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Pharmaceutical Microbiology

El-Hassan El-Sadek
Microbiology Research
Agenda

By the end of the day you should be able to know:

 Introduction to Microbiology

 Microbiology lab. Overview

 Microbiology Lab. Role

 Pharmaceutical Microbiology

 Microbiological tests for pharmaceuticals

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1 2 3
Introduction to Microbiology Microbiology
Microbiology lab. Overview lab. Role

4 5
Pharmaceutical Microbiological
Microbiology tests
 Section No. 1

Introduction to
Microbiology
4
Microbiology definition
Microbiology definition

Micro + bio + logy

Microorganisms – Found in almost all environments
 Microbiology includes study of

Viruses Fungi

Bacteria

Protozoa Algae
Who is it?
Two

1 2 3
Introduction to Microbiology Microbiology
Microbiology lab. Overview lab. Role

4 5
Pharmaceutical Microbiological
Microbiology tests
 Section No. 2

Microbiology lab.
Overview
13
Microbiology Laboratory
Microbiology Laboratory

Bench surface sealed to wall

 Microbiology Laboratory

Floors covered to walls for easy decontamination

>>
 Microbiology Laboratory
Desing lab
 Microbiology Laboratory

<

<<
Microbiology Laboratory

Front View
Microbiology Laboratory

Front View
 Preparation Room

Distillator
 Preparation Room

Glassware ( Class A )
 Preparation Room

Hot plate
 Preparation Room

Sterilization Area
 Culture Room

Laminar Air Flows

(Culture Room )
 Microbiology Laboratory

Cooling Incubators
(Incubation area)
Three

1 2 3
Introduction to Microbiology Microbiology
Microbiology lab. Overview lab. Role

4 5
Pharmaceutical Microbiological
Microbiology tests
 Section No. 3

Microbiology lab.
Role
28
Four

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Introduction to Microbiology Microbiology
Microbiology lab. Overview lab. Role

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Pharmaceutical Microbiological
Microbiology tests
 Section No. 4

Pharmaceutical
Microbiology
34
 Good Manufacturing Practice
Good manufacturing practice (GMP) :
Is a production and testing practice that helps to
ensure a quality product.

www.AssignmentPoint.co
Why is GMP required?

1. To minimize human error.

2. To prevent the contamination of pharmaceuticals.
3. To ensure high quality of product.
GMP Guidelines for Microbiology Laboratory:

1. Personnel : All personal must be wear apron, gloves.

2. Environment: Control air, temperature & humidity.
3. Equipment: Must be cleaned up & stored.
4. Validation: To ensure stability & conformity.
Sources of Contamination

• People/Personnel

• Air/Environment

• Equipment

• Surfaces

• Others
Contamination Control
 Particle Size Range
Color Guide
= biological
= inert
pollen
= virus

bacteria

mold

dust

smog

Virus

0.2mm 0.5mm 1mm 5mm 50mm

Particle size
 Clean Rooms & Microbiology –
Activities vs. Particles Generated

Sitting Quietly Moving Walking

Particles shed per minute

100,000 1 Million 5 Million

Environmental Monitoring :

 Air Sampler (Active air )

 Settling plates (Passive air)
 Contact plates (Rodac Plate)
 Swabs
 Finger plates (staff)
 Gown plates
CFUs are determined 48 hours after the incubation at 30 – 35 oC
Five

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Introduction to Microbiology Microbiology
Microbiology lab. Overview lab. Role

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Pharmaceutical Microbiological
Microbiology tests
 Section No. 5

Microbiological tests
for pharmaceuticals 46
Microbiological Test Methods
Microbiological tests for pharmaceuticals fall into
several categories :

1. Microbial limit test.

2. Sterility testing.
3. Bacterial Endotoxin Test.
4. Growth promotion test
5. Water Microbiological analysis.
6. Microbial identification
Bioburden Testing (Microbial Limits Test) :

This test is used to estimate the total

number of viable microorganisms.

The microbial content of the product

includes the total bacterial count (TBC), total
yeast and mold count (TYMC).
Sterility Testing.

Disinfection or
Sterilization !!
Sterility Testing.

Sterility testing is done on wide range of

pharmaceutical products as eye drop,
antibiotic, and medical devices.
Bacterial Endotoxin (LAL Testing)

Endotoxins are natural compounds released

by the cell wall of gram negative bacteria.

 that are potentially toxic to humans.

Bacterial Endotoxin (LAL Testing)

The test for bacterial Endotoxin is used to

detect or quantify endotoxins using Limulus
Amoebocyte Lysate (LAL)

 LAL is an extract of blood cells from the

horseshoe crab (Limulus polyphemus)
The Growth Promotion test

It is a quality control test of media.

It is measure the ability of any media

used to support growth when the inoculum
contains a small number of microorganisms.
Water Testing

 Water is one of the major supplies

consumed by the pharmaceutical industry.

 Total viable count is studied to rule out

microbial contamination.
Microbial identification

Detection, isolation and identification

of microorganism :

 E.COLI TEST

 SALMONELLA TEST

 PSEUDOMONAS AERUGONSA TEST

 STAPHYLOCOCCUS AURUES TEST

Thank you ..
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2/10/2019