PHARMACEUTICAL MICROBIOLOGY Animesh Shukla.pptx

In this ppt I have covered basic concept of pharmaceutical microbiology, it's objectives, branches, scope and testing.

1. PHARMACEUTICAL MICROBIOLOGY Animesh Shukla BSc. Sem 5 ECC, Prayagraj

2. INTRODUCTION OF PHARMACEUTICAL MICROBIOLOGY Microbiology is the branch of science that is concerned primarily with the biology of microorganisms and their effects on other living organisms e.g., bacteria, protozoa, algae, fungus and viruses. What is pharmaceutical microbiology ? When microbiological concepts , processes and techniques are applied to pharmaceutical applications, the subjects is then called as ‘ pharmaceutical microbiology’

3. OBJECTIVES OF PHARMACEUTICAL MICROBIOLOGY Objectives of pharmaceutical microbiology is to ensure safety and efficacy of pharmaceutical products. It embraces to validation of disinfectants, evaluation of the efficacy of disinfectants in suspension, on surfaces and through field trials. It offers protocols and techniques associated with the operation and assurance of clean-room, aseptic-room and controlled environments for preventing any possible microbial contamination and introduces risk assessment and practical contamination control strategies.

4. BRANCHES OF MICROBIOLOGY

5. Microbiology may be pure or applied PURE MICROBIOLOGY Includes bacteriology, mycology, protozoology, phycology, parasitology, virology, nematology, cellular microbiology, molecular microbiology etc. APPLIED MICROBIOLOGY Includes medical microbiology, pharmaceutical microbiology, industrial microbiology, food microbiology, soil microbiology, water microbiology, air microbiology and microbial biotechnology.

6. SCOPE OF PHARMACEUTICAL MICROBIOLOGY Production of antibiotics : 2/3 rd of antibiotics are produced from microorganisms. Many antibiotics are isolated from natural microrganisms by the process of fermentation. Eg. Penicillin from Penicillium species, Streptomycin from Streptomyces griseus Tetracycline from Streptomyces aureofaciens

7. Treatment of industrial waste material: Most industrial processes produce waste water , salts, organic matter and spent media and these are toxic. Many microbial species are used for decomposition of such waste materials and organic components e.g. Actinomycetes, fungi, protozoa,etc. Diagnosis of diseases and treatment : Different tests are used to detect infectious microorganisms e.g.; ELISA, Widal test etc.

8. Sterile product preparation: Pharmaceutical microbiology plays a major role in preparation of sterile products. Deals with sterile rooms , aseptic techniques, detection of microbes by sampling and sterility testing of different sterile preparations. Sterilization Any processes that eliminates, removes, kills all forms of life and other biological agents(bacteria, fungi, viruses etc ) called sterilization. Moist heat sterilization, dry heat sterilization, membrane filtration, gaseous sterilization and chemical sterilization are the methods used for killing microrganisms.

9. Production of enzymes and vaccines Microbial cells produce intracellular and extracellular enzymes and these enzymes are important for the success of pharmaceutical fermentation process Eg. amylase, protease, lipase, invertase, oxidase, catalase etc. Bio-surfactants have a lot of application in agriculture, food industries, industrial cleaning, paper and metal industries, textiles, cosmetics and the pharmaceutical industry. Different types of bio-surfactants are synthesised by a number of microorganisms. Eg. Bacillus species , Pseudomonas species , Rhodococcus species etc.

10. Identification of microorganisms : One of the vital function of pharmaceutical microbiology is identification of microorganisms found in products and the manufacturing environment. The microorganisms are isolated and identified by morphological, biochemical, cultural, microscopic characteristics and genetic studies. Steroid bio-transformation: Steroids are physiologically active compounds of complex structure e.g.. Ergosterol, testosterone, progesterone, cholesterol etc. Important steroids can be produced by microbiological transformations of naturally occurring steroids e.g.., Streptomyces spp. , Rhizopus spp. , Aspergillus spp. , Penicillium spp.

11. Plant growth promotion : Many microbial cells present in soil play an important role in soil fertility, herbicidal resistance, insect resistance, change in protein content and enhanced quality of plant products e.g. Rhizobium species , Azotobacter species , Acetobacter species, Rhodospirillum species , Agrobacterium rhizogenes. Azotobacter chroococcum is living nitrogen fixing bacterium capable of synthesizing and secreting plant growth substances like thiamine, riboflavin, IAA, gibberellin etc.

12. TESTING OF PHARMACEUTICAL

13. Microbiological assays of antibiotics The antibiotic bioassay provides a potency for the overall biological activity of an antibiotic preparation. Agar diffusion(plate assay) and turbidometric assay. Evaluation of disinfectant Effective cleaning and disinfection of manufacturing facilities are crucial to the achievement and maintenance of high quality standard required for medicine and medical devices. Cup plate method, turbidometric method, phenol coefficient test.

14. Antimicrobial preservative efficacy testing : Different types of pharmaceutical products and cosmetics are protected from attack by microorganisms by using preservatives. Eg: Methyl, ethyl, propyl Parabens, Sorbic acid. The preservatives should be non toxic, easily available and have broad spectrum activity. Cup- plate method, turbidometric method and total viable counting techniques are used for determination of anti-microbial efficacy of preservatives.

15. Endo-toxin testing: Bacterial endotoxin or pyrogens have a number of physiological effects following intravenous injections such as fever, activation of cytokine system, endothelial, cell damage and intravascular coagulation. The bacterial Endo-toxins test(BET) is most important in microbiology laboratories involved with quality control of medical devices. LAL test, gel-clot method, chromogenic end point, kinetic turbidometric assay and kinetic chromogenic assay are also used to detect endotoxins.

16. Raw material and finished products: The presence of microorganisms like E.coli, Salmonella species, Pseudomonas aeruginosa and Staphylococcus aureus , in the raw materials and finished products may be deteriorate their efficacy and potency. Test the presence of microbes are described in the IP, USP, EP and BP. Limit on the total number of viable microbes in given product (TVC) and involved in exclusion of specific pathogens.

17. Test for support of the sterility assurance system: Sterility test mainly applicable in running an aseptic area and microbiology lab. It is mainly performed in laminar air flow cabinets for parenteral preparations and other sterile pharmaceuticals to detect presence of microorganism. Bioburden testing is used to estimate the number of microorganisms in the product prior to sterilization .

18. Biopharmaceutical testing: A biopharmaceutical also known as a biological medical product or biologic, is any pharmaceutical drug product manufactured in, extracted from or semi synthesized from biological sources. They can be used in both human and animal medicine. Biopharmaceutical are a class of medical products which are typically produced using biotechnology, most commonly in a bioreactor. These include therapeutic proteins, vaccines, oligonucleotides etc. The production of these molecules is a complex and sensitive to contamination. Pharmaceutical microbiology is an applied branch of microbiology.

19. Cell banks : A cell banks refers to the facility that stores cells of specific genome for the purpose of future use in a products or medicine needs. The advantages of cell banks are: Detailed characterization of the cell line. Decrease in the likelihood. An increase in the detection of cross contamination of the cell line. Services of pharmacist are required in analysis and quality control section.

20. Cosmeceuticals Microbial contamination of cosmetic products is a matter of great importance to the industry and it can become a major cause of both product and economic losses. The water and nutrients present in cosmetics make the susceptible to microbial growth, although only a few cases of human injury due to contaminated cosmetics have been reported. Therefore studying microbiology is necessary for preparation, processing, and quality control of cosmeceuticals.

21. Medical devices Studying microbiology helps in understanding principle of medical devices such as fluorescent fusion, which are used for fast and precise detection of pathogens in tissue samples. It is a technology for carrying out immunofluorescence studies that may be applied to find specific cells in complex biological system.

22. THANK YOU