2. Agenda
Introduction to Microbiology
Microbiology lab. Overview
Microbiology Lab. Role
Pharmaceutical Microbiology
Microbiological tests for pharmaceuticals
By the end of the day you should be able to know:
35. Good Manufacturing Practice
Is a production and testing practice that helps to
ensure a quality product.
Good manufacturing practice (GMP) :
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36. Why is GMP required?
1. To minimize human error.
2. To prevent the contamination of pharmaceuticals.
3. To ensure high quality of product.
37. 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.
47. Microbiological Test Methods
1. Microbial limit test.
2. Sterility testing.
3. Bacterial Endotoxin Test.
4. Growth promotion test
5. Water Microbiological analysis.
6. Microbial identification
Microbiological tests for pharmaceuticals fall into
several categories :
48. 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).
52. Bacterial Endotoxin (LAL Testing)
Endotoxins are natural compounds released
by the cell wall of gram negative bacteria.
that are potentially toxic to humans.
53. 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)
54. 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.
55. Water Testing
Water is one of the major supplies
consumed by the pharmaceutical industry.
Total viable count is studied to rule out
microbial contamination.
56. Microbial identification
E.COLI TEST
SALMONELLA TEST
PSEUDOMONAS AERUGONSA TEST
STAPHYLOCOCCUS AURUES TEST
Detection, isolation and identification
of microorganism :