كتاب  Pharmaceutical microbiologyالكتب و الموسوعات العامة

كتاب Pharmaceutical microbiology

Pharmaceutical microbiology من كتب علمية Cover for Pharmaceutical Microbiology Authors: B l Chaudhary Harshada jcshi PREFACE The textbook of ‘Pharmaceutical Microbiology’ specifically aims at the ever demanding thoughtful need of an absolutely well-documented compilation of factual details related to : theoritical principles, classifications, diagramatic profiles, graphic presentations, critical explanation, latest examples for the Pharmacy Degree (B. Pharm.,) throughout the Indian Universities, SAARC-countries, and similar curricula adopted abroad. Modern invigorative society, based on the overwhelming and overemphasized broad-spectrum importance vis-a-vis utilities of ‘Microbiology’ profusely gets benefited from the intricate species of scores of microorganisms in several ways and means, namely : antibiotics, vaccines, enzymes, vitamins etc. Nevertheless, a quantum-leap-forward in the field of ‘Modern Biotechnology’ rests predominantly upon reasonably sound microbiological foundation. Besides, microorganisms do modulate a plethora of vital and critical functionalities, such as : ( a ) enable completion of cycles of C, O, N and S which essentially occur in both terrestrial and aquatic systems ; ( b ) provide absolutely indispensable components of prevailing ecosystem ; and ( c ) serve as a critical source of ‘nutrients’ occurring at the grass-root of practically a large segment of ecological food webs and chains. The entire course-content presented in ‘Pharmaceutical Microbiology’ has been meticulously and painstakingly developed and expanded as per the AICTE-Approved Syllabus–2000. Each chapter has been duly expatiated in a simple, lucid, and crisp language easily comprehensible by its august readers. A unique largely acceptable style of presentation has been adopted, viz., brief introduction, principles, labeled figures, graphics, diagrams of equipments, descriptions, explanations, pharmaceutical applications, and selected classical examples. Each chapter is duly elaborated with adequate foot-notes, references, and ‘further reading references’ at the end. An exhaustive ‘Glossary of Important Microbiological Terminologies’ has been duly annexed at the end of the textbook. A fairly up to date computer-generated ‘Index’ in the textbook will surely enlarge the vision of its readers in gaining an easy access of subject enriched well documented text materials. Pharmaceutical Microbiology consists of Ten Chapters : (1) Introduction and Scope ; (2) Structure and Function : Bacterial Cells ; (3) Characterization, Classification and Taxonomy of Microbes ; (4) Identification of Microorganisms ; (5) Nutrition, Cultivation and Isolation : Bacteria- Actinomycetes-Fungi-Viruses ; (6) Microbial Genetics and Variations ; (7) Microbial Control by Physical and Chemical Methods ; (8) Sterility Testing : Pharmaceutical Products ; (9) Immune Systems ; and (10) Mi crobiological (Microbial) Assays : Antibiotics–Vitamins–Amino Acids. The text material essentially embodies not only an ample emphasis on the vivid coverage of fundamental principles of microbiology as a scientific discipline but also maintains a manageable length for the apprehension of brilliant students. CONTENTS 1. Introduction and Scope ... 1 1.1 Introduction ... 1 1.2 Historical Development of Microbiology ... 3 1.2.1. The Microscope ... 3 1.2.2. Spontaneous Generation Vs Biogenesis ... 4 1.2.3. Fermentation ... 6 1.2.4. Germ Theory ... 6 1.2.5. Classical Laboratory Methods and Pure Cultures ... 7 1.2.6. Immunity ... 8 1.2.7. Medical Microbiology ... 9 1.2.8. Pharmaceutical Microbiology ... 10 1.2.9. Industrial Microbiology ... 