Introduction to Pharmaceutical

Microbiology
MICROBIOLOGY
Micro small
Biology study of living things

Microbiology is the study of all living organisms that are too small to
be visible with the naked eye.
This includes bacteria, archaea, viruses, fungi, prions, protozoa, and
algae.

Microbiologists:
Jenner vaccine against smallpox
Fleming discovery of penicillin
Marshall identification of the link between Helicobacter pylori
infection and stomach ulcer
zur Hausen identified the link between papilloma virus and
cervical cancer
Pharmaceutical Microbiology
Is an applied branch of microbiology that is responsible
for ensuring that medications do not contain harmful
levels of microbes such as bacteria, yeast and molds.
It mainly focuses on the manufacturing techniques,
process controls, and finished attributes that limit the
harmful effects of microorganisms on the drug product.
Why Microbiology in Pharmaceutical
Industry?
Pharmaceutical products can save lives and bring back the
health of patients, but what if these products are
contaminated?

Effects of microbial contamination in pharmaceutical

products
Patients Company
Infections Product recalls
Serious illness Loss of sales
Death Financial loss
Decreased customer
confidence
Damage to companys
reputation
Legal proceedings
Microorganisms and Medicines
1977 eradication of smallpox
2011 rinderpest
High mortality cattle disease (contributed poverty and famine
in Africa and Asia)
Polio and guinea-worm infection
 Pharmaceutical companies
Development of vaccines
Rising standards for product quality
Regulation of manufacturing procedures
 Most medicines consist of an active ingredient that is
formulated with a variety of other materials to ensure
that the medicine is effective and remains stable,
palatable, and safe during storage and use.
 Microorganisms
Initiate infections
Cause product spoilage (by chemically decomposing the active
ingredient or the excipients): may lead to a product that is
under-strength, physically and chemically unstable

Pharmaceutical Microbiology MUST encompass the

subjects of STERILIZATION AND PRESERVATION
against microbial spoilage.
Disinfectant vs. Antiseptic
ANTISEPTIC
Applied to living skin or tissue to prevent infection

DISINFECTANT
Applied to surfaces, equipment or other inanimate objects
Sterilization vs. Disinfection
STERILIZATION
Kills all living organisms (including viruses, bacteria and cells,
from an object)

DISINFECTION
removes disease-causing organisms, but not necessarily all
organisms present on an object
ANTIBIOTIC
Originally defined as a naturally occurring substance that
was produced by one organism that inhibited the growth
or killed another microorganism
More recently defined as a certain synthetic agent used to
treat infection
ANTIBIOTIC
1940s Penicillin
1950s steroids
Last three decades of the 20th century recombinant
DNA technology
21st century physiology and genetics of microorganisms
Genetic techniques (eg. Ribotyping) increasingly used to identify
cross-infection and optimize management of hospital acquired
infections
 Microorganisms have the ability to take advantage in
practices and procedures in medicine and surgery.
One feature of modern surgery: increasing use of plastic,
ceramic and metal devices that are introduced into the body
Urinary or venous catheters, heart valves, hip prostheses
Microorganisms in pharmacy: benefits and
problems
Benefits and uses Related study Harmful effects Related study
topics topic
The manufacture of: Good May contaminate Non-sterile
Antibiotics, steroids, manufacturing non-sterile and medicines
therapeutic practice. sterile medicines
enzymes, with a risk of Enumeration of
polysaccharides, Industrial infection. microorganisms in
products of fermentation the manufacturing
recombinant NA technology. environment
technology
Microbial genetics Identification and
detection of specific
organisms
Microorganisms in pharmacy: benefits and
problems

Benefits and uses Related study Harmful effects Related study

topics topic
Use in the Quality control of Sterile medicines:
production of immunological Sterilization
vaccines products methods
Sterilization
monitoring and
validation
procedures
Sterility testing
Assessment and
calculation of
sterility assurance
Aseptic
manufacture
Microorganisms in pharmacy: benefits and
problems

Benefits and uses Related study Harmful effects Related study

topics topic
As assay organisms Assay methods
to determine
antibiotic, vitamin
and amino acid
concentrations
To detect Ames mutagenicity May contain non- Characteristics,
mutagenic or test sterile and sterile selection and
carcinogenic activity medicines with risk testing of
of product antimicrobial
deterioration preservatives

