Drug Delivery Automation Slide

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.

Andersen Evaluation Kit

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.

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.

Andersen Evaluation Kit

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.

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 nameXelize 1 SeriesXelize 3 SeriesXelize 5 Series
DescriptionAnalyst workstationsSemi automated platformsFull automated systems – 24/7 unattended operation
Core TechnologyUses Astech core technology for dose collection, dose recovery or plate coating operationsUses Astech core technology for dose collection, dose recovery and plate coating operations
MDI/BAI/DPI configurations availableYesYesYes
Inhaler ShakingYes, 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 typeYes, actuation mechanisms and shakers can be supplied to suit any inhaler  type
Automated waste fire sequencesXelize 1 series workstations are available for waste firing and dose collection including sonic flow confirmationAllows execution of pre-approved sequences for waste firing. Dose collections can be scheduled anywhere in the sequence.
Automated dose collectionAutomated 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 rateYesYes
Sonic flow confirmation (P2 & P3)YesYes
Force/displacement measurements for inhaler actuationOptionalOptionalOptional
Verification of ACI assemblyYes, leak test performed on assembled ACI prior to dose collection
Weighing of inhaler for determination of dose weightNoOptionalOptional
Addition of solvent to pre separator cup prior to dosingYesYes.
Automated plate coatingA Xelize 1 series workstation is available for plate coating applicationsYesYes
Automated dose recovery from stages & platesYes, 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 separatorYes, proven techniques are used to recover drug from the pre separator
Automated dose recovery from throatYes, proven techniques are used to recover drug from the throat
Analytical standardsYes, the solution can be configured to use internal and external standards
Use of multiple reagents in single run
Sample presentationSamples delivered to vials or well plates for transfer to analysis equipment. HPLC racks can be specified by the client
HPLC integrationOptional, 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 cleanupYes, automated cleanup of plates, stages, preseparator, throat and all other drug contact surfaces
Other integrationsOptional 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 operationNoNoYes
21 CFR Part 11 compliant softwareYesYesYes
Validation pack providedYesYesYes