Chapter 1

Introduction of Pharmaceutical Microbiology

PowerPoint® Lecture Slide Presentation

REFERENCES

Tortora GJ, Funke BR, Case CL, 2007, Microbiology an

Introduction, 9th edition, Benjamin Cummings, San
Francisco, CA 94111, USA

Madigan MT, Martinko JM, 2006, Brock Biology of

Microorganisms, 11th edition, Pearson Education Inc., USA

Denyer SP, Hodges NA, Gorman SP, 2004, Hugo and

Russell’s: Pharmaceutical Microbiology, 7th edition,
Blackwell Science Ltd., Blackwell Publishing Company, USA

Doorne H, 2008, Seminar of Course on Current

Pharmaceutical Microbiology: Methods, Harmonization
and Technology, Faculty of Pharmacy UBAYA, Indonesia

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 Microbes in Our Lives

• Microorganisms are organisms that are too small

to be seen with the unaided eye
• Size < 0,1 mm; bacterial cell ± 1 µm
• “Germ” refers to a rapidly growing cell
• Microbiology revolves around 2 basic themes:
• The basic science of understanding life
• The application of science to human needs

Knowledge of microorganisms

• Microorganisms play the central role in both human

activities and the web of life on Earth
• Maintaining balance of environment
• Human:
• Food, Chem., Pharmaceutical, Biotech. industries
• A few are pathogenic, disease-causing
• Allows humans to:
• Prevent food or products spoilage
• Prevent disease occurrence

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 Characteristic of the cell: living system

Naming and Classifying

Microorganisms

• 1735, Linnaeus established the

system of scientific nomenclature
• Each organism has two names :
the genus and specific epithet
• Describe an organism, honor a
scientist or identify the habitat of
a species

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 Type of Microorganisms

• Bacteria
• Archaea
• Fungi
• Protozoa
• Algae
• Viruses
• Multicellular animal parasites

A Brief History of Microbiology

• Ancestors of bacteria were the first life on Earth
• The first microbes were observed in 1673

THE FIRST OBSERVATION:

• 1665, Robert Hooke (English): living things were
composed of little boxes or cells.
• Cell Theory. All living things are composed of cells

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 The First Observations

• 1673-1723, Antoni van

Leeuwenhoek (Dutch
merchant)
• Observed via teeth
scrapings, rain water, and
feces
• “animalcules”

The First Observations

300x

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 The Debate Over Spontaneous Generation

• The hypothesis: spontaneous generation

• A “vital force” forms life (air)
• The alternative: biogenesis

Aristoteles (300 BC)

Evidence Pro and Con

• 1668, Francisco Redi (Italian

physician) filled six jars with
decaying meat.

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 Evidence Pro and Con

• 1745, John Needham (English): Nutrient broth heated,

then poured in the sealed flask
• Microorganisms from the air probably had entered

• 1765, Lazzaro Spallanzani (Italian scientist): Nutrient

broth heated after being sealed in the flask

Evidence Pro and Con

• 1861, Louis Pasteur (French

scientist)
• Microorganisms are present in
the air and can contaminated
sterile solution; but air itself do
not create microbe

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 The Theory of Biogenesis
a.

b.

The Theory of Biogenesis

PASTEUR SHOWED THAT:

• Microorganisms can be present in the non living
matter – on solids, liquids and in the air
• Microbial life can be destroyed by heat and that
methods can be devised to block the access of
airborne microorganisms to nutrient environments.
• These discoveries form the basis of aseptic
techniques, which are now the standard practice
in laboratory, many medical procedure and more
important things that a beginning microbiologist
learns

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 The Golden Age of Microbiology
• 1857-1914, beginning with Pasteur and Robert Koch:
establishment of microbiology as a science
• Discoveries included
• Relationship between microbes-disease, immunity,
and antimicrobial drugs
• Chemical activity of microorganisms, techniques
improvement for performing microscopy and
culturing microorganisms

Fermentation and Pasteurization

• Fermentation: yeast convert the sugar to alcohol in

the absence of air
• Bacteria use alcohol and produce acetic acid spoil
wine by turning into vinegar
• The application of a high heat for a short time is called
pasteurization
• 1876, Robert Koch (German physician): proofs that a
bacterium causes anthrax and provides the
experimental steps
• Koch’s postulates: specific microbe causes a
specific disease.

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 The Germ Theory of Disease

The Birth of Modern Chemotherapy

• 1928, Alexander Fleming

discovered the first
antibiotic
• Penicillium fungus made
an antibiotic, penicillin,
that killed S. aureus
• 1940, penicillin was
tested clinically and mass
produced

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 Modern Developments in Microbiology

Pharmaceutical Microbiology

MICROBIOLOGY PHARMACY

PRODUCTS
• GMP: products (sterile; non-sterile), quality
• Efficacy, Safety, Stability, Acceptability

CLINICAL
• Disease; mechanisms of pathogenicity
• Antimicrobial Drugs and Assay

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 Pharmaceutical Microbiology

• Deterioration or spoilage of the products due to

microbial growth may results:
• LOSS of consistency, organoleptic and preservative
quality, package integrity, therapeutic activity

• Trigger a disease depends on various factors:

• Number of CFU’s of the pathogen present and the
properties of particular strain (toxin)
• Condition of the patient
• Route of administration

Pharmaceutical Microbiology

• Microbial limits of pharmaceutical preparations are

given in relevant monographs of the leading
pharmacopoeias (FI IV, USP, EuP)

• Factors related to microbiological quality:

• Properly formulated products
• The use of microbiologically pure raw materials
• The strict adherence to cGMP guidelines
• Use of adequate primary packaging material

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 Pharmaceutical Microbiology

• Harmful effects of microorganisms in pharmacy:

• May contaminate non-sterile and sterile medicine
with increase of products deterioration
• May contaminate non-sterile and sterile medicine
with increase the risk of infection
• Cause pyrogenic reactions (fever) when introduced
into the body even in the absence of infection
• Provide the reservoir of antibiotic resistance genes

Pharmaceutical relevance to microorganisms

Contamination Pathogens Resistance to Resistance to Used in the
or spoilage of antibiotics sterilizing manufacture
Type of raw material and biocides agents and of therapeutic
microorganism and medicines processes agents

Viruses +

Prions + + +

Bacteria
Gram (-) + + + +
Gram (+) + + + + (spores) +
Mycobacteria + +
Streptomycetes + +
Chlamydia +
Rickettsia +
Fungi
Yeasts + + + +
Moulds + + + +

Protozoa +

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