Validation With the HP 1100 - Five Easy Steps
Compliance can be a productivity bottleneck for laboratories in regulated industries. Typically, five steps are required for full instrument, methods, and data validation. HP 1100 Series systems offer an extensive array of validation features to help laboratories meet even the most demanding regulatory and qualitystandard requirements without affecting productivity.
HP designs, develops and validates products according to documented procedures. A Declaration of System Validation, shipped with each computer system, provides assurance that the system has been validated during development. Details of the procedure and evidence of successful development validation are available on request.
HP ChemStation software includes procedures for selfverification of the HPLC hardware and HP ChemStation software. The user selects test items and acceptance criteria from a menu. Upon completion of these performance verification procedures, the user receives a full report documenting expected and actual results. Standard operating procedures for these tests are provided in electronic form for easy customization.
In addition, a holmium oxide filter is built into the UVVisible detectors for automated verification at different wavelengths. There is no need to fill the flow cell with a liquid calibration standard. The filter's wavelength accuracy and the chemical kits for performance verification are traceable to national standards.
The HP ChemStation includes software for automated method validation. The user specifies parameters from a menu; the tasks are automatically executed and the results documented.
Optional database provides online quality control charts for chromatographic performance parameters
Critical chromatographic parameters - the resolution between two peaks, for example - can be measured automatically during routine operation, using standards or qualitycontrol samples. For easy review of system performance status, the HP ChemStation's optional database plots longterm quality control charts for chromatographic performance parameters and results, together with userdefined warning and action lines. Maintenance activities are documented in the instrument's electronic logbook.
To assure security, HP provides passwordprotected user access. For data integrity and traceability, the software saves method parameters, instrument conditions such as pressure and temperature, instrument logbooks, column parameters (as recorded by the new column identification module), and instrument serial numbers, together with raw data in checksumprotected binary register files.
| Test Method: | C:\HPCHEM\1\VERIF\Check M | ||
| Data File Directory: | C:\HPCHEM\1\VERIF\Result D | ||
| Original Operator: | Dr. Watson | ||
| Test Item | User Limit | Actual | Com. |
|---|---|---|---|
| DAD noise | <5 x 105 AU | 10 x 105 AU | Pass |
| Baseline drift | <2 x 103 AU/hr | 1.5 x 104 AU/hr | Pass |
| DAD WL calibration | ±1 nm | ±1 nm | Pass |
| DAD linearity | 1.0 AU ± 5 % | 1.5 AU ± 5 % | Pass |
| Pump performance | <0.3 % RSD RT | 0.15 % RSD RT | Pass |
| Temp stability | ± 0.15°C | ±0.1°C | Pass |
| Precision of Peak area | <0.5 % RSD | 0.35 % RSD | Pass |
| Verification Test Overall Results: Pass | |||
| HP 1100 Series System, Friday, November 10, 1995 | |||
| Test Engineer | |||
| Name: | Signature: | ||
Test Method: C:\HPCHEM\1\VERIF\Check M Data File Directory: C:\HPCHEM\1\VERIF\Result D Original Operator: Dr. Watson Test Item User Limit Actual Com. DAD noise <5 x 105 AU 10 x 105 AU Pass Baseline drift <2 x 103 AU/hr 1.5 x 104 AU/hr Pass DAD WL calibration ± 1 nm ± 1 nm Pass DAD linearity 1.0 AU ± 5 % 1.5 AU ± 5 % Pass Pump performance <0.3 % RSD RT 0.15 % RSD RT Pass Temp stability ± 0.15°C ± 0.1°C Pass Precision of <0.5 % RSD 0.35 % RSD Pass Peak area Verification Test Overall Results: Pass HP 1100 Series System, Friday, November 10, 1995 Test Engineer Name: Signature:
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