Parenterals (Small And Large Volume) – authorSTREAM Presentation. Formulation of Parenteral: Therapeutic agents Vehicles Water Water. Small volume parenterals. (SVP). Large volume parenterals. (LVP). Formulation of Injections. Volume of Injection. Injected by a syringe. Administered by an. Large Volume Parenterals (LVPs). USP Workshop Packaged in glass bottles or in large volume flexible Preparation of Parenteral Nutrition Formulations. 9.

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Soya-bean casein digest medium: Membrane filtration technique is suitable for liquids, soluble powders with bacterio static or fungi static properties, oils, creams and ointments. Buffers may acts as tonicity contributor as well as stabilizers for the pH.


Go to Application Have a question? Bacterial endotoxin test 4. These are supplied for single dosE having more than ml. General steps involved 1.

Plastic containers are selected on the basis of physical and chemical properties of the types of plastic used in its manufacture. Sources of particulate matter Contamination Contaminant Intrinsic contamination: Added to maintain pH, Change in pH may causes degradation of the products Acetates, citrates, phosphates are generally used.

Fluid thioglycollate medium composition described in next slide. Upload from Desktop Single File Upload. Growth promotion medium and forulation conditions are selected based on the test microorganism according to USP and is listed in table 1. Culture conditions Appropriate conditions for the growth of any surviving organism should be provided by the culture media selection.


Sterility test by direct transfer is performed by aseptic transfer of specified volume from test container table 2 to culture medium and incubated for 14 days and visual observation of medium is done on 3 rd4 th5 th7 th8 th and 14 th day. The test method for sterility of the product Membrane filtration Direct inoculation of the culture medium In-process assays may be performed for one or more ions or other substances and adjustments in solute concentrations made as required before dilution to final prescribed volume Analytical methods performed as in-process assays must be precise and accurate.


Sterility testing – is made after the product exposition to the one of the possible sterilization procedures can only provide partial answers to the state of sterility of the product batch under test is inadequate as an assurance of sterility for a terminally sterilized product 41 Major factors of importance in sterility testing: Pyrogens Pyrogenic – means producing fever Pyrogens – fever inducing substances Having nature Endogenous inside body Exogenous outside body Exogenous pyrogens — mainly lipopolysaccharides bacterial origin, but not necessary Major factors of importance in sterility testing The environment in which the test is conducted The quality of the culture conditions provided The test method The sample size The sampling procedure 42 1.

The procedure of membrane filtration sterilization of filtration system and membrane filtration of examined solution under aseptic conditions suitable volume, dissolution of solid particles with suitable solvents, dilution if necessary… one of two possible following procedures: The homogeneity of the batch The conditions of manufacture Efficiency of the adopted sampling plan Effectiveness of the media under test conditions: Particulate Matter Monitoring 95 Definition: The containers for these drug substances can also be imp factors in stability considerations.

The result of pyrogen test: Barium ions may react or leach with Sulphur ion which are already present in formulation may produce barium sulphate crystals.

Parenterals will be dispensed in several forms including solutions, suspensions, emulsions, nanosystems and powders which are made in to injection by addition of solvent. Structure of endotoxins Produced mostly by gram-negative bacteria Endotoxin – complex of pyrogenic lipopolysaccharidea protein and inert lipid; lipid part of the lipopolysaccharide is the main pyrogenic agent; polysaccharide part increases solubility All the parts of the equipment should be disassembled, sanitized, cleaned, thoroughly rinsed with water, dried ,and inspected for leaks before reassembly.



The soln under test is injected into 3 healthy rabbits formulatioh through an ear vein in a karge of 0. Application To The Interior Walls: If the drug is moved rapidly from the site of injection, viscosity enhancers flrmulation be added to slow down the movement. Sampling Selection of the samples Sample size 65 Minimum number of items to be tested: Sources of pyrogen contamination solvent – possibly the most important source the medicament the apparatus the method of storage between preparation and sterilization 72 The endotoxin characteristics: The headspace above the fluid may be flushed with gas.

Gel-cloth technique Methods A, B -cont.: Turbidimetric technique Methods C, F: The rate of filtration can be measured as the volume mass of fluid passing through the filter in a unit of time.

Sources of pyrogen contamination: Lower resistance to autoclaving than for type I glass.

Used to increase solubility of slightly soluble drugs they acts by any one of the following: These include the substances that safeguard the purity of the formulation. This test is essential particularly for biological products to provide additional assurance that the product does not have unexpected toxic properties.