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Sterile Dosage Form Sterile Dosage Form

Sterile Dosage Form. Parentral Preparations. Ophthalmic Preparations

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Page 1: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Sterile Dosage FormSterile Dosage Form

Page 2: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Sterile Dosage FormSterile Dosage Form

Parentral Preparations.Parentral Preparations.

Ophthalmic Ophthalmic Preparations.Preparations.

Page 3: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Methods of Sterilization.

Sterility Testing.

Pyrogen Test.

Page 4: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Sterilization

Sterilization:Sterilization: It is the process that kills or removes all

living microorganisms including bacterial endospores.

A Sterile Product:A Sterile Product: It should be free from all living microorganisms.

Page 5: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Sterilization

Bacterial endospores are Bacterial endospores are more resistantmore resistant ( Why? )( Why? )

Low water content and low metabolic Low water content and low metabolic activities.activities.

Thick spore coat.Thick spore coat. Presences of heat resistant Presences of heat resistant

chemicals such as diplocolinic acid chemicals such as diplocolinic acid and dicarboxylic acid.and dicarboxylic acid.

Page 6: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Methods of SterilizationMethods of Sterilization

Heat Sterilization

Dry Heat Moist Heat Radiation FiltrationToxic gases

Cold Sterilization

Page 7: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Heat SterilizationHeat Sterilization

Used only for Used only for Thermostable Thermostable materialsmaterialsMode 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.

Page 8: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

HeatHeat SterilizationSterilization

Dry Heat: Incineration: ( Flaming ) Example: Flaming of inoculating loop.

Hot air oven:•Sterilization temperature: 160 180oC for 1 – 2 hrs.Used for: glass wares, metals, unhydrous powders, oils and waxes.

Page 9: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Heat SterilizationHeat SterilizationMoist Heat:

Autoclaving:• depends on the use of moist heat under pressure.• Sterrilization temperature: 121oC 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.

Page 10: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Cold SterilizationCold Sterilization

I. Radiation:I. Radiation:

Ionizing Radiation: ( δ-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

Page 11: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Cold SterilizationCold Sterilization

I. Radiation: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

Page 12: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Cold SterilizationCold 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.

Page 13: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Cold SterilizationCold Sterilization

III. Filtration:Used for thermolabile fluids such as vitamines, hormones and some ophthalmic solutions.

Page 14: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Bacterial FilterBacterial Filter

Page 15: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Cold SterilizationCold SterilizationIII. 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 0.4µm.- Disadvantage: viruses and Mycoplasma (which having no cell wall) can pass through these filters

Page 16: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Test for the Test for the EfficiencyEfficiency of of the Sterilization the Sterilization

ProcessesProcesses Autoclave:Autoclave:• Klintex Paper.Klintex Paper.• Klintex bars.Klintex bars.• Bacillus sterothermophilus Bacillus sterothermophilus

(biological indicator).(biological indicator).

Page 17: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Test for the Test for the EfficiencyEfficiency of of the Sterilization the Sterilization

ProcessesProcesses Bacterial Filter:Bacterial Filter: using a broth culture of using a broth culture of Serratia Serratia

marcescensmarcescens– It is the smallest bacteria ( 0.75 µm It is the smallest bacteria ( 0.75 µm

diameter).diameter).– Produce red pigment at 25Produce red pigment at 25ooC. C.

Page 18: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Test for the Test for the EfficiencyEfficiency of of the Sterilization the Sterilization

ProcessesProcesses

Procedure:Procedure:1.Filter a broth culture of 1.Filter a broth culture of Serratia Serratia

marcescens through the membrane marcescens through the membrane filterfilter

2. Aseptically, place the membrane 2. Aseptically, place the membrane filter by means of sterile forceps on filter by means of sterile forceps on the surface of a nutrient agar plate.the surface of a nutrient agar plate.

3.Incubate the plate and the filtrate 3.Incubate the plate and the filtrate at 25at 25ooC for24 hrs.C for24 hrs.

Bacterial Filter:Bacterial Filter:

Page 19: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

Test for Test for thethe Efficiency of the Efficiency of the BacterialBacterial Filter 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.

Page 20: Sterile Dosage Form.  Parentral Preparations.  Ophthalmic Preparations

بخير وأنتم عام بخير كل وأنتم عام كل

With my Best Wishes,,,Manal Abu El-Khair