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Comparing Container Closure Integrity Test Methods—Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
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Correlating GC/MS Relative Response Factors to Analyte’s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
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Leachables Analysis from a Closed Connected Single-Use mAb Purification Process
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Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
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Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices
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Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
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Impact of Dimensional Variability of Primary Packaging Materials on the Break-Loose and Gliding Forces of Prefilled Syringes
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Degradation of Obidoxime Chloride Solution for Injection upon Long-Term Storage under Field Conditions of Mediterranean Climate vs the Controlled Environment
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Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
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Parenteral Drug Association, Inc.