‘benefits of technology’ don singer - pqripqri.org/wp-content/uploads/2015/11/singer.pdf ·...
TRANSCRIPT
‘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 <1207.1>
Package Integrity Leak Test Methods <1207.2>
Package Seal Quality Test Methods <1207.3>
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 (e.g., dye)
Pressure decay Bubble tests
Tracer gas (vacuum mode) Tracer gas (sniffer mode)
Vacuum decay ---
Mass extraction ---
Technology may lead the way in options
Standardization of classical methods, next
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