Process Intensification Enabling Continuous Manufacturing Processes Using Modular Continuous Vacuum Screw Filter

2021 ◽  
Author(s):  
Claas Steenweg ◽  
Astrid Ina Seifert ◽  
Nils Böttger ◽  
Kerstin Wohlgemuth
Keyword(s):  
Process Intensification ◽  
Manufacturing Processes ◽  
Continuous Manufacturing ◽  
Continuous Vacuum

scholarly journals Towards Continuous Primary Manufacturing Processes—Particle Design through Combined Crystallization and Particle Isolation

Processes ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 2187
Author(s):  
Claas Steenweg ◽  
Anne Cathrine Kufner ◽  
Jonas Habicht ◽  
Kerstin Wohlgemuth
Keyword(s):  
Quality Control ◽  
Product Quality ◽  
Scale Up ◽  
Small Scale ◽  
Manufacturing Processes ◽  
Continuous Manufacturing ◽  
Product Quality Control ◽  
Combined Crystallization ◽  
Fast Start ◽  
Continuous Vacuum

Integrated continuous manufacturing processes of active pharmaceutical ingredients (API) provide key benefits concerning product quality control, scale-up capability, and a reduced time-to-market. Thereby, the crystallization step, which is used in approximately 90% of API productions, mainly defines the final API properties. This study focuses on the design and operation of an integrated small-scale process combining a continuous slug flow crystallizer (SFC) with continuous particle isolation using the modular continuous vacuum screw filter (CVSF). By selective adjustment of supersaturation and undersaturation, the otherwise usual blocking could be successfully avoided in both apparatuses. It was shown that, during crystallization in an SFC, a significant crystal growth of particles (Δd50,3≈ 220 µm) is achieved, and that, during product isolation in the CVSF, the overall particle size distribution (PSD) is maintained. The residual moistures for the integrated process ranged around 2% during all experiments performed, ensuring free-flowing particles at the CVSF outlet. In summary, the integrated setup offers unique features, such as its enhanced product quality control and fast start-up behavior, providing a promising concept for integrated continuous primary manufacturing processes of APIs.

Control of Continuous Manufacturing Processes for Production of Monoclonal Antibodies

2021 ◽  
pp. 39-74
Author(s):  
Anurag S. Rathore ◽  
Garima Thakur ◽  
Saxena Nikita ◽  
Shantanu Banerjee
Keyword(s):  
Monoclonal Antibodies ◽  
Manufacturing Processes ◽  
Continuous Manufacturing

An Enhanced Quality Evaluation System for Continuous Manufacturing Processes, Part 1: Theory

1990 ◽  
Vol 112 (1) ◽  
pp. 57-62 ◽  
Author(s):  
K. J. Dooley ◽  
S. G. Kapoor
Keyword(s):  
Evaluation System ◽  
Quality Evaluation ◽  
Quality Characteristic ◽  
Rule Base ◽  
Manufacturing Processes ◽  
Cusum Chart ◽  
Continuous Manufacturing ◽  
Chi Square ◽  
Chi Square Test ◽  
Quality Evaluation System

A quality evaluation system is presented which gives enhanced information about the nature of quality changes in continuous manufacturing processes. The system monitors a quality characteristic of the process via stochastic time series models and detects shifts in the process mean, variance, and dynamic parameters. A rule base classifies the type of change that occurred, and change magnitude and time of occurrence are estimated. Part 1 of the work addresses the theoretical issues concerning the statistics used by the rule base and their behavior under various process changes. The characteristics of the cusum chart, autocorrelation chart, and Chi-Square test are derived with respect to each of the possible change mechanisms.

Progress in the Development of Continuous Manufacturing Processes for HTS Conductors

1993 ◽  
pp. 811-814
Author(s):  
H.-W. Neumüller ◽  
W. Schmidt ◽  
M. Wilhelm ◽  
U. Härlen ◽  
G. Hofer ◽  
...  
Keyword(s):  
Manufacturing Processes ◽  
Continuous Manufacturing

scholarly journals Enhanced Transport Capabilities via Nanotechnologies: Impacting Bioefficacy, Controlled Release Strategies, and Novel Chaperones

2011 ◽  
Vol 2011 ◽  
pp. 1-14 ◽  
Author(s):  
Thomai Panagiotou ◽  
Robert J. Fisher
Keyword(s):  
Controlled Release ◽  
Process Analytical Technology ◽  
Critical Role ◽  
Process Intensification ◽  
Therapeutic Interventions ◽  
Continuous Manufacturing ◽  
Transfer Energy ◽  
Analytical Technology ◽  
The Brain

Emerging nanotechnologies have, and will continue to have, a major impact on the pharmaceutical industry. Their influence on a drug's life cycle, inception to delivery, is rapidly expanding. As the industry moves more aggressively toward continuous manufacturing modes, utilizing Process Analytical Technology (PAT) and Process Intensification (PI) concepts, the critical role of transport phenomena becomes elucidated. The ability to transfer energy, mass, and momentum with directed purposeful outcomes is a worthwhile endeavor in establishing higher production rates more economically. Furthermore, the ability to obtain desired drug properties, such as size, habit, and morphology, through novel manufacturing strategies permits unique formulation control for optimum delivery methodologies. Bottom-up processing to obtain nano-sized crystals is an excellent example. Formulation and delivery are intimately coupled in improving bio-efficacy at reduced loading and/or better controlled release capabilities, minimizing side affects and providing improved therapeutic interventions. Innovative nanotechnology applications, such as simultaneous targeting, imaging and delivery to tumors, are now possible through use of novel chaperones. Other examples include nanoparticles attachment to T-cells, release from novel hydrogel implants, and functionalized encapsulants. Difficult tasks such as drug delivery to the brain via the blood brain barrier and/or the cerebrospinal fluid are now easier to accomplish.

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