Stability Storage

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 is part of a validation study to evaluate a collection of test samples placed into environmentally controlled chambers in order to determine how the quality of that product varies with time under environmental conditions such as temperature, light, and humidity. Samples are observed and retrieved at varying storage lengths to determine if any changes to physical, chemical, or microbiological makeup have occurred. Data collected during the study can then be used to define the maximum length of time the will be able to maintain its integrity and predict what product changes can occur over time with exposure to specific environmental stressors.

Stability Storage Industry Solutions

BioStorage

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:

Pharmaceutical Storage

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:

Cosmetics Storage

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.

Our Purple Diamond Laboratory Chambers Include:

Our Purple Diamond Chamber Logs Include:

In addition to a comprehensive stability testing capabilities list, Purple Diamond provides storage areas for your products for use during both long and short term stability storage studies. Our team is committed to delivering high-quality results as we develop a comprehensive solution to your stability storage and testing needs.

Accreditations

Achieving ISO 17025 Accreditation is the pinnacle in third-party laboratory testing accreditation. It confirms that the facility has management, quality, and technical systems in place to ensure accurate and reliable analyses.
ISTA is revered as the certification standard for package testing for distribution. ISTA’s Testing Protocol remains a series of testing methodologies and standards well recognized within the packaging community.
A select few companies are authorized by PHMSA as an approved third-party packaging testing laboratory in accordance with Hazardous Materials Regulations, critical to ensuring safe transport of dangerous goods.

Affiliations

With over 12,000 standards globally, ASTM International’s fully transparent standards development enhances performance and confidence in consumer choices.
The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

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