Dose Content Uniformity

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

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.

DCU Evaluation kit

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.

Uses Astech core technology for dose collection and dose recovery operations.

 

Download the Xelair® Series Overview to compare the specs of the different series.

Xelair®
1 Series

Analyst workstations
  • Shake Waste Firing and Dose Collection standalone workstations
  • Need to be loaded and unloaded

Xelair®
3 Series

Semi automated platforms
  • Combines 2 or more workstations for a semi automated solution
  • Less manual intervention needed

Xelair®
5 Series

Full automated systems
  • Dose Content testing from start to finish; shake and waste fire to collection.
  • Unattended 24 hour high throughput operation

UoDD, DDU or DCU?

Within the safety and efficacy testing of inhaled drugs the terminology Uniformity of Delivered Dose, Delivered Dose Uniformity or Dose Content Uniformity are used depending on the pharmacopoeia. Whilst broadly similar, a differing sequence of sampling is required to meet the guidelines.

Astech’s Relovex® software allows simple set up of waste fire and sample collection profiles. Additionally, Relovex® provides a fully traceable and 21CFR Part11 compliant digital record.

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