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Stability Studies

Reliable Stability Studies & Shelf-Life Testing

Enhance the shelf life of your drug product and ensure regulatory compliance with our stability testing and storage services. Our team manages state-of-the-art laboratories equipped with stability storage chambers mapped and continuously monitored using a validated, continuous monitoring system. These facilities fulfill requirements for stability studies, shelf-life testing, and shelf-life determination, whether we follow client-supplied methods, compendial methods, or methods developed and validated by our own analysts.

We support studies for both short-term (accelerated) and long-term stability programs as well as photostability programs for both research and development and commercial products.

Our chambers and monitoring system are supported by external back-up power generators in the event of power failure. Although our stability storage capabilities are geared toward providing pharmaceutical and biopharmaceutical stability storage, we also provide stability storage on medical devices and other types of products.

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Stability & Storage Services

Storage Chambers

Our facilities offer a variety of storage conditions supported by a validated continuous monitoring system and external back-up power generators. These storage chambers operate at a variety of set points, with custom conditions available, as well.

Freeze Thaw Cycling

We design and execute stabilities studies to establish a clear understanding of the impact temperature changes have on your product during shipping or storage. By partnering with our expert team, you can leverage our expertise if results present less than ideal findings.

Photostability

We employ photostability chambers that are temperature-controlled with calibrated UV and visible light sources. These studies are executed based on your internal protocol or our team can draft a protocol. 

Custom Storage Conditions. Pace Life Sciences scientists working in storage testing chamber.

Custom Storage Conditions

We provide custom storage conditions and frequently introduce new storage options to broaden our capabilities. We perform testing tailored to your needs to accommodate various specifications relevant to your drug product or medical device.

To remain aligned with your goals, our staff reconciles all stability samples prior to initiating any stability study. We then enter the protocol information into our stability tracking system and develop stability protocols as needed.

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.