scholarly journals A Concept of Process Validation in Pharmaceutical Industries

2020 ◽  
Vol 5 (6) ◽  
pp. 1427-1431
Author(s):  
Devendra Kumar Mishra ◽  
Shubham Shukla
Keyword(s):  
Microbial Contamination ◽  
Basic Structure ◽  
Technical Support ◽  
Clean Room ◽  
Primary Stage ◽  
Process Validation ◽  
General Review ◽  
Pharmaceutical Industries ◽  
Two Stages ◽  
Structure Period

The aim of the article is to provide a brief presentation and general review on the criticalness of technical support of the pharmaceutical collecting strategy to ensure the security and minimization of the microbial turn of events. The process validation in the manufacturing unit is highly important to verify the surety at each and every stage of production. The microbial danger to aseptically created things in pharmaceutical clean rooms can be reviewed by the use of significant conditions that model the dispersing, move and explanation of microbial contamination, and the usage of numerical characteristics or risk descriptors. This should be conceivable in two-stages, with the primary stage used to overview the trading of contamination from the whole of the sources inside the clean room suite and the resulting stage used to assess both air and surface contact pollution inside fundamental creation locales. These two systems can be used to assess and diminish microbial danger at the basic structure period of the clean room and related collecting processor, brilliantly, for a developed gathering movement. Along these lines, underwriting is a basic piece of value confirmation. This separates the need for pharmaceutical and underwriting, the different ways of thinking, methods, and steps to be checked during the gathering process.

scholarly journals The Formation of Disk Galaxies

1988 ◽  
Vol 130 ◽  
pp. 301-310
Author(s):  
K.C. Freeman
Keyword(s):  
Radial Velocity ◽  
Milky Way ◽  
Velocity Dispersion ◽  
Basic Structure ◽  
Disk Galaxy ◽  
Disk Galaxies ◽  
The Sun ◽  
Structural Components ◽  
General Review

In this talk, I will discuss a few particular topics, rather than attempting a general review of the formation of disk galaxies. First recall the basic structure and kinematics of a disk galaxy like the Milky Way. The Table below lists the four main structural components as they are presently understood, and gives typical masses, and (if known) the characteristic rotational velocities (at the sun) and the radial velocity dispersion for each component. For more details, see Freeman (1987).

Spread of Marker Bacteria from the Hides of Cattle in a Simulated Livestock Market and at an Abattoir

2004 ◽  
Vol 67 (11) ◽  
pp. 2397-2402 ◽  
Author(s):  
V. J. COLLIS ◽  
C.-A. REID ◽  
M. L. HUTCHISON ◽  
M. H. DAVIES ◽  
K. P. A. WHEELER ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Pseudomonas Fluorescens ◽  
Nalidixic Acid ◽  
Microbial Contamination ◽  
Market Process ◽  
Market Environment ◽  
E Coli ◽  
Environmental Surfaces ◽  
K 12 ◽  
Two Stages

The spread of microbial contamination on the hides of beef was investigated at two stages in the meat chain: (i) in a simulated livestock market (“the market”) using 33 animals, and (ii) in the unloading-to-skinning area of a commercial abattoir using 18 animals. At both stages, harmless bacterial markers (nalidixic acid–resistant Escherichia coli K-12; rifampicin- and nalidixic acid–resistant Pseudomonas fluorescens; and a tetracycline-resistant E. coli) were inoculated on the hides of a small number of selected animals, and their transfer to other animals and the environment was examined. At the market, the initial prevalence of animals positive for the hide markers (9.1% in each phase) introduced in the presale pen, sale ring, and postsale pen changed to 39.4, 15.1, and 54.5%, respectively, by the end of the market process. In addition, widespread contamination of the market environment with the hide markers was observed. At the abattoir, the initial prevalence of animals positive for the hide marker (11.1%) inoculated at unloading increased to 100% (hide before skinning) and 88.8% (skinned carcass). In addition, another marker inoculated on environmental surfaces in lairage pens, races, and stunning box was detected on 83.3% (hide before skinning) and 88.8% (skinned carcass). These results, although obtained with a relatively small number of animals, demonstrate that both the livestock market process and the unloading-to-skinning process at abattoirs can facilitate the extensive spread of microbial contamination on hides not just within, but also between, batches of animals.

