The Presentation Include overview of Introduction and application of Microbiology in Pharma industry

1. Sanjay Pathak
Sr. QC Microbiologist
Amtech Med. Pvt. Ltd.(Nepal)
Application of Microbiology in
Pharmaceuticals

2. Agenda

3. Introduction to Microbiology
Micro + bio + logy

4. Virus Fungi
Bacteria
protozoan Yeast

5. Introduction Contd….
 Study of microbes such as Bacteria, Virus, Protozoa etc.
 Microbes Act as a guardian of our planet ensuring that key minerals
such as carbons and nitrogen are constantly recycled.
 Microbiology started after 17th century when Robert Hooke invented
Microscope.
 Louis Pasteur is considered as father of microbiology.

6. Microbiology Lab Review

7. Microscope

8. Glassware ( Class A )
Distillator

9. Incubation areaLaminar Air Flows
(Culture Room )
Sterilization AreaHot plate

10. Microbiology Lab. Role

12. Aerobic Count
MLT
AST
Biochemical Testing

13. Application

14. Application In Pharma Industry

15. Pharmaceutical Microbiology
Good Manufacturing Practice
 Is a production and testing
practice that helps to ensure
a quality product.
Why is GMP required?
 To minimize human error.
 To prevent the contamination
of pharmaceuticals.
 To ensure high quality of
product.

16. Pharmaceutical Microbiology Contd..
GMP Guidelines for Microbiology Laboratory:
 Personnel : All personal must be wear apron, gloves.
 Environment: Control air, temperature & humidity.
 Equipment: Must be cleaned up & stored.
 Validation: To ensure stability & conformity.

17. Pharmaceutical Microbiology Contd..
Sources of Contamination
 People/Personnel
 Personnel Accessory
 Air/Environment
 Equipment
 Surfaces
 Others

18. Pharmaceutical Microbiology Contd..
Contamination Control

19. Pharmaceutical Microbiology Contd…

20. Pharmaceutical Microbiology Contd…

21. Pharmaceutical Microbiology Contd…
Environmental Monitoring
 Air Sampler (Active air )
 Settling plates (Passive air)
 Contact plates (Rodac Plate)
 Swabs
 Finger plates (staff)
 Gown plates

22. Pharmaceutical Microbiology Contd…
CFUs are determined 48 hours after the incubation at 30 – 35°C

23. Pharmaceutical Microbiology Contd…

24. Contribution
 Microbial Contamination
 Antibiotics
 Vaccine
 Enzymes
 Vitamins
 Probiotics
 Amino Acids
 Quality Control (Microbiological Testing)

25. Microbiological tests for pharmaceuticals
 Microbial limit Testing (MLT)
 Sterility testing
 Bacterial Endotoxin Test
 Water Microbiological analysis
 Growth promotion test
 Microbial Assay
 Preservative Effectiveness Testing
 Environmental Monitoring

28. keep in touch:
 https://www.linkedin.co
m/in/sanjay-pathak-
07731b104/
 jaysanpathak@gmail.com
 Face book- Sanjay Pathak