Contamination and spoilage of liquid

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AIMST,SPOILAGE

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Pharmaceutical products used in the prevention, treatment and diagnosis of disease contain a wide variety of ingredients , often in quite complex physicochemical states. Such products must not only meet current pharmaceutical Good Manufacturing Practice (GMP) requirements for quality, safety and efficac y , but also must be stable and sufficiently elegant to be acceptable to patients . introduction

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Products made in the pharmaceutical industry today must meet high microbiological specifications (sterile) . Nevertheless, from time to time a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality assurance net .

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The penalty of such contamination may be serious and important on several accounts, particularly if contaminants have had the opportunity to multiply to high levels . Firstly, the product may be spoiled , rendering it unfit for use through chemical and physicochemical deterioration of the formulation. Spoilage and subsequent wastage of individual batches usually results in major financial problems for the manufacturer through direct loss of faulty product .

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Through spoilage, active drug constituents may be metabolized to less potent or chemically inactive forms . Under laboratory conditions, it has been shown that a variety of microorganisms can metabolize a wide assortment of drugs , resulting in loss of activity . Materials as diverse as alkaloids ( morphine, strychnine, atropine ), analgesics ( aspirin, paracetamol ), thalidomide, barbiturates, steroid esters and mandelic acid can be metabolized and serve as substrates for growth.

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Mechanism of microbial spoilage Microbial contamination (spoilage) can be introduced via, raw material, the processing plant, packaging material, Operative (or) else where in the environment. If the formulation exposure to ambient condition of temperature and humidity encourage their multiplication.

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When changes in formulation liquid formulation, its depend upon one (or) more of the following ways Toxic effects-microbial toxins Metabolic products Irritancy Change of activity Visible effects visible growth colour changes gas production other changes

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Toxic effects Several species of micro organisms produce toxic molecule Will support toxin production Degradation ( spoilage of product) dangerous

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Endotoxins produced by gram –negative bacteria (Escherichia coli) Toxin of this type are poorly absorbed by the oral route But its sensitive connection with injection(perfusion fluid) Properties: Closely bound to the cell Lipopolysaccharide in nature Sterilization method won’t in activate the organism( Thermostable ) withstand 120°C for over 3 hours unaffected by the common bactericides non-volatile insensitive to pH changes

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Aflatoxin produced by aspergillus flavus it is difficult to visualize in pharmaceutical product. Exotoxins produced by clostridium botulinum Potential damage to pharmaceutical liquid formulation and cosmetic. Toxin produced by Certain staphylococcus aureus problem to the pharmaceutical formulation.

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Metabolic product Microbial toxins (complex molecule) Stimulate biosynthetic product Catabolic product (organic acid and amine) If swallowed Toxic to man ,but less toxic Metabolites Shows pharmacological activity This metabolic product Not possible to idenfied in liquid formulations Containing flavoring Agents (mask an unpleasant taste)

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irritancy Case one : Ophthalmic eye drops Contain a high level of microbial contamination Direct evidence that irritation is caused by the presence of the micro organism Case two : Contaminants leach of foreign protein Promote allergic dermatitis reaction Or Metabolites cause primary irritant reaction Note You can’t eliminate left in the formulation metabolite You can eliminate in the formulation Organisms

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Change of activity Microbial contamination In activation of drug molecule Change in activity Pencilline injection – by β - lactamase -producing bacteria Produce Broad range of micro organism Less active, no active Chloramphenical oral solution- by acetylase microbial enzyme Inactivate chloramphenical

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Atropine eye drops-by carnebacterium and pseudomonas spp Loss of atropine 20% Aspirin suspension Microbial hydrolysis of aspirin in suspension by esterase producing Bacteria,Using distilled water ( acinetobacter and woffi ) In activate Heroin,morphine injection by acinetobacter inactivate

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Analgesics –Aspirin,phenaction and paracetamol(liquid formulation) Degraded By corynebacterium (present in laboratory dust) Liquid shampoo loose surface active properties By contaminating bacteria Visible effects When micro organisms can actually be observed in (or) on a product Then there is obviously no doubt that microbial spoilage has occurred

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Identification Sediment, turbidity Colonies, colour change due to bacteria, yeast(or) moulds Colour changes : colour changes due to alteration in the components Change in P H pigment production Pseudomonas Metabolize very broad range of compound Produce soluble pigments Colour changes blue to green Acid product contaminated with Oxidative yeasts pH rise by utilizing organic acid Encourage bacterial growth

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Gas production Microbial metabolism produce gas Gas Amount exceed Visible bubbles, froth(pressure increase in side the container) spoilage of liquid formulation Carbohydrate containing liquid preparation Go for fermentation process Spoilage of product

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Glycerol containing preparation fermentation process by Spoilage of liquid Other changes: Emulsion(o/w and w/o) Hydrolysis of oil phase oil Water- pH Change in water phase Cause visible change(spoilage)

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Suspension Organism utilize sugar Contaminants broke down (larger molecule) Cause aggregation of particle in suspension Olfactory effects Taste Texture Audible effects

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Olfactory effect Many organisms produce characteristic odour (aroma producing bacteria) Due to contaminants Change in aroma Produce nauseating smell(terrible) liquid formulation Actiomycetes present in taint Water Undesirable earthy-smelling Neutral oil contaminate by bacteria Strong earthy-smelling Liquid product Fermentation process by yeast Alcoholic odour in the product

