xelair

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

Readily adapted to any inhaler type

Yes, actuation mechanisms and shakers can be supplied to suit any inhaler  type

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

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

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 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.

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.