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:
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 | ||
| 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 |
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