![]() Sampling for microbiological testing shall be performed prior to collecting samples for other purposes.Sample documentation procedures shall be followed for intimations and sample processing (refer to the current version of SOP for Microbiological Culture Management.General Sampling Process under the Aseptic Technique :.Sterilization: The act or process, physical or chemical, of destruction or elimination of all viable organisms.Ħ.0 PROCESS DESCRIPTION – ASEPTIC TECHNIQUE :.Sterility Test: Tests performed to determine if viable microorganisms are present.Sterile:Absence of any viable organisms.The act or process, physical or chemical, of reducing viable organisms on a surface to a defined acceptable level.An aseptic manipulation or activity performed by personnel that occurs within the critical area.Test performed to demonstrate that media will support microbial growth per Pharmacopeia specified challenge organisms.Note that APS is understood to be synonymous with media fill.A means for establishing the capability of an aseptic process, as performed using a growth medium in place of the typically filled material.An area that has defined environmental control of particulate and microbial contamination and is constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area used for the processing of sterile products.Assembly of sterilized components and products in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to control microbial and particulate contamination to acceptable levels.Part of aseptic processing where a pre-sterilized product is filled and/or packaged into sterile or dehydrogenated containers and partially closed and/or closed.Assuring that all personnel has been trained and qualified in proper aseptic technique before being assigned activities that require collecting or testing any material.Ĥ.0 ABBREVIATIONS AND DEFINITIONS -ASEPTIC TECHNIQUE :.Head Microbiology / Designee shall be responsible for:.The aseptic technique described herein is provided as a foundation to be practiced with all microbiological sampling and testing to prevent contamination of test samples and to minimize the possibility of mixed (contaminated) cultures.Guidance is also provided for proper aseptic technique when preparing for and performing tests and analyses in the laboratory, including standard laboratory tests, such as.Performing environmental monitoring and. ![]()
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