Safety and cleanliness all along the line
Medical products are designed for very long-term stability and continuity. The medical technology market is considered stable and crisis-proof. On the other hand, there are long development times, rigid and strict regulations and the associated high costs at all stages of product development. Traceable, validated, transparent and hygienic manufacturing processes are a prerequisite. And this starts with material management. The motan group contributes its many years of experience in the field of medical technology to special MED versions of various product lines and thus supports plastics processors in optimally fulfilling the special requirements of the medical and pharmaceutical industry.
The medical technology market is growing despite high regulatory requirements and geopolitical changes. Frost & Sullivan forecasts an average annual growth in the global medical technology market of around 5 per cent in the coming years. The field of application for plastics seems limitless. Whether surgical instruments, ventilators, diagnostic components, syringes, implants and prostheses or disposable laboratory products such as cuvettes and pipette tips, whether small series or mass products – the regulations must be mastered. These include the requirements of GMP (Good Manufacturing Practices), the regulations of the American regulatory authority FDA (Food and Drug Administration) or the EMA (European Medicines Agency) as well as the EN ISO 13485 quality management system for medical device manufacturers.
Safe, stable and clean production processes are essential. As the global market leader, motan develops and builds products, systems, and system solutions for the complete handling of raw materials. From the contamination-free storage process in small containers or external silos to fully documented drying and high-precision, constant dosing and mixing technology through to a mix-up-proof conveying concept, motan offers customized solutions including intelligent control and regulation technology for the medical and pharmaceutical industry.
The risk of particle contamination must be eliminated from the delivery of raw materials such as granulates, masterbatches and additives to the end product. For this reason, motan has designed the METRO G med material loaders and the GRAVICOLOR 110 med gravimetric batch dosing and mixing unit especially for plastics processors in the medical and pharmaceutical industries. The comprehensive METRO G med range of units is based on the established METRO G series and fulfils all strict hygiene requirements in accordance with FDA 21 CFR. During development, particular attention was paid to process-safe use in cleanrooms. Special filters with high-quality FDA-compliant seals and electropolished stainless steel surfaces ensure reliable, dust-free and contamination-free operation. One highlight is the new membrane implosion vacuum valve, which does not require compressed air.
The new FDA-compliant version of the GRAVICOLOR 110 med gravimetric batch dosing and mixing unit was developed by motan for flexible and reliable mixing and dosing in injection moulding, blow moulding and extrusion applications. The integrated and improved IntelliBlend analysis function records the recipe, material and application environment and documents all process data. This seamless logging is essential for continuous batch tracking.