Pharmaceuticals Microbiology

Pharmaceuticals Microbiology

 TEST FOR STERILITY-:

                                                            INTRODUCTION

The tests for sterility are intended for detecting the presence of viable forms of microorganisms in or on pharmacopoeia preparations. The tests must be carried out under conditions designed to avoid accidental contamination of the product during the test. Precautions taken for this purpose should not adversely affect any microorganisms, which should be revealed in the test.

Microbiological
   Limit Test

For

Purified Water and Raw Water

Microbiological Test for Purified Water

The microbiological limit test is designated for the estimation of the number of viable aerobic microorganism present and for detecting the presence of designated microbial species in purified water and pharmaceuticals substance. The term ‘growth’ is used to design the presumed proliferation of viable microorganism.

 

 

 

 

 

 

TEST FOR PATHOGENIC MICROORGANISM: Include test for following Microorganisms -:

1, Escherichia coli:

           

 

 

 

 

Positive  Control    of  E. coli

 

 

 

2. Pseudomonas aeruginosa

 

 

 

 

Positive Control For Salmonella typhi

 

3. Salmonella species

 

 

 

 

 

Positive Control For Salmonella typhi

4. Staphylococcus aureus

 

 

 

 

 

 

Positive Control For Staphylococcus aureus

 

Petri Plate Containing Positive control for  all four tests carried out above.

Bio burden Testing of Drug Solution Prior to Aseptic Filtration

Microbial testing is conducted in sterile pharmaceutical industry in support of sterile product development, for in-process monitoring during aseptic processing and filling operations. The role that microbial testing play in promoting sterility assurance of aseptically filled sterile product.

Environment Monitoring In the Aseptic Area

Environment monitoring in the Aseptic area is done to know the bio-burden of the environment of the Aseptic area presenting the air,  attached to some surface of equipments, walls, roof or floor etc. the microorganisms are also spread by the person working in the Aseptic manufacturing area. Therefore the environment monitoring in the Aseptic area is done by different methods to know the microorganisms present in the different sites and location in the Aseptic manufacturing area.  If the bio-burden of the Aseptic area exceeds the limits it shows that there is a contamination in the area .

BACTERIAL ENDOTOXIN TEST

 

ENDOTOXIN:

Gram negative bacteria have lipo-polysaccharide (heat stable) in the outer membrane of their cell wall that under certain circumstances, is toxic to specific host because it is bound to the bacterium and is released when the microorganism lysis. (heat). Some is also released during bacterial multiplication.

 

 

 

 

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One Response to “Pharmaceuticals Microbiology”

  1. M. Krishnaraj May 20, 2012 at 4:53 pm #

    I really like your services offered to the society. We too offering contract research services such as, PCR amplifications, DNA Sequencing, Biotechnology database analyses, Fermentation, In vitro Bioassays, Phytochemical Analysis, Drug Development from Plants and Microbes, Primer Design and Production, Protein/Secondary Metabolites Purification and Spectral Analyses to companies related with production of biopharmaceuticals and bioproducts.

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