progress through material competence
The demands placed on pharmaceutical packaging are varied and high. Packaging made predominantly of plastic and aluminum must meet high functional requirements, for example with regard to barrier, sealability or formability. The high quality requirements often conflict with material and cost reductions. Consequently, the physical and mechanical properties of the materials should be exploited as far as possible. This requires a sound and comprehensive understanding of materials.
Suisse Technology Partners Ltd. is a long-standing partner and independent service provider to the pharmaceutical industry and supports its customers in packaging development, product and process optimization or in the event of failure (failure analysis).
The failure analysis is a systematic procedure for the identification of failures and the determination of their cause.
With the help of extensive analysis methods, first the exact failure is identified, then its cause is determined and then a solution to the problem is worked out in order to avoid cost-intensive product damage and production downtimes in the future.
Suisse TP can quickly analyze the case of failure through extensive method competence and extensive expertise in the field of surface and material analysis, thus decisively shortening the reaction time.
Keywords: failure analysis / surface and material analysis
The mechanical characterization of packaging materials and the simulation of forming processes can be used to predict the extent to which certain materials can be formed or which thinning, e.g. of a foil, is caused by the process.
A forming analysis is suitable to analyze the process reliability or to specifically optimize the process for cold-formed blisters.
In the case of thermoformed blisters, the forming process has a direct effect on the barrier property of the packaging and consequently on the shelf life of the product. By using numerical simulation methods, predictions can be made without having to invest in expensive forming tools.
The material properties required for this are determined in specially developed test procedures in the company's own laboratories.
Keywords: Barrier / Thermoforming / Cold forming / Process optimization / Sealing layer / Forming limit diagram FLD / Forming limit curve FLC
Barrier and shelf life prediction
In order to guarantee the functionality and shelf life of pharmaceutical products, the contents must be protected from external influences such as humidity or oxygen and temperature effects.
The barrier of thermoformed as well as cold-formed blisters can be determined by numerical simulation and analytical calculation methods. Taking into account the physical properties of the product, it is possible to directly predict its shelf life. Thus complex stability tests can be shortened or even completely replaced.
Keywords: Barrier WVTR, OXTR / Shelf life / LOD (loss on drying) / Cross diffusion
Packaging validation & Performance testing
Suisse TP supports customers in the validation of your packaging and packaging processes. In very extensive laboratories Suisse TP carries out both standardized and customer-specific tests:
- Leak tests (e.g. dye leak test)
- Seal integrity
- Seal strength
- Seal tightness
- Analytical examination of the sealed seam using CT, microscopy or REM
- Foil thickness measurement
- Accelerated aging, climate and UV tests
- Mechanical and physical testing
- Failure and problem analyses
- Polymer technical and chemical investigations
- Measurement of cross diffusion
- USP c671
- Customer-specific tests