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  • Europlaz - Medical Device Packaging & Labelling
    codes and serial numbering A range of pre validated pouches are available to speed up your product development Liquid filling Foil Sealing Blister Packing and lidding Aseptic Filling Flow wrapping Medical Pouch Packing Pouch sealing Roller and bar Multi colour pad printing Packaging validation and life testing is also available Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/packaging-and-labelling (2016-02-12)
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  • Medical Device Sterilisation Management
    of sterilisation process development and validation The sterilisation process needed for your device will be taken into consideration from the very start of the design process to ensure packaging materials and processes comply with sterilisation needs Sterilisation management is part of our process and devices are tested vigorously before and after sterilisation before they are despatched to any customer or end user Medical device development Markets Prototyping Validation Project Management

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/sterilisation (2016-02-12)
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  • Europlaz - Stores, Despatch and Logistics
    value added manufacturing services both before and after production Our value added service means we are able to manage everything from concept to completion leaving you to concentrate on getting your product to market Small and large batch sizes One off trials CE marking Component outsourcing Material management Automated manual assembly Packaging development testing Artwork generation and translation services Storage logistics and dispatch to the end user Medical device development

    Original URL path: http://www.europlaz.co.uk/manufacturing-services/sterilisation-despatch-and-logistics (2016-02-12)
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  • Europlaz - Validation
    validate the process providing a high level description of the overall philosophy intention and approach Process Failure Mode and Effects Analysis pFMEA helps to identify potential failure modes based on past experience with similar products or processes enabling action to be taken to design those failures out of the system at the earliest possible stage of the project minimizing effort resource and expenditure thereby reducing development time and costs Installation qualification IQ provides objective evidence to demonstrate all key aspects of the process equipment and ancillary system installation adhere to the manufacturer s approved specification and the recommendations of the supplier of the equipment are suitably considered Design of Experiments DOE allows for multiple input factors to be manipulated determining their effect on a desired output response By manipulating multiple inputs at the same time DOE can identify important interactions that may be missed when experimenting with one factor at a time All possible combinations can be investigated full factorial or only a portion of the possible combinations fractional factorial Operational qualification OQ provides objective evidence to demonstrate when operated at the extremes of the established process control limits the product meets all of the pre determined requirements Performance qualification PQ provides objective evidence to demonstrate the process under anticipated conditions consistently produces a product that meets all pre determined requirements Product Characteristics Evaluation provides objective evidence by way of a full dimensional report to confirm the tooling is capable of producing product within specification The report is conditionally formatted to provide a clear visual indicator to show where the measured dimension fits within the specified tolerance Gauge R R Measurement system analysis MSA provides objective evidence of the capability of the measurement system If you don t measure it you can t Manage it If you do measure it

    Original URL path: http://www.europlaz.co.uk/quality-control/validation (2016-02-12)
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  • Europlaz - Cleanroom Quality Control
    in accordance with ISO14698 1 2003 Cleanroom and associated controlled environments Bio contamination control Part 1 General principles and methods Microbial monitoring includes passive air sampling using settle plates and active air microbial monitoring using RCS centrifugal air sampler for bacteria and fungi Surface sampling for bacteria and fungi using contact plates is also carried out at various locations and includes work stations walls and floors Medical device development Markets

    Original URL path: http://www.europlaz.co.uk/quality-control/cleanroom-quality-control (2016-02-12)
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  • Europlaz - DVT Breakthrough
    a manufacturer operating under ISO 13485 able to translate the concept idea of this device into working manufacturing processes The Solution Key capabilities Injection mould critical product components within a cleanroom environment Complex assembly The GEKO device is assembled from four main sub assembly components including one electrical board and two adhesive surfaces Europlaz was asked as a leading complete service medical contract manufacturer to take the class II medical device from concept design to clinical batch manufacture The GEKO is a disposable item which means production volumes are naturally high and manufacturing speeds need to keep up The cleanroom design and environment at Europlaz match this requirement perfectly to ensure efficient working practices can be used throughout assembly Europlaz suggested cost effective solutions for all aspects of production including a process of over moulding which cut out timely assembly processes Europlaz cost effectively deliver Sturdy plastic housing around the electronic component An optimized adhesive layer Over moulding One touch on off button Class 7 cleanroom moulding assembly and ultra sonic welding Europlaz is currently developing a process of automation to manage an anticipated increase in demand Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing

    Original URL path: http://www.europlaz.co.uk/case-studies/dvt-breakthrough (2016-02-12)
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  • Europlaz - Auto-Injector
    pack holds two individually sealed syringe cartridges Also included is a pen device used to automatically inject one dose of medicine from each syringe cartridge A complex and user friendly medical device The Challenge This medical device composes of two syringe cartridges an auto injector pen and a carry case The product is designed to be used by patients to easily self inject a pre filled dose of medicine A large US pharma company looked to the UK to find a manufacturing partner to help bring their product to the EU market Key capabilities Tooling design and development High volume production Cleanroom injection moulding Cleanroom manual and automated assembly Steriliastion and drug filling management Storage and EU distribution links Complex moulding and Assembly this device has over 15 separate components All plastic components are injection moulded within ISO class 7 cleanrooms for direct delivery to a dedicated production cell within a medical assembly cleanroom Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation Additional Services Quality control Certificates Validation Cleanroom Quality Control Case studies DVT Breakthrough Autoinjector Kit Flowfusor TIVA Anaesthesia Sets Contact Europlaz Technologies Limited The Maltings Industrial

    Original URL path: http://www.europlaz.co.uk/case-studies/auto-injector (2016-02-12)
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  • Fresenius Kabi, Irrigation System, Flowfuser Spike, Flow Fuser Spike - Europlaz Technologies Limited
    to stop buying ready assembled components from the USA and design and manufacture their own parts with a trusted British company The Flowfusor Irrigation System is used by surgeons during endoscopic procedures When the Flowfusor is inverted the spike pierces the bottle releasing fluid to wash away any impurities obscuring the viewfinder Fresenius Kabi wanted a UK supplier who could simplify the design yet still meet their demanding standards The Solution An inspired redesign by Europlaz removed one of the parts to fit a porous filter disc Europlaz not only included testing programmes into the design and manufacture process but custom made equipment to assure 100 quality The Verdict Europlaz encouraged us to take an active role in the redesign and manufacture of the spike assembly and we felt that we were very much in control in the progress of our project Their innovative solution to a difficult technical challenge means that we can provide our customers with a better product Dr Robin Taylor Fresenius Medical device development Markets Prototyping Validation Project Management Tooling Manufacturing services Cleanroom Manufacturing Assembly Technical Injection Moulding Packaging Labelling Sterilisation Additional Services Quality control Certificates Validation Cleanroom Quality Control Case studies DVT Breakthrough Autoinjector Kit

    Original URL path: http://www.europlaz.co.uk/case-studies/flowfusor (2016-02-12)
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web-archive-uk.com, 2017-12-17