A presentation of Bio-contamination during the manufacture of pharmaceutical products

1. Biocontamination
Welcome
Presentation on
To
Presented By
A N M Sharif
anm.sharif@live.com

2. Living organisms (such as bacteria, enzymes, fungi,
viruses) or their products that can be hazardous to animal or
human health if inhaled, swallowed, or otherwise absorbed into
the body.
Definition:
Biocontamination means contamination with biological
material or agents

3. Source:
 Microorganism (such as bacteria, enzymes, fungi, viruses)
 Water
 Insects
 Soil

4. Several types of Biocontaminants
are found in the environment
Indicator molds
• Molds are fungi that act as environmental decomposers that aid in the
decomposition of plant matter such as trees and leaves and also
decaying organic material.
• Three categories of different types of molds are
1. common indoor,
2. common outdoor,
3. water damage indicators.

5. Gram negative and positive
bacteria
Gram Negative Bacteria
Gram-negative bacteria are a group of bacteria that do not retain
the crystal violet stain used in the gram staining method of bacterial
differentiation.
Gram Positive Bacteria
Gram-positive bacteria are bacteria that give a positive result in the
gram stain test.

6. Microbial Particulates
• Different microbial organism or particulate presence in the bio
can be as an indicator of the biocontamination.
• Different types of microbial organisms grow into different types of
environments.
• Due to having different types of environments different types of
microbial particulate growing can easily be used as a
biocontaminant.

7. Mycotoxins
• The word Mycotoxin came from Greek word mykes, mukos meaning
"fungus" and toxikon meaning "poison").
• It is a toxic secondary metabolite produced by organisms of the
fungus kingdom, commonly known as molds.
• The term 'mycotoxin' is usually reserved for the toxic chemical
products produced by fungi that readily colonize crops.

8. Galactomannans
• Galactomannans are often used in food products to increase
the viscosity of the water phase.
• Guar gum has been used to add viscosity to artificial tears,
but is not as stable as carboxymethyl cellulose.
• As it is used as a food for different materials so it can easily
used to biocontaminate.

9. Bio-Contamination of Drinking Water

11. Types of Biological Organisms Present
in Water
(a)Bacteria
(b)Algae and plant-like flagellate protozoa
(c)Pathogenic protozoa

12. Biofilm formation
Initial
attachment
Irreversible
attachment
Mutation
Dispersion

13. Example

14. Bio-contamination
of pharmaceutical
product

15. Biocontamination of air in pharmaceutical area

16. Biocontamination Effect
Decrease
Efficacy
Decrease
Pharmacological
properties

17. Biocontamination control
techniques
The following control techniques may be used alone or more
commonly in combination:
• Continuous turbulent flow circulation.
• Avoid dead legs.

18. • Pipe work of ambient temperature system, isolated from hot
pipes.
• Growth
• For Bioflim removal it is necessary to conduct a series of
sanitation and chemical steps. E.g. chlorine, formaldehyde.

19. ISO Biocontamination Standards
• Part 1 : General principles, describes the principles and
basic methodology for a formal system to assess and
control biocontamination
• Part 2: Evaluation and interpretation of biocontamination
data, gives guidance on basic principles and methodological
requirements for all microbiological data evaluation, and
the estimation of biocontamination data obtained from
sampling for viable particles in zones at risk, as specified
by the system selected

20. Prevention of pharmaceutical
biocontamination
1. Ultraviolet radiation and Ozone
2. Temperature
3. Cross contamination prevention
4. Reverse osmosis

21. Essential facts related
to Biocontamination

23. If you have any
question, Please
feel free to ask
me!!!!!!!