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Freeze-thaw Cycling

Informative Freeze Thaw Stability Testing

Prepare your product and packaging for freeze thaw cycling with stability studies powered by our expert team. The various environmental conditions your product is exposed to during shipping and storage have the potential to compromise overall stability and return it to the base state. Our team helps you predict possible outcomes by designing and executing freeze thaw studies, giving you confidence that your product will not be compromised by fluctuating temperatures.

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Freeze Thaw Methods & Stability Studies

Freeze thaw studies are performed to determine the impact temperature changes have on your product stability and viability. These services are often paired with other available in-house testing options at the end of each cycle. Our experienced team works with you to design studies suitable to your products with the following considerations:

Secure Data Accessibility

Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.

The copies are offered in high-resolution and in color, giving your team easy and clear viewing. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.

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.