You have put years of time, money, and research into the development of your product. Through testing and trials, you and your team have worked hard to affirm the product’s quality. However, how can you be sure that its quality doesn’t degrade once it reaches the hands of your consumers? Stability studies for pharmaceuticals, biologics, and cosmetics are critical for quality assurance.
Stability studies evaluate how a product’s quality changes over time depending on temperature, humidity, and light. Using these insights, you can determine the product’s shelf life and storage needs.
Here at Purple Diamond, we have a team of experts who specialize in stability storage testing. Here is what we look for and how we ensure you deliver a product that is safe and effective.
A Stability Studies Overview
Stability studies rely on comprehensive temperature and humidity testing. These tests evaluate the effects of environmental conditions on products or materials.
When subjected to harsh environments or extreme temperatures, the quality and reliability of the product can become compromised. Using environmental chambers, our team can replicate real-world conditions, like extreme temperature, pressure, or humidity changes.
Some other conditions we look for include:
- Altitude
- Humidity Exposure
- Temperature-Lifecycle
- Thermal Shock
During testing, samples are observed and retrieved at various times to determine if any changes to their physical, chemical, or microbiological makeup have occurred.
Data collected during the study can then be used to define the maximum length of time the product, whether a new vaccine, a human tissue sample, or even a tinted moisturizer, maintain its integrity.
At Purple Diamond, we can perform stability studies for pharmaceuticals, biological materials, and cosmetics. While the foundation and end-goal of the tests are the same, the methods vary slightly.
Stability Studies for Pharmaceuticals
Stability evaluations play a crucial role in advancing product quality and longevity in the pharmaceutical industry. These assessments allow researchers to understand how drug products and medical substances react when exposed to potentially compromising environmental factors such as temperature fluctuations, light exposure, and varying humidity levels.
At Purple Diamond, we strictly adhere to the ICH Harmonized Guidelines. This internationally recognized standard, set forth by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides comprehensive guidance for stability testing. The guideline covers not only new drug formulations but also extends to reformulations of previously approved medicines, detailing scenarios where reduced stability data may be acceptable.
Bio-Storage Stability Studies
When dealing with biological materials, like tissue samples, blood components, or cells, stability and sterility are paramount.
Purple Diamond offers cGMP-compliant biorepository facilities that provide secure, dependable storage and management for packaged biological products, supporting researchers in clinical trials, medical device storage, and vaccine studies. Our specialized stability storage chambers accommodate a wide range of biological items under customized conditions. These chambers are engineered to safeguard various materials including biological samples, clinical trial materials, pharmaceuticals, and vaccines. We offer storage options across multiple temperature ranges, from room temperature to ultra-low Freezer.
These services are designed to meet the diverse needs of researchers and pharmaceutical companies, ensuring the integrity and efficacy of biological products throughout their lifecycle.
Stability Studies for Cosmetic Products
Stability storage studies play a crucial role in the cosmetic industry, providing essential insights that help define the optimal shelf life of cosmetic products within ASTM (American Society for Testing and Materials) standards. These studies are fundamental in ensuring product quality and consumer safety.
Purple Diamond’s state-of-the-art certified laboratories are fully equipped to conduct rigorous stability testing on a wide range of cosmetic items, including natural cosmetics, organic cosmetics, and synthetic cosmetics.
By leveraging advanced testing methodologies and adhering to industry standards, Purple Diamond ensures that cosmetic manufacturers can confidently assess and optimize the stability and shelf life of their products, regardless of their composition or origin.
Stability Storage Studies from Purple Diamond
As you plan your go-to-market strategy, don’t forget about stability studies. Quality stability studies from a trusted partner not only help you understand how your product will perform under various environmental conditions but also protect your brand’s reputation and ensure consumer safety. By investing in rigorous stability testing, you can confidently bring your product to market, knowing it will maintain its integrity in the hands of consumers.
Purple Diamond offers comprehensive stability studies for pharmaceuticals, biologics, and cosmetics, ensuring product quality and efficacy over time. To safeguard your product’s quality and determine optimal shelf life, contact Purple Diamond’s team of experts today. Our customized stability studies can provide the critical data you need to succeed in a competitive marketplace.
