THE PARTNER FOR INNOVATIVE SOLUTIONS

Transcription

1 04 THE PARTNER FOR INNOVATIVE SOLUTIONS

2 THE COMPANY WHO ARE WE? Over the past 30 years, ROVIPHARM has become the specialist manufacturer of medical and dosing devices for the pharmaceutical and healthcare industries. OUR VALUES Rovipharm is a French SME located at the heart of Europe, and has become a global market leader in dosing devices, including dosing syringes, dosing cups and spoons, droppers and dosing accessories. With its state-of-the-art injection moulding, printing, and assembly processes, ROVIPHARM can fulfill your needs for primary and secondary packaging, plastic components and medical devices. Our Mission Meeting the expectations of our clients by designing and manufacturing plastics devices in a competitive, efficient and innovative way. Completely dedicated to the pharmaceutical and healthcare markets, we contribute to improving patients health. Our Vision To become a reference, by developing dosing systems and medical devices through innovation, excellence of our processes and the commitment of our team. All products are manufactured in ISO8 classified cleanrooms. ROVIPHARM has established strong relationships with leading global pharmaceutical companies. Renowned for its proactive, flexible and innovative approach, ROVIPHARM pays close attention to its clients needs to collaboratively develop new products. 04 Exports to over 40 countries PARTNERSHIP : Customer listening to offer the most relevant solutions. COMMITMENT : Respect our commitments in compliance with procedures and regulations. INTEGRITY : Honesty and Transparency to ensure a long-term success. TEAM SPIRIT : The garantee for making your project a success. EXCELLENCE : Competitive products and services through operational performance. INNOVATION : An innovation capacity with a client-oriented approach. P. 2 P. 3

3 STANDARD DOSING PRODUCTS CUSTOM DOSING PRODUCTS DOSAGE DOSAGE ROVIPHARM has developed a wide range of dosing devices, including syringes, cups, spoons, droppers and easy-to-use accessories, for medical and pharmaceutical applications. In collaboration with its clients, ROVIPHARM has developed several custom dosing devices, including syringes, cups, spoons and strips for various product types: liquid, semi-solid or pasty, solid. These devices are proprietary to our clients. Dosing syringes Dosing spoons Dosing cups Dosing droppers sets Dosing syringe 1 ml Dropper plugs Dosing syringe with dip tube Specific engraved dosing cups From 0,3ml to 10ml and its accessories 2,5 and 5 ml dosing volume From 2,5ml to 20ml dosing volume Available in different lengths and types and compatible with various bottle necks format Scale in drops Controlled dropper plug, starting from 0,3ml dose volume, for PE bottles Dip tube insert for dosing syringe connection Dosing syringe equipped with dip tube for ampoules Adjusted to match clients package closure P. 4 P. 5

4 CUSTOM PRODUCTS CUSTOM PRODUCTS MEDICAL MEDICAL DIAGNOSTIC We offer our experience and expertise in manufacturing products for the healthcare industry to bring your projects to fruition, from the early concepts to the finished product. ROVIPHARM works together with key players in the diagnostics field for manufacturing equipment, consumables and medical devices. Primary packaging for dental implant Packaging for pre-filled syringe Needle sheath Syringe plunger rod Chamber of dialyser medical device Luer lock connector Diagnostic equipment Diagnostic Consumables Function : protect the implant before use Function : protect the pre-filled syringe before use and the medical personnel from injuries after use Function : protect the needle before use Function : connection with the stopper and administration of the drug Function : dialysis Function : connection to a perfusion line and to a syringe Various components for diagnostic tests P. 6 P. 7

5 EXPERTISE EXPERTISE PROJECT MANAGEMENT INNOVATION DESIGN DEVELOPMENT INDUSTRIALIZATION Inventory of customer requirements and feasibility studies Research and patenting Technical and economic study Performance Qualification (PQ) monitored by the Project Benchmarking / Brainstorming Accompanying product design and material choices Project monitoring by a multi-disciplinary Project Committee Committee Ideas book, concept proposal and situational solutions Models, rapid prototyping, functional prototypes and final (reports and action plans, MS project planning) Technical-economical project assessment Definition of specifications prototypes 2D and 3D computer modeling (SolidWorks ) Development phase marked by four milestones : Project launch, Off Tool, Off Process, first pre-production run Transfer of the project to the production department Continuous improvement (PDCA process and product Design qualification (DQ) Equipment qualification : Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) management method) Installation Qualification (IQ) and Operational Qualification (OQ) protocols Complete post-fabrication services (assembly, printing, packaging, sterilization...) P. 8 P. 9

6 04 40 THE MANUFACTURING PLANT THE MANUFACTURING PLANT INJECTION MOULDING In order to maintain a high level of quality and performance, our investment policy allows us to regularly renew our machinery to ensure cleanliness, efficiency and reliability of our processes. Our moulding machines are fully automated. We have two cleanrooms entirely dedicated to plastic injection moulded parts with a total of 26 injection moulding machines. We process a wide range of medical grade plastics (USP, European Pharmacopoeia, ISO 10993) from commodity plastics (HDPE, LDPE, PP, PS, rigid or flexible PVC) to engineered plastics (PA, PC, ABS, ABS/ PC, PETG, PMMA, PU, SBS, SEBS, EVA, POM, PVDF,...). PRINTING, ASSEMBLY AND PACKAGING A facility equipped with 8 fully automated lines is dedicated to printing, assembly and packaging operations. With our injection moulding machinery, ranging in clamping force from 60 to 200 tons, we can manufacture precision parts from 0.1g to 200g. We specialize in multi cavity injection moulding, and high-speed injection moulding for medium and large runs. We use 2K injection moulding and insert moulding technologies. QUALITY A total quality management approach subscribed by all employees and at each production step. Our technical expertise and tooling flexibility also allow us to meet the markets for smaller runs. To assure this, Rovipharm has organized quality control and clear, efficient and proven operational processes. ISO 9001:2008 ISO 13485:2012 CE compliant with Council Directive 93/42/EEC ISO8 clean rooms compliant with ISO P. 10 P. 11

7 ROVIPHARM S.A.S. Pôle d Activités de Lucinges 86, Route du plan d eau - TREFFORT VAL-REVERMONT - France contact@rovipharm.com Tél. +33 (0) Fax. +33 (0)