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Proveris Scientific - Indizo<sup>®</sup> Automated Nasal Spray Collection System

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.

Technical specifications

System - Vereo NSx Actuator for vertical actuation or SSx Actuator for side actuation
- Viota Software
- Mettler Toledo Analytical Balance
- Uninterrupted Power Supply (UPS)
Tray Configuration - Spray content uniformity / pump delivery: 10 device capacity with 20 dose content collectors and 10 sample collectors
- Pump delivery only: 20 device capacity and 20 sample collectors
Size - Floor-standing system / self-contained
- Height: 74.3 in (189 cm) Width: 46 in (117 cm) Depth: 31 in (80 cm)
Electrical Requirements - 100-120VAC 50/60Hz 10A or 220-240VAC 50/60Hz 5A

Key features

  • Delivers up to 300% increase in throughput using 50% less 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
  • 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

  • Biopharmaceutical and Biotechnology
  • Education & Academics
  • Medical
  • Pharmaceutical
Proveris Scientific

To help our customers bring optimally-performing orally inhaled and nasal drug products to patients around the world.

Proveris Scientific Corporation delivers innovative testing platforms, laboratory services, and deep product knowledge to customers who develop, manufacture or test orally inhaled and nasal drug products (OINDPs).

Our worldwide customer base includes the top innovator and generic pharmaceutical companies, device manufacturers, CDO/CRO/CMOs, and regulatory agencies.

By understanding the critical quality attributes affecting the performance of OINDPs, and effectively controlling them from a testing and patient usability perspective, our expert team of engineers, scientists, and service professionals can help you:

  • Ensure successful product development, and prevent late-stage development failures
  • Realize significant savings in time and resources by streamlining testing workflows and eliminating manual processes
  • Evaluate the suitability of various OINDP delivery devices for compound and optimize device parameters for maximum efficacy
  • Eliminate testing variables to maintain batch-to-batch reproducibility, simplifying regulatory submissions
[Nasal spray collection system, automated nasal spray system, automated pump delivery, spray content uniformity testing]