This question is part of the following Ask The Expert session:
To address integrity concerns, companies that manufacture single-use components will typically conduct a visual inspection as well as perform pressure decay testing. Pressure decay testing is the industry standard for validating single-use component integrity, however there are limitations to the level of assurance this testing can provide.
Pressure decay testing measures a drop in pressure within a bag body or vessel to determine the existence of a leak. This type of test method is limited in scope to stand-alone bag compartments and can be inhibited if the bag compartment is connected to tubing and other single-use components. The sensitivity of a pressure decay test was demonstrated to be 50 microns defect size for 50L bags and 100 micron for 200L bags. The cycle time for such a test could range from 10 minutes to upwards of 45-60 minutes depending on the equipment used and bag compartment size. Pressure decay testing is commonly used by bag manufacturers to ensure product quality prior to shipment.
Even though the product is tested at manufacturing, there is no guarantee that the components are still intact by the time they reach point of use. Shipping of these items can create possible breaches. After the box leaves the manufacturer, there are many potentially hazardous scenarios – dropping the box, box damage, Gamma irradiation and temperature extremes can all compromise the integrity of plastic single-use components. The HIT™ System was designed to allow end-users the option of point-of-use testing, thereby ensuring integrity immediately prior to usage.