3-D SMART™ – Applying Risk Assessment to Blister Packaging

Montesino Associates and Prodieco Pharmaceutical Components of Dublin, Ireland are pleased to offer a new technology-based solution to longstanding pharmaceutical industry concerns regarding blister packages produced using different tools and forming equipment.

3-D SMART™ represents an effort to provide users with the capability to ensure that tools are manufactured as designed, new blister packages scaled up correctly from stability to production, new drug packages standardized across global regions, and finished package dimensions match design criteria.

  
     
 

3-D SMART™ is composed of the following elements:

 


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3-dimensional scanning capability for existing tools

  • Forming, plug-assist, sealing, perforation & punch tools may all be measured
  • Full cavity as well as cross-sectional scans are typically performed
  • Data includes detailed worksheets with key dimensions for each cavity scanned and 3-dimensional graphic images (Fig. 1 + 2)

 

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Rendering of 3-dimensional data into eDrawing™ format

  • eDrawing™ is a component of SolidWorks, an open source software package similar to Adobe Acrobat/Reader in that it permits easy transfer and access to files
  • eDrawing™ format permits easy analysis and comparison of measured dimensions by enabling all parties to view and compare actual data in graphic form (Fig. 3)
  • Cavity-to-cavity and tool-to-tool comparisons are quantifiable and allow a scientific approach to subjects such as transfer of cavity & blister design from stability study to production operation, global scale-up and product transfer from one facility to another
  • 3-dimensional data from scanning operation (as well as conventional 2-dimensional data from existing tooling depictions) can be rendered into eDrawing™ format

 

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3-D Pack Layout

  • 3-dimensional version of traditional tool drawing allows complete information transfer for design and manufacture of new tools as well as package design (Fig. 4)
  • Specified information in 3-D Pack Layout is significantly greater than in traditional 2-D vendor tool drawings
  • 3-D Pack Layout represents actual data collected and not just a graphic depiction
  • Easy to manipulate SolidWorks™ software allows package development staff to exert greater control over blister package design in an efficient manner
  • Change from “vendor-proprietary” approach to design, manufacture, qualification and maintenance of blister tooling
 
     
 

Utilising these and other elements of 3-D SMART™, including Montesino technical expertise on high-barrier blister films and thermoforming conditions, clients will be able to for the first time:

  • Compare and qualify production tools with those used in corresponding stability studies
  • Compare and qualify stability tools used at multiple sites
  • Model and measure cavity surface area & volume, draft angle, minimum seal area, seal knurl, perforation pattern and a host of other attributes (design vs. actual)
  • Develop detailed tooling specifications that define (instead of partially resemble) package designs and actual tools
  • Utilise detailed tooling specifications to evaluate alternative tool suppliers
  • Utilise detailed tooling specifications to more accurately assess need for high-cost barrier films
  • Utilise detailed tooling specifications as part of equipment maintenance program
  • Provide tangible evidence of rigorous and detailed blister validation efforts, in line with FDA focus upon risk assessment.