Depyrogenation Services Performed at Gibraltar Laboratories, Inc.
Gibraltar Laboratories, Inc. performs depyrogenation services on a routine basis as a part of internal and external processes. Depyrogenation services refer to the removal of pyrogens most commonly from injectable pharmaceuticals.
Pyrogens can be difficult to remove due to the high variability of their molecular weight. They are also relatively thermally stable and insensitive to pH changes. Despite this, several removal techniques exist:
Ion exchange chromatography
Gibraltar Laboratories, Inc. provides depyrogenation services to support programs requested by clients such as cleaning and process validation. The depyrogenation services provided at Gibraltar are heating methods which include heating the material to 250°C for up to 30 minutes. Such materials can include glass and other types of lab equipment to provide and ensure a 3 log reduction of any pyrogens, if present.
To learn more about Deprygenation Services from Gibraltar Laboratories, Inc., please call us at (973) 227-6882