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 | |||
| 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 |