Indizo is a fully walk away platform that automates the labor intensive and error-prone tasks of spraying, weighing, and sample collection for pump delivery and dose content uniformity testing for vertically and side-actuated nasal sprays .
Using Vereo® Actuator technology as its core engine and Viota® software for control and analysis, the system reduces out-of-specification results and manual inconsistencies with precise, repeatable actuation, offering a superior level of parameter control to mimic human usage.
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Delivers up to 300% increase in throughput using 50% fewer resources (based on standard batch size of 10 devices)
Capable of both delivered and metered shot weights using integrated Mettler Toledo Analytical Balance
Performs required release testing from beginning of life (BoL) through end of life (EoL)
User friendly, step-by-step method setup and operational pre-checks ensure deck is loaded properly before each testing run
Precision fit sample collector eliminates variation due to "spray and flip" manual method
10 device capacity for pump delivery and spray content uniformity with 20 dose content collectors and 10 pump delivery collectors (shown above)
20 device capacity for pump delivery with 20 sample collectors
Industry-leading software offers intuitive instrument control, method development, data analysis tools, as well as a full audit trail for your product
Intuitive user-guided workflows ensure quality data generation and minimize errors
Comprehensive technical controls and reporting functionality facilitate compliance with U.S. 21 CFR Part 11 regulations for electronic records, electronic signatures, audit trails, and data/system/user traceability
Connection to a central database lets you create, validate, and deploy testing methods, which can be easily transferred to other instruments and other sites around the world
Applicability to FDA Guidance
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