Final ProgramCPSA 2011
Science and Technology Coming Together to Make a Difference
October 3 - 6, 2011
Bucks County Sheraton Hotel
Langhorne, PA
Poster Abstract #02
Qualification of a Robotic Liquid Handler to Perform Bioanalytical Validation or Sample Analysis Runs
AIT Bioscience, LLC, 7840 Innovation Dr., Indianapolis, IN 46278 USA
Programs based on Hamilton's Venus One software were developed to analyze Watson LIMS Worklists and build processsing sequences for a Hamilton Microlab Star liquid handler. The program was based on 3 modules: barcode recognition of sample ID's and comparison to Watson worklists, the construction of a matrix standard curve, and the creation and transfer of aliquots of each type of sample to 96-well plates. The liquid handler was first verified to factory specifications for precision and accuracy of liquid transfers. An Operational Qualification Plan was then written as a series of 10 scripts based on 4 analytical runs that covered every type of validation or study sample expected from current regulatory guidance. The samples were based on a validated method for methadone and its EDDP metabolite in human plasma. The execution of the scripts involved LC-MS/MS or colorimetric measurement.
The test scripts evaluated the performance of the system towards recognizing the requirements of each Watson Worklist. System-generated standard curves covering 3 orders of magnitude demonstrated mean bias less than 5%, with most values less than 2%. Barcoded sample positions were recognized and diluted correctly for transfer to plates. Quality control pools were measured with CV's ranging from 3% to < 1%. Carryover and control negative samples were never contaminated in any machine transfers. Analytical runs up to 250 samples were interpreted and processed correctly.
Validation samples were identified by the system according to Watson Sample ID or barcodes relating to each type of special sample. Samples were correctly aliquotted by the program, according to: the required base material (blank matrix, neat solvent, or prepared matrix sample), any dilution factor, and the use of a normal or surrogate internal standard.
Automated processing of samples on the Hamilton system gave results that were more accurate and precise than manual means. The test scripts provided a reasonable confidence that the system would improve lab efficiency and eliminate inter-analyst dependencies on assay performance. The operating program permitted the complete construction of assay validation run sets without human intervention.
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