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?
Industry Stability Storage 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 Stability Storage Services Include:
- Clinical Trials
- ICH Stability Storage
- Medical Device
- Package Integrity Testing
- Pallet Testing
- Shipping Lane Studies
- Vaccine Storage
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 Stability Storage Services Include:
- Accelerated Test Programs
- ICH Stability Storage
- Client Specific Storage Conditions
Cosmetics Stability Storage
Cosmetic 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 for Stability Storage?
At Purple Diamond, our team of 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 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:
- Audible and Visual Alarms for Temperature and Humidity
- Back-Up Generator with Automatic Transfer Unit
- Storage Units Under 24/7 Security
Our Purple Diamond Chamber Logs Include:
- Continuous Monitoring and Alarm Callouts
- Data Acquisition System
- Uninterrupted Power Source on Data Loggers
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.
As always, Purple Diamond offers you the ability to either schedule an initial consultation, complimentary, OR you can book a facility tour and come on in and visit. Definitely feel free to stop in to the lab if you are close to the Lehigh Valley. The packaging and whole Purple Diamond team is here to assist you anyway that we can. The initial consultation can be either a phone call or a zoom call, whatever is more convenient for you. Reach out via the Contact Us page by either filling out the contact us form OR booking some time on the calendar below the contact form. Either way we will get back to you! Thank you so much for reading down this far and thank you for considering Purple Diamond as your dedicated testing, engineering, and design facility for all of your packaging needs.Â
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Related Testing Standards
- ASTM D642
- ASTM D685
- ASTM D880
- ASTM D951
- ASTM D999
- ASTM D3078
- ASTM D3103
- ASTM D3285
- ASTM D4169
- ASTM D4332
- ASTM D4728
- ASTM D5265
- ASTM D5276
- ASTM D5277
- ASTM D5487
- ASTM D6055
- ASTM D6179
- ASTM D6344
- ASTM D6653
- ASTM D7386
- ASTM F88
- ASTM F1140
- ASTM F1886
- ASTM F1929
- ASTM F1980
- ASTM F2096
- ASTM F2250
- ASTM F3039