The Shelf life of a product is often estimated using two kinds of stability testing: real time and accelerated. Stability testing permits you to quickly evaluate the stability of your product and determine the projected life and expiry. We recommend conducting stability testing for in vitro diagnostic crucial reagents including antibodies, enzymes, and other biologics.Our real time stability testing is used to confirm or set long-term stability for your merchandise. This analysis will evaluate performance based on physical characteristics and activity of your merchandise for its projected life and finally determine the expiration. Rockland can run real time studies based on your specified conditions with time factors for 6 months, 1 year, or as many as 2–5 decades.
Accelerated Stability Study Services
Rockland’s Accelerated stability testing can help you in bringing fresh or re-manufactured product to market at the earliest possible moment. Accelerated Stability Testing is a modified method we use to rapidly gauge the expiration date or life span of your merchandise when real time information is inaccessible. We execute our accelerated stability study by exposing the product to a heightened level of anxiety like controlled changes in humidity or temperature. The testing period is dependent on the time period anticipated or required for the expiry of this item.Upon successful testing, your product can then be released to advertise with confidence in its performance.
Accelerated information is recognized by international regulatory bodies as a suitable means to immediately generate required data, but is only accepted when these tests can be replicated on real time samples. Thus, we recommend running a real-time stability test in tandem with the accelerated stability test.Rockland’s open Orin use stability testing is intended to mimic the effects of regular usage, such as freeze/thaw cycles, reconstitution, or aliquot size. This study can allow you to understand and give advice to end users of your product. Our open equilibrium studies are quantified using industry standard reproducibility dimensions including accuracy andic. All stability studies conducted at Rockland can include customized reports or reports using your specified reporting template.