Overview
INTEGRA-LAB redefines the boundaries of Container Closure Integrity Testing (CCIT). Built on the fundamental physics of ASTM F2338-24 Vacuum Decay standards, this compact standalone system eliminates the subjectivity and waste of traditional destructive methods, delivering accurate, deterministic, and quantitative results for pharmaceutical containers. The system can be equipped with various product-specific vacuum chambers to suit any format; an automation-aided changeover process ensures seamless transitions between different containers.
What truly sets INTEGRA-LAB apart is its integrated, recipe-controlled handling system. This innovation allows operators to conduct tests under both static and dynamic conditions, simulating real-world mechanical stress on the package. This capability is specifically engineered for feasibility studies on IV bags, where controlled movement acts as a powerful catalyst to reveal capillary leaks or structural defects that static tests might miss. Whether in a stability lab or a production QA/QC environment, INTEGRA-LAB provides a holistic approach to package quality, ensuring that even the most sensitive and Difficult to Inspect Products (DIPs) reach the patient in perfect condition.
Main features
• Non-Destructive & Non-Invasive CCIT based on Vacuum Decay/Pressure Decay methods
• Static and Dynamic Test capabilities through an integrated motion control system (*)
• MALL-Level Sensitivity: high-precision detection of micro-leaks down to 1μm (**)
• Deterministic & Quantitative Measurements: eliminates operator bias and ensures high repeatability and data integrity
More features
• Fully Regulatory Compliance with ASTM F2338-24, USP <1207>, FDA 21 CFR Part 11
• Ease-of-Use: compact benchtop design with an intuitive touchscreen HMI, comprehensive recipe management, and automation-aided chamber replacement for rapid changeovers
(*) patent pending
(**) depending on product (format size, packaging, fill level) and measurement time (seconds to 1 minute)
Compatible containers
Contatti
