Sterile Dosage Form. ïƒ Parentral Preparations. ïƒ Ophthalmic Preparations
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Transcript of Sterile Dosage Form. ïƒ Parentral Preparations. ïƒ Ophthalmic Preparations
- Slide 1
- Sterile Dosage Form
- Slide 2
- Parentral Preparations. Ophthalmic Preparations.
- Slide 3
- Methods of Sterilization. Sterility Testing. Pyrogen Test.
- Slide 4
- Sterilization Sterilization: Sterilization: It is the process that kills or removes all living microorganisms including bacterial endospores. A Sterile Product: It should be free from all living microorganisms.
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- Sterilization Bacterial endospores are more resistant ( Why? ) Bacterial endospores are more resistant ( Why? ) Low water content and low metabolic activities. Thick spore coat. Presences of heat resistant chemicals such as diplocolinic acid and dicarboxylic acid.
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- Methods of Sterilization Heat Sterilization Dry HeatMoist Heat RadiationFiltrationToxic gases Cold Sterilization
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- Heat Sterilization Used only for Thermostable materials Used only for Thermostable materials Mode of Action: Evaporation of water leading to increase conc. of electrolyes within the cells causing toxic effects. Denaturation of proteins such as enzymes. Leakage of plasma membrane.
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- Heat Sterilization Dry Heat: Incineration: ( Flaming ) Example: Flaming of inoculating loop. Hot air oven: Sterilization temperature: 160 180 o C for 1 2 hrs. Used for: glass wares, metals, unhydrous powders, oils and waxes.
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- Heat Sterilization Moist Heat: Autoclaving: depends on the use of moist heat under pressure. Sterrilization temperature: 121 o C for 15 20 min. Used for : glass wares, metals, such as surgical instruments and culture media. It has the advantage of less temperature and shorter time. i.e: less destructive to materials.
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- Cold Sterilization I. Radiation: Ionizing Radiation: ( -radiation ) Mode of action: It cause ionization of cell constituents leading to formation of free radicals which are highly toxic to the cell. Used for: Plastic items such as Petri-dishes, pharmaceutical containers, syrings, surgical gloves, dressings and sutures. Used only for Thermolabile materials
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- Cold Sterilization I. Radiation: Used only for Thermolabile materials Nonionizing Radiation: (UV radiation ) Mode of action: It cause only excitation of DNA leading to bond breakage and reformation of DNA Disadvantage: It has low penetration power. So, used only to reduce microbial load of air in rooms and areas wanted to be disinfected
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- Cold Sterilization II. Using of toxic gases: Such as Ethylene oxide, Propylene oxide and Formaldehyde. Used for: Plastic items such as Petri-dishes, pharmaceutical containers, syrings, surgical gloves, dressings and sutures. * The most important step in gas sterilization is the removal of the toxic gas.
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- Cold Sterilization III. Filtration: Used for thermolabile fluids such as vitamines, hormones and some ophthalmic solutions.
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- Bacterial Filter
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- Cold Sterilization III. Filtration: Types of Filters: Asbestos, Porcelain filters: -Thick and porous material. - Disadvantage : Having no unique pore size, So do not give 100% efficiency. Membrane Filters : - Made of polymers of cellulose acetate or cellulose nitrate. - Advantage:Thin, having a pore size of 0.4m. - Disadvantage: viruses and Mycoplasma (which having no cell wall) can pass through these filters
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- Test for the Efficiency of the Sterilization Processes Autoclave: Autoclave: Klintex Paper. Klintex Paper. Klintex bars. Klintex bars. Bacillus sterothermophilus (biological indicator). Bacillus sterothermophilus (biological indicator).
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- Test for the Efficiency of the Sterilization Processes Bacterial Filter: Bacterial Filter: using a broth culture of Serratia marcescens using a broth culture of Serratia marcescens It is the smallest bacteria ( 0.75 m diameter). Produce red pigment at 25 o C.
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- Test for the Efficiency of the Sterilization Processes Procedure: 1.Filter a broth culture of Serratia marcescens through the membrane filter 2. Aseptically, place the membrane filter by means of sterile forceps on the surface of a nutrient agar plate. 3.Incubate the plate and the filtrate at 25 o C for24 hrs. Bacterial Filter: Bacterial Filter:
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- Test for the Efficiency of the Bacterial Filter Results: If the filtrate show no growth of Serratia marcescens ( no red pigment ), While there is a growth of red colonies on the surface of the membrane filter. This will means that the filter is efficient.
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- With my Best Wishes,,, Manal Abu El-Khair