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InnovaSystems, Inc. Technology Engineering

MMDDII DDWW – Automated Dose Weight

• Automated Metered Dose Inhaler Testing

• MDI DW (Dose Weight) Automates FDA Recommended Tests: • Actuations

• Dose (Shot) Weights

• Priming/Repriming

• Tail-Off

• Leak Rate

• Automates Agitation and Actuation to Waste of Metered Dose Inhalers

• Increases Throughput and Productivity

• Improves the Accuracy and Reproducibility of Results

Automates the routine Waste Sprays and Dose (Shot) Weights of the Metered Dose Inhaler Product. Provides unattended processing of up to 40 inhalers, agitating and actuating four inhalers simultaneously on the MDI FD-4. Transports inhalers, with the XYZ gantry, to perform agitations, waste sprays and weighing. Capable of testing both x-valve or x-actuator. Sprays are collected via a waste collection manifold or filter system. Supports 21 CFR Part 11 Compliance and simplifies validation with the IQ/OQ documentation.

The MDI DW…

InnovaSystems, Inc. 1245 N. Church Street, Unit 6 Moorestown, NJ 08057 856-722-0410 www.InnovaSystemsInc.com [email protected]

For more information contact:

ISIMDIDWV1.3

PRODUCT PARAMETERS

Includes • Dose Weight Station with Transport,

Gripper and Controller

• MDI FD-4

• Analytical Balance

• Canister Trays

• Enclosure

• Validation Protocols, IQ/OQ

• MDI DW Application Software

METHOD EDITOR

Space Requirements Height Width Depth

Station 84in 72in 45in

Power Air Vacuum

Utilities 110/220 VAC 50/60 Hz

80-100 PSI 30 liters/minute @100mbar

Specifications

Two Models of the MDI DW are available:

• MDI DW-XV (X-Valve, without the patient actuator)

• MDI DW-XA (X-Actuator, with the patient actuator)

MMDDII AACC22 – Automated Canister Cutter

• Automation to Support Metered Dose Inhaler Canister Cutting

• Automates Canister Cutting for Total Can Content Analysis

• Accommodates Most Canister Sizes

• Reduces Injuries


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Station 8.5in 7.4in 7.0in

Power


Specifications

Automates the routine cutting of caps or containers in preparation for total container content and other tests. Station accommodates a range of container sizes:

The MDI AC2…


For more information contact

ISIMDIAC2V1.2

MDI AC2 includes • MDI AC

2 Automated Canister

Cutter Station

• One (1) Canister Adapter

• Users’ Guide

Is Easy to Use

6 Easy Steps: 1. Place depressurized canister in adapter 2. Lock canister in place 3. Close cover 4. Engage blade 5. Raise cover 6. Remove cut canister

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• Automates Agitation and Actuation to Waste of Metered Dose Inhalers

• Increases Throughput

• Reproducible Agitation and Actuation Force

• Eliminates Repetitive Motion Injuries


Includes • MDI Fire-Down Station • (2) Canister Rack/Waste Manifold Sets, x-valve • Printer Options • Force Verification Kit • Validation Protocols, IQ/OQ • Canister Rack/Waste Manifold Sets, x-valve • Patient Actuator Rack/Waste Manifold Set, x-actuator



Power Air Vacuum


80-100 PSI 30 liters/minute @100mbar

Specifications

Automates the routine Waste Sprays of your Metered Dose Inhaler Product. Simultaneously processes 10 canisters with user-defined parameters for agitations, actuations and delay times. Is easy to use. Just place the canisters (x-valve or x-actuator) in the rack, load the rack in the FD-10, select a stored method, and start. It agitates the canisters, rotating 180°

, actuates and contains the spray with the integrated waste manifold connected to the laboratory vacuum. Simplifies validation with the optional IQ/OQ documentation and restricts modification of protected methods.

The MDI FD-10…



CONTROLLER

DATA OUTPUT

ISIFD10V1.3

HAM – Hand Actuation Monitor

• Hand Actuation Monitor for: • Nasal and Oral Spray Products

• Metered Dose Inhalers

• Determines the Parameter Settings for use on InnovaSystems Automated Actuation Stations

• Minimizes Methods Development Time


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InnovaSystems, Inc. 1245 N. Church Street, Unit 6 Moorestown, NJ 08057 856-722-0410 www.InnovaSystems.com [email protected]


ISIMRV1.2

Facilitates methods development per the FDA’s BA and BE guidance recommendation that parameters be varied to simulate in vitro performance upon hand actuations.

HAM…

Supports 21CFR Part 11 Compliance and simplifies validation with the optional IQ/OQ documentation.

Is easy-to-use. A User places a product on the hand actuator and actuates for a User-specified number of times. At the end of the User actuation sequence, the software automatically plots both travel and force profiles of the hand actuations as well as calculates and displays the corresponding automated actuation parameter values. These values can be entered into the automated actuator to simulate the hand actuation.

