Used to measure product efficacy and ultimately ensure the safety of the end user, stability storage studies are a fundamental stage in the development and production of products like Biologics, Cosmetics, and Pharmaceuticals. Environmental conditions play a large role in the degradation of these products. A stability study for a pharmaceutical product can determine the time frame during which a drug product or medical substance is expected to remain at its prescribed potency when stored in specific environmental conditions. Such testing helps product owners and manufacturers validate the integrity of their products in understanding how to transport or store these packaged products aptly around the world.
What Is Stability Storage?
Stability Storage Industry Solutions
Quality biological products require reliable biomaterials and stability storage studies that can be trusted. That means guaranteeing that the integrity of your materials stays consistent through every testing stage. As part of our dedication to promoting quality storage testing for biological products, Purple Diamond provides researchers with cGMP-compliant biorepository laboratories that deliver safe, reliable storage and management of your packaged biological products.
Purple Diamond can securely store your biological items to custom conditions. Our stability storage chambers are designed to store and protect your biological materials, clinical trial materials, pharmaceuticals, vaccines, and more. Storage ranges for biological materials begin at Room Temperature 15C – 27C, Refrigerated Storage 2C-5C, Freezer Storage -20C, and finish at Ultra Low Freezer -80C.
Biological Storage Services Include:
Stability evaluations allow critical advancements in product stability to be applied to drug products or medical substances subjugated to compromising environmental factors, including temperature, light, and humidity. Data from these studies help produce quality storage conditions and establish product life cycles. Stability testing for pharmaceuticals ensures the quality, efficacy, and safety in the development of drugs, medicines, and controlled substances produced are maintained to meet the highest standards.
Purple Diamond adheres to the ICH Harmonised Guideline set forth by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline extends to new formulations of already approved medicines and details the circumstances under which reduced stability data can be considered acceptable.
Pharmaceutical Storage Services Include:
Stability storage studies for cosmetic goods deliver critical insights used to define the optimal shelf life for cosmetic products within ASTM standards. Evaluating stability and determining the shelf life of a cosmetic product can be achieved by monitoring changes in the integrity and quality of its composition or material makeup over time. Stability and product integrity of cosmetic goods can be affected by major factors including storage variation, ingredient quality, and processing aids, as well as the type of and quality of packaging used.
Purple Diamond’s certified laboratories are equipped to perform testing on all types of cosmetic items, regardless of whether those products are considered to be of natural, organic, or synthetic makeup.
Why Purple Diamond?
At Purple Diamond, our team of stability storage specialists develop and implement stability test plans designed to meet your products distinct storage needs. Our certified laboratories are equipped to perform industry specific stability testing, including stability storage studies for Biologics, Cosmetics, and Pharmaceuticals. By choosing stability storage services with Purple Diamond, rest assured knowing your product will be monitored and protected from the second it’s put into the chamber to the final day of testing.