Pharmaceutical microbiology

Pharmaceutical microbiology

1. PHARMACEUTICAL MICROBIOLOGY - Vennela Nampalli

2. MICROBIOLOGY Microbiology is the study of micro-organisms such as bacteria, protozoa, fungi & similar organisms which can’t be seen by naked eyes. The need to study these minute organisms started when scientists discovered the association of microbes to specific diseases. The role of microbiology on the advances in the healthcare industries especially in pharmaceuticals and medical industry have led to great discoveries from vaccines to medical devices.

3. LOUIS PASTEUR ANTONY VAN LEEUWENHOOKE

4. PHARMACEUTICAL MICROBIOLOGY Pharmaceutical microbiology is the combined field of Microbiology and Pharmacy, wherein study of microorganisms that are related to production of antibiotics, enzymes, vitamins, vaccines and other pharmaceutical products are detailed. It also deals with causative agents of disease; diagnostic procedures for identification of causative agents; preventive measures.

5. SIGNIFICANCE Our cells have been fighting microbes that enter our body and commonly exhibited by pus formation & inflammation of wounds. Macrophages play role in immune system bcoz they are capable of ingesting microbes that enter our body through open wounds. However, some microbes adapt & mutate rapidly, resulting in infectious diseases like- HIV. So are antibiotics, vaccines, etc. produced to get resistance from microbes. On the contrary, microbes help us like- Lactobacillus which functions in our digestive system.

6. FACTORS INVOLVED : Pharmaceutical Microorganisms. Pharmaceutical Contamination Pharmaceutical Products & Microbial Risks. Microbial Limits Test & Assay Microbial Spoilage & Preservation. Antimicrobial Preservation Disinfection & Sterilization Technologies. Clean rooms & Controlled Techniques. Drug Quality Control Validation of Test Methods. Drug Safety /Pharmacovigilance Sterile Pharmaceutical Manufacturing Biological Indicators

7. Pharmaceutical Contamination Pharmaceutical Contamination involves the introduction of microbes into pharmaceutical finished products. Sources include: During manufacture, Raw material used, Environmental sources , Cleaning equipments, Packing, Containers that are frequently reused, Repackaging of products, Processing, Storage & Transportation. Factors affecting Microbial spoilage of Pharmaceutical products include: Types & size of contaminant inoculums, Factors related to -pH, Moisture content, Storage temperature, Packaging design, etc.

8. Microbial Limits Test & Assay Microbial limits testing is performed to determine whether a product complies compendial specifications for microbial quality. It includes 2 phases: quantitative phase which covers the Microbial Enumeration, gives the total number of aerobic organisms & total yeast and mold count on product. Microbial assay works on the principle that the organism is inoculated into the medium containing all the growth factors needed except the one under examination; the rate of growth is then proportional to the amount of this nutrient added in the test substance.

9. Antimicrobial Preservation Preservation is the process of inhibiting or minimizing microbial growth during the storage & multi-dose application the risk of microbial contamination of pharmaceutical products. A chemical substance used to preserve pharmaceuticals, food and other organic material by preventing the growth of microorganisms is termed as antimicrobial preservation. Antimicrobial preservatives include: Methyl, ethyl, propyl and butyl Parabens, Sorbic acid, Na, K & Ca Sorbate, Benzoic acid, Na, K & Ca Benzoate, Sodium metabisulfite, Propylene glycol. BTH, BHA, Benzaldehyde, Essential oils, Phenol and Mercury compounds

10. Drug Quality Control According to WHO, term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical.Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. It not only protects the manufacturer against compensation claims, but also guarantees the patient a safe and effective product.

11. Drug Safety & Pharmacovigilance Drug safety covers the topics on the epidemiology, clinical features, prevention & management of adverse effects of individual drugs and drug classes. Benefit-risk assessment proved an in-depth review of adverse effect and efficacy data for a drug in a defined therapeutic area. Pharmacovigilance (PV or PhV) also known as drug safety is the pharmacological science relating to the collection, detection, assessment monitoring of drug for its proper use.

12. Sterile Pharmaceutical Manufacturing   The primary goal of final pharmaceutical product is Quality and Safety. Active Pharmaceutical Ingredients (API’s), used as Ingredients in sterile medicinal products, must be sterile unless the final dosage form is terminally sterilized, or produced by a process including a sterilising filtration step. API’s intended for use in parenteral products must also comply with relevant specifications on pyrogens or bacterial endotoxins. The manufacture of sterile API’s must be strictly controlled in order to minimize the risk of contamination with micro- organisms, endotoxins and particles. If the final dosage form is not to be sterilised by filtration, the API’s should be practically free of particles.    

13. Biological Indicators Biological indicator (BI) is type of monitoring which provides direct evidence that sterilization process conditions are sufficient to kill spores. It uses microbes that are highly resistant to the type of sterilization process you are monitoring. BIs are considered the gold standard of load sterilization monitoring. They are widely recommended as the preferred device for monitoring and releasing loads.  

14. MERITS High Reliability Product Safety Faster Times to Market More Innovation Type of antimicrobic drugs and their application areas are known The effects of antimicrobic and non-antimicrobic drugs on immune system are known . GMP and GLP applications regarding microbiology in pharmaceutical industry can be known

15. DEMERITS Time Required Limited Accuracy Transfer Errors Data Entry Errors Difficult Interim Counts New Drugs are Expensive Adverse Drug Reactions and Side Effects Some medicines have Low Therapeutic index

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