Are there any special processing or handling concerns for flexible intravenous (IV) solution bags?
Are there any special processing or handling concerns for flexible intravenous (IV) solution bags?
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Yes, due to their soft and flexible design, IV solution bags can be easily damaged if not handled properly during processing and labeling. A damaged IV solution bag may not protect the contents from exposure to microbiological contamination as intended. Detection of a damaged IV solution bag by leaks or by examination of the bag may not be possible. In fact, a microscopic defect may not be evident until microbiological contamination becomes visible, which is too late. Prevention of this potentially serious problem is important. FDA is aware of product recalls where IV products in flexible plastic bags were exposed to rough surfaces or sharp objects during labeling, creating microscopic punctures or weakening the bag surfaces. When a compromised IV solution bag is filled with liquid and expands as intended, holes may form at the weak points, leading to a loss of sterility or assurance of sterility.
Manufacturers are reminded that drug product containers and closures must be handled and stored in a manner to prevent contamination (see 21 CFR 211.80(b) and also 211.94).
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Date: 7/5/2011