scholarly journals PROCESS DEVELOPMENT, OPTIMIZATION AND VALIDATION OF MANUFACTURING PROCESS OF ALLOPURINOL

2021 ◽  
pp. 58-60
Author(s):  
SAYYED MOHSINA CHISHTI ◽  
NIMITA MANOCHA
Keyword(s):  
Manufacturing Process ◽  
Process Development ◽  
Scale Up ◽  
Research Work ◽  
Batch Size ◽  
Critical Parameters ◽  
Ideal Condition ◽  
Process Operation ◽  
Machine Speed ◽  
Control Limits

Objective: The objective of the present research work is to identify the critical parameters in the process that affect the quality of the finished product. The processs validation of the manufacturing process for Allopurinol tablet USP, 300 mg to be manufactured with change in manufacturing site and with increased batch size. Methods: Prior to Scaling up to production, pilot batches were manufactured. Three consecutive commercial batches are to be produced using similar test equipment and in full compliance with cGMP and existing SOPs. Critical process parameters of the machine was set within operating range and was not exceeded upper and lower control limits during process operation. Equipment were operated within its assigned control limits, which shows upon scale up into new site, the specification for hardness did not meet requirements that had been set during development. There was no significant effect observed on thickness, friability, disintegration, dissolution, uniformity of dosage and were found within specification. Pre process batch was challenged by manufacturing product at upper and lower processing limits and circumstances which pose the greatest chance of process or product failure compared to ideal condition. Results: Based on the data obtained from pre-process validation batch, operating ranges for compression force and machine speed had been established. Collected data shows robustness around these parameters and there is increased confidence that the process can be successfully scaled up under target conditions for these parameters. Conclusion: From this study, it was concluded that process was optimized and gave a reproducible product that meet predetermined quality requirements and do so consistently and reliably.

scholarly journals Upscale Design, Process Development, and Economic Analysis of Industrial Plants for Nanomagnetic Particle Production for Environmental and Biomedical Use

Materials ◽  
2020 ◽  
Vol 13 (11) ◽  
pp. 2477
Author(s):  
Paulo A. Augusto ◽  
Teresa Castelo-Grande ◽  
Diana Vargas ◽  
Alvaro Pascual ◽  
Lorenzo Hernández ◽  
...  
Keyword(s):  
Economic Analysis ◽  
Manufacturing Process ◽  
Magnetic Particles ◽  
Particle Production ◽  
Process Development ◽  
Scale Up ◽  
Production Capacity ◽  
Process Engineering ◽  
Market Demand ◽  
Industrial Plants

Very few economical and process engineering studies have been made concerning the scale-up and implementation of nanomagnetic particle manufacturing into a full-scale plant, and determination of its viability. In this work we describe such a study for two types of industrial plants, one for manufacturing magnetic particles for applications in the environmental area, and the other for manufacturing nanomagnetic particles for applications in the biotechnology area; the two different applications are compared. The following methodology was followed: establish the manufacturing process for each application; determine the market demand of the product (magnetic nanoparticles) for both applications; determine the production capacity of each plant; engineer all the manufacturing process, determining all the process units and performing all the mass and energy balances for both plants; scale-up the main equipment; and determine the global economic impact and profitability. At the end both plants are found to be technologically and economically viable, the characteristics of the final products being, however, quite different, as well as the process engineering, economic analysis, and scale-up.

scholarly journals Optimization of Process Parameters for Formulation of Fluvastatin Tablet by Using Dry Granulation Method

2020 ◽  
Vol 10 (5-s) ◽  
pp. 97-107
Author(s):  
Nikhil Arun Shete ◽  
Vishwajeet Swami ◽  
Vaibhav Kulkarni ◽  
Gajanan Paratkar ◽  
Rahul Mohan
Keyword(s):  
Process Parameters ◽  
Manufacturing Process ◽  
Quality By Design ◽  
Flow Behavior ◽  
Scale Up ◽  
Dissolution Time ◽  
Optimization Of Process Parameters ◽  
Study Results ◽  
Tablet Dissolution ◽  
Machine Speed

