What is reagent onboard stability?
On-board stability, stability after reconstitution, open vial/bottle stability. — the monitoring of stability of IVD reagents already placed on the market; — the verification of stability specifications after modifications of the IVD reagent that might affect stability.
What is reagent stability?
Stability of an in vitro diagnostic (IVD) reagent indicates its ability to maintain expected, and consistent, performance over time without degradation. “It relates to performance of a product within a specified time period.
What is stability testing for medical devices?
According to the FDA “the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf …
What is an in vitro reagent?
Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
What is onboard stability?
Onboard stability (e.g., the maximum length of time IVDs can be loaded onto an instrument and still perform according to specifications). Shortened onboard stability requires more user intervention to replace reagents and creates delays in work output.
What is in use stability study?
The purpose of in-use stability testing is to establish a time period during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured).
How do you conduct a stability study?
7 Steps for Stability Testing
- Step 1: Batch Production.
- Step 2: Product Container Filling.
- Step 3: Initial Test (Time Point Zero).
- Step 4: Product Storage.
- Step 5: Product Evaluation.
- Step 6: Determine Stability.
- Step 7: Conclusion Report.
What is shelf life testing?
Shelf-life testing is designed to provide an objective measure of the quality factors that define the food and the point at which failure occurs. This failure is the point at which the food exhibits physical, chemical, microbiological, or sensory characteristics that are unacceptable to the consumer.
What is vitro diagnostic testing?
In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.
What is Vitro testing?
A test performed in vitro (“in the glass”) means that it is done outside of a living organism and it usually involves isolated tissues, organs or cells.
What is IMO stability criteria?
For a cargo vessel, the intact stability requirements are follows- Initial GM or metacentric height should not be less then 0.15 m. Righting lever GZ should be at least 0.2 m and angle of heel Ѳ ≥ 30̊. Maximum righting lever should occur at heel >30̊ preferably but not less than 25̊.
What is the purpose of Intact Stability Code?
The purpose of the Code on Intact Stability for All Types of Ships Covered by IMO Instruments, hereinafter referred to as the Code, is to recommend stability criteria and other measures for ensuring the safe operation of all ships to minimize the risk to such ships, to the personnel on board and to the environment.