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Sulphur containing product Hydrogen sulphide (metabolites) Spoiled egg smell Fatty acid - sickly smell Amine - fishy odour Ammonia - astringency

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Taste Abnormal taste (That they me be spoiled) Sense of taste varies widely between individuals (person to person) Not acceptable to predict the spoiled product Combination of smell and taste Highly acceptable to predict the spoiled product (mainly in plain liquid, unflavoured liquid) Some organic compounds responsible for giving flavour to liquid Formulation by microorganism 1.Alcohol 2.Aldehyde 3.Ketone 4.acetals 5..Acids 6.Amines 7.Esters 8.phenols

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Texture Due to contamination Change in viscosity of liquid preparation Can be detected when applied to the skin Audible effects Contaminated liquid formulation While opening pack Explosion occurs(indication that a gas producing microorganism)

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Types of susceptible product Aqueous preparation Oil preparations Shampoo Syrups Tincture Elixir and linctuses

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Aqueous preparation Water is a major constituents of living organism and participates in many metabolic reaction All product containing large amounts of free water can be particularly susceptible to spoilage by bacteria High microbiological quality Generally suitable for the formulations Low microbiological quality (Distilled or deionized water) May be chemically pure but can constitute a greater microbiological hazard

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Water with out effective treatment With in few days contaminate by organisms First gram – ve bacteria and + ve bacteria occurs Second wide variety of bacteria, moulds and yeasts occurs Spoilage of liquid formulation(foul taste)

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Distilled water Readily pick up organisms from pipes, tubing and ion exchange column Become reservoir of organisms Deionized water Affected by pseudomonades(resistance to preservatives) Spoilage of liquid formulation

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Strong solution of copper sulphate and sulphric acid Affected by some kind of moulds Spoilage of product Ammonium carbonate Neutral ammonium tartrate Calcium gluconate Pot. Citrate Amaranth B.P Affected with algae,moulds,bacterial and yeast Turbidity(spoilage of liquid) Even preserved all solution with chloroform

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Concentrated Peppermint water B.P.C (preserved by preservative) Diluted (Concentration of preservative also diluted) Source of contamination in ingredient Potential pathogen have been transmitted to patients

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Organic polymers (thickening and suspending agents) used in pharmaceutical formulations microbial depolymerization by specific classes of extracellular enzymes yielding nutritive fragments and monomers

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Surface-active agents. Anionic surfactants, such as the alkali metal and amine soaps of fatty acids Stable slightly alkaline pH of the formulations readily degraded once diluted into sewage water . Non-ionic surfactants ( alkyl polyoxyethylene alcohol ) emulsifiers readily metabolized by a wide variety of microorganisms. Increasing chain lengths and branching again decrease ease of attack. Alkylphenol polyoxyethylene alcohols are similarly attacked

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Amylases (starches) pectinases ( pectins ) cellulases ( carboxymethylcelluloses ) uronidases ( polyuronides such as in tragacanth and acacia) dextranases ( dextrans ) proteases (proteins) Agar (a complex polysaccharide) inert polymer support for solidifying microbiological culture media. While the microbial metabolism of pharmaceutical hydrocarbon oils is rarely reported, this is a problem in engineering and fuel technology when water droplets have accumulated in oil storage tanks and subsequent fungal colonization has catalysed serious corrosion.

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Sweetening, flavouring and colouring agents used in pharmacy are ready substrates for microbial growth. Preservatives and disinfectants . Many preservatives and disinfectants can be metabolized by a wide variety of Gram-negative bacteria. Growth of pseudomonads in stock solutions of quaternary ammonium antiseptics and chlorhexidine has resulted in infection of patients. Pseudomonas spp . have metabolized 4-hydroxybenzoate ester preservatives contained in eye-drops and caused serious eye infections , and have also metabolized the preservatives in oral suspensions and solutions.

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Factors affecting microbial spoilage of pharmaceutical products Types and size of contaminant inoculum Successful formulation of products against microbial attack. protection as possible against microbial attack. When failures inevitably occur from time to time , knowledge of the microbial ecology and careful identification of contaminants can be most useful in tracking down the defective steps in the design or production process. Positive negative control compared with formulation pseudomonads

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Nutritional factors many common spoilage microorganisms enable them to utilize many formulation components as substrates for biosynthesis and growth. use of crude vegetable or animal products in a formulation Moisture content Microorganisms require readily accessible water in appreciable quantities for growth to occur.

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Redox potential The ability of microbes to grow in an environment is influenced by its oxidation-reduction balance (redox potential) The redox potential even in fairly viscous emulsions may be quite high due to the appreciable solubility of oxygen in most fats and oils

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Spoilage of pharmaceuticals could occur potentially over the range of about -20°C to 60°C ‘store in a cool place’ such as a domestic fridge (- 8°, –12°C),partly to reduce the risk of growth of contaminants Storage temperature pH Extremes of pH prevent microbial attack. fruit juice-flavoured syrups with a pH 3–4), mould or yeast attack is more likely

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Wide-mouthed cream jars have now been replaced by narrow nozzles Packaging design Self-sealing rubber. Disposable packaging Cardboard outer packaging and labels themselves can become substrates for microbial attack under humid conditions

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Thank you

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