The manufacturing process of the tablet is a very complex process; it can be affected by the several process parameters or variables. The aim of this study was to understand and optimize the process parameters such as mixing, granulation, lubrication and tablets compression processes using quality by design (QbD) approach for a model Anti- Hyperlipidemic drug Fluvastatin sodium. During the processes there are several parameters which may influence or affect product quality. So the main objective of present work was to identify various process parameters and optimize this parameter, for the formulation of good quality product which needs to optimize Blending time, Roller force, Compression force and machine speed. A scale up batch was taken to evaluate and optimize the parameters. Critical quality attributes (CQA) such as flow behavior, granules parameters, Blend uniformity, tablet appearance, effect on tablet quality like physical appearance (surface, weight etc.) and tablet dissolution time as well as drug release.  The test results of following parameters at various in-process phases are complies with the specified limits and finished product sample results were found to be within specified limits. This study results assures the manufacturing process is reproducible, robust and will yield consistent product, which meets specification. Keywords: Process Parameters, Quality by Design, Fluvastatin, Granulation, Blending, Compression etc,. 

scholarly journals Melt Polycondensation for the Synthesis of Polyester Amides using Kneader Reactor Technology

2020 ◽  
Vol 74 (12) ◽  
pp. 1024-1025
Author(s):  
Lucien Blanchard ◽  
Chris Rader ◽  
Ennio Vanoli ◽  
Roger Marti
Keyword(s):  
Mechanical Properties ◽  
Mass Transfer ◽  
High Temperature ◽  
Process Development ◽  
Scale Up ◽  
Laboratory Scale ◽  
Critical Parameters ◽  
Thermal And Mechanical Properties ◽  
Reactor Technology ◽  
Melt Polycondensation

In this work, we discuss the process development and scale-up of the melt polycondensation of polyester amides from a laboratory scale to kg-scale in a kneader reactor. We identified and optimized the most important critical parameters and produced kg-quantities of polyester amides with Mn up to 25'000 g/mol and reproducible thermal and mechanical properties. The special kneader reactor allows safe and efficient scale-up of polymerisation reactions at high temperature and viscous melts due to good mixing and efficient mass transfer.

scholarly journals Scaling-up production of plant endophytes in bioreactors: concepts, challenges and perspectives

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Seedhabadee Ganeshan ◽  
Seon Hwa Kim ◽  
Vladimir Vujanovic
Keyword(s):  
Crop Production ◽  
Process Development ◽  
Hazard Analysis ◽  
Scale Up ◽  
Process Technology ◽  
Lack Of Information ◽  
Agriculture Industry ◽  
Start Up ◽  
Plant Growth Promoting ◽  
Agriculture And Food

AbstractThe benefit of microorganisms to humans, animals, insects and plants is increasingly recognized, with intensified microbial endophytes research indicative of this realization. In the agriculture industry, the benefits are tremendous to move towards sustainable crop production and minimize or circumvent the use of chemical fertilizers and pesticides. The research leading to the identification of potential plant endophytes is long and arduous and for many researchers the challenge is ultimately in scale-up production. While many of the larger agriculture and food industries have their own scale-up and manufacturing facilities, for many in academia and start-up companies the next steps towards production have been a stumbling block due to lack of information and understanding of the processes involved in scale-up fermentation. This review provides an overview of the fermentation process from shake flask cultures to scale-up and the manufacturing steps involved such as process development optimization (PDO), process hazard analysis (PHA), pre-, in- and post-production (PIP) challenges and finally the preparation of a technology transfer package (TTP) to transition the PDO to manufacturing. The focus is on submerged liquid fermentation (SLF) and plant endophytes production by providing original examples of fungal and bacterial endophytes, plant growth promoting Penicillium sp. and Streptomyces sp. bioinoculants, respectively. We also discuss the concepts, challenges and future perspectives of the scale-up microbial endophyte process technology based on the industrial and biosafety research platform for advancing a massive production of next-generation biologicals in bioreactors.

scholarly journals Training Tips for the Transformer Model

2018 ◽  
Vol 110 (1) ◽  
pp. 43-70 ◽  
Author(s):  
Martin Popel ◽  
Ondřej Bojar
Keyword(s):  
Sentence Length ◽  
Batch Size ◽  
Critical Parameters ◽  
Neural Machine Translation ◽  
Training Time ◽  
Multiple Gpus ◽  
Translation Quality ◽  
Transformer Model ◽  
Data Constraints ◽  
And Training

Abstract This article describes our experiments in neural machine translation using the recent Tensor2Tensor framework and the Transformer sequence-to-sequence model (Vaswani et al., 2017). We examine some of the critical parameters that affect the final translation quality, memory usage, training stability and training time, concluding each experiment with a set of recommendations for fellow researchers. In addition to confirming the general mantra “more data and larger models”, we address scaling to multiple GPUs and provide practical tips for improved training regarding batch size, learning rate, warmup steps, maximum sentence length and checkpoint averaging. We hope that our observations will allow others to get better results given their particular hardware and data constraints.