Includes • Hand Actuation Monitor

• Calibration Kit, Force & Travel

• Actuation Software

Options • Computer


Nasal Spray Product Hand Actuator

MDI Hand Actuator

MMDDII AASS – Automated Agitation/Actuation


• MDI AS – Agitates and Actuates a Single Canister within Its Patient Actuator

• Provides Unattended Wasting, Weighing and Collection for Analysis

• Minimizes Dose Content Uniformity Variability Providing Reproducible Agitation and Actuation

• Reduces Repetitive Motion Injuries


Automates the agitation and actuation of a MDI canister. Agitates and actuates a single MDI in a patient actuator to the priming/wasting port or to an external device for collection or analysis.

Integrated with the Docking/Collection Station automates wasting, actuating for spray pattern and plume geometry and collection for particle size. Can dock to a collection device for dose assay and to the Anderson Cascade Impactor and Next Generation Impactor to support particle size testing. Integrated with the Dose Weight & Docking/Collection Station automates all of the above functions plus weighing for dose weights.

Supports 21 CFR Part 11 Compliance and simplifies validation with the optional IQ/OQ documentation.

The MDI AS…



ISIMDIASV1.2

Includes • MDI AS Station

• One (1) Patient Actuator Adaptor

• Calibration Kit

• MDI AS Application Software

Options • Collection Station

• Dose Weight & Collection Station

• Computer

• IQ/OQ, Validation Protocols


Actuator 10.0in 4.0in 9.0in

Power Air


80-100 PSI

Specifications

COLLECTION STATION

CONTROL PARAMETERS

Collection into Cascade Impactor or Collection Tube

MMDDII AASS – Automated Agitation/Actuation


• MDI AS – Agitates and Actuates a Single Canister within Its Patient Actuator

• Provides Unattended Wasting, Weighing and Collection for Analysis

• Minimizes Dose Content Uniformity Variability Providing Reproducible Agitation and Actuation



Automates the agitation and actuation of a MDI canister. Agitates and actuates a single MDI in a patient actuator to the priming/wasting port or to an external device for collection or analysis.

Integrated with the Docking/Collection Station automates wasting, actuating for spray pattern and plume geometry and collection for particle size. Can dock to a collection device for dose assay and to the Anderson Cascade Impactor and Next Generation Impactor to support particle size testing. Integrated with the Dose Weight & Docking/Collection Station automates all of the above functions plus weighing for dose weights.


The MDI AS…



ISIMDIASV1.2

Includes • MDI AS Station

• One (1) Patient Actuator Adaptor

• Calibration Kit

• MDI AS Application Software

Options • Collection Station

• Dose Weight & Collection Station

• Computer

• IQ/OQ, Validation Protocols


Actuator 10.0in 4.0in 9.0in

Power Air


80-100 PSI

Specifications

COLLECTION STATION

CONTROL PARAMETERS

Collection into Cascade Impactor or Collection Tube

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• Automated Nasal Spray Products Testing

• Automated Actuator for Nasal Spray Products

• Easy Transfer of Actuation Technology

• Automation of FDA Recommended Tests

• Reproducible Actuation Force

• Monitors Force and Travel

• Reduced Repetitive Motion


Includes • Actuation Station & Controller • Calibration Kit, Force & Travel • Actuation Software Options • Computer • Waste Spray Collector • Validation Protocols, IQ/OQ • Hand Actuation Monitor (HAM) Interfaced to the the MightyRunt, captures and stores parameters from manual actuations

• Angle Mount Stand-alone unit provides for orientation with other devices




• Actuator

• I/O Controller

7.9in (20.0cm) 6.8in (17.1cm)

3.9in (9.9cm) 6.1in (15.5cm)

8.5in (21.4cm) 10.2in (25.7cm)

Power Air


100-120 PSI

Specifications

Automates the routine Actuation of your Nasal Spray Product. Just place the Bottle on the platform, select a stored method, and start. The station sprays the bottle with the user-defined, reproducible actuation force and times.

The MightyRunt…

CONTROL PARAMETERS

DATA OUTPUT

ISIMRV1.3

Supports 21CFR Part 11 Compliance and simplifies validation with the optional IQ/OQ documentation.

Allows you to start simple and easily add capabilities as your needs change. Since the MightyRunt Technology is integral to all the Nasal Spray automation stations, transfer those product parameters to any of InnovaSystems’ products.


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• NSP DW – Automates FDA Recommended Tests: • Dose (Shot) Weights


• Tail-Off



• Insures Reproducible Actuation Force

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Space Height Width Depth

Station

84in 54in 32in

Power Air


100-120 PSI

Specifications

Automates the routine Actuation (waste sprays) and Weighing of your Nasal Spray Product. Processes up to 20 sample bottles, unattended, and provides a documented sample history. Transports bottles, with the XYZ gantry, to the actuator station, bottle shaker and balance. Waste sprays will be contained and drained into a waste vessel. Supports 21 CFR Part 11 Compliance and simplifies validation with the IQ/OQ documentation.

