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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Material comes from outside or environment e. Siliconization of Parenteral Packaging: The process is employed to counteract some forms of drug or chemical toxicity as well as to treat acute renal insufficiency.


Originally present in products e. Soya-bean casein digest medium primarily intended for the culture of both fungi and aerobic bacteria specific role of some ingredients incubation of the media: Finishing and packaging area: Used for membrane representing total volume from the appropriate number of containers. Heat ,light, moisture and air can adversely effect many of these materials. Sterilization 6 Formulation of Parenteral: These are used for harmone and vitamin preparations.

As a diuretic 33 PowerPoint Presentation: Permitted limits of particulate matter: Some substances like proteins degrade with the change in PH.

Tests for pyrogenic activity: Total Parenteral Nutrition TPN may be defined as provision of nutrition for metabolic requirements and growth through the parenteral route.


LAL Limulus Amebocyte Lysate test is used to characterize the bacterial endotoxin that may be present. The batch is send to packing after issuing satisfactory reports of analysis from Largd If any problem is observed in above analysis the decision is to be taken for reprocessing or others.

Corn oil, Peanut oil, Cotton seed oil.

Added parenteras fungistatic or bacteriostat action or concentration Used to prevent the multiplication of micro-organisms Ex. Acetic acid ,adipic acid, benzoic acid, citric acid, lactic acid Used in the conc. Pyrogen test It is performed by using rabbits as test animals.


As ofrmulation name suggests, the drug particles are suspended in suitable vehicle. It is a liquid preparation consisting of drug. 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 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 The test is performed using stated amounts of volumes of products, standard, positive control, negative control of endotoxin.

Culture conditions Factors affecting growth of bacteria Phases of bacterial growth Culture media for sterility testing 45 1. Chromogenic technique Methods D, E measuring the chromophore released from a suitable chromogenic peptide by the reaction of endotoxins with the lysate end-point test Method E: Membrane filtration Appropriate for: Is is simply water for injection which is sterilized without having antimicrobial agent.


Sterility testing – definition Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample number of containers taken from batch of product. Few important are explained over here. General steps involved 1.

Minimum number of items to be tested: Fluid thioglycollate medium composition described in next slide. Identification of Particulate Matter Microscopy X- ray parentedals diffraction Mass microscopy Microchemical tests Electron microscopy etc… Significance of Particulate Matter monitoring: It is also water for injection, which is sterilized and doesnot contain any anti microbial agent or any other substance.

Effectiveness of the media under test conditions: The machines require a minimum number of operating personnel.


Large Volume Flexible Containers: Sources if pyrogen contamination solvent – possibly the most important source the medicament the apparatus the method of storage between preparation and sterilization Fluid thioglycollate medium Soya-bean casein digest medium other media 49 1.

Gel-cloth technique Methods A, B -cont. Preservatives prevent the growth of micro organisms.