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SOVRIN | Technical Moulding
Speciality Orthopaedic Syringe
A company with a requirement for a unique design of syringe for delivery of their novel product asked plastic injection moulding specialists Sovrin to conduct a DFM, manufacture mould tools and provide volume injection moulding and assembly
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Validation
Sovrin are committed to meeting customer specifications in relation to design, manufacture and qualification of all processes, facilities and equipment. Design, installation, operational and performance qualification ensure complete and seamless validation.
- Full validation of mould tools, processes and equipment
- Creation of Validation Master Plans covering all aspects of:
- Design Qualification
Component DFM, Mould tool design, URS, Risk Assessment, FAT - Installation Qualification
R & R, MSA, SAT, Equipment Environment Facility - Operational Qualification
Process optimisation, Process capability analysis, Functional & dimensional assessment - Performance Qualification
In-process testing, Product training, Batch traceability, Production control - Final Summary Report
IQ/OQ/PQ Checklists, FAT & SAT Reports, FOIRs/ISIRs, MSA/R & R Studies, Capability Studies, Interchangeability Studies
- Design Qualification