14 1.2.10. Emergence of Molecular Biology ... 15 1.2.11. Emergence of Virology ... 17 1.2.12. Microorganisms as Geochemical Agents ... 19 1.2.13. Microbiology in the New Millennium ... 19. 2. Structure and Function : Bacterial Cells ... 23 2.1 Introduction ... 23 2.2 Characteristic Features ... 23 2.2.1. Shape ... 23 2.2.2. Size ... 23 2.2.3. Reproduction ... 24 2.2.4. Formation of Colony ... 24 2.2.5. Mutation ... 24 2.2.6. Motility ... 24 2.2.7. Food and Oxygen Requirements ... 24 2.2.8. Temperature Requirements ... 24 2.3 Activities ... 25 2.4 Organization of Microbial Cells ... 25 2.4.1. Type of Cells ... 26 2.4.1.1. Eukaryotic Cells ... 27 2.4.1.2. Prokaryotic Cells ... 33 2.5 Archaeobacteria and Eubacteria ... 37 2.5.1. Methanogenic Bacteria [Methanogens] ... 38 2.5.2. Extreme Halophiles ... 40 ( ix ) 2.5.3. Thermoacidophiles ... 41 2.5.3.1. Thermoplasma ... 41 2.5.3.2. Sulfolobus ... 41 2.6 The Bacterial Cells ... 42 2.6.1. Typical Bacterial Cells ... 43 2.6.2. Capsules and Slimes ... 44 2.6.3. Flagella and Fimbria ... 46 2.6.3.1. Flagella ... 46 2.6.3.2. Fimbria [or Pili] ... 48 2.6.4. Cell Envelope ... 49 2.6.5. Gram-Positive and Gram-Negative Bacteria ... 51 2.6.6. Significance of Teichoic Acids ... 53 2.6.7. The Cell Membrane ... 54 2.6.8. Bacterial Cytoplasm ... 55 2.6.9. Ribosomes ... 57 2.6.10. Cellular Reserve Materials ... 58 3. Characterization, Classification and Taxonomy of Microbes ... 62 3.1 Introduction ... 62 3.2 Characterization ... 62 3.2.1. Morphological Characteristics ... 63 3.2.2. Chemical Characteristics ... 64 3.2.3. Cultural Characteristics ... 64 3.2.4. Metabolic Characteristics ... 66 3.2.5. Antigenic Characteristics ... 66 3.2.6. Genetic Characteristics ... 67 3.2.6.1. DNA Base Composition ... 67 3.2.6.2. Sequence of Nucleotide Bases in DNA ... 68 3.2.7. Pathogenecity ... 69 3.2.8. Ecological Characteristics ... 69 3.3 Classificiation ... 70 3.3.1. Difficulties Encountered in Classification of Microorganisms ... 70 3.3.2. Objectives of Classification ... 70 3.3.3. Genetic Methods of Classifying Microbes ... 71 3.3.3.1. Genetic Relatedness ... 71 3.3.3.2. The Intuitive Method ... 72 3.3.3.3. Numerical Taxonomy ... 72 3.3.4. Systemetized Classification ... 75 3.3.4.1. Natural Classification ... 75 3.3.4.2. Phyletic Calssification ... 75 ( x ) 3.3.4.3. Linnear Binomial Scheme ... 76 3.3.4.4. Phenotypic Classification ... 77 3.3.4.5. Microscopic Examination ... 79 3.3.4.6. Cataloguing rRNA ... 80 3.3.4.7. Computer Aided Classification ... 81 3.3.4.8. Bacterial Classification ... 82 3.4 Taxonomy ... 87 3.5 The Kingdom Prokaryotae ... 88 3.5.1. Actinomyctes ... 89 3.5.1.1. General Characteristics ... 89 3.5.1.2. Significance of Actinomycetes ... 90 3.5.1.3. Classification ... 91 3.5.1.3.1. Whole Cell Carbohydrate Patterns of Aerobic Actinomycetes ... 91 3.5.1.3.2. Major Constituents of Cell Wall Types of Actinomycetes ... 91 3.5.1.3.3. Groups of Actinomycetes Based on Whole Cell Carbohydrate Pattern and Cell Wall Type ... 92 3.5.1.3.4. Actinomycetes with Multiocular Sporangia ... 92 3.5.1.4. Actinomycetes and Related Organisms ... 93 3.5.1.4.1. Group ... 93 3.5.1.4.2. Genus ... 94 3.5.1.4.3. Order ... 97 3.5.1.4.4. Family ... 98 3.5.2. Bacteria ... 102 3.5.2.1. Salient Features ... 103 3.5.2.2. Structure and Form of the Bacterial Cell ... 104 3.5.2.2.1. Size and Shape ... 105 3.5.2.2.2. Structure ... 105 3.5.3. Rickettsia and Coxiella ... 107 3.5.4. Spirochaetes ... 108 4. Identification of Microorganisms ... 112 4.1 Introduction ... 112 4.2 Morphology ... 113 4.3 Selective and Diagnostic Media ... 113 4.3.1. Differential Media ... 116 4.3.1.1. Eosin Methylene Blue Agar [EMB-Agar] ... 116 ( xi ) 4.3.1.2. MacConkey Agar ... 116 4.3.1.3. Hektoen Enteric Agar [HE-Agar] ... 