Cause infectious Immunology and

and other diseases infectious diseases
Criteria and standards for the microbiological quality of
medicines depend upon the route of administration of the
medicine.
Medicines given by mouth or placed on the skin (non sterile)
they may contain some microorganisms but within limits and
concentration
Injections and ophthalmic products (sterile) containing NO
living organism
Other anatomical sites (e.g. nose, vagina, ear, and bladder) are
often sterile
A pharmaceutical microbiologist should
possess
The ability to identify organisms present
Enumerate microbial contaminants in the manufacturing
environment
Familiarity with the characteristics of antimicrobial
preservatives that may be a component of the medicine
required to minimize the risk of microbial growth
 Sterile medications may be manufactured by two different
strategies:
1. Most preferred option: to make the product, pack it in
its final container and sterilize it by heat and
radiation
2. Alternative option: manufacture the product from
sterile ingredients under conditions that do not
permit the entry of contaminating organisms
(termed as aseptic manufacture)
Development in Pharmaceutical
Microbiology:
DNA technology development of vaccines (prevention
of Hepatitis B); genetically engineered surface antigens
making it more effective
Enzymes were developed for use in:
cancer chemotherapy (asparaginase)
Digest blood clots (streptokinase)
Polysaccharides found in therapeutic applications
(dextran used as a plasma expander)

Insulin (1982) first therapeutic product of DNA technology to be

licensed for human use
Fundamental features of
Microbiology
Introduction
Microorganisms differ in terms of their:
Size
Shape
Appearance
Genetic and metabolic characteristics
Microorganisms:

Viruses, viroids and prions

Bacteria and archaea
Fungi
Protozoa
Viruses, viroids and prions
Viruses
Do not have cellular structure
Particles composed of nucleic acid surrounded by protein
Do not contain enzymes (incapable of independent
replication)

ALL Viruses are INTRACELLULAR parasites and

are reproduced using the metabolic capabilities of
the host cell.
Viruses
Shape
Size
Nucleic acid composition
Viroids and Prions
VIROIDS
virusoids
Simpler than viruses
Single-stranded RNA without any protein

PRIONS
no nucleic acid
Atypical form of a mammalian protein that can interact with a
normal protein molecule
Agents responsible for transmissible spongiform
encephalopathies (e.g. Creutzfeldt-Jakob disease or CJD and
Bovine spongiform encephalopathy or BSE)
EUKARYOTES vs. PROKARYOTES
Characteristics EUKARYOTES PROKARYOTES
Size Normally >10 um Typically 1-5 um
Location of chromosomes Within a true nucleus In the cytoplasm, usually
separated from the attached to the cell
cytoplasm by a nuclear membrane
membrane
Nuclear division Exhibit mitosis and meiosis Mitosis and meiosis are
absent
Nucleolus Present Absent
Reproduction Asexual or sexual Normally asexual
production reproduction
Chromosome number >1 1
Mitochondria and May be present Absent
chloroplasts
Cell membrane Sterols present Sterols absent
composition
Cell wall composition Cell walls usually contain Walls usually contain
cellulose or chitin but not peptidoglycan
peptidoglycan
EUKARYOTES vs. PROKARYOTES

Characteristics EUKARYOTES PROKARYOTES

Ribosomes Cytoplasmic ribosomes Ribosomes are smaller,
are 80S usually 70S
Flagella Structurally complex Structurally simple
Pili Absent Present
Fimbriae Cilia Present
Storage compounds Poly-B-hydroxyburate Poly-B-hydroxyburate
absent often present
FUNGI
Structurally more complex and varied in appearance than
bacteria
Non-photosynthesizing plants
Fungus (covers both yeasts and moulds)

Yeasts Moulds
-unicellular organisms - Describes fungi that do
larger than bacteria not form fruiting bodies
(typically 5-10 um) - Most moulds consists of
-divide either by binary a tangled mass
fission or budding (mycelium) of filaments
or threads (hyphae)
which vary between 1
and over 50 um wide
PROTOZOA
Eukaryotic
Unicellular organisms (regarded as animals rather than
plants)
Many protozoa are free-living motile organisms (that
occur in water and soil)
Protozoa are NOT normally found as contaminants of
raw materials (they primarily cause disease)
Naming of microorganisms
Two names:
Genus
Species

Example:
Staphylococcus aureus or S. aureus or Staph. aureus
TAPOS NA LECTURE, WAG NA
KAYONG MATULOG