Particle Size Determination (NGI)


Particle Size Determination By Next Generation Impactor (NGI)

The Xelox® offers the latest technology in particle size determination. Based around a Next Generation Impactor (NGI) the Xelox® offers automated solutions for labour intensive processes.

The Xelox® range includes analyst workstations, semi-automated platforms and fully automated systems for unattended 24/7 operation. The analyst workstations are based upon Astech’s innovative X-product technology whilst the semi-automated and fully automated platforms utilize technology developed by Astech for a Consortium of leading pharma.


Key benefits of Xelox® range include:

  • Reduced variability in results
  • Increased volumes of test data
  • Increased productivity
  • Greatly reduced analyst time spent on labour intensive processes
  • Significant reduction in Health and Safety issues including WR-ULD
  • Contained handling of drug product, minimising operator exposure
  • Upgrade paths throughout the Xelox range
  • Harmonised testing throughout the Xelox range

1 Series

The Xelox® 1 Series are analyst workstations. They automate individual stages of the particle size determination process. They improve data consistency by removing manual errors from key stages of the test sequence.

3 Series

The Xelox® 3 Series are semi-automated platforms. They automate the entire particle size determination process, including waste firing, dose collection, dose recovery, assay preparation, clean up and cup coating.

5 Series

The Xelox® 5 Series are fully automated systems. They offer 24/7 high throughput unattended operation.

Product name Xelox 1 Series Xelox 3 Series Xelox 5 Series
Description Analyst workstations Semi automated platforms Full automated systems – 24/7 unattended operation
Core Technology Uses Astech core technology for sample introduction and dose collection Uses Astech core technology for sample introduction and dose collection. Uses technology developed by Astech and a consortium of leading pharma for dose recovery and cup coating operations
MDI/BAI/DPI configurations available Yes Yes Yes
Inhaler Shaking Yes, a number of shake profiles are available including linear shaking, rotary shaking and arc inversion shaking. Frequencies up to 6 Hz with “true” user configurable profile generation and profile monitoring
Readily adapted to any inhaler type Yes, actuation mechanisms and shakers can be supplied to suit any inhaler  type
Automated waste fire sequences Xelox 1 series workstations are available for waste firing and dose collection including sonic flow confirmation Allows execution of pre-approved sequences for waste firing. Dose collections can be scheduled anywhere in the sequence
Automated dose collection Automated dose collection into a standard NGI. Single or multiple shot configurable via the method. Automated dose collection into a standard NGI. Single or multiple shot configurable via the method.
Automated control of vacuum flow rate Yes Yes
Sonic flow confirmation (P2 & P3) Yes Yes
Force/displacement measurements for inhaler actuation. Optional Optional Optional
Verification of NGI assembly   Yes, leak test performed on assembled NGI prior to dose collection
Weighing of inhaler for determination of dose weight No Optional Optional
Addition of solvent to pre separator cup prior to dosing   Yes
Automated cup coating A Xelox 1 series workstation is available for cup coating applications Yes
Automated dose recovery from cups   Yes, cups are isolated and recovered in parallel
Automated dose recovery from pre separator   Yes, proven techniques are used to recover drug from the pre separator
Automated dose recovery from throat   Yes, proven techniques are used to recover drug from the throat
Analytical standards   Yes, the solution can be configured to use internal and  external standards
Use of multiple reagents in single run   Yes, multi-reagent compatible. The type and capacity of reagent vessels can be specified by the client
Sample presentation   Samples delivered to vials or well plates for transfer to analysis equipment. HPLC racks can be specified by the client
HPLC integration   Optional, HPLC integration by automated vial transfer or direct injection methods. Data integration can be performed by XML file export or using the SDK supplied with a client’s chosen CDS
Automated equipment cleanup   Yes, automated cleanup of cup tray, pre separator, throat and all other drug contact surfaces
Other integrations Optional integrations e.g. run definitions from LIMs or run results to LIMs.  Integrations are dependent on requirements e.g. XML file, CSV file, direct data connection such as ODBC.
Unattended 24 hour high throughput operation No No Yes
21 CFR Part 11 compliant software Yes Yes Yes
Validation pack provided Yes Yes Yes