the device, enhancing security and compliance with internal protocols.
CFR 21 Part 11 Compliance: The IGT-200 is fully CFR 21 Part 11 compliant, ensuring that the device meets regulatory requirements for electronic records and signatures. This ensures the integrity of data collected during testing and supports compliance with industry standards.
PDF Reports: The IGT-200 can generate PDF reports for easy storage, sharing, and archiving. This feature makes it easy to maintain a digital record of glove integrity testing for regulatory audits, internal reviews, and quality control purposes.
Why Choose the RAVONA IGT-200 Standalone Glove Tester?
Applications of the RAVONA IGT-200 Standalone Glove Tester
The RAVONA IGT-200 Standalone Glove Tester is ideal for industries where gloves play a critical role in protecting operators and maintaining the integrity of aseptic and containment systems. Key applications include:
Pharmaceutical Manufacturing: For testing gloves used in containment isolators and RABS systems during the handling of HP APIs, cytotoxic drugs, and other hazardous materials, ensuring the gloves remain leak-proof and safe.
Biotechnology: Used in biotech labs for cell and gene therapy applications, where gloves provide a critical barrier against biological agents or sensitive materials, ensuring both operator safety and aseptic integrity.
Aseptic Processing and Filling: Ensures glove integrity in aseptic environments, such as during freeze-drying, small-scale filling, and high-speed filling operations, where gloves maintain sterility during product handling.
Sterility Testing and Quality Control: The IGT-200 is essential for testing gloves in sterility testing environments, ensuring gloves used during testing procedures remain intact and free of leaks, preserving the integrity of the testing process.
Research and Laboratory Environments: In clinical or research labs, the IGT-200 tests gloves used to handle potent drugs, biological agents, or other sensitive materials, ensuring the operator’s safety and preventing contamination.
Why Choose RAVONA for Glove Testing?
- Industry Expertise: RAVONA has extensive experience in the design and manufacturing of advanced containment and aseptic systems, ensuring that all of our testing solutions, like the IGT-200, meet the highest standards for performance and safety.
- Comprehensive Solutions: The IGT-200 is part of a complete portfolio of testing solutions, enabling full compliance and efficient quality assurance for aseptic and containment systems.
- Commitment to Safety and Compliance: At RAVONA, we are committed to providing advanced tools that enhance
