xelair

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