Whether you're concerned about extractables and leachables, need hard data on container closure integrity or are looking for specialist assistance in developing a new medical device, West is ideally placed to assist.
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West's Analytical Labs are GMP and FDA compliant. The Labs are also DEA
licensed, certified to ISO 9001:2008 and ISO 15378:2011, and have two
VeriSure™ Report / Extractables Data Report / Materials Characterization
Theoretical Material Extractables
Prefilled Cartridges and Needle Based Injection Systems
Ready to Fill and Prefilled Glass and Advanced Polymer Syringes
Glass and Advanced Polymer Vial Containers and Vial Adapters and other Transfer Devices
Regulatory and Custom Testing Collaboration
Optical microscopy / FT-IR / SEM/EDS
LIBS (Laser Induced Breakdown Spectroscopy Raman)
Tracer Gas Detection, vacuum mode (helium mass spectrometry)
High Voltage Leak Detection
Frequency Modulation Spectroscopy (oxygen headspace)
Tracer Liquid (dye ingress)
For more information on West's analytical services you can visit their website here.
West have established a reputation as a global leader in contract manufacture by providing on-time commercialization of projects ranging from product design to complex, turn-key manufacturing solutions.
West Contract Manufacturing benefits from 1,000,000 sq. ft. of manufacturing space.
Design Concept Development / Design Exploration / Mechanical Design Refinement
Mechanical Design Release / Design Verification / Mold Flow Analysis / Finite Element Analysis
Clinical Support / Drug Re-packaging / Serialisation/Track and Trace
User research / Interface design / Industrial design / Mechanical design / Prototyping
Global development and manufacturing deployment
Prototype development and sourcing / Design for manufacturability
Decoupled 2&3 process development
Extensive use of DOEs to help define processes
IQ/OQ/PQ protocols that ensure a robust production process
Incorporation of “Advanced Process Monitoring”
Archived data for continuous improvement and root cause analysis
Injection molding with fully-integrated downstream assembly
Dedicated, ISO Class 7 and 8 cleanroom assembly
Primary and secondary packaging / Drug repackaging and Labeling
Needle handling, UV bonding, laser etching, printing, welding, leak testing
Seven ISO certified production facilities worldwide
More than 300 molding machines worldwide
ISO Class 7 and 8 cleanrooms (molding and assembly)
Real-time process monitoring
Specialized Molding-Multi-shot, Insert, LSR, Optical
For more information on West's contract manufacturing services you can visit their website here.