Pharmaceutical microbiology

1. -Vennela Nampalli

2. MICROBIOLOGY
Microbiology is the
study of micro-organisms such as
bacteria, protozoa, fungi & similar
organisms which can’t be seen by
naked eyes. The need to study
these minute organisms started
when scientists discovered the
association of microbes to specific
diseases. The role of microbiology
on the advances in the healthcare
industries especially in
pharmaceuticals and medical
industry have led to great
discoveries from vaccines to
medical devices.

3. LOUIS PASTEURANTONY VAN
LEEUWENHOOKE

4. PHARMACEUTICAL
MICROBIOLOGY
Pharmaceutical
microbiology is the combined field
of Microbiology and Pharmacy,
wherein study of microorganisms
that are related to production of
antibiotics, enzymes, vitamins,
vaccines and other pharmaceutical
products are detailed. It also deals
with causative agents of disease;
diagnostic procedures for
identification of causative agents;
preventive measures.

5. SIGNIFICANCE
Our cells have been fighting microbes that enter our
body and commonly exhibited by pus formation &
inflammation of wounds. Macrophages play role in
immune system bcoz they are capable of ingesting
microbes that enter our body through open wounds.
However, some microbes adapt & mutate rapidly,
resulting in infectious diseases like-HIV. So are
antibiotics, vaccines, etc. produced to get resistance
from microbes. On the contrary, microbes help us
like- Lactobacillus which functions in our digestive
system.

6. FACTORS INVOLVED :
 Pharmaceutical Microorganisms.
 Pharmaceutical Contamination
 Pharmaceutical Products & Microbial Risks.
 Microbial Limits Test & Assay
 Microbial Spoilage & Preservation.
 Antimicrobial Preservation
 Disinfection & Sterilization Technologies.
 Clean rooms & Controlled Techniques.
 Drug Quality Control
 Validation of Test Methods.
 Drug Safety /Pharmacovigilance
 Sterile Pharmaceutical Manufacturing
 Biological Indicators

7. Pharmaceutical Contamination
Pharmaceutical Contamination involves the
introduction of microbes into pharmaceutical
finished products.
Sources include: During manufacture,
Raw material used, Environmental sources ,
Cleaning equipments, Packing, Containers that
are frequently reused, Repackaging of products,
Processing, Storage & Transportation.
Factors affecting Microbial spoilage of
Pharmaceutical products include: Types & size
of contaminant inoculums, Factors related to -
pH, Moisture content, Storage temperature,
Packaging design, etc.

8. Microbial Limits Test & Assay
Microbial limits testing is performed to determine whether a
product complies compendial specifications for microbial quality. It
includes 2 phases: quantitative phase which covers the Microbial
Enumeration, gives the total number of aerobic organisms & total
yeast and mold count on product.
Microbial assay works on the principle that the organism is
inoculated into the medium containing all the growth factors
needed except the one under examination; the rate of growth is then
proportional to the amount of this nutrient added in the test
substance.

9. Antimicrobial Preservation
Preservation is the process of inhibiting or minimizing microbial
growth during the storage & multi-dose application the risk of
microbial contamination of pharmaceutical products.
A chemical substance used to preserve pharmaceuticals, food and
other organic material by preventing the growth of microorganisms
is termed as antimicrobial preservation.
Antimicrobial preservatives include: Methyl, ethyl, propyl and butyl
Parabens, Sorbic acid, Na, K & Ca Sorbate, Benzoic acid, Na, K &
Ca Benzoate, Sodium metabisulfite, Propylene glycol. BTH, BHA,
Benzaldehyde, Essential oils, Phenol and Mercury compounds

10. Drug Quality Control
According to WHO, term quality control
refers to the sum of all procedures
undertaken to ensure the identity and purity
of a particular pharmaceutical.Quality
control is an essential operation of the
pharmaceutical industry. Drugs must be
marketed as safe and therapeutically active
formulations whose performance is
consistent and predictable. It not only
protects the manufacturer against
compensation claims, but also guarantees
the patient a safe and effective product.

11. Drug Safety & Pharmacovigilance
Drug safety covers the topics on the
epidemiology, clinical features, prevention &
management of adverse effects of individual
drugs and drug classes. Benefit-risk
assessment proved an in-depth review of
adverse effect and efficacy data for a drug in
a defined therapeutic area.
Pharmacovigilance (PV or PhV) also
known as drug safety is the pharmacological
science relating to the collection, detection,
assessment monitoring of drug for its proper
use.

12. Sterile Pharmaceutical Manufacturing
The primary goal of final pharmaceutical
product is Quality and Safety. Active
Pharmaceutical Ingredients (API’s), used as
Ingredients in sterile medicinal products,
must be sterile unless the final dosage form
is terminally sterilized, or produced by a
process including a sterilising filtration step. API’s intended for use in parenteral
products must also comply with relevant specifications on pyrogens or bacterial
endotoxins. The manufacture of sterile API’s must be strictly controlled in order
to minimize the risk of contamination with micro- organisms, endotoxins and
particles. If the final dosage form is not to be sterilised by filtration, the API’s
should be practically free of particles.

13. Biological Indicators
Biological indicator (BI) is type of monitoring which provides
direct evidence that sterilization process conditions are
sufficient to kill spores. It uses microbes that are highly resistant
to the type of sterilization process you are monitoring.
BIs are considered the gold standard of load sterilization
monitoring. They are widely recommended as the preferred
device for monitoring and releasing loads.

15. MERITS
 High Reliability
 Product Safety
 Faster Times to Market
 More Innovation
 Type of antimicrobic drugs
and their application areas are
known
 The effects of antimicrobic
and non-antimicrobic drugs on
immune system are known.
 GMP and GLP applications
regarding microbiology in
pharmaceutical industry can be
known

16. DEMERITS
 Time Required
 Limited Accuracy
 Transfer Errors
 Data Entry Errors
 Difficult Interim Counts
 New Drugs are Expensive
 Adverse Drug Reactions and
Side Effects
 Some medicines have Low
Therapeutic index