The FDA receives a substantial volume of drug label information daily, encompassing both new submissions and revisions. By accessing the OpenFDA platform, particularly through the Drug API Endpoints under Product Labeling, you can visualize the trends in drug label submissions over the years. Astonishingly, around 40,000 labels were submitted in 2023 alone. These drug labels, […]

I assume some of you have been trying to develop a simulation tool to estimate the dosing time for an autoinjector. However, you may have encountered difficulties due to some complicate math and the need for specialized software like MATLAB or Mathcad. I used Mathcad when I worked at a company, but not everyone can […]

I am both a user and developer of simulation models, and I understand that applying the first principles of heat transfer can accurately estimate the temperature of products. Today, I would like to share my direct experience with Python and ChatGPT. Python is a programming language known for its readability, simplicity, and versatility. Currently, I […]

Tolerance stack-up analysis is an invaluable tool for designing and verifying devices (e.g., prefilled syringes, autoinjectors). However, relying solely on tolerance stack-up analysis may not be sufficient in certain scenarios. Consider, for instance, the sterile seal created by the rubber plunger stopper against the barrel of a syringe. When the plunger stopper is placed within […]

Are you using laser-drilled holes or micropipettes to prepare defect samples? I used these methods before, but not anymore. I can help you prepare defect samples in-house within a couple of hours. As you might guess, it costs significantly less compared to using laser-drilled holes or micropipettes. I briefly explained the defects created by wires […]

As packaging engineers, it is essential to conduct thorough engineering analyses before proceeding with testing. In this blog, I introduce a straightforward method for calculating the Water Vapor Transmission Rate (WVTR). This simple analysis will assist you in selecting the appropriate materials and suppliers, as well as in designing effective blister tooling. Furthermore, you can […]

Are you determining the shelf life of a product or designing a container closure system (CCS) to ensure the product achieves its desired shelf life? Traditionally, shelf life determination involves placing the product in various CCS configurations, periodically testing its stability, and recording the duration for which it meets the required criteria. This classical approach […]