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:
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.
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.
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|
|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|
|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 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.|
|Unattended 24 hour high throughput operation||No||No||Yes|
|21 CFR Part 11 compliant software||Yes||Yes||Yes|
|Validation pack provided||Yes||Yes||Yes|