Cleanroom Design and Control of Contamination
This eLearning module explores how personnel and other sources of contamination impacts the final product. , and how to behave appropriately in a clean room to maintain sterile environment
Aspects of contamination, cross contamination and mix-ups that can impact product quality and patient health
Different types of contaminants
Sources of contamination
Control of contamination by defining suitable processes and personnel control
Cleanrooms, air flow principles, and cleanroom behavior
Change rooms and airlocks
Types of gowning and usage in the appropriate cleanroon grade.
Hygiene practices, wet and dry cleaning, and general sterilityy assurance
Why it matters
Contaminants (or undesired impurities) can enter the product or process at different stages of manufacturing such as receipt, production, packaging, storage and transportation. Microbial contamination in drug products can pose serious danger to patient health and can reduce therapeutic effectiveness. Control measures can minimize the risk of microbiological, particulate and pyrogen contamination.
Who is it for
Employees involved in the handling of drug product and drug substance in clean rooms, process design, microbial quality control, environmental monitoring, engineering and validation of clean rooms should complete this module.