Applied Technology

Cinteger Applied Technology serves clients in the Pharmaceutical, Biotechnology and Health Care Industries in the following areas:

 Go to example projects or management bio

Research & Development

• Prototype design
  
• Proof-of-concept modeling
  
• 3D simulation
  
• Equipment modifications
  
• Reverse engineering
  
• Replacement & spare parts
  
• Change parts
  
• Component integration
  
• Instrument interfacing
  
• Enhanced or expanded functionality
  
• Quality by Design (QbD)
  
• Design of Experiments (DOE)

Technology Transfer

• GAP analysis
  
• Risk assessment
  
• Protocol development
  
• Acceptance criteria
  
• Methods transfer
  
• Equipment selection and qualification
  
• Cleaning verification
  
• Documentation
  
• Report Development

Manufacturing

• Equipment design and modifications
  
• Engineering to enhance or expand functionality
  
• Manufacturing process and packaging support
  
• Functional specifications
  
• Capital justification and equipment selection
  
• FAT, SAT, IQ/OQ/PQ
  
• Process Analytical Technology (PAT)
  
• Lean Six Sigma (LSS)
  
• Key performance indicators (KPI’s) and baselining

Quality & Compliance

• Develop quality standards
  
• Equipment IQ/OQ/PQ
  
• Process validation
  
• SOP’s and supporting documentation
  
• Deviation investigations with root cause analysis
  
• Corrective and preventative action (CAPA)
  
• Role training matrix
  
• Staff training and records
  
• Lean Six Sigma
  

Project Management

• Lead and develop cross-functional teams
  
• Alignment of members to team’s objectives
  
• Schedule and cost tracking
  
• Chair and facilitate meetings
  
• Team decision making and commitment to action plans & assigned deliverables
  
• Conflict and constraint resolution
  
• Results and execution focus

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Examples of Projects  (back to top of page)

1. Fill Line Data Logger
2. Impaction Plate & Stage Auto Rinser
3. Process Analytical Technology (PAT) Evaluation
4. Powder Fill Uniformity
5. Polystyrene Bead Processing
6. Root Cause Analysis

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 Fill Line Data Logger

 

Challenge

• Issues with leaking of metered dose inhalers (MDI) due to suspected filling line issues
• Need to accurately measure critical parameters as container is processed
  

Solution

• Design monitoring device based upon form factor for 120 dose MDI
• Design electronics and sensors to fit inside MDI
  
• Data can be collected and downloaded to spreadsheet via docking cradle
  

Value

• Identified correlation of equipment settings with line performance
• Allowed for optimization of equipment
  
• Avoided failure of lots and cost of API

 Back to Project List

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 Impaction Plate & Stage Auto Rinser

Challenge

• Manual rinsing and collection of samples introduced high variability in analysis
• Very labor intensive process
  

Solution

• Design and build automated system to rinse and prepare samples for HPLC
• Accommodates standard stages and plates
  
• Ease of training and use by lab staff
  

Value

• Automated system allowed technicians to perform more value-added tasks
• Increased lab throughput by >3-5x per day
  
• Reduced variability in results due to human variability in sample preparation

Back to Project List

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 Process Analytical Technology (PAT) Evaluation

Challenge

• Evaluate potential of Process Analytical Technologies (PAT) for powder blending
• Use small scale equipment to minimize API usage
  
• Concurrent measurements with various sensor types
  

Solution

• Modification of small scale commercial blender
• Integrate probes to evaluate temperature, humidity, and other spectroscopic (non-destructive) measurements
  

Value

• Characterize blending process
• Optimize process parameters
  
• Correlation of analytical measurements
  

Back to Project List

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 Powder Fill Uniformity

Challenge

• Variability in manual separation and weighing of individual sealed cavities from foil strip
• Tedious and labor intensive

Solution

• Automated system to evaluate filling uniformity
• Uses laser sensors to accurately align blister cavities with punch
• Precision load cells accurately weigh mass of each individual cavity

Value

• Testing automated; less labor required
• Reduced time and variability in measurement
• Immediately evaluate equipment performance

Back to Project List

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 Polystyrene Bead Processing

 

Challenge

• Collection of beads in each well “pool”
• Separate each beads into individual well to allow cleavage and further characterization
• Very slow manual activity

Solution

• Automated system to pick and place beads
• Custom probe to verify bead is present
• Integrate with commercial small scale XYZ system

Value

• Unattended operation
• Reduce processing rate from 3-5 minute to 5 seconds per bead

 Back to Project List

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Quality & Compliance

 

Challenge

• Process variance observed
• Lot(s) placed “on hold”
  
• Impact and root cause to be determined
  

Solution

• Identify root cause and associated contributing factors
• Determine product impact
  
• Justify lot disposition
  
• Implement CAPA
  

Value

• Process improvement
• Product quality
  
• Prevent reoccurrence

Back to Project List

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