Products & Services

Product Development

• Primary container development
• Connectors
• Secondary packaging
• Pilot Scale manufacture
• Sterilization cycle development/validation
• Perform stability studies under ICH conditions
• Support licence application both Europe and USA

Production

• Class 10,000 Clean Rooms
• Terminally sterilized using steam
• Contract manufacture of sterile solutions in pvc, non-pvc, and polypropylene bottles

Chemistry Laboratories

• Analytical methods development
• Analytical method validation
• Raw material sourcing
• Raw material testing to USP/Ph.Eur
• Component testing
• Sub-visible particle testing
• Finished Product testing

Microbiology Laboratories

• Bioburden testing
• Sterility testing
• Endotoxin testing
• Environmental monitoring
• Class 100 Sterility test suite

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