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:
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
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
| 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 |
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| Readily adapted to any inhaler type |
Yes, actuation mechanisms and shakers can be supplied to suit any inhaler type |
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| 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. |
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| Unattended 24 hour high throughput operation |
No |
No |
Yes |
| 21 CFR Part 11 compliant software |
Yes |
Yes |
Yes |
| Validation pack provided |
Yes |
Yes |
Yes |
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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