Microstructure and Resistivity OFCr75 Si25 Thin Films

1986 ◽  
Vol 71 ◽  
Author(s):  
B. Z. Weiss ◽  
K. N. Tu ◽  
D. A. Smith
Keyword(s):  
Thin Films ◽  
Room Temperature ◽  
Volume Fraction ◽  
Amorphous Film ◽  
Gradual Decrease ◽  
Major Portion ◽  
Primary Stage ◽  
Microstructural Changes ◽  
Secondary Stage ◽  
Two Stages

AbstractThe electrical and microstructural changes of initially amorphous Cr75Si25 thin coevaporated alloy films have been studied as a function of temperature from room temperature to 950°C. Crystallization occurs in two stages. In the “primary” stage the major portion of the amorphous film crystallizes and a steep drop in resistivity occurs. In the “secondary” stage the amorphous residue crystallizes and is accompanied by a further gradual decrease in resistivity. The resistivity depends linearly on the volume fraction Vτ(t) crystallized to give Cr3Si only for Vτ(t) < 0.35.

scholarly journals Monitoring of microbial contamination of the educational and scientific clean laboratory module

2021 ◽  
Vol 8 (1) ◽  
pp. 18-26
Author(s):  
А. V. Berestina ◽  
А. V. Bakhvalov
Keyword(s):  
Pharmaceutical Industry ◽  
Nuclear Power ◽  
Microbial Contamination ◽  
Contamination Level ◽  
Production Facility ◽  
Production Environment ◽  
Clean Room ◽  
Class D ◽  
Sanitary Treatment ◽  
Clean Laboratory

The production environment in pharmaceutical industry should not be a source of microbial contamination of the product. The purpose of this study was to examine the patterns of changes in the microbial contamination level in clean rooms. The study was conducted at the educational and scientific clean room module of the Biotechnology Department of the Obninsk Institute of Nuclear Power Engineering (IATE NRNU MEPhI). It was shown that the level of contamination of surfaces in production facility increases with the presence of personnel on the premises. The degree of microbial contamination of the air varies slightly depending on the type of activity and the number of personnel on premises. The compliance of the investigated clean room module with class D for clean rooms was confirmed. It was concluded that it is necessary to monitor microbial contamination of premises more often, as well as to implement the sanitary treatment in order to eliminate the sources of spore-forming microflora.

scholarly journals A Review on Pharmaceutical Validation

2020 ◽  
Vol 11 (03) ◽  
pp. 338-342
Author(s):  
Sudarshan Balasaheb Kakad ◽  
Mahesh Hari Kolhe ◽  
Tushar Pradip Dukre
Keyword(s):  
Analytical Procedure ◽  
Multiple Views ◽  
Current Interest ◽  
Validation Process ◽  
Specific Test ◽  
Process Validation ◽  
Analytical Method Validation ◽  
Pharmaceutical Industries ◽  
High Degree ◽  
Intended Use

Quality is the primordial intention of any industry and its products manufactured. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry, and it has been maintained by validation. Validation is documented evidence that provides a high degree of assurance. Validation has become one of the pharmaceutical industries’ most recognized subjects. This article provides detailed information about pharmaceutical validation and its importance. Quality is always an imperative prerequisite when we consider the product. In this article, we discuss the types of validation, process validation, equipment validation, cleaning, and analytical method validation. Validation is the process that is used to confirm that the analytical procedure employed for a specific test is suitable for the intended use.

Altered Fine Structure of B Lymphocytes Correlated with Defective Terminal Differentiation

1973 ◽  
Vol 31 ◽  
pp. 386-387
Author(s):  
Dale E. Bockman ◽  
L. Y. Frank Wu ◽  
Alexander R. Lawton ◽  
Max D. Cooper
Keyword(s):  
Immune Deficiency ◽  
B Lymphocytes ◽  
Plasma Cells ◽  
Present Report ◽  
Specific Antigen ◽  
Terminal Differentiation ◽  
Second Stage ◽  
Two Stages ◽  
Deficiency Diseases ◽  
Cell Line Generation

B-lymphocytes normally synthesize small amounts of immunoglobulin, some of which is incorporated into the cell membrane where it serves as receptor of antigen. These cells, on contact with specific antigen, proliferate and differentiate to plasma cells which synthesize and secrete large quantities of immunoglobulin. The two stages of differentiation of this cell line (generation of B-lymphocytes and antigen-driven maturation to plasma cells) are clearly separable during ontogeny and in some immune deficiency diseases. The present report describes morphologic aberrations of B-lymphocytes in two diseases in which second stage differentiation is defective.

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