Assay and content/blend uniformity for up to 100 samples
20 – 520 mL initial extraction volume
Waters Empower™ Interface
Powerful dEsign™ variables for streamlined DoE studies
Extraction
After weighing the sample, the TPW uses a high-shear homogenizer to provide a consistent wet grinding process to quickly extract samples. With this tool, the TPW can achieve efficient and reproducible extraction for even the most challenging dosage forms. Common sample types include traditional solid oral dosage forms including tamper-resistant products, osmotic pump, modified/extended and delayed release formulations. Cleaning between samples is easily programmed into the method to eliminate sample carry-over. The updated TPW is enhanced to reduce cycle times by adding efficiency to the clean-up and dilution processes.
Filtration & Dilution
Consistent volumetric preparations are confirmed gravimetrically at every step throughout the process. The TPW uses a fluid metering pump to filter extracted samples as they are transferred from the extraction vessel to processing tubes. Post filtration, the system can perform up to 1:100,000 dilutions within a single method. For every sample, the system audit trail combined with the advanced error handling capabilities provides a detailed and comprehensive record of the entire preparation process.
Analysis & Storage
The built-in HPLC injector supports on-line analysis. Optionally, all pertinent sample information is transferred to Empower™ as the sample sequence is built by the interface as the TPW run list progresses. In addition to on-line HPLC analysis, samples can also be collected in sealed HPLC vials on the autosampler. Finally, the TPW has the capability to transfer samples to a UV spectrophotometer to act as an autosampler for on-line UV analysis.
| | APW | TPW |
| Max. Sample | 300 samples | •100 samples (extraction mode 1) |
| Throughput per Run | (extraction mode 1 & 2) | •200 samples (extraction mode 2) |
| Sample Containers | • 16 x 100 mm tubes | • 20 x 150 mm tubes |
| | | •16 x 150 mm tubes |
| | | • 16 x 100 mm tubes |
| Sample Confirmation | 5-place and 4-place weighing | 5-place and 4-place weighing |
| (min. weight of 100 mg | (min. weight of 100 mg |
| or 200 mg, respectively) | or 200 mg, respectively) |
| Sample Tracking | Linear barcode reader | Linear barcode reader |
| Extraction & Liquid Handling | |
| Extraction Mode 1 | Sonicator (with UV | Homogenizer |
| Temperature sensor) | (2k RPM – 20k RPM) |
| Extraction Mode 2 | Vortexer | Vortexer |
| Extraction Volume | • 1 mL – 10 mL | • 20 mL – 100 mL (extraction vessel), or |
| (16 x 100 mm test tube) | • 50 mL – 520 mL (extraction vessel), or |
| | • 1 mL – 10 mL (16 x 100 mm test tube) |
| Filtration | Syringe | Fluid metering pump and syringe |
| Syringe-driven | 0.05 mL – 10 mL | 0.05 mL – 10 mL |
| Liquid Dispensing | | |
| Max. Dilution Ratio | 1:100,000 | 1:52,000,000 |
| Max. Number of | 9 solvents | 5 solvents |
| Solvents Connected | | |
| Analytical Finish | | |
| Off-Line | • Sample collection | • Sample collection |
| in test tube racks | in test tube racks |
| on APW platform | on TPW platform |
| • Sample collection into | • Sample collection into |
| sealed vials in SAM | sealed vials in SAM |
| HPLC On-Line | • HPLC fixed loop injector | • HPLC fixed loop injector |
| | • incl. Waters EmpowerTM | • incl. Waters EmpowerTM |
| | interface | interface |
| UV-Vis On-Line | Sample collection followed | Sample collection followed |
| by automated transfer | by automated transfer |
| into UV-Vis | into UV-Vis |
| Controls (Minimum Requirements) | |
| PC | • Windows 7-64 bit • Dual Core Processor |
| Database | • MS SLQ Server 2000 or greater • Express, Workgroup or Standard Edition |
| Dimensions | | |
| APW / TPW Automated | • Height: 42” / 107 cm (incl. Light Tower) • Width: 45.5” / 116 cm |
| Sample Prep. | (with balance LCD panel) • Depth: 36” / 91 cm |
| Workstations | | |
| SAM Sample Manager | • Height: 27.5” / 69 cm • Width: 21.5” / 55 cm • Depth: 30” / 76 cm | |
| | |
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