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WHAT are sampling errors-and WHAT can we do about them? Part 1
Contributor(s):: Romañach, Rodolfo J., Joubert Castro, Aidalu, Esbensen, Kim H
The objective of this column is to provide easy-to-understand examples of sampling errors. Prompted by recent participationsand presentations at on-line conferences and meetings, we believe there is a need for a more fulfilling introduction andexemplification of the concept and real-world...
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Theory of Sampling (TOS): A necessary and sufficient guarantee for reliable multivariate dara analysis in pharmaceutical manufacturing
Contributor(s):: Esbensen, Kim H, Romañach, Rodolfo, J.Ferrerira, Ana P., Menezes, Jose C., Tobyn, Mike, Román-Ospino, Andrés D.
Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each...
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Real-Time Quantification of Low-Dose Cohesive Formulations within a Sampling Interface for Flowing Powders
Contributor(s):: Sierra-Vega, Nobel. O., Romañach, Rodolfo J., Mendez, Rafael
This study investigates the performance of a sampling interface for monitoring cohesive, flowing powder formulations with Hausner's Ratio and Carr's Index higher than 1.5 and 35%, respectively. The sampler device was operated in combination with near-infrared (NIR) spectroscopy to quantify...
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Near Infrared Method Development for a Continuous Manufacturing Blending Process
Contributor(s):: Colon, Yleana, Florian, Miguel, Acevedo, David, Mendez, Rafael, Romañach, Rodolfo
Purpose This study describes the validation of a near infrared spectroscopic method for monitoring a continuous manufacturing system. The achievement of this goal requires determining the near infrared (NIR) method’s accuracy, precision, obtaining an estimate of the sample volume analyzed, and...
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Method transfer of a near-infrared spectroscopic method for blend uniformity in a poorly flowing and hygroscopic blend
Contributor(s):: Alvarado-Hernández, Bárbara, Scicolone, James, Ortega-Zuñiga, Carlos, Román-Ospino, Andrés, Colón-Lugo, Yleana, Aymat, Efrain, Sánchez, Eric, Muzzio, Fernando, Romañach, Rodolfo
The challenges in transferring and executing a near-infrared (NIR) spectroscopic method for croscarmellose (disintegrant) in binary blends for a continuous manufacturing (CM) process are presented. This work demonstrates the development of a NIR calibration model and its use to determine the...
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Introduction to the Theory and Practice of Sampling
Contributor(s):: Esbensen, Kim H
Sampling is an important, but sometimes hidden, part of everyday life in science, technology, industry, society and commerce where decisions are made based on analytical results, which must be based on reliable samples. However, there is a very long and complex pathway from heterogeneous...
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An Innovative Sampling Interface for Monitoring Flowing Pharmaceutical Powder Mixtures
Contributor(s):: Martínez-Cartagena, Pedro, Romañach, Rodolfo J., Sierra-Vega, Nobel O; Alvarado-Hernández, Bárbara B; Méndez, Rafael
A chute was designed following the principles of the Theory of Sampling to minimize the variations in powder flow and provide all particles in the flowing blends with the same opportunity of being selected as a sample. The design also reduces the thickness of the chute to allow the analysis of a...
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A sampling system for flowing powders based on the theory of sampling
Contributor(s):: Alvarado-Hernández, Bárbara B, Sierra-Vega, Nobel O, Martínez-Cartagena, Pedro, Hormaza, Manuel, Méndez, Rafael, Romañach, Rodolfo J.
An innovative chute and stream sampler system for flowing powders has been developed and tested. The system is designed for representative sampling based on the principles of the Theory of Sampling (TOS). The sampling system was used in combination with near infrared (NIR) spectroscopy to...
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A Framework for Representative Sampling for NIR Analysis – Theory of Sampling (TOS)
Contributor(s):: Esbensen, Kim H, Ciurczak, Emil W., Igne, Benoît, Workman, Jr.,Jerome, Burns, Donald A., Romañach, Rodolfo J.
This chapter deals with all critical steps before near-infrared spectroscopy (NIR) analysis, irrespective of whether the total sampling error contribution is large, intermediate, or small – all cases can be treated identically, including the widespread sensor-based solutions from the...