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 significant role in the degradation of these products. A stability study for a pharmaceutical product can decide the time 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 confirm 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 to decide how the quality of that product varies with time under environmental conditions such as temperature, light, and humidity. Samples are seen and retrieved at varying storage lengths to decide 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 they will be able to keep its integrity and predict what product changes can occur over time with exposure to specific environmental stressors.

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 in 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 set up product life cycles. Stability testing for pharmaceuticals ensures the quality, efficacy, and safety in the development of drugs, medicines, and controlled substances produced are kept meeting the highest standards.

Purple Diamond adheres to the ICH Harmonized 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:

Cosmetics Stability Storage

Cosmetic storage studies for cosmetic goods deliver critical insights used to define the best shelf life for cosmetic products within ASTM standards. Evaluating stability and deciding 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 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 checked 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:

At Purple Diamond, we offer a free consultation or a guided tour of our facilities. Consultations can be done over the phone or on zoom, so choose what suits you best. To get in touch, go to our Contact Us page and fill out the form or book an appointment using the calendar below. Our goal is to assist you in any way possible, so please don’t hesitate to contact us. 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.

Related Testing Standards

ASTM

ISTA

TAPPI

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Accreditations

Achieving ISO 17025

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.

International Safe Transit Association

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.

Un Certification for Packaging

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

ASTM INTERNATIONAL

With over 12,000 standards globally, ASTM International’s fully transparent standards development enhances performance and confidence in consumer choices.

TAPPI

The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

The APASS program was designed by Amazon to help support vendors, sellers, and manufacturers in obtaining certification of their products as Frustration Free Packaging (FFP), Ships in Own Container (SIOC), or Prep-Free Packaging (PFP).

Services

Materials Testing

Package Testing

Product Testing