How Can We Help?
Genesis brings to the table much more than the time-honored Westcapper® sealing technology. We bring a complete understanding of the parenteral package itself. Our technical experts maintain long-standing relationships with parenteral package component manufacturers. We know the vial package. Our expertise in the science of sealing is deep-rooted and so is our commitment to seal integrity.
Parenteral pharmaceutical packaging is the core of our work. 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. We serve on various technical committees, and interest groups of organizations such as PDA, ISPE, ISO and ASTM. We are teachers, sharing our knowledge at seminars and training sessions around the world.
Our Affiliates
Experts in the World of Parenteral Pharmaceutical Packaging.
What We Do...
Package Characterization Studies
- Evaluation of Stopper Compression
- Residual Seal Force (RSF) Measurements
- Container Closure Integrity Testing (CCIT): He Leak Testing, Laser Headspace Analysis, HVLD, Vacuum Decay, Mass Extraction (Contracted Through Approved Suppliers)
- Correlation of RSF with Stopper Compression and CCIT
- Computer X-Ray Micro Tomography Scans (Contracted Through Approved Suppliers)
- Interference Fit and Stack-up Analysis
- Visual Assessment
For users of SMARTSKIN Seal Tightness Drones for Sealing Process Monitoring
- Correlation of RSF with Seal Tightness Measurements on Drones
Training and Education (Virtual and On-Site)
- Fundamentals of Container Closure Integrity in Parenteral Packaging
- Introduction to Residual Seal Force Testing, Equipment & Practices
- Basic Principles of Benchtop Spinning Roller Cappers (Genesis Integra machine)
- ABC’s of Production Scale Spinning Roller Cappers (Genesis PW/NPW machines)
- Understanding High Speed Rail Cappers (Genesis Aptus & RW machines)
Technical Consultation
In all areas of parenteral packaging including the selection and utilization of container/closure components and materials of construction, packaging development, risk assessments, supplier qualification, container/closure integrity and regulatory compliance.
Meet Our Scientist
Carolina González Gaitán works as a Parenteral Packaging Scientist here at Genesis Packaging Technologies. In her current role, she is responsible for the consulting department, where she designs package characterization studies and supports pharmaceutical companies in understanding sealing process principles and Residual Seal Force (RSF) fundamentals and in evaluating package selection. She has taught in courses offered by PDA on container closure integrity testing, specifically on RSF. She holds a Ph.D. in Materials Science from the University of Alicante, Spain.
Carolina has been featured in Pharma's Outsourcing's "Women in Science" Newsletter.