116 4.3.2. Enrichment Media ... 116 4.3.2.1. Blood Agar ... 116 4.3.2.2. Chocolate Agar ... 117 4.3.3. Characteristic Media ... 117 4.3.3.1. Triple Sugar Iron Agar [TSI-Agar] ... 117 4.4 Cultural Characteristics ... 119 4.5 Biochemical Tests (or Properties) ... 120 4.5.1. Carbohydrate (Sugar) Fermentation ... 120 4.5.2. Litmus Milk ... 120 4.5.3. Indole Production ... 120 4.5.4. Methyl Red Test [MR-Test] ... 121 4.5.5. Voges-Proskauer Test [VP-Test] ... 121 4.5.6. Citrate Utilization ... 121 4.5.7. Nitrate Reduction ... 122 4.5.8. Ammonia Production ... 122 4.5.9. Urease Test ... 122 4.5.10. Production of Hydrogen Sulphide ... 123 4.5.11. Reduction of Methylene Blue ... 123 4.5.12. Production of Catalase [Tube Catalase Test] ... 123 4.5.13. Oxidase Reaction ... 123 4.5.14. Egg-Yolk Reaction ... 124 4.5.15. Growth in Presence of Potassium Cyanide ... 124 4.5.16. Composite Media ... 124 4.6 Profile of Microbial Stains ... 127 4.6.1. Preparation of Bacterial Specimens for Light Microscopy ... 128 4.6.1.1. Standard Preparations ... 128 4.6.1.2. Preparation of Smears for Staining ... 128 4.6.1.3. Gram Staining ... 129 4.6.1.4. Differential Staining ... 131 4.6.1.4.1. Gram’s Stain ... 131 4.6.1.4.2. Acid-Fast Stain ... 131 4.6.1.5. Miscellaneous Staining ... 131 4.6.1.5.1. Capsule Staining ... 132 4.6.1.5.2. Endospore Staining ... 132 4.6.1.5.3. Flagella Staining ... 133 ( xii ) 4.6.2. Microscopy : The Differential Instruments ... 133 4.6.2.1. Concepts ... 133 4.6.2.2. Microscope Variants ... 134 4.6.2.2.1. Bright-Field Microscope ... 134 4.6.2.2.2. Dark-Field Microscope ... 136 4.6.2.2.3. Phase-Contrast Microscope ... 136 4.6.2.2.4. Differential Interference Contrast (DIC) Microscope ... 139 4.6.2.2.5. Fluorescence Microscope ... 139 4.6.2.2.6. Electron Microscope ... 141 4.6.2.2.6.1. Transmission Electron Microscope (TEM) ... 142 4.6.2.2.6.2. Scanning Electron Microscope (SEM) ... 143 5. Nutrition, Cultivation and Isolation : Bacteria-Actinomycetes-Fungi-Viruses ... 146 5.1 Introduction ... 146 5.2 Bacteria ... 146 5.2.1. Nutrition of Microorganisms ... 146 5.2.2. Cultivation of Bacteria ... 147 5.2.2.1. Binary Fission ... 148 5.2.2.2. Normal Growth Curve of Microorganisms ... 149 5.2.2.3. The Lag Phase of Microbial Growth ... 150 5.2.2.4. Translational Periods Between Various Growth Phases ... 150 5.2.2.5. Synchronous Growth ... 151 5.2.2.6. Effect of Nutritional Concentration Vs Growth Rate of Bacterial Culture ... 152 5.2.2.7. Growth Determining Techniques ... 152 5.2.3. Isolation of Bacteria ... 154 5.2.3.1. Selective and Diagnostic Media ... 154 5.2.3.2. Bismuth Sulphate Agar ... 154 5.2.3.3. Selective Media for Staphylococci ... 155 5.3 Actinomycetes ... 155 5.4 Fungi ... 156 5.4.1. Reproduction of Fungi ... 158 5.4.1.1. Asexual Reproduction ... 158 5.4.1.2. Sexual Reproduction ... 159 5.4.2. Industrial Importance of Fung Methods and specifications Testing of pharmaceutical products is carried out according to a Pharmacopeia of which there are a few types. For example: In America, the United States Pharmacopeia is used; in Japan there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia and in Europe the European Pharmacopeia. These contain a test method which is to be followed when testing, along with defined specifications for the amount of microorganisms allowed in a given amount of product. The specifications change depending on the product type and method in which it is introduced to the body. The pharmacopoeia also covers areas like sterility testing, endotoxin testing, the use of biological indicators, microbial limits testing and enumeration, and the testing of pharmaceutical grade water.
-
من كتب علمية - مكتبة الكتب و الموسوعات العامة.

