Before your Pharmaceutical products get to market, a period of Stability Testing is required, to ensure product safety and efficacy. However, the process of stability testing (also known as Stability Trials) can be time-consuming and expensive.
Stability testing is crucial, because improper packaging can cause costly recalls and damage to your brand. For instance; in 2012, 67% of US drug deficiencies were due to quality issues.1 With this in mind, in this article, we’ll reveal how you can reduce costly stability trials, without compromising your high standards.
SUPERDRYSIM™ software helps to reduce the time spent assessing a product’s shelf-life, compared to the old-fashioned methods associated with traditional stability trials. It decreases your product’s time-to-market, and also significantly reduces labour and facility costs associated with lab trials. It is especially applicable to the Pharmaceutical, Medical Device and Packaging sectors. The convenience of SUPERDRYSIM™ makes it a viable solution for companies of all sizes, that are looking to validate their packaging solutions quickly and efficiently.
How can SUPERDRYSIM™ Speed-Up Stability Testing of Pharma Products?
SUPERDRYSIM™ Predictive Software can supercharge stability testing. It works by utilising data from previous real-world stability tests, and predicts the performance of new product/packaging combinations. Pharmaceutical manufacturers (large and small) use it to identify which products are likely to be stable, and which may be at risk of failing invitro trials even before any lab work has started! By identifying packaging with a high risk of failure, researchers can optimise the testing process, and reduce potential problems.
“Any pharmaceutical manufacturer using SUPERDRYSIM™ will have a significant advantage over their competition in reducing time to market”
Modelling Pharma Zones to Speed-Up Stability Testing
SUPERDRYSIM™ can also be used to simulate the impact of different climate conditions on the stability of pharma products. This helps manufacturers identify vulnerabilities that are specific to different ICH Pharma regions, such as Zone-4 (Thailand, Cambodia etc.) and optimize their packaging accordingly.
Other Advantages of SUPERDRYSIM™ in Stability Testing
Quicker design iteration is another result of SUPERDRYSIM™ usage. Manufacturers can rapidly test and iterate different packaging designs, in order to bring a product to market speedily, thus saving time / money with prototype packaging options. Any pharmaceutical manufacturer using SUPERDRYSIM™ will have a significant advantage over their competition in reducing time to market, and will gain a large first mover advantage for new pharmaceuticals and diagnostic products.
Our Data-Set Advantage
The efficacy of any predictive modelling software is proportional to the size of the data that is available, so it’s important to have lots of high-quality data, from previous stability tests, in order to achieve accurate predictions. Given its wide use in the pharma market, SUPERDRYSIM™ has one of the largest data sets available, and is therefore likely to generate excellent predictive results for you and your products.
Let us Help You…
With over 60 years experience in Pharmaceutical packaging and with full ISO:9001 accreditation, we have the necessary calibre, professionalism, and expertise to help you. Click HERE to book a call with Dr Mark Valentine (DPhil), or call us now on +44 (0) 1628 531 900, and we’ll be happy to help!
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Citations:
1: S. Shukar, F. Zahoor, K. Hayat, A. Saeed, A. H. Gillani, S. Omer, S. Hu, Z.-U.-D. Babar, Y. Fang, and C. Yang, “Drug shortage: Causes, impact, and Mitigation Strategies,” Frontiers in pharmacology, 09-Jul-2021. [Online]. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299364. [Accessed: 31-Mar-2023]
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