Xelize®
Particle Size Determination By Andersen Cascade Impactor
The Xelize® is an established product designed around the traditional Andersen Cascade Impactor. It is the only one of its kind, revolutionising how Andersen Cascade Impaction is performed in the modern laboratory.
As always, Astech offers a range of solutions incorporating analyst workstations, semi automated platforms and fully automated systems for high throughput applications. Xelize offers parallel recovery of all stages and plates within the Andersen Cascade Impactor. It eliminates the human variability factor, produces repeatable and reliable data and caters for changing client needs by allowing seamless migration between products in the Xelize range. Core technology at the heart of the Xelize ensures data is harmonised across the entire range.
Key benefits of Xelize automation 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 Xelize range
- Harmonised testing throughout the Xelize range
- Payback typically achieved within 12 months of purchase
1 Series
The Xelize 1 Series are analyst workstations. They automate individual stages of the particle size determination process.
3 Series
The Xelize 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 plate coating.
5 Series
The Xelize 5 Series are fully automated systems. They offer 24/7 high throughput unattended operation.
Product name |
Xelize 1 Series |
Xelize 3 Series |
Xelize 5 Series |
Description |
Analyst workstations |
Semi automated platforms |
Full automated systems – 24/7 unattended operation |
Core Technology |
Uses Astech core technology for dose collection, dose recovery or plate coating operations |
Uses Astech core technology for dose collection, dose recovery and plate 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 |
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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 |
Xelize 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 Andersen Cascade Impactor. Single or multiple shot configurable via the method. |
Automated dose collection into a standard Andersen Cascade Impactor. 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 ACI assembly |
|
Yes, leak test performed on assembled ACI 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 |
Yes. |
Automated plate coating |
A Xelize 1 series workstation is available for plate coating applications |
Yes |
Yes |
Automated dose recovery from stages & plates |
|
Yes, proven techniques are used to isolate and recover the drug from each stage and plate. All recoveries take place 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 plates, stages, preseparator, 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 |
Manual test apparatus is available for evaluation and method development on a commercial loan or purchase basis. The apparatus uses the core technology at the heart of the Xelize range. Methods developed using the manual apparatus can be transferred onto platforms in the Xelize range.
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