Simulation Black Box
Overview: Defining the edges of failure
Simulation of forming processes is a well-established technique used extensively within the automotive, aviation and aerospace industries. By understanding key mechanical and thermal properties of multilayer blister films, formulating mathematical models to describe material behavior, and utilizing a finite-element-analysis (FEA) approach, simulation can be used to accurately predict finished blister thickness distribution within a cavity.
This allows finished blister barrier performance to be predicted with a high degree of certainty, prior to the initiation of any costly and time-consuming stability studies.
Typical uses for simulation include:
- Prediction of thermoforming window
- Demonstration of barrier equivalency
- Optimization of plug shapes
- Demonstration of tool equivalency
Black Box FEA simulations vary from actual measured permeation rates of no more than 10%. Black Box is the industry pioneer, and has enjoyed tremendous success in advancing blister science within the global pharmaceutical industry.
Black Box provides a scientific framework for consideration of material and tooling options.
- Drug product shape
- Blister film specification
- Tool design/dimensions
- Thermoforming conditions
- Moisture barrier
- Light barrier
- Gas barrier
- Crush strength
- Tablet fit
- Validation packages available for review
- Two double-blind studies, peer-reviewed and published
Black Box™ is a trademark of Amcor Flexibles