ASEPTIC TECHNIQUES - 2 DAY PROFESSIONAL DEVELOPMENT HANDS ON PRACTICE
Aseptic Techniques Overview-2 Day Professional Development
Hands On Practice
Training of operators in aseptic techniques is a critical step in protecting the product from contamination. It is by understanding contamination sources and the transport mechanism of contaminants to the product, that we can truly master and execute good aseptic techniques. Contamination sources may stem from inadequate design of the cleanroom or barrier system, improper cleaning, mismanagement of gowns as well as flawed gowning practices and more. In order to execute proper aseptic techniques, these sources of contamination should be considered. Any contamination source in the proximity of an open product has the chance to contaminate the product. When performing aseptic manipulations, there are some ground rules which need to be followed by the analysts or operators. Aspects to be considered are: never breaking first air or reaching over exposed product, components, or fill lines, not touching sterile items with nonsterile items, not exposing sterile items to nonsterile environments and using sterile components and gloves. These are the first steps to steering clear of contamination.
This holistic approach to aseptic techniques will be addressed in the two day training and the data resulting from the hands on qualification exercise will be utilized as a measure of training efficacy.
Understanding Aseptic Techniques
· What is meant by aseptic techniques
· Why follow aseptic techniques
· How operators can transport contamination into controlled environments and onto the product
· Cleanroom behavior
· Understanding cleanroom airflows
· Types of organisms found in cleanrooms
· Sources of cleanroom contaminants
· The science behind gowning
· Gown management
· Common errors made when donning gowns and other PPEs
Cleaning and Disinfection
· Understanding disinfectants and cleaning agents
· Myths and facts about disinfection and disinfectant qualification
· Common errors during cleanroom and barrier system cleaning
Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of facilities, quality assurance, quality control, microbiology, and validation.
Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her PhD degree. Her career includes founding and managing clinical laboratories for Maccabi Medical in Israel. She uses her extensive experience to teach why medical product contamination is directly related to facility design, operations, testing and aseptic technique flaws.
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