Process Development and Scale-up of T3-Sulfate, A New Prodrug Alternative to the Conventional Hormone Therapy of Hypothyroidism

2014 ◽  
Vol 18 (10) ◽  
pp. 1175-1180 ◽  
Author(s):  
Luciano Lattuada ◽  
Maria Argese ◽  
Valeria Boi ◽  
Laura Galimberti ◽  
Sonia Gazzetto
Keyword(s):  
Hormone Therapy ◽  
Process Development ◽  
Scale Up

Manufacturing Process Development for Thin Film Filaments as a New Product

2020 ◽  
pp. 513-522
Author(s):  
Bahadır Tunaboylu ◽  
Biset Toprak ◽  
Ahmet Korhan Binark ◽  
Osman Öztürk ◽  
Selim Zaim
Keyword(s):  
Thin Film ◽  
Manufacturing Process ◽  
Process Development ◽  
New Product

scholarly journals Ethiopian Banknote Recognition Using Convolutional Neural Network and Its Prototype Development Using Embedded Platform

2022 ◽  
Vol 2022 ◽  
pp. 1-18
Author(s):  
Dereje Tekilu Aseffa ◽  
Harish Kalla ◽  
Satyasis Mishra
Keyword(s):  
Optimization Technique ◽  
Research Work ◽  
Optimization Techniques ◽  
Magnetic Sensors ◽  
Batch Size ◽  
Raspberry Pi ◽  
Prototype Development ◽  
Embedded Platform ◽  
Artificial Intelligence Technology ◽  
Banknote Recognition

Money transactions can be performed by automated self-service machines like ATMs for money deposits and withdrawals, banknote counters and coin counters, automatic vending machines, and automatic smart card charging machines. There are four important functions such as banknote recognition, counterfeit banknote detection, serial number recognition, and fitness classification which are furnished with these devices. Therefore, we need a robust system that can recognize banknotes and classify them into denominations that can be used in these automated machines. However, the most widely available banknote detectors are hardware systems that use optical and magnetic sensors to detect and validate banknotes. These banknote detectors are usually designed for specific country banknotes. Reprogramming such a system to detect banknotes is very difficult. In addition, researchers have developed banknote recognition systems using deep learning artificial intelligence technology like CNN and R-CNN. However, in these systems, dataset used for training is relatively small, and the accuracy of banknote recognition is found smaller. The existing systems also do not include implementation and its development using embedded systems. In this research work, we collected various Ethiopian currencies with different ages and conditions and applied various optimization techniques for CNN architects to identify the fake notes. Experimental analysis has been demonstrated with different models of CNN such as InceptionV3, MobileNetV2, XceptionNet, and ResNet50. MobileNetV2 with RMSProp optimization technique with batch size 32 is found to be a robust and reliable Ethiopian banknote detector and achieved superior accuracy of 96.4% in comparison to other CNN models. Selected model MobileNetV2 with RMSProp optimization has been implemented through an embedded platform by utilizing Raspberry Pi 3 B+ and other peripherals. Further, real-time identification of fake notes in a Web-based user interface (UI) has also been proposed in the research.

scholarly journals Development of a Scalable Process of Film-Coated bi-Layer Tablet Containing Sustained-Release Metoprolol Succinate and Immediate-Release Amlodipine Besylate

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1797
Author(s):  
Nguyen Thi Linh Tuyen ◽  
Le Quan Nghiem ◽  
Nguyen Duc Tuan ◽  
Phuoc Huu Le
Keyword(s):  
Sustained Release ◽  
Manufacturing Process ◽  
High Speed ◽  
Immediate Release ◽  
New Drugs ◽  
Batch Size ◽  
Average Weight ◽  
Amlodipine Besylate ◽  
Metoprolol Succinate ◽  
Dry Mixing

The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and X¯ charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.

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