TurboFil Packaging Machines LLC, an equipment specialist dedicated solely to the design and development of liquid filling and assembly machines, now provides RAVONA’s advanced glove testing systems through its US distribution partnership. Capable of detecting holes as small as 50-100 microns, the IGT Series of automated glove testing systems uses pressure decay measurement compliant with ISO 10648-2 standards.
Comprising a battery-powered glove tester and an FDA 21 CFR Part 11-compliant software interface, the modular system can be deployed as a standalone unit (IGT-200), a multiple testers trolley (IGT-300), or an integrated part of an isolator platform (IGT-400).
IGT-200 Glove Tester
Combining precision with versatility, the equipment-agnostic IGT-200 can be adapted to various glove port types and containment environments, ensuring compatibility with a wide range of applications. The IGT-200 is designed to ensure that gloves used in aseptic isolators, containment isolators, and R.A.B.S systems are leak-proof, safeguarding aseptic/sterile drugs and protecting operators from exposure to HPAPIs and other potentially hazardous substances. The tester can detect even the most minuscule defects in glove integrity, substantially aiding a facility’s quality assurance standards and regulatory compliance.
IGT-300 Glove Tester
Featuring an intuitive HMI interface for consistent cross-team glove testing, the fully integrated IGT-300 works seamlessly within SCADA systems for centralized monitoring and real-time glove integrity status feedback. The system is fully compliant with FDA 21 CFR Part 11 and, like the IGT-200, can detect leaks as tiny as 50-100 microns, providing unsurpassed exposure prevention. To support traceability and documentation, the IGT-300 automatically generates PDF reports for simplified storage, access, and compliance auditing.
IGT-400 Glove Tester
Designed for premium portability, the IGT-400’s wireless design allows operators to place the tester where it is most effective without dealing with cumbersome cables or mobility-restricting issues. Seamless integration with corresponding isolators’ HMI and PLC systems creates an efficient, comprehensive solution for glove condition monitoring, allowing for a unified validation process for both isolators and glove monitoring. Continuous, real-time monitoring ensures that any integrity failures or breaches are immediately noticed, with alerts sent to the operator interface so that swift corrective actions can be performed. Like its sister solutions, the IGT-400 can detect holes as small as 50-100 microns.
Earlier this summer, TurboFil became the exclusive US distributor for RAVONA’s range of premium aseptic and containment technologies and glove integrity testers, allowing for turnkey integration of those systems with TurboFil’s range of aseptic-ready manufacturing and filling lines. The partnership was forged to meet growing needs for aseptic pharma manufacturing, particularly in the injectables space.
“RAVONA’s IGT Series of isolator glove testing systems set industry standards for precision, versatility and operator-centric design,” said Deborah Smook, VP of Marketing & Business Development for TurboFil Packaging Machines LLC. “The three-solution set truly supports our shared goal of safeguarding aseptic manufacturing environments, to the benefit of operators, downstream value chain stakeholders and, of course, patients.”