xelair

Dose Content Uniformity of the Emitted Dose

Xelair® is our ground breaking series of products for testing Dose Content Uniformity of the Emitted Dose. Recognised by the Queen’s Award for Enterprise (Innovation 2009), Xelair is fast becoming the industry standard used by a broad range of pharmaceutical clients.

The Xelair range incorporates analyst workstations, semi automated platforms and fully automated systems for high throughput applications. Xelair eliminates the human variability factor, produces repeatable and reliable data and caters for changing client needs by allowing seamless migration between products in the Xelair range. Core technology at the heart of the Xelair ensures data is harmonised across the entire range.

Key benefits of Xelair automation include:

  • Reduced variability in results
  • Increased volumes of test data
  • Increased productivity
  • Significant reduction in Health and Safety issues including WR-ULD
  • Contained handling of drug product, minimising operator exposure
  • Upgrade paths throughout the Xelair range
  • Harmonised testing throughout the Xelair range
  • Payback typically achieved within 12 months of purchase

1 Series

The Xelair 1 Series are analyst workstations. They automate individual stages of dose content uniformity testing.

3 Series

The Xelair 3 Series are semi-automated platforms. They automate the entire through life testing of an inhaler device.

5 Series

The Xelair 5 Series are fully automated systems. They offer 24/7 unattended operation.


Product name

Xelair 1 Series

Xelair 3 Series

Xelair 5 Series

Description

Analyst workstations

Semi automated platforms

Full automated systems – 24/7 unattended operation

Core Technology

Uses Astech core technology for dose collection or dose recovery operations

Uses Astech core technology for dose collection and dose recovery 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

A Xelair 1 series workstation is 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 Astech’s collection chamber. Single shot or multiple shot configurable via the method.

Automated dose collection into Astech’s collection chamber. Single shot or multiple shot configurable via the method.

Automated control of vacuum flow rate

Yes

Yes

Sonic flow confirmation (P2 & P3)

Yes

Yes

Inhaler air flow resistance testing (P1)

Yes

Yes

Force/displacement measurements for inhaler actuation

Optional

Optional

Optional

Weighing of inhaler for determination of dose weight

No

Optional

Optional

Automated dose recovery

A Xelair 1 series workstation is available for dose recovery and assay preparation. A number of sample output options are available

Yes, proven techniques are used to recover the dose from the collection chamber and form a homogenous solution

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 the collection chamber and all 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

Manual test apparatus is available for evaluation, method development and routine laboratory use on a commercial loan or purchase basis. The apparatus uses the core technology at the heart of the Xelair range. Methods developed using the manual apparatus can be transferred onto any platform in the Xelair range.

An example of a Xelair 5 Series system.