Why use FreeThink’s ASAPprime® Stability Software
FreeThink’s ASAPprime® software, based on the Accelerated Stability Assessment Program, enables scientists to quickly and accurately determine product shelf life. A range of scientifically and statistically designed exposure conditions are used to force a product to fail (hit its stability specification limits). Using these edge-of-failure times (isoconversion times) at a range of conditions allows the software to project the long-term storage shelf life based on short-term data.
ASAPprime® is now widely used in the pharmaceutical and other industries to speed up many aspects of product development, to make better decisions faster, and in some cases, to meet regulatory requirements.
To learn more about ASAPprime® and schedule a demonstration, please contact us.
Learn More About
Stability Software

Stability Software
ASAPdesign™
ASAPprime®
Regulatory
Services

Stability Software
ASAPdesign™
ASAPprime®
Regulatory
Services
ASAPdesign™
ASAPdesign™ is a subroutine within ASAPprime® that designs an optimal study for data modeling. ASAPdesign™ first considers the precision of the measurements needed to determine the failure point and thereby establishes the number of repeats needed to power the study. From the number of analyses used and how long the study will last, the program populates an optimized design with respect to repeats, conditions (temperature, relative humidity), and timepoints. The design space is limited based on any phase boundaries. To hit the product’s specification limit at as many conditions as possible, available prior knowledge (or default behavior) is used to establish appropriate conditions and timepoints.
When an ASAPprime® study is carried out in shorter overall times, there is a greater extrapolation to the long-term conditions with correspondingly larger error bars.
When the design requires relative humidity control, ASAPdesign™ provides information about the appropriate saturated salts to use at each condition. These studies are carried out in individual jars containing vials of salt slurries to control the relative humidity in “mini chambers.”
ASAPprime®
When the degradation behavior of a product is not linear, fitting of the data to temperature models can be non-predictive. With ASAPprime®, data are analyzed using different curve shapes to determine isoconversion times (tiso). The isoconversion times at all conditions are fit to the moisture modified or standard Arrhenius equation, which has been shown to work across all chemical and most physical changes that occur as samples age. The probability that a product will remain within its specification limits at the end of its shelf life is calculated using Monte Carlo simulations.
Ideal packaging is determined by combining calculated relative humidity as a function of time inside a package with the moisture sensitivity of the product from the ASAPprime® fitting. The relative humidity versus time behavior is calculated using the balance of moisture transfer rates and the ability of the product to hold moisture as a function of relative humidity. ASAPprime® uses an extensive database of both packaging material moisture permeabilities (bottles, blisters, and drums) and moisture sorption isotherms of most pharmaceutical materials.
Regulatory
To learn more about how ASAPprime® has been used in regulatory submissions:
Services
Training
FreeThink provides complimentary training for new customers who license ASAPprime®. This covers practical lessons for carrying out experiments, hands-on work with the software, and theoretical background (science and statistics). The course is taught by a FreeThink authorized trainer and can be completed on-site or virtually. Customers who complete the training will receive a certificate. FreeThink also provides options for subsequent refresher and advanced training.
Consulting
FreeThink offers consulting services for software customers needing assistance with designing, analyzing, or interpreting their ASAP studies. We also help prepare regulatory documentation for clinical, market, and post-approval applications using ASAPprime®. We have extensive experience in the use of ASAPprime® with most health authorities.
IQ/OQ
ASAPprime® customers can purchase onsite Installation Qualification and Operational Qualification (IQ/OQ) services. These qualification services are useful when using ASAPprime® in regulatory filings. An authorized FreeThink representative works with your IT and/or technical staff to install ASAPprime® under a pre-approved protocol and carries out extensive tests to demonstrate the validated software was delivered as specified (IQ) and will function according to operational specifications (OQ). Documentation is provided following a successful IQ/OQ.
ASAPprime®GO!™
The ASAPprime®GO!™ Study Starter Kit is used as a tool to ensure proper running of an ASAP laboratory and use of the software for analysis and to establish Performance Qualification (PQ). Each kit includes:
- Specially designed active tablets for stressing
- Saturated salts with vials having prepared lids (24 count)
- Analytical method and standards
- Labels for glassware
- Detailed instructions for carrying out work and using ASAPprime® for modeling
- Expected results to verify against