Business Case for PlugandPack

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Business Case for Plug-and-Pack

• Applications in Pharmaceutical Packaging

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Pfizer Global Manufacturing

• Purpose
• We improve the quality of peoples lives by
  assuring the supply of Pfizers high-quality
  human and animal health products.
• Mission
• We will be the 1 supply organization in our
  industry and a strategic asset to Pfizer.

3
Business Dynamics

• Product development costs
• Patent protection
• Regulatory compliance
• Pricing pressure
• Global competition

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Manufacturing Opportunity
New Prescription For Drug Makers Update the
Plants
Source Wall Street Journal, September 3, 2003
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Call to Action
new standards are being designed to encourage
cost-reducing and precision-enhancing innovation
in manufacturing
Source The Food and Drug Administrations
Strategic Action Plan August, 2003
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OMAC Packaging Workgroup (OPW)

• Mission
• Maximize the business value of packaging
  machinery by developing guidelines that lead to
  the most appropriate application of advanced
  automation technology.
• Plug-and-PackTM Guidelines

Source www.OMAC.org
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Best-value Packaging Solutions

• Meet all user requirements
• Performance accuracy speed,
• Reliability,
• cGMP validation,
• Competitive cost,
• Delivery time,
• and more
• in the right proportions

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Packaging System Evolution
Source ARC Advisory Group
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Standards-BasedGuidelines
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Plug-and-PackTM Application
Tube Filler and Robotic Tube Loader
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Plug-and-Pack Off-the-Shelf

• Integrated Logic/Motion Control
• Industry Standard Networks
• IEC 61131-3 Software
• PackMLTM State Model

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Performance Enabled by Gen 3
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Additional Benefits

• Configuration not customization
• Cost, delivery, risk improved
• Value-add technology integration
• Vision inspection
• Robotic loader
• Interface to SCADA
• PackMLTM States
• Validation supported by design

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Validation Method
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Design Method Supports Validation
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Summary

• Business environment demands higher quality and
  lower costs
• Gen 3 solutions are an enabler
• Plug-and-PackTM Guidelines provide a road map
• Collaboration drives standards
• OEM implementation is pivotal

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• Thank you