SCIEMETRIC LAUNCHES PROCESS SIGNATURE VERIFICATION SYSTEM FOR MEDICAL DEVICE MANUFACTURING
SigPOD® Medical uses proven technology to automate inspection
Sciemetric Instruments, a leading provider of assembly manufacturing quality systems, today announced the general availability of SigPOD Medical, a system to verify parts and processes in the manufacturing of medical devices.
Regulatory initiatives such as the FDA’s Process Analytical Technology (PAT) and the Global Harmonization Task Force (GHTF) are driving medical device manufactures to reduce risk in production processes and apply in-process verification. These manufacturers are also shifting to increasing volume and decreasing margins and moving from batch to single part flow systems. These factors lead to the requirement for manufacturing automation, in-process verification and the ability to maintain traceability records on these activities.
“Medical device manufacturers are looking to gain from the experience of high volume, high complexity manufacturing environments for tools and techniques to assist in controlling product and process variability,” said Nathan Sheaff, Founder of Sciemetric. “SigPOD Medical technology is proven to meet these requirements while offering some of the more specialized features that are required by the sensitive nature of the parts that are manufactured.”
SigPOD is a robust, industry-leading platform designed for usability and visibility in the live production environment. Sciemetric offers a full range of SigPOD instrumentation products that are used to verify and control a variety of standard manufacturing operations. SigPOD Medical was designed for the medical device manufacturing environment, it is CFR 21 Part 11 security compatible, features serialization support and validation documentation.
Traceability and detailed analysis, through SigPOD Medical companion product and database QualityWorX software, enables medical device manufacturers to conduct true multi-variable analysis based on real-world sources of variation in manufacturing, develop standards for monitoring and improve and adjust processes to meet quality and volume objectives, all utilizing data collected in-process.
SigPOD Medical monitors physical parameters during manufacturing processes such as press assembly, crimping and swaging, corona and plasma monitoring, adhesive dispensing, injection molding and many more. It applies the science of Process Signature Verification (PSV) to provide a detailed analysis of the health of the process and indicate pass/fail in real time on the production line.