Application of microbiological techniques in the analysis of water for injections
- Water in pharmaceutical industry
- Sampling plan in the industry
- A study on the requirements
- Presence of microorganism (bacteria and fungi) in given water samples by various microbiological methods
- Antimicrobial preservative efficacy test in given finished pharmaceutical products
- Microbial Susceptibility Test (Antibacterial / Antifungal activity) of given medicinal preparations
- Determining the presence or absence of endotoxin in the given sample with the help of LAL test
- Reference table for enterobacteriaceae count
- Most probable number of bacteria
- Mircobial monitoring
- Preservative efficacy tests
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 analysis of Microbial Load helps in the estimation of viable aerobic microorganism that can deteriorate the water quality and render it unfit for human consumption. Feed water and Blow down doesn't comply with the standard due to higher bacterial count. On the other hand, the rest water samples (purified water and water for injections) were found to be safe due to nil bacterial count. Membrane Filteration Method is applied in case of packed drinking water. The water of such type may get contaminated during the course of filling and packaging in the respective industries. [...]