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Automated Shake, Fire & Flow Control

Automated Shake, Fire & Flow Control
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Automated Shake, Fire & Flow Control

Product catalog summary
Overview: The document provides detailed information about the Vertus III range, a series of automated systems designed for testing metered dose inhalers (MDIs), nasal sprays, and nasal aerosols. These systems automate the processes of shaking, firing, and flow control to ensure precise and repeatable delivery for Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) testing.
Key Features:
  • Compatibility with over 40 different collection device combinations, including DUSA, NGI, and Spray Force Tester.
  • Compliance with Ph. Eur., EMA, USP, FDA, ChP, and NMPA standards, as well as 21 CFR Part 11.
  • Precise control over test parameters such as shaking profile, firing profile, and air flow.
  • Integrated static eliminator to minimize electrostatic charge build-up.
  • Optional features like an external label printer and analytical balance for shot weight measurement (Vertus III+ only).
Technical Specifications:
  • Shaking and firing parameter controls include speed, angle, duration, force, rise time, hold time, and release time.
  • Air flow parameter control includes rate and measurement.
  • User interface features a 10.1” color touchscreen.
  • Connectivity options include Ethernet, USB, RS-232, and more.
DecaVertus III: This system is compatible with the Vertus III range and automates firing-to-waste for through-life testing of up to ten MDIs per test run. It enhances test repeatability, conserves analyst time, and reduces the risk of repetitive strain injury.
Benefits:
  • Improves reproducibility and frees up analyst time.
  • Independent air flow control per channel to minimize clogging.
  • Extensive reporting options and method storage capabilities.
Conclusion: The Vertus III and DecaVertus III systems offer comprehensive solutions for automated testing of MDIs, nasal sprays, and nasal aerosols, ensuring compliance with industry standards and enhancing testing efficiency and accuracy.
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Catalog excerpts

Automated Shake, Fire & Flow Control-1

Automated Shake, Fire & Flow Control Reliable Results, Every Time for Metered Dose Inhaler (MDI), Nasal Spray & Nasal Aerosol Testing

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Automated Shake, Fire & Flow Control-2

Vertus® III Range Offering precisely controlled and repeatable delivery for Delivered Dose Uniformity (DDU) testing and Aerodynamic Particle Size Distribution (APSD) measurement, the Vertus III and Vertus III+ automate all aspects of MDI, nasal spray and nasal aerosol dose testing. Compatible with over 40 different collection device combinations including DUSA, Next Generation Impactor (NGI), Alberta Idealised Throat and Nasal Inlets, and Spray Force Tester, the Vertus III range offers total control over the test technique, but the flexibility to apply any industry-standard shake and fire test...

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Automated Shake, Fire & Flow Control-3

Interchangeable interface plates make switching between collection devices quick and simple Large, modern and intuitive touchscreen on adjustable arm for greater accessibility Integrated Static Eliminator minimises electrostatic charge build-up. Optional extra for Vertus III Analytical balance for rapid and efficient shot weight collection. Vertus III+ only Automatically operated enclosure to protect precision analytical balance from draughts. Vertus III+ only Optional: External label printer Shot Weight Measurement Exhaust Port The Vertus III+ has the additional capability of measuring shot...

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Automated Shake, Fire & Flow Control-4

Interface Plates The Vertus III range is compatible with collection devices for all compendial testing, plus other standard tests for MDIs, nasal sprays and nasal aerosols. Interface Plates for MDIs Priming & Waste Module The new Priming & Waste Module integrates firing-towaste into automated test methods, enabling compendial entire contents testing with minimal manual input. Vertus III shown here with DUSA Stack and Priming & Waste Module Each interface plate can be placed directly on top of the Priming & Waste Module. Vertus III and Vertus III+ can switch automatically between priming and test...

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Automated Shake, Fire & Flow Control-5

Interface Plates for Nasal Sprays & Nasal Aerosols For DDU testing of nasal sprays and nasal aerosols, USP <601> recommends a ‘mechanical actuation procedure’ to control actuation force, speed, stroke length and for units to be ‘thoroughly shaken’ prior to firing the dose. In addition to this, the 2003 FDA guidance on Bioavailability and Bioequivalence recommends automated actuation systems for BE assessments to decrease variability in drug delivery. Vertus III shown here with DUSA Interface Plate Compatible Test Interfaces Nasal Spray Dose Collector NSDC Nasal Spray Waste Collector NSWC Next...

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Automated Shake, Fire & Flow Control-6

Shake start angle tee»> rotation angle (tleg) User log-in screen Main run test screen: single step - ready to test (Vertus 111+) Main run test screen: multi-step ready to test (Vertus III+) Test in progress: multi-step (Vertus 111+)

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Automated Shake, Fire & Flow Control-7

Shaking parameter control includes: Firing parameter control includes: Qualification & Maintenance• Comprehensive IQ/OQ documentation• Qualification kit available• Extended warranty available• Remote support and field servicing available Air flow parameter control includes: Air flow rate ✓ Vertus IN & Vertus III+: Reporting Air flow measurement Extensive data output options are available as standard: Shot weight measurement (Vertus IM+ only) Device compatibility User interface: • Balance for shot weight collection • Temperature & Relative Humidity probe • Label Printer Reports:• Run report •...

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Automated Shake, Fire & Flow Control-8

DecaVertus® III Automating firing-to-waste for through life testing of up to ten MDIs per test run, the DecaVertus is a high-throughput system for reproducible, controlled testing. Highly advantageous from the perspective of enhancing test repeatability, conserving analyst time and eliminating the risk of repetitive strain injury (RSI), the DecaVertus ensures firing-to-waste occurs under closely controlled conditions, eliminating potential sources of variability from testing. DecaVertus III offers complete control over all test parameters, including: Shaking profile • Speed • Angle • Duration...

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Automated Shake, Fire & Flow Control-9

Capacity for up to 10 inhalers at a time Suitable for device and can-only testing Large, modern, and intuitive touchscreen for ease of use Optional: External label printer Exhaust Port The exhaust port supports the efficient extraction of flammable propellants and/or high potency drugs where additional safety measures are required. Independent air flow control for each channel: each inhaler has its own dedicated air flow channel to minimise clogging and enable high-volume products to be tested in a single run, reducing the need to stop and clean the filters.

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Automated Shake, Fire & Flow Control-10

Copley User Shake aUrt angle (beg) Shake rotation angle (beg) Copley User A User log-in screen Main run test screen (ready to test) C J Main run test screen (test in progress)

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Automated Shake, Fire & Flow Control-11

Shaking parameter control includes: Firing parameter control includes: Qualification & Maintenance• Comprehensive IQ/OQ documentation• Qualification kit available• Extended warranty available• Remote support and field servicing available Air flow parameter control includes: Air flow before firing ✓ DecaVertus III: Reporting Air flow after firing Extensive data output options are available as standard: Device compatibility MDIs: User interface: • Label Printer Reports:• Run report • Audit report • Method reportDecaVertus III Cat. No. Description 9870 DecaVertus III Shake and Fire to Waste System...

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Automated Shake, Fire & Flow Control-12

COPLEY Copley Scientific Limited Colwick Quays Business Park, Road No.2 Nottingham, NG4 2JY United Kingdom © 2023 Copley Scientific Limited. All rights reserved.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.