Xelox®
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 |
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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 |
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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 |
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Use of multiple reagents in single run |
|
Yes, multi-reagent compatible. The type and capacity of reagent vessels can be specified by the client |
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Sample presentation |
|
Samples delivered to vials or well plates for transfer to analysis equipment. HPLC racks can be specified by the client |
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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 |
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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. |
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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 |
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