وصف الكتاب : Pharmaceutical microbiology من كتب علمية

Cover for Pharmaceutical Microbiology
Authors:
B l Chaudhary
Harshada jcshi




PREFACE
The textbook of
‘Pharmaceutical Microbiology’
specifically aims at the ever demanding
thoughtful need of an absolutely well-documented compilation of factual details related to : theoritical
principles, classifications, diagramatic profiles, graphic presentations, critical explanation, latest examples
for the Pharmacy Degree (B. Pharm.,) throughout the Indian Universities, SAARC-countries, and similar
curricula adopted abroad.
Modern invigorative society, based on the overwhelming and overemphasized broad-spectrum
importance
vis-a-vis
utilities of
‘Microbiology’
profusely gets benefited from the intricate species of
scores of microorganisms in several ways and means, namely :
antibiotics, vaccines, enzymes, vitamins
etc. Nevertheless, a quantum-leap-forward in the field of
‘Modern Biotechnology’
rests predominantly
upon reasonably sound
microbiological foundation.
Besides, microorganisms do modulate a plethora
of vital and critical functionalities, such as : (
a
) enable completion of cycles of C, O, N and S which
essentially occur in both
terrestrial and aquatic systems ;
(
b
) provide absolutely indispensable
components of prevailing
ecosystem ;
and (
c
) serve as a critical source of
‘nutrients’
occurring at the
grass-root of practically a large segment of
ecological food webs and chains.
The entire course-content presented in
‘Pharmaceutical Microbiology’
has been meticulously
and painstakingly developed and expanded as per the
AICTE-Approved Syllabus–2000.
Each chapter
has been duly expatiated in a simple, lucid, and crisp language easily comprehensible by its august
readers. A unique largely acceptable style of presentation has been adopted,
viz.,
brief introduction,
principles, labeled figures, graphics, diagrams of equipments, descriptions, explanations, pharmaceutical
applications, and selected classical examples. Each chapter is duly elaborated with adequate foot-notes,
references, and ‘further reading references’ at the end.
An exhaustive
‘Glossary of Important Microbiological Terminologies’
has been duly annexed
at the end of the textbook. A fairly up to date computer-generated
‘Index’
in the textbook will surely
enlarge the vision of its readers in gaining an easy access of subject enriched well documented text
materials.
Pharmaceutical Microbiology
consists of
Ten Chapters :
(1) Introduction and Scope ;
(2) Structure
and Function : Bacterial Cells ; (3) Characterization, Classification and Taxonomy of
Microbes ; (4) Identification of Microorganisms ; (5) Nutrition, Cultivation and Isolation : Bacteria-
Actinomycetes-Fungi-Viruses ; (6) Microbial Genetics and Variations ; (7) Microbial Control by Physical
and Chemical Methods ; (8) Sterility Testing : Pharmaceutical Products ; (9) Immune Systems ; and
(10) Mi
crobiological (Microbial) Assays : Antibiotics–Vitamins–Amino Acids.
The text material essentially embodies not only an ample emphasis on the vivid coverage of
fundamental principles of microbiology as a scientific discipline but also maintains a manageable length
for the apprehension of brilliant students.
CONTENTS
1. Introduction and Scope
...
1
1.1 Introduction
...
1
1.2 Historical Development of Microbiology
...
3
1.2.1. The Microscope
...
3
1.2.2.
Spontaneous Generation
Vs
Biogenesis
...
4
1.2.3. Fermentation
...
6
1.2.4. Germ Theory
...
6
1.2.5. Classical Laboratory Methods and Pure Cultures
...
7
1.2.6.
Immunity
...
8
1.2.7. Medical Microbiology
...
9
1.2.8. Pharmaceutical Microbiology
...
10
1.2.9. Industrial Microbiology
...
14
1.2.10. Emergence of Molecular Biology
...
15
1.2.11. Emergence of Virology
...
17
1.2.12.
Microorganisms as Geochemical Agents
...
19
1.2.13. Microbiology in the New Millennium
...
19.
2. Structure and Function : Bacterial Cells
...
23
2.1 Introduction
...
23
2.2 Characteristic Features
...
23
2.2.1. Shape
...
23
2.2.2. Size
...
23
2.2.3. Reproduction
...
24
2.2.4. Formation of Colony
...
24
2.2.5. Mutation
...
24
2.2.6.
Motility
...
24
2.2.7. Food and Oxygen Requirements
...
24
2.2.8. Temperature Requirements
...
24
2.3 Activities
...
25
2.4 Organization of Microbial Cells
...
25
2.4.1. Type of Cells
...
26
2.4.1.1. Eukaryotic Cells
...
27
2.4.1.2. Prokaryotic Cells
...
33
2.5 Archaeobacteria and Eubacteria
...
37
2.5.1. Methanogenic
Bacteria [Methanogens]
...
38
2.5.2. Extreme Halophiles
...
40
(
ix
)
2.5.3. Thermoacidophiles
...
41
2.5.3.1. Thermoplasma
...
41
2.5.3.2. Sulfolobus
...
41
2.6 The Bacterial Cells
...
42
2.6.1. Typical Bacterial Cells
...
43
2.6.2. Capsules and Slimes
...
44
2.6.3. Flagella and Fimbria
...
46
2.6.3.1. Flagella
...
46
2.6.3.2. Fimbria [or Pili]
...
48
2.6.4. Cell Envelope
...
49
2.6.5. Gram-Positive and Gram-Negative Bacteria
...
51
2.6.6. Significance of Teichoic Acids
...
53
2.6.7. The Cell Membrane
...
54
2.6.8. Bacterial Cytoplasm
...
55
2.6.9. Ribosomes
...
57
2.6.10. Cellular Reserve Materials
...
58
3. Characterization, Classification and Taxonomy of Microbes
...
62
3.1 Introduction
...
62
3.2 Characterization
...
62
