scholarly journals Study of a Critical Process Parameter in the meningococcal C conjugate vaccine manufacturing developed by Bio-Manguinhos

2018 ◽  
Author(s):  
William Silva ◽  
Flávia Silva ◽  
Felipe Silva ◽  
Iaralice Souza ◽  
Milton Silva ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Process Parameter ◽  
Critical Process Parameter ◽  
Critical Process

STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (10) ◽  
pp. 42-50
Author(s):  
Hemant S. Kandle ◽  
Sangram S. Patil ◽  
Sujata S. Sawant ◽  
Ganesh B. Vambhurkar ◽  
Asha M. Jagtap ◽  
...  
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Process Parameter ◽  
Regulatory Requirements ◽  
Validation Data ◽  
Process Validation ◽  
Critical Process Parameter ◽  
Quality Control Testing ◽  
Quality Product ◽  
High Degree ◽  
Critical Process

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assurance that the product meets the predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging its in house and compendial specification. Three initial process validations batches APL/008, APL/009 and APL/010 were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance so that manufacturing process produces a quality product.

Research of the True Flow with High Polymers as a Critical Process Parameter

2014 ◽  
Vol 490-491 ◽  
pp. 34-37
Author(s):  
Xian Wei Wang ◽  
Guang Liang Cheng
Keyword(s):  
Intermolecular Interaction ◽  
Process Parameter ◽  
Polymer Materials ◽  
Practical Significance ◽  
Fixed Temperature ◽  
Polymer Swelling ◽  
Chain Flexibility ◽  
Critical Process Parameter ◽  
Critical Process ◽  
True Flow

In this article should be noted that the accuracy of determining the viscosity of the flow is particularly low in the highly elastic with state of the polymer. It is therefore very important to identity the viscosity of the flow, which has great practical significance. solidity can be changed as a result of intermolecular interaction which can be observed in the process of polymer swelling, which means improving its chain flexibility and lowering the temperature of vitrifying. It should be noted that the processing of the experiment showed no pronounced dependence of the voltage, so it is under-read as the average results for all levers of the stress at a fixed temperature. Processed a method for determining the viscosity of polymer materials, which allows you to divide segmental strength and toughness of the true flow.

scholarly journals PREPARATION AND SCALE-UP STUDY OF TREATED FAMOTIDINE FOR THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS USING A COMPLEX FLUIDIZED-BED GRANULATOR EQUIPPED WITH A PARTICLE-SIZING MECHANISM

2018 ◽  
Vol 10 (5) ◽  
pp. 35
Author(s):  
Shouichi Hosaka ◽  
Masaki Yamazawa ◽  
Yoshiteru Takahashi
Keyword(s):  
Particle Size ◽  
Fluidized Bed ◽  
Scale Up ◽  
Process Parameter ◽  
Air Pressure ◽  
Particle Sizing ◽  
Critical Process Parameter ◽  
Orally Disintegrating Tablets ◽  
Critical Process ◽  
Scale Up Study

Objective: Bitter taste-masked drug substance should be needed for the development of orally disintegrating tablets (ODT). We selected a new type of a complex fluidized-bed granulator equipped with a particle-sizing mechanism for treating famotidine (FAM). This study was conducted to demonstrate the critical process parameter, which controls particle size of treated FAM, to determine its acceptable particle size considering uniformity of assay and to perform scale-up study from a laboratory scale to a commercial scale.Methods: Particle size of treated FAM was evaluated by changing spraying air pressure on the operation of a complex fluidized-bed granulator. Uniformity of assay in granules after blending and tablets were compared at different particle size of treated FAM. On the scale-up study, particle size and assay of treated FAM in both scales were evaluated.Results: The particle size of treated FAM decreased as the increase in spraying air pressure in relation to the spraying mist size. Better uniformity of assay was observed when the diameter of treated FAM was 20 µm compared to that of 50 µm. Therefore, target particle size of treated FAM was set at approximately 20 µm. Similar qualities could be obtained between both scales in the points of particle size and assay.Conclusion: On the operation of a complex fluidized-bed granulator, spraying air pressure was the critical process parameter that controlled particle size of treated FAM. On Scale-up study of treated FAM, spraying air pressure in relation to the spraying mist size was important.

Evaluation of a critical process parameter: Oxygen limitation during cultivation has a fully reversible effect on gene expression ofBordetella pertussis

2009 ◽  
Vol 102 (1) ◽  
pp. 161-167 ◽  
Author(s):  
Mathieu Streefland ◽  
Bas van de Waterbeemd ◽  
Joeri Kint ◽  
Leo A. van der Pol ◽  
E. Coen Beuvery ◽  
...  
Keyword(s):  
Gene Expression ◽  
Oxygen Limitation ◽  
Process Parameter ◽  
Reversible Effect ◽  
Critical Process Parameter ◽  
Ofbordetella Pertussis ◽  
Critical Process

scholarly journals Cryopreservation timing is a critical process parameter in a thymic regulatory T-cell therapy manufacturing protocol

Cytotherapy ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1216-1233 ◽  
Author(s):  
Katherine N. MacDonald ◽  
Sabine Ivison ◽  
Keli L. Hippen ◽  
Romy E. Hoeppli ◽  
Michael Hall ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Therapy ◽  
Regulatory T Cell ◽  
Process Parameter ◽  
T Cell Therapy ◽  
Critical Process Parameter ◽  
Critical Process
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