Abstract
In GLP safety assessment studies, by comparison to other route of administration, inhalation can exhibit a relatively high level of variation in dosage due to the intrinsic characteristics of inhalation study technology. To generate aerosols, different air flow rates must be carefully and consistently controlled. Any change of air flow will cause instant changes of aerosol concentration leading to variation of dosage received by the animal. Most Inhalation delivery systems require a high level of manual intervention to control and adjust air flow; monitoring of the system is manual and often not continuous. This approach is both labor intensive and liable to mistakes. It also lacks precision. An important issue for study integrity is that if the air flow is not continuously monitored and a record maintained, the dosing process becomes a kind of “black box”. Any variation of the flow rate may not be identified immediately resulting in an inability to quantify the extent of a deviation, and leading to GLP compliance problems. Our inhalation system applies an automated control and recording system, which allow us to control, continuously monitor, and retain raw data of all exposure parameters for air flow and concentration of oxygen, carbon dioxide, temperature, humidity throughout the aerosol exposure process. The system will alarm, immediately prompting remedial/corrective action, should any parameter go out of pre-specified range and maintain an audit trail of this. This type of automated inhalation delivery system results in better animal welfare, more complete and reliable study data and excellent GLP compliance.