3.2.1. Morphological Characteristics
...
63
3.2.2. Chemical
Characteristics
...
64
3.2.3. Cultural Characteristics
...
64
3.2.4. Metabolic Characteristics
...
66
3.2.5. Antigenic Characteristics
...
66
3.2.6. Genetic Characteristics
...
67
3.2.6.1. DNA Base Composition
...
67
3.2.6.2. Sequence of Nucleotide Bases in DNA
...
68
3.2.7. Pathogenecity
...
69
3.2.8. Ecological Characteristics
...
69
3.3 Classificiation
...
70
3.3.1. Difficulties Encountered
in Classification of Microorganisms
...
70
3.3.2. Objectives of Classification
...
70
3.3.3. Genetic Methods of
Classifying Microbes
...
71
3.3.3.1. Genetic Relatedness
...
71
3.3.3.2. The Intuitive Method
...
72
3.3.3.3. Numerical Taxonomy
...
72
3.3.4. Systemetized Classification
...
75
3.3.4.1. Natural Classification
...
75
3.3.4.2. Phyletic Calssification
...
75
(
x
)
3.3.4.3. Linnear Binomial Scheme
...
76
3.3.4.4. Phenotypic Classification
...
77
3.3.4.5. Microscopic Examination
...
79
3.3.4.6. Cataloguing rRNA
...
80
3.3.4.7. Computer Aided Classification
...
81
3.3.4.8. Bacterial Classification
...
82
3.4 Taxonomy
...
87
3.5 The Kingdom Prokaryotae
...
88
3.5.1. Actinomyctes
...
89
3.5.1.1. General Characteristics
...
89
3.5.1.2. Significance of Actinomycetes
...
90
3.5.1.3. Classification
...
91
3.5.1.3.1. Whole Cell Carbohydrate Patterns of Aerobic
Actinomycetes
...
91
3.5.1.3.2. Major Constituents of Cell Wall Types of
Actinomycetes
...
91
3.5.1.3.3. Groups of Actinomycetes Based on Whole
Cell Carbohydrate Pattern and Cell
Wall Type
...
92
3.5.1.3.4. Actinomycetes with Multiocular Sporangia
...
92
3.5.1.4. Actinomycetes and Related Organisms
...
93
3.5.1.4.1. Group
...
93
3.5.1.4.2. Genus
...
94
3.5.1.4.3. Order
...
97
3.5.1.4.4. Family
...
98
3.5.2. Bacteria
...
102
3.5.2.1. Salient Features
...
103
3.5.2.2. Structure and Form of the Bacterial Cell
...
104
3.5.2.2.1. Size and Shape
...
105
3.5.2.2.2. Structure
...
105
3.5.3. Rickettsia and Coxiella
...
107
3.5.4. Spirochaetes
...
108
4. Identification of Microorganisms
...
112
4.1 Introduction
...
112
4.2 Morphology
...
113
4.3 Selective and Diagnostic Media
...
113
4.3.1. Differential
Media
...
116
4.3.1.1. Eosin Methylene Blue Agar [EMB-Agar]
...
116
(
xi
)
4.3.1.2. MacConkey Agar
...
116
4.3.1.3. Hektoen Enteric Agar [HE-Agar]
...
116
4.3.2. Enrichment Media
...
116
4.3.2.1. Blood Agar
...
116
4.3.2.2. Chocolate Agar
...
117
4.3.3. Characteristic Media
...
117
4.3.3.1. Triple Sugar Iron Agar [TSI-Agar]
...
117
4.4 Cultural Characteristics
...
119
4.5 Biochemical Tests (or Properties)
...
120
4.5.1. Carbohydrate (Sugar) Fermentation
...
120
4.5.2. Litmus
Milk
...
120
4.5.3. Indole Production
...
120
4.5.4. Methyl
Red Test [MR-Test]
...
121
4.5.5. Voges-Proskauer Test [VP-Test]
...
121
4.5.6. Citrate Utilization
...
121
4.5.7. Nitrate Reduction
...
122
4.5.8. Ammonia Production
...
122
4.5.9. Urease Test
...
122
4.5.10. Production of Hydrogen Sulphide
...
123
4.5.11. Reduction of Methylene Blue
...
123
4.5.12. Production
of Catalase [Tube Catalase Test]
...
123
4.5.13. Oxidase Reaction
...
123
4.5.14.
Egg-Yolk Reaction
...
124
4.5.15. Growth in Presence of Potassium Cyanide
...
124
4.5.16. Composite Media
...
124
4.6 Profile of Microbial Stains
...
127
4.6.1. Preparation of Bacterial Specimens for Light Microscopy
...
128
4.6.1.1. Standard Preparations
...
128
4.6.1.2. Preparation of Smears for Staining
...
128
4.6.1.3. Gram Staining
...
129
4.6.1.4. Differential Staining
...
131
4.6.1.4.1. Gram’s Stain
...
131
4.6.1.4.2. Acid-Fast Stain
...
131
4.6.1.5. Miscellaneous Staining
...
131
4.6.1.5.1. Capsule Staining
...
132
4.6.1.5.2. Endospore Staining
...
132
4.6.1.5.3. Flagella Staining
...
133
(
xii
)
4.6.2. Microscopy : The Differential Instruments
...
133
4.6.2.1. Concepts
...
133
4.6.2.2. Microscope Variants
...
134
4.6.2.2.1. Bright-Field Microscope
...
134
4.6.2.2.2. Dark-Field Microscope
...
136
4.6.2.2.3. Phase-Contrast Microscope
...
136
4.6.2.2.4. Differential Interference Contrast
(DIC) Microscope
...
139
4.6.2.2.5. Fluorescence Microscope
...
139
4.6.2.2.6. Electron Microscope
...
141
4.6.2.2.6.1. Transmission Electron
Microscope (TEM)
...
142
4.6.2.2.6.2. Scanning Electron
Microscope (SEM)
...
143
5. Nutrition, Cultivation and Isolation : Bacteria-Actinomycetes-Fungi-Viruses
...
146
5.1 Introduction
...
146
5.2 Bacteria
...
146
5.2.1. Nutrition of Microorganisms
...
146
5.2.2. Cultivation of Bacteria
...
147
5.2.2.1. Binary Fission
...
148
5.2.2.2. Normal Growth Curve of Microorganisms
...
149
5.2.2.3. The Lag Phase of Microbial Growth
...
150
5.2.2.4. Translational Periods Between Various Growth Phases
...
150
5.2.2.5. Synchronous Growth
...
151
5.2.2.6. Effect of Nutritional Concentration
Vs
Growth Rate of
Bacterial Culture
...
152
5.2.2.7. Growth Determining Techniques
...
152
5.2.3. Isolation of Bacteria
...
154
5.2.3.1. Selective and Diagnostic Media
...
154
5.2.3.2. Bismuth Sulphate Agar
...
154
5.2.3.3. Selective Media for Staphylococci
...
155
5.3 Actinomycetes
...
155
5.4 Fungi
...
156
5.4.1. Reproduction of Fungi
...
158
5.4.1.1. Asexual Reproduction
...
158
5.4.1.2. Sexual Reproduction
...
159
5.4.2. Industrial Importance of Fung


