Consulting

How Can We Help?


Parenteral pharmaceutical packaging is the core of our work. It’s scope includes the traditional, vials with elastomeric stoppers, cartridges and pre-filled syringe systems, and in developing novel and innovative components, and drug delivery systems including combination products. We have extensive experience with the customary materials of glass, rubber and metals, but also with the advanced plastics and laminate materials being promoted today. Genesis provides technical consultation and training in all areas of parenteral packaging including the selection and utilization container/closure components including: materials of construction, packaging development, risk assessments, supplier qualification, container/closure integrity, regulatory compliance, and investigations.

We are very knowledgeable of the regulatory requirements and guidances concerning the packaging of pharmaceuticals and container closure systems and have experience with US and worldwide authorities. Our consultants are professionals serving on and leading various technical committees, and interest groups of organizations such as PDA, ISPE, ISO and ASTM. They are teachers, sharing their knowledge at seminars and training sessions around the world.

RW Westcapper Training

What We Do...


Container/Closure System Development
  1. Dosage Form Considerations
  2. Market Needs
  3. Materials of Construction
  4. Specification Development
  5. Component Selection and Design
  6. Form, Fit and Function
  7. Identification of Critical Attributes
  1. Processing/Handling Optimization
  2. Investigation Support
  3. Efficiency and Yield Increases
  4. Quality Enhancement
  5. Regulatory Support
  1. Extractables and Leachables
  2. Container Closure Integrity
  3. Functionality
  4. Machinability
  5. FMEA
  6. Risk Assessment
  1. Selection and Qualification Support
  2. Supplier Quality Agreements
  3. Supplier/Packaging Evaluations
  4. Change Management
  5. Improvement Projects
  6. Site Visits/Audits
  1. Selection and Utilization of Glass Containers for Parenteral Packaging
  2. Understanding Glass Quality (PDA TR 43)
  3. Selection and Utilization of Elastomeric Components for Parenteral Packaging
  4. Extractables and Leachables
  5. Suitability of Packaging: Drug-Packaging Compatibility
  6. Container/Closure Integrity and Testing
  7. Processing and Handling of Parenteral Packaging Components
  8. Fundamentals of Lyophilization: Principles and Practices