ArticleInternational journal of pharmaceutics2019
Data reconciliation in the Quality-by-Design (QbD) implementation of pharmaceutical continuous tablet manufacturing.
Article in International journal of pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 46 citations in OpenAlex.
- Implementing QbD for Nano-Pharmaceuticals and Complex Formulations to Achieve Predictable and High-Quality Outcomes.AAPS PharmSciTech · 2026Review
- Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design.Pharmaceutics · 2025Article
- Application of quality by design in optimization of nanoformulations: Principle, perspectives and practices.Drug delivery and translational research · 2025Review
- Blockchain-enabled quality by design system for clinical trials.Frontiers in medicine · 2025Article
- Rational Function-Based Approach for Integrating Tableting Reduced-Order Models with Upstream Unit Operations: Dry Granulation Case Study.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Semi-mechanistic reduced order model of pharmaceutical tablet dissolution for enabling Industry 4.0 manufacturing systems.International journal of pharmaceutics · 2023Article
- Surface Modifiers on Composite Particles for Direct Compaction.Pharmaceutics · 2022Review
- A benchmark simulator for quality-by-design and quality-by-control studies in continuous pharmaceutical manufacturing - Intensified filtration-drying of crystallization slurries.Computers & chemical engineering · 2022Article
- Real-Time Monitoring of Powder Mass Flowrates for Plant-Wide Control of a Continuous Direct Compaction Tablet Manufacturing Process.Journal of pharmaceutical sciences · 2022Article
- Estimation of Feeding Composition of Industrial Process Based on Data Reconciliation.Entropy (Basel, Switzerland) · 2021Article
- Evaluation of a Combined MHE-NMPC Approach to Handle Plant-Model Mismatch in a Rotary Tablet Press.Processes (Basel, Switzerland) · 2021Article
- Design of condition-based maintenance framework for process operations management in pharmaceutical continuous manufacturing.International journal of pharmaceutics · 2020Article
- A Quality-by-Control Approach in Pharmaceutical Continuous Manufacturing of Oral Solid Dosage via Direct Compaction.ESCAPE. European Symposium on Computer Aided Process Engineering · 2019Article
Corrections and comments
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Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
Data provided by in situ sensors is always affected by some level of impreciseness as well as uncertainty in the measurements due to process operation disturbance or material property variance. In-process data precision and reliability should be considered when implementing active product quality control and real-time process decision making in pharmaceutical continuous manufacturing. Data reconciliation is an important strategy to address such imperfections effectively, and to exploit the data redundancy and data correlation based on process understanding. In this study, a correlation between tablet weight and main compression force in a rotary tablet press was characterized by the classical Kawakita equation. A load cell, situated at the exit of the tablet press chute, was also designed to measure the tablet production rate as well as the tablet weight. A novel data reconciliation strategy was proposed to reconcile the tablet weight measurement subject to the correlation between tablet weight and main compression force, in such, the imperfect tablet weight measurement can be reconciled with the much more precise main compression force measurement. Special features of the Welsch robust estimator to reject the measurement gross errors and the Kawakita model parameter estimation to monitor the material property variance were also discussed. The proposed data reconciliation strategy was first evaluated with process control open-loop and closed-loop experimental data and then integrated into the process control system in a continuous tablet manufacturing line. Specifically, the real-time reconciled tablet weight measurements were independently verified with an at-line Sotax Auto Test 4 tablet weight measurements every five minutes. Promising and reliable performance of the reconciled tablet weight measurement was demonstrated in achieving process automation and quality control of tablet weight in pilot production runs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.