Different_Sources_Of_Contamination_In_Aseptic_Area.pptx

Different Sources Of Contamination In Aseptic Area

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2. Different Sources Of Contamination In Aseptic Area The microbiological contamination of pharmaceutical products is influenced by the environment in which they are manufactured and by the materials used in their formulation. Different pharmaceutical formulations may be contaminated by the atmosphere, raw materials, water, equipments and human sources and get spoiled.

3. Different Types Of Contamination Atmosphere Operator Equipment Raw Material

4. Atmosphere : The atmosphere is unable to support microbial growth but dust particles in outside air (originate from soil) may carry soil microorganisms. e.g. Bacillus spp., Clostridium spp , yeasts and moulds . Indoor air may also contain Staphylococcus spp. and Streptococcus spp. on particles of skin or clothing. These microbes also occur in droplets expelled into the atmosphere from the mouth and respiratory tract by talking, sneezing and coughing. Microorganisms free from dust particles, mainly mould spores, are commonly found in indoor and outdoor air.

5. A damp atmosphere usually contains less microorganisms than a dry one as the contaminants are carried down by the droplets of moisture. Thus, the air in a cold- store is usually free from microorganisms. Prevention The microbial count of air or atmosphere may be reduced by chemical disinfection, ultraviolet light, filtration and gaseous agents.

6. Operator : The skin, hair and clothing of the operator are potent sources of microbial contamination. Microorganisms mainly present on the skin include Staphylococcus spp., lipophilic yeasts and dermatophytic fungi. Poor personal hygiene can result in the presence of skin coliforms and other intestinal bacteria. Open wounds are a source of saprophytic and pathogenic microorganisms. The nasal passages may contain Staphylococcus aureus, Staphylococcus albus, Neisseria pharyngis etc.

7. Raw materials: Raw materials may account for a high proportion of microbial contamination into pharmaceutical products. Drugs which are prepared from animal, plant or other natural sources are frequently contaminated with bacteria, yeasts and molds. Water is also a prime source of microbial and particulate contamination. Deionised water, distilled water and water for injections are commonly used for preparation of different pharmaceuticals.

8. Water may be treated by ultraviolet light, filtration or stored at elevated temperature to discourage microbial growth Prevenention Heat treatment, filtration, recrystallisation, irradiation or any other sterilisation processes are mainly applied for reduction of the microbial load in raw materials.

9. Equipment : Equipments used for formulation of pharmaceuticals are also a source of microbial and particulate contamination. Working surfaces and external surfaces of equipment are also potential sources of contamination due to sedimentation of particles and droplets from the atmosphere. Prevenention Equipments may be sterilized or disinfected by heat, gaseous agents or chemicals.

10. Many tanks, containers, small equipments and reaction vessels are sterilized by steam under pressure (autoclave).

11. Reference: Pharmaceutical Microbiology, Nirali Publication Imagen (For Image Genreration ) DaVinci(For Image Genreration )

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