VALIDATION AND PILOT PRODUCTION

MOULD TESTING

Our process specialists have industry recognised expertise in  the required systematic process development approach expected within the medical industry (Scientific Moulding). This approach encompasses all phases from debugging , material-tests, samples for automation testing and Mould-FAT. Even our FOT samples are a product from a systematic process optimization provided with in-house 3D scanned report including a comprehensive action-tracker document to highlighting all critical parameters.  This systematic approach enable us to deliver the shortest possible process time from the FOT to the approved mould FAT. We test in secure and closed environments to guarantee confidentiality.

 

 

PILOT PRODUCTION

Formteknik offer to get your product on the market in a unique market leading lead-time by our integrated concept from validated pilot production leading into your Scale-Up requirements. We deliver a fully debugged solution, including first phase pipe line filling production in ISO 13485 and clean room environment if required.

TRANSFER MOULDING

In parallel with supporting  pipeline filling or pilot production we build the upscale turnkey solutions ready for transfer and volume production without mixed risk responsibility. This first phase production concept ensures that critical product and development knowledge is securely retained while providing significant opportunities for quality improvement and cost optimisation. This is associated with delivering high OEEs of the high-volume moulds and the transfer of validated turn-key cells ready for high-volume production. Our customers will always have online access to history, know-how, 3D-scan measuring and process data before transferring to the manufacturer.

 

 

PERFORMANCE MONITORING

Formteknik’s process monitoring system is an option for all Formteknik’s moulds and is integrated in the MouldCat software. A GSM or a network connection enable external monitoring of the mould performance, process changes, quality and a mould service indicator. Since Formteknik program all servo movements or safety signals and sensors in to the integrated PLC, we are able to connect and provide online support or diagnosis.  

SUPPORT CONCEPTS

Formteknik´s dedicated service department travels around the globe and provides service and support to our moulds and IM process. Our local service partners in Brazil, USA and China ensure a quick response to our customers in these regions. In Brazil we also offer local manufacturing of moulds and spare parts according to Formtekniks design to ensure the quality and warranty. In addition to our hands-on service we offer online performance tracking and preventative maintenance via MouldCat and our Mouldbox. We can access the Mouldbox and monitor the performance, process changes, quality or undertake mould diagnostics online.