In developing and producing drugs for use as medications to address every ailment known to man, the pharmaceutical sector has become a vast, extremely complex, highly regulated industry – with corresponding demands on critical manufacturing processes such as weighing, batching and foreign body detection. Minebea Intec has decades of experience in supplying solutions to meet these demands, for pharmaceutical companies all around the world.
The solutions are optimised to the industry’s particular needs – for instance, with state-of-the-art manual and automated formulation systems, advanced tracking and tracing features, the abilities to be readily validated and calibrated, and cleanroom