Validation of Sterile Filtration of Liquid Nitrogen

Liquid nitrogen (LN2) is widely used in the pharmaceutical,biopharmaceutical, and life sciences industries for lyophilization and quick-freezing of pharmaceutical preparations and storage of cells and microbial cultures.
As a refrigerant, LN2 can act as a vehicle for transmitting contaminant
microorganisms.Whether as the original source of contamination or as a conduit, LN2 has been reported as a potential biohazard (1). Fungal and bacterial contaminants have been found in both the freezers that use LN2 and the cultures stored in them (2). An outbreak of hepatitis B in patients undergoing
cytotoxic treatment has been traced to LN2, suggesting that contaminants can move both in and out of cryostorage containers (3). In other instances, storage tanks that use LN2 were reported to be contaminated by Bacillus (4), and storage tanks holding cryopreserved stem cells also were found to be contaminated (5).

Leesa D. McBurnie and Barry Bardo
Pharmaceutical Technology OCTOBER 2002

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