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INNOVATIVE SOLUTIONS FOR DRUG DELIVERY AND MEDICAL DEVICES
FORTEQ GROUP
With over 40 years of experience and the skills of more than 800 competent employees forteq offers know-how of functional plastics, gears and transmis-sion systems. Customers choose forteq to convert their ideas into tangible solutions for Automotive, Medical and Consumer products. They rely on our
FORTEQ HEALTHCARE
As a leading provider of innovative solutions for precise and complex drug delivery systems, forteq provides product design, development and indus-trialisation, including contract manufacturing and
DESIGN & DEVELOPMENTSERVICES
forteq Healthcare provides a comprehen-sive design and development service for the Healthcare industry, with a focus on parenteral injection systems, inhalation products and medical devices.
• Creative concept generation• Product & process development• Predictive and simulation software• FMEA - Design & Process• Robust design – product & process• GMP parts / components for clinical trials phase I, II or III• Prototypes & low volume manufacture• Detailed design for manufacturing (DFM)• Design verification & validation• R&D Metrology lab & clean rooms• Specialist gear systems & mechatronics
CONTRACT MANUFACTURING SERVICES
An efficient contract manufacturing service is offered for medium - high volume production and assembly of medical & drugdelivery devices. Low volume productionrequirements including device clinical trials and testing are also catered for.
• Clean room manufacturing (ISO 7, ISO 8)• High precision injection moulding• Two shot moulding (2K)• High speed volume assembly• Printing and ultrasonic welding• Supply chain management• Equipment sourcing and qualification• Process validation• Final packaging• Sterilisation (outsourced)
QUALITY
forteq Healthcare has accreditation for ISO 9001:2008 / 13485:2003 and clean rooms that meet the requirements of ISO14644, class 7 & 8 and EU GMP class C. Swissmedic license and GMP certificate tohandle and pack drug products in primarycontainers.
ISO 14644CL. 7 & 8, GMP CLASS C
competences in mould tool engineering, plastic mate-rials expertise and experience in processing compo-nents and assemblies of high quality and reliability.forteq has manufacturing plants in Switzerland, UK, Czech Republic, USA, Italy and China.
final packaging of devices in clean room conditions in compliance with cGMP. forteq’s technology experi- ence includes inhalation, injection devices and combination drug products.
DEVICE EXPERIENCEAND KNOW-HOW
• Metered dose inhalers (pMDI)• Dry powder inhalers (DPI)• Liquid spray inhalers (LSI)• Dose counting systems• Auto injectors & Pen injectors• Needle free devices• Reconstitution devices• Drug implant delivery systems• Diagnostic devices• Surgical instruments• Drug rod inserters• Intrauterine devices (IUD)• Ophthalmic drug delivery
DRUG IMPLANT DELIVERYTECHNOLOGY
MANUAL IMPLANT APPLICATOR Implant size: Ø 1.5 mmMultiple implants; max. length 25 mmSuitable for POC medication
AUTOMATIC IMPLANT APPLICATOR Multiple implantsZero-force on implantsSuitable for self medication
COMBINATION DRUG PRODUCTSAND PACKAGING
Along with component manufacturing and device assembly, forteq provides additional services to assemble the primary drug container into a medical device or co-pack with a device to provide a combination drug product. Thisservice is provided in compliance with a cGMP license from Swissmedic for handling drugs inprimary containers. The drug product or medical device can then be finished packed by forteqwith the patient information leaflet, instructionsfor use leaflet, other secondary packaging andcartoning.
HEADQUARTERSAND TECHNOLOGY CENTRE
forteq Nidau AGIpsachstrasse 14CH-2560 NidauSwitzerland
t +41 32 332 73 32f +41 32 332 73 [email protected]
SALES CENTRAL EUROPE
forteq Nidau AGIpsachstrasse 14CH-2560 NidauSwitzerlandt +41 32 332 73 32f +41 32 332 73 [email protected]
www.forteq-group.com
SALES NORTHERN EUROPE
Creggan, Dublin RoadAthlone, WestmeathIreland
t +353 90 663 59 64f +353 90 663 59 [email protected]
LOCATION OF FORTEQ HEALTHCARE
forteq’s Technology Centre for medical and pharmaceutical device development & manufacturing is located in Nidau, Switzerland. This area is also the centre of the Swiss watch making industry and is easily accessible by rail or car from all the major international airports in Switzerland: Zurich, Basel and Geneva.
