virtual manufacturing

Pharmaceutical Bilcare optimizes its package design and development process using thermoforming simulation

THE CHALLENGE Bilcare Research aims at innovate and develop pioneering packaging solutions meeting the complex needs of the Pharmaceutical industry. With PAM-FORM, Bilcare Research engineers benchmarked blister cavity design, packaging film selection based on its formability and barrier properties and virtually optimized process parameters. THE BENEFITS Reduce more than 50% of the packaging production line time Improve packaging design by choosing the most appropriate material Help avoiding quality defects Improve the process parameters with validation by simulation Save material and production costs by eliminating the need for a physical prototype Benefit from the support and the expertise of ESI teams Due to their ease of production, their low cost and their high performance, thermoformed plastic blisters are widely used to package pharmaceutical dosages. Thermoformed part are generally not uniform in thickness. Non-uniform thickness and thinning in the corners of the container are major limitations of thermoforming. Because of stringent regulatory and extended stability requirements, the packaging of new and existing pharmaceutical products is more demanding on moisture barrier. Therefore if a change of packaging material is to be considered, the challenge is to respect efficiency, cost and environmental concerns by providing sufficient water vapor barrier at an acceptable cost.

Predicting the thickness distribution with simulation

Bilcare has developed a scientific packaging development method which is first of its kind globally called BilcareOptimaTM which studies the degradation profile of the drug formulation and thereby determine the barrier property required in the package to protect the product over its shelf life period and thus define the most optimum packaging/packaging material for the product. While developing a bottle or pouch packaging by using the results are straight forward, developing an blister packing option is more challenging because of the change of properties which the material undergoes during the packaging process. The barrier properties of thermoformed blister is directly associated with the thickness distribution of plastic film after the cavity formation.

The main function of any packaging is to provide required protection from moisture, oxygen and light along with a mechanical rigidity for safe transport, handling and storage to reach the end user safely with the expected quality. Selecting the right barrier packaging material, optimizing the package design and processes with classical trial and error method with long term stability studies could be ruled out by adopting scientific methods like Bilcare OptimaTM and Advanced Package Design Services with PAM-FORM. Samir Bagalkote, Assistant Manager , R&D Bilcare Research
Simulated thickness distribution

The thickness distribution through-out the blister is based on the thickness of base film, die design, and thermoforming condition. The parameters like forming temperature, pressure/vacuum range, visco-elastic deformation properties of plastic material, die geometry, contact & friction between the blank and die which has a direct or indirect effect on wall thickness distribution in thermoformed blister. Thus it is important to predict the wall thickness distribution on blister cavity formation of the barrier films to determine the barrier property of the final blister pack.

Virtually validate the blister cavity and the packaging film selection
Thus the main objective of this work is to develop a system which can predict the wall thickness distribution and change in barrier properties of polymeric films after thermoforming to a blister pocket, with respect to material properties, cavity design and processing parameter. This information also will be used to develop a benchmarking for deciding the optimum blister cavity design. We are able to develop a system of predicting the thinning profile on blister formation and the barrier property by using this finite element analysis tool by systematically studying the physical, mechanical and thermal properties/behavior of film during its cavity formation process. The earlier software tool we were using had lot of limitation and by introducing PAM-FORM 2G as the FEA tool we are able to predict this behavior more accurately with a great flexibility and user friendliness which helped us to speed up our process.

Representation of the mold, blank and blank holder.

Simulated thickness distribution at various locations in blister pocket

The film visco-elastic deformation behavior was validated based on comparison of the experimental and simulated stress-strain data at various temperature and strain rates.
In the typical process a preheated plastic sheet is clamped on the mould with the help of blankholder and pressure or vacuum is progressively applied. PAM-FORM performs the forming simulation in a 3D virtual environment and the post processor produced a unique topography of thickness, stress-strain distribution, forming zones etc. in thermoformed pocket.

We have been using scientific CAE tools for almost a decade, but change over to the ESI group s software from the earlier tool made significant improvement in terms of accuracy and speed. We are using PAM-FORM 2G since, 2008. For blister design and assessment of formability and barrier properties we use PAM FORM 2G Software for validating the changes made in blister cavity design, film initial thickness and thermoforming process parameters

Results were very encouraging and gave Bilcare Research an immense confidence in trying new designs and materials which will make productivity enhancements in the pharmaceutical business.

The difference between the predicted and experimental results showed the accuracy of the simulation method: the correlation between the experimental results and the simulation was validated.

To find out more about ESI s thermoforming simulation tool PAM-FORM, please visit: www.esi-group.com/pam-form