NSP DW…

PRODUCT PARAMETERS

ISINSPDWV1.3

Includes • Dose Weight Station with

Transport, Gripper and Controller

• MightyRunt Actuator


• Bottle Shaker

• Bottle Tray

• Enclosure


• NSP DW Application Software

DATA OUTPUT


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WWeeiigghhttss,, CCoolllleeccttiioonnss


• NSP DWC (Dose Weight with Collection) - Automates FDA Recommended Tests: • Dose (Shot) Weights


• Tail-Off

• Collection for Content Uniformity



• Insures Reproducible Actuation Force

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Power Air Vacuum


100-120 PSI 5-25” Hg

Specifications

Automates the routine actuation (waste sprays), weighing of the nasal spray product, and preparation of the sample for further analysis. Processes up to 20 sample bottles, unattended, and collects up to 60 vials. Transports bottles, with the XYZ gantry, to perform waste sprays, weighing the nasal spray bottle, collection of the spray into vials, dilution of the spray in the vial, weighing to confirm spray and solvent additions, capping and mixing the diluted spray. Supports 21 CFR Part 11 Compliance and simplifies validation with the IQ/OQ documentation.

NSP DWC…

RUN SCREEN



ISINSPDWCV1.3

Includes • Dose Weight Station with Transport,


• MightyRunt Actuator with Collection


• (2) Vortex Mixers

• Liquid Dispenser

• Vial Capper/Uncapper

• Bottle and Vial Trays

• Enclosure


• NSP DWC Application Software

CONTROL PARAMETERS

NSP UA – Automated Actuations

And More …

Nasal Spray Products Universal Actuator (NSP UA)

Automation of FDA Recommended Tests

Multiple Actuation Modes

o Reproducible Velocity, Force and Stroke Length

Every Actuation Monitored Pass/ Fail

Easy Transfer of Actuation Parameters

Graphical Output

Eliminate Repetitive Motion

Superior Accuracy and Reliability

- Dose Weight - Collection for Content Uniformity - Droplet Size

… Automation for Nasal Spray Product Testing

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InnovaSystems, Inc. 1245 N Church St, Unit 6 Moorestown, NJ 08057 856-722-0410 www.InnovaSystems.com [email protected]

For more information contact: morneContact Details


Actuator

I/O Controller

6.6in 9.8in

4.2in 9.6in

9.8in 13.0in

Power


Specifications

Automates the routine Actuation of your Nasal Spray Products. Allows the User to select velocity or force mode actuation for testing the product. New Linear-motor technology makes the NSP UA the most accurate and reliable actuator on the market

The NSP UA…

PARAMETERS

C ON T R O

L

DATA

OUTPU

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ISINSPUAV1

Supports 21CFR Part 11 Compliance and simplifies validation with IQ/OQ documentation included.

It is easy-to-use; just place the bottle on the platform, select a stored method, and start. The Station sprays the bottle with reproducible velocity, force and stroke length while monitoring the actual velocity, force and distance.

Includes Actuation Station & Controller

Calibration Kit for Force

Actuation Software

Options Computer

Waste Spray Containment

Fan Hood

Vertical Mount

http://www.innovasystems.com/


PPAAWWSS – Automated Actuations, Weights


• PAWS – Pump Actuation and Weight Station

• Automates Waste Sprays and Dose (Shot) Weight Determinations

• Reproducible Actuation Force

• Monitors Force and Travel


• Fits on Standard Lab Bench

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Utilities Power Air

110/220 VAC 50/60 Hz

90-120 PSI

Specifications

Uses MightyRunt technology to spray a Nasal Spray Product (NSP) to waste and weigh the bottle before and after spraying to determine Dose (Shot) Weight. Automates the acquisition of Shot Weights at user-specified points in a NSP’s life.

PAWS… PRODUCT PARAMETERS

ISIPAWSV1.3


Compact design, fits on a standard laboratory bench and is easy-to-use. Just place the bottle on the platform, select a stored method, and click the “Run” button. The station alternates between spraying and weighing an NSP following the sequence defined by the method.

Includes • Actuation Station with Waste

Collector


• Actuator Platform Enclosure

• Actuation Software

• Printer

Options • Computer

• IQ/OQ Validation Protocols

• Installation, Training and Validation Protocol Execution

DATA OUTPUT

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• Automated Extractions of Gels, Pastes and Ointments

• AES – Automated: • Dispensing of Semi-solid to Target Weight

• Decapping/Capping

• Solvent Dispensing

• Mixing – Horizontal or Vortex


• Relieves Scientist of Routine Sample Preparation


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Station

38in 29in 30in

Power Air


100-120 PSI

Specifications

Automates the routine Extractions performed on gels, pastes and ointments. Processes up to 48 samples unattended, and provides documented weights. Decaps and caps vials, dispenses samples to target weight, dispenses solvent and shakes to extract. Horizontal shaking provides optimum extraction efficiency. Supports 21 CFR Part 11 Compliance and simplifies validation with the IQ/OQ documentation.

AES…

SETUP SCREEN/DATA OUTPUT

ISIAESV1.1

Includes • Extraction Station with Transport,


• Decapper/Capper

• Disposable Syringe Dispense Station


• Solvent Dispenser

• Vial Shaker

• Vial Tray

• Enclosure


• AES Application Software

Decapper/ Capper

Balance

Gripper

Date post:	10-Jun-2020
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