Pharmaceutical Stability Facility Supports Studies
Does your freezer go down to -80ºC? The freezers in our pharmaceutical stability facility do.
As pharmaceuticals are under development or when finished pharmaceuticals are enrolled in on-going stability studies, manufacturers need a facility to store these products and assess them over time. Stability studies are used to generate evidence on how the quality of a drug substance or formulated drug product varies with time under the influence of a variety of environmental factors. These studies help determine the shelf life, purity, and storage needs for pharmaceuticals prior to commercial approval and ensure that the integrity of the active ingredient is safe for distribution.
Our 3,500 square foot pharmaceutical stability facility in North Kansas City meets that need. In the same building as our repository and biorepository, it serves the many commercial and government clients who rely on us to support complex multi-storage temperature studies, or multi-storage temperature/humidity studies.
This facility houses 40 chambers that span all possible storage conditions, including Refrigerated (+2ºC to +8ºC), Frozen (≤ -20ºC), Ultra Cold (≤ -80ºC), or Climate Controlled (25ºC/60%Relative Humidity [RH], 35ºC/60%RH, 40ºC/75%RH), and also includes an oven for controlled degradation studies. The stability chambers are also programmable to provide customized storage conditions to meet any study requirements that a client may have. Additionally, the entire facility is designed and tested to ensure it maintains Controlled Room Temperature of +20ºC to +25ºC to allow for stability study conditions to be provided on large open shelving areas.
For our pharmaceutical clients, this facility provides efficiency and convenience, coupled with our unmatched reputation for quality in everything we do.
The next time you want to get cold, call us.
GETTING STARTED WITH MRIGLOBAL
As a not-for-profit contract research organization, we have proven ourselves as an objective partner driven to make our clients’ products more successful. We specialize in defense, human health, pharmaceutical sciences, in-vitro diagnostics, energy and environment, agriculture, and global health.
To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.
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