Methods and specifications
Testing of pharmaceutical products is carried out according to a Pharmacopeia of which there are a few types. For example: In America, the United States Pharmacopeia is used; in Japan there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia and in Europe the European Pharmacopeia. These contain a test method which is to be followed when testing, along with defined specifications for the amount of microorganisms allowed in a given amount of product.

The specifications change depending on the product type and method in which it is introduced to the body. The pharmacopoeia also covers areas like sterility testing, endotoxin testing, the use of biological indicators, microbial limits testing and enumeration, and the testing of pharmaceutical grade water.


عدد مرات التحميل : 19264 مرّة / مرات.
تم اضافته في : الجمعة , 25 مارس 2016م.
حجم الكتاب عند التحميل : 4.2 ميجا بايت .

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Pharmaceutical microbiology من كتب علمية


CONTENTS
1. Introduction and Scope
...
1
1.1  Introduction
...
1
1.2  Historical Development of Microbiology
...
3
1.2.1.  The Microscope
...
3
1.2.2.
Spontaneous Generation 
Vs
 Biogenesis
...
4
1.2.3.  Fermentation
...
6
1.2.4.  Germ Theory
...
6
1.2.5.  Classical Laboratory Methods and Pure Cultures
...
7
1.2.6.
Immunity
...
8
1.2.7.  Medical Microbiology
...
9
1.2.8.  Pharmaceutical Microbiology
...
10
1.2.9.  Industrial Microbiology
...
14
1.2.10.  Emergence of Molecular Biology
...
15
1.2.11.  Emergence of Virology
...
17
1.2.12.
Microorganisms as Geochemical Agents
...
19
1.2.13.  Microbiology in the New Millennium
...
19.
2. Structure and Function : Bacterial Cells
...
23
2.1  Introduction
...
23
2.2  Characteristic Features
...
23
2.2.1.  Shape
...
23
2.2.2.  Size
...
23
2.2.3.  Reproduction
...
24
2.2.4.  Formation of Colony
...
24
2.2.5.  Mutation
...
24
2.2.6.
Motility
...
24
2.2.7.  Food and Oxygen Requirements
...
24
2.2.8.  Temperature Requirements
...
24
2.3  Activities
...
25
2.4  Organization of Microbial Cells
...
25
2.4.1.  Type of Cells
...
26
2.4.1.1. Eukaryotic Cells
...
27
2.4.1.2. Prokaryotic Cells
...
33
2.5  Archaeobacteria and Eubacteria
...
37
2.5.1.  Methanogenic 
Bacteria  [Methanogens]
...
38
2.5.2.  Extreme Halophiles
...
40
(
ix
)
2.5.3.  Thermoacidophiles
...
41
2.5.3.1.  Thermoplasma
...
41
2.5.3.2.  Sulfolobus
...
41
2.6  The Bacterial Cells
...
42
2.6.1.  Typical Bacterial Cells
...
43
2.6.2.  Capsules and Slimes
...
44
2.6.3.  Flagella and Fimbria
...
46
2.6.3.1. Flagella
...
46
2.6.3.2. Fimbria [or Pili]
...
48
2.6.4.  Cell Envelope
...
49
2.6.5.  Gram-Positive and Gram-Negative Bacteria
...
51
2.6.6.  Significance of Teichoic Acids
...
53
2.6.7.  The Cell Membrane
...
54
2.6.8.  Bacterial Cytoplasm
...
55
2.6.9.  Ribosomes
...
57
2.6.10.  Cellular Reserve Materials
...
58
3. Characterization, Classification and Taxonomy of Microbes
...
62
3.1  Introduction
...
62
3.2  Characterization
...
62
3.2.1.  Morphological  Characteristics
...
63
3.2.2.  Chemical 
Characteristics
...
64
3.2.3.  Cultural  Characteristics
...
64
3.2.4.  Metabolic  Characteristics
...
66
3.2.5.  Antigenic  Characteristics
...
66
3.2.6.  Genetic  Characteristics
...
67
3.2.6.1. DNA Base Composition
...
67
3.2.6.2. Sequence of Nucleotide Bases in DNA
...
68
3.2.7.  Pathogenecity
...
69
3.2.8.  Ecological  Characteristics
...
69
3.3  Classificiation
...
70
3.3.1.  Difficulties Encountered 
in Classification of Microorganisms
...
70
3.3.2.  Objectives of Classification
...
70
3.3.3.  Genetic Methods of 
Classifying Microbes
...
71
3.3.3.1. Genetic Relatedness
...
71
3.3.3.2. The Intuitive Method
...
72
3.3.3.3. Numerical Taxonomy
...
72
3.3.4.  Systemetized Classification
...
75
3.3.4.1. Natural Classification
...
75
3.3.4.2. Phyletic Calssification
...
75
(
x
)
3.3.4.3. Linnear Binomial Scheme
...
76
3.3.4.4. Phenotypic Classification
...
77
3.3.4.5. Microscopic Examination
...
79
3.3.4.6. Cataloguing rRNA
...
80
3.3.4.7. Computer Aided Classification
...
81
3.3.4.8. Bacterial Classification
...
82
3.4  Taxonomy
...
87
3.5  The Kingdom Prokaryotae
...
88
3.5.1.  Actinomyctes
...
89
3.5.1.1. General Characteristics
...
89
3.5.1.2. Significance of Actinomycetes
...
90
3.5.1.3.  Classification
...
91
3.5.1.3.1. Whole Cell Carbohydrate Patterns of Aerobic
Actinomycetes
...
91
3.5.1.3.2. Major Constituents of Cell Wall Types of
Actinomycetes
...
91
3.5.1.3.3. Groups of Actinomycetes Based on Whole
Cell Carbohydrate Pattern and Cell
Wall  Type
...
92
3.5.1.3.4. Actinomycetes with Multiocular Sporangia
...
92
3.5.1.4. Actinomycetes and Related Organisms
...
93
3.5.1.4.1.  Group
...
93
3.5.1.4.2.  Genus
...
94
3.5.1.4.3.  Order
...
97
3.5.1.4.4. Family
...
98
3.5.2.  Bacteria
...
102
3.5.2.1. Salient Features
...
103
3.5.2.2. Structure and Form of the Bacterial Cell
...
104
3.5.2.2.1. Size and Shape
...
105
3.5.2.2.2.  Structure
...
105
3.5.3.  Rickettsia and Coxiella
...
107
3.5.4.  Spirochaetes
...
108
4. Identification of Microorganisms
...
112
4.1  Introduction
...
112
4.2  Morphology
...
113
4.3  Selective and Diagnostic Media
...
113
4.3.1.  Differential 
Media
...
116
4.3.1.1. Eosin Methylene Blue Agar [EMB-Agar]
...
116
(
xi
)
4.3.1.2. MacConkey Agar
...
116
4.3.1.3. Hektoen Enteric Agar [HE-Agar]
...
116
4.3.2.  Enrichment Media
...
116
4.3.2.1. Blood Agar
...
116
4.3.2.2. Chocolate Agar
...
117
4.3.3.  Characteristic Media
...
117
4.3.3.1. Triple Sugar Iron Agar [TSI-Agar]
...
117
4.4  Cultural  Characteristics
...
119
4.5  Biochemical Tests (or Properties)
...
120
4.5.1.  Carbohydrate (Sugar) Fermentation
...
120
4.5.2.  Litmus 
Milk
...
120
4.5.3.  Indole Production
...
120
4.5.4.  Methyl 
Red Test [MR-Test]
...
121
4.5.5.  Voges-Proskauer Test [VP-Test]
...
121
4.5.6.  Citrate Utilization
...
121
4.5.7.  Nitrate Reduction
...
122
4.5.8.  Ammonia Production
...
122
4.5.9.  Urease Test
...
122
4.5.10.  Production of Hydrogen Sulphide
...
123
4.5.11.  Reduction of Methylene Blue
...
123
4.5.12.  Production 
of Catalase [Tube Catalase Test]
...
123
4.5.13.  Oxidase  Reaction
...
123
4.5.14.
Egg-Yolk Reaction
...
124
4.5.15.  Growth in Presence of Potassium Cyanide
...
124
4.5.16.  Composite Media
...
124
4.6  Profile of Microbial Stains
...
127
4.6.1.  Preparation of Bacterial Specimens for Light Microscopy
...
128
4.6.1.1. Standard Preparations
...
128
4.6.1.2. Preparation of Smears for Staining
...
128
4.6.1.3. Gram Staining
...
129
4.6.1.4. Differential Staining
...
131
4.6.1.4.1. Gram’s Stain
...
131
4.6.1.4.2. Acid-Fast Stain
...
131
4.6.1.5. Miscellaneous Staining
...
131
4.6.1.5.1.  Capsule  Staining
...
132
4.6.1.5.2.  Endospore  Staining
...
132

Methods and specifications
Testing of pharmaceutical products is carried out according to a Pharmacopeia of which there are a few types. For example: In America, the United States Pharmacopeia is used; in Japan there is the Japanese Pharmacopeia; in the United Kingdom there is the British Pharmacopoeia and in Europe the European Pharmacopeia. These contain a test method which is to be followed when testing, along with defined specifications for the amount of microorganisms allowed in a given amount of product.

The specifications change depending on the product type and method in which it is introduced to the body. The pharmacopoeia also covers areas like sterility testing, endotoxin testing, the use of biological indicators, microbial limits testing and enumeration, and the testing of pharmaceutical grade water.

Cleanrooms and controlled environments
Pharmaceutical microbiologists are required to assess cleanrooms and controlled environments for contamination (viable and particulate) and to introduce contamination control strategies. This includes an understanding of risk assessment.[3]

Risk management has been successfully employed in various industrial sectors like US Space industry (NASA), nuclear power industry and automobile industry which benefited these industries in several areas. But in application, the pharmaceutical sector is still in its infancy and the utilization of risk assessment techniques to pharmaceutical production is just beginning and the potential gains are yet to be realized.

Cleanrooms and zones are typically classified according to their use (the main activity within each room or zone) and confirmed by the cleanliness of the air by the measurement of particles. Cleanrooms are microbiologically assessed through environmental monitoring methods.

Viable monitoring is designed to detect levels of bacteria and fungi present in defined locations /areas during a particular stage in the activity of processing and filling a product. Viable monitoring is designed to detect mesophilic micro-organisms in the aerobic state. However, some manufacturers may have requirements to examine for other types of microorganisms (such as anaerobes if nitrogen lines are used as part of the manufacturing process).[4]

Surface methods include testing various Surfaces for numbers of microorganisms, such as:

•    Product Contact Surfaces •    Floors •    Walls •    Ceilings

Using techniques like:

•    Contact Plates •    Touch Plates •    Swabs •    Surface Rinse Method

For air monitoring, this is undertaken using agar settle plates (placed in the locations of greatest risk) or active (volumetric) air-samplers (to provide a quantitative assessment of the number of microorganisms in the air per volume of air sampled). Active air-samplers generally fall into the following different models:

•    Slit to Agar •    Membrane Filtration    •    Centrifugal Samplers

Monitoring methods will all use either a general purpose culture medium like tryptone soya agar (TSA), which will be used at a dual incubation regime of 30 °C – 35 °C and 20 °C – 25 °C or two different culture media are used at two different temperatures, of which one of the media is selective for fungi (e.g. Sabouraud Dextrose agar, SDA). The choice of culture media, incubation times and temperatures requires validating.

Professional guidance
The main sources of education and professional guidance for pharmaceutical microbiology come from Dr Tim Sandle's Pharmaceutical Microbiology Resources, Dr Scott Sutton's Microbiology Network, and the UK and Ireland Pharmaceutical Microbiology Interest Group (Pharmig).

References
 Saghee M, Sandle T, Tidswell E (editors) (2011). Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices (1st ed.). Business Horizons. ISBN 978-8190646741.[1]
 Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms. Surrey, UK: Grosvenor House Publishing. pp. 1–30. ISBN 978-1781487686.
 Sandle, T. & Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and Healthcare. Passfield, UK: Euromed Communications.
 Based on definition from Environmental Monitoring.
External links
Pharmaceutical Microbiology educational resources
Pharmaceutical Microbiology Company
Microbiology Network
Categories: Pharmaceutical microbiologyMicrobiology
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