Optimization of process parameters for naringinase production by Aspergillus tubingensis UA13 and pilot scale-up study

2021 ◽  
pp. 1-8
Author(s):  
Xin-Ke Xia ◽  
Yuan-E. Zhang ◽  
Sheng-Jiao Lei ◽  
Biao Hu ◽  
Cai-Xia Fu
Keyword(s):  
Process Parameters ◽  
Scale Up ◽  
Pilot Scale ◽  
Aspergillus Tubingensis ◽  
Optimization Of Process Parameters ◽  
Scale Up Study

Development, Scale-up, and Optimization of Process Parameters

2009 ◽  
pp. 715-724 ◽  
Author(s):  
Timothy J. Smith ◽  
Gary Sackett ◽  
Paul Sheskey ◽  
Lirong Liu
Keyword(s):  
Process Parameters ◽  
Scale Up ◽  
Optimization Of Process Parameters

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 Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

Pharmaceutics ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 252 ◽  
Author(s):  
Jong Kwon Han ◽  
Beom Soo Shin ◽  
Du Hyung Choi
Keyword(s):  
Multivariate Analysis ◽  
Process Parameters ◽  
Scale Up ◽  
Pilot Scale ◽  
Quality Attributes ◽  
Wet Granulation ◽  
High Shear ◽  
Critical Quality Attributes ◽  
High Shear Wet Granulation ◽  
The Relationship

A robust manufacturing process and the relationship between intermediate quality attributes (IQAs), critical quality attributes (CQAs), and critical process parameters (CPPs) for high-shear wet granulation was determined in this study. Based on quality by the design (QbD) approach, IQAs, CQAs, and CPPs of a telmisartan tablet prepared by high-shear wet granulation were determined and then analyzed with multivariate analysis (MVA) to evaluate mutual interactions between IQAs, CQAs, and CPPs. The effects of the CPPs on the IQAs and CQAs were quantitatively predicted with empirical models of best fit. The models were used to define operating space, and an evaluation of the risk of uncertainty in model prediction was performed using Monte Carlo simulation. MVA showed that granule size and granule hardness were significantly related to % dissolution. In addition, granule FE (Flow Energy) and Carr’s index had effects on tablet tensile strength. Using the manufacture of a clinical batch and robustness testing, a scale-up from lab to pilot scale was performed using geometric similarity, agitator torque profile, and agitator tip speed. The absolute biases and relative bias percentages of the IQAs and CQAs generated by the lab and pilot scale process exhibited small differences. Therefore, the results suggest that a risk reduction in the manufacturing process can be obtained with integrated process parameters as a result of the QbD approach, and the relationship between IQAs, CQAs, and CPPs can be used to predict CQAs for a control strategy and SUPAC (Scale-Up and Post-Approval Guidance).

scholarly journals Optimization of process parameters for pilot-scale liquid-state bioconversion of sewage sludge by mixed fungal inoculation

2015 ◽  
Vol 37 (1) ◽  
pp. 1-15 ◽  
Author(s):  
Roshanida A. Rahman ◽  
Abul Hossain Molla ◽  
Hind F. A. Barghash ◽  
Ahmadun Fakhru'l-Razi
Keyword(s):  
Sewage Sludge ◽  
Process Parameters ◽  
Liquid State ◽  
Pilot Scale ◽  
Optimization Of Process Parameters ◽  
Fungal Inoculation

Optimization of Process Parameters for Production of Pectinase using Bacillus Subtilis MF447840.1

2019 ◽  
Vol 13 (1) ◽  
pp. 69-73 ◽  
Author(s):  
Ram Balak Mahto ◽  
Mukesh Yadav ◽  
Soumya Sasmal ◽  
Biswnath Bhunia
Keyword(s):  
Bacillus Subtilis ◽  
Process Parameters ◽  
Volume Ratio ◽  
Optimum Process ◽  
Agitation Rate ◽  
Fermentation Condition ◽  
Optimization Of Process Parameters ◽  
Food And Beverage ◽  
Pectinase Production ◽  
Sterile Product

Background: Pectinase enzyme has immense industrial prospects in the food and beverage industries. </P><P> Objective: In our investigation, we find out the optimum process parameters suitable for better pectinase generation by Bacillus subtilis MF447840.1 using submerged fermentation. </P><P> Method: 2% (OD600 nm = 0.2) of pure Bacillus subtilis MF447840.1 bacterial culture was inoculated in sterile product production media. The production media components used for this study were 1 g/l of pectin, 2 g/l of (NH4)2SO4, 1 g/l of NaCl, 0.25 g/l of K2HPO4, 0.25 g/l of KH2PO4 and 1 g/l of MgSO4 for pectinase generation. We reviewed all recent patents on pectinase production and utilization. The various process parameters were observed by changing one variable time method. </P><P> Results: The optimum fermentation condition of different parameters was noticed to be 5% inoculums, 25% volume ratio, temperature (37°C), pH (7.4) and agitation rate (120 rpm) following 4 days incubation. </P><P> Conclusion: Maximum pectinase generation was noticed as 345 ± 12.35 U following 4 days incubation.

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