Elcam Medical New Generation Flexi-Q Auto-Injectors
Elcam Medical New Generation Flexi-Q Auto-Injectors Elcam Medical New Generation Flexi-Q Auto-Injectors
Summary: Needle Tip Quality Confirmed The needle quality is NOT compromisedwhen using the Flexi-Q DV and P-DVRauto-injectors It was proved that the same needle canbe used both for drug aspiration /reconstitution and for injectionAcknowledgement: Melab GmbH, Leonberg, Germany44
Testimonials – from recent work withpharma companiesYear /Company* Description Testimonials452010One of top10 pharmaTechnical duediligenceperformedby a US third-partyon behalf of apharma customerfor the use of theFlexi-Q PFSautoinjector for aPhase III drug(auto-immuneindication)"The assembly steps as outlined here look relativelyeasy to manage and tool for scale up activities...""One thing that jumps out of the design review is that ingeneral, clever and novel design approaches areevident throughout the product...“"The product uses the minimum number ofcomponents to achieve the desired functionality,without undue component complexity... “"… we consider the device to be below average riskfor dose repeatability, and generalized functionalperformance.“"… our assessment of the “robustness” of thedesign, its perceived fault tolerance, and ability tofunction reliably and repeatably in a wide variety ofmanufacturing and environmental conditions isfavorable.“J.C., CEO, founder, major US-based engineering firm performingtechnical due-diligence* Due to confidentiality agreements, no disclosure of company names are possible
- Page 1 and 2: Elcam MedicalNew GenerationFlexi-Q
- Page 3 and 4: Elcam’s Manufacturing Facilities
- Page 5 and 6: 5Elcam’s Major Customers
- Page 7 and 8: Novel, Commercially AvailableFlexi-
- Page 9 and 10: Flexi-Q DV Design Characteristics -
- Page 11 and 12: Vial Adaptor Options• Standard Vi
- Page 13 and 14: Yellow RodRed INJECTButtonGrip Area
- Page 15 and 16: 1. Remove the Safety Cover of theAu
- Page 17 and 18: 41. Gently Push the Yellow Rodall t
- Page 19 and 20: 61. Hold the Auto-injector vertical
- Page 21 and 22: 81. Tap near Dosage Window to movel
- Page 23 and 24: 101. Remove the Gray Connector bypr
- Page 25 and 26: 121. Hold the Auto-injector at the
- Page 27 and 28: • Discard the device according to
- Page 29 and 30: Device Validation• Simulated Clin
- Page 31 and 32: Study Results1. All users successfu
- Page 33 and 34: 33Flexi-Q P-DVR use by RA Patient:v
- Page 35 and 36: Background• Flexi-Q DV is assembl
- Page 37 and 38: Background (cont.)• In many cases
- Page 39 and 40: Method• Glass syringe, 3-bevel 27
- Page 41 and 42: Results & DiscussionTPE SeptumF 1 -
- Page 43: ConclusionsUsing the TPE Septum mat
- Page 47: Summary: Elcam Medical• Elcam has
Testimonials – from recent work withpharma companiesYear /Company* Description Testimonials452010One of top10 pharmaTechnical duediligenceperformedby a US third-partyon behalf of apharma customerfor the use of the<strong>Flexi</strong>-Q PFSautoinjector for aPhase III drug(auto-immuneindication)"The assembly steps as outlined here look relativelyeasy to manage and tool for scale up activities...""One thing that jumps out of the design review is that ingeneral, clever and novel design approaches areevident throughout the product...“"The product uses the minimum number ofcomponents to achieve the desired functionality,without undue component complexity... “"… we consider the device to be below average riskfor dose repeatability, and generalized functionalperformance.“"… our assessment of the “robustness” of thedesign, its perceived fault tolerance, and ability tofunction reliably and repeatably in a wide variety ofmanufacturing and environmental conditions isfavorable.“J.C., CEO, founder, major US-based engineering firm performingtechnical due-diligence* Due to confidentiality agreements, no disclosure of company names are possible
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