Microorganisms constitute the world of microscopic or sub-microscopic form of diverse life. They constitute a world of their own, full of uniqueness from different biological standpoints. These micro organisms not only contribute to the well being of mankind, they also put lives at risk due to their pathogenic nature. They are not only harmful to humans but to various industries such as food, pharmaceuticals etc. as they contaminate the products of these industries and render them unfit for human consumption and may cause serious diseases and disorders. Big economic losses have been recorded by microbial contamination. Microbial contamination means presence of viable bacterial and fungal cells in the products and associated materials. It is necessary to enumerate total microbial count in finished products as their presence indicates the poor quality of products. The main source of bacterial and fugal contaminations in pharmaceutical industries are from the unhygienic area, unprocessed water, contaminated equipments and containers, person itself and contaminated material being used for drug formation.
Now a days, plant derived pharmaceutical products are being used worldwide as they do not put the human life at risk by their adverse side effects as the synthetic pharmaceutical preparations do. Moreover certain injections which are water based are also being increasingly used These preparations are believed to promote health and maintain body's resistance against infection by re-establishing the body's equilibrium.
Comparatively drugs are at a higher risk of contamination as their active ingredients are obtained from soil, water etc. where enormous microbial niche is already present. Improper harvesting and handling of plant material increases the load of contamination. Further interference of the handlers and workers and lack of proper hygiene of individuals and machineries also increase the numbers of microorganisms.
In order to check the growth of these pathogens and to ensure a pathogen free and potent pharmaceutical product, it is mandatory to apply microbiological techniques for microbial analysis (from the area of production to the finished product) so that safe medicine comes in market and the patient could consume it fearlessly. The present course of study has been done to evaluate medicinal materials for total bacterial count, total fungal (yeast and molds) count, total enterobacters count. There are huge numbers of microbial pathogens and all of them could not be detected at same time. So we have considered only those microbes which are commonly responsible for drug contamination and are associated with humans such as E.coli, Salmonella sp., Pseudomonas aeruginosa, Staphylococcus aureus etc.
[...] SECTION 4.4 To determine the presence of microorganism (bacteria and fungi) in the given water samples by various microbiological methods. EXPERIMENT OBJECTIVE: To determine the Most Probable Number (M.P.N) of bacteria in the given water sample (feed water) PRINCIPLE: Water contains many bacteria as it generally gets contaminated by industrial effluents, human activity etc. Although there are no. of pathogenic microbes responsible for water contamination but E.coli and Streptococcus faecalis are the important bio-indicators of water pollution as they are lactose fermenting, gas producing coliform bacteria. [...]
[...] In order to check the growth of these pathogens and to ensure a pathogen free and potent pharmaceutical product, it is mandatory to apply microbiological techniques for microbial analysis (from the area of production to the finished product) so that safe medicine comes in market and the patient could consume it fearlessly. The present course of study has been done to evaluate medicinal materials for total bacterial count, total fungal (yeast and molds) count, total enterobacters count. There are huge numbers of microbial pathogens and all of them could not be detected at same time. [...]
[...] The water sample from different sources were analyzed for the presence of any pathogen. Verification of label claim of drugs was also done and was accompanied with the endotoxin test. The experimental area was found to be under aseptic limits. Presence of fungal count was recorded in some of the drugs and in comparison to this, bacterial count was slightly more than the later. Analysis showed that except some, all the drug samples were under safe limits. Few drug samples (intermediate form) were failing to match with the standards due to the presence of pathogens. [...]
[...] However, for the protection of the consumers, the concentration of a preservative shown to be effective in the final packaged product should be considerably below the concentration of the preservative that may be toxic to man. REQUIREMENTS: Test tubes, Petri plates, Conical flasks, Micropipettes, Autoclaved water blanks, Incubator. CULTURE MEDIA: Soya bean Casein Digest Agar Sabourad Dextrose Agar Tested sample for preservative efficacy test: S.No. Sample name Batch number Storage condition TEST ORGANISM: The organism specified for use in the test are intended to be representative of group that might be expected to be found in the environment where manufacturing process, and storage is carried out. [...]
[...] PREPARATION OF CULTURE MEDIA (For all experiments): Dehydrated culture media of were used and were prepared in accordance to the manufacturer's instruction by mixing the required quantity of media in the purified water and by autoclaving it at 121°C at 15 lbs for 15 minutes. All the above media was incubated for 24 hr at 30˚C before use. Any appearance of microbial contamination in Petri plates was discarded. SAMPLE PREPARATION (For bacterial / fungal /Enterobacters counts) WATER-SOLUBLE PRODUCTS 10g or 10ml of the sample material was mixed in Fluid Soybean Casein Digest Medium or in another suitable medium proven to have no antimicrobial activity. [...]
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