Validating to be processes
“The chambers will pull a particular vacuum, commonly referred to as deep or shallow vacuum.
A deep vacuum is typically below six psia, pounds per square inch absolute,” said Littley. Some of the smaller test chambers are in the 9-ft³ range, but larger industrial units handle 30 pallets, a full load for a tractor trailer.
According to Littley, there are two ways to verify the resistance.
“One is direct innoculation of the product, where a BI is placed in the most difficult-to-sterilize location of the device, such as restricted pathways, mated surfaces or long narrow lumens,” Littley said.
“Depending on the cycle and product, there might be a few nitrogen washes during the initial stages to flush the residual oxygen.Endospores are so durable some have been pulled off of ancient mummies making them at least 4,000 years old.Spore-forming microorganisms are used as the indicator because they are difficult to kill.” After the pre-conditioning phase, operators quickly load the product into the sterilization chamber so as to not lose heat from preconditioning.“In theory, the process should kill a given population of that organism.The biological indicator, with a minimum of one million organisms on a paper strip, is our ‘meter stick’ for determining the sterility-assurance level.
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This is more common in shallow vacuums of 6 psia or greater.