Transcription of ‘Benefits of Technology’ Don Singer - PQRI
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‘Benefits of Technology’ Don Singer - PQRI
benefits of technology Don Singer FDA/PQRI Conference on Evolving Product Quality Bethesda, MD Sep 2014 Classical methods vs. technology Accuracy Precision Linearity and range Specificity Robustness Ruggedness Limit of detection Limit of quantitation Methods Container-closure systems Combo systems Product complexity Pharmacopeial Forum Sep-Oct 2014 Collaborative activity Microbiology Expert Committee Packaging Storage & Distribution Expert Committee <1207> Sterile Product Package Integrity Evaluation Introduction Package Integrity and Test Method Selection < > Package Integrity Leak Test Methods < > Package Seal Quality Test Methods < > Deterministic vs. Probabilistic Deterministic methods Probabilistic methods Reproducible Not reproducible Sensitive Insensitive Highly instrumental Little or no instrumentation used Quantitative test result outcome Qualitative, interpretive results Minimal test sample preparation or manipulation Considerable test sample preparation and/or manipulation Risk of error - LOW Risk of error - HIGH Deterministic methods Probabilistic methods Electrical conductivity and capacitance test (HVLD) Microbial challenge Laser-based headspace analysis Liquid tracer tests ( , dye) Pressure decay Bubble tests Tracer gas (vacuum)
Deterministic methods Probabilistic methods Electrical conductivity and capacitance test (HVLD) Microbial challenge Laser-based headspace analysis Liquid tracer tests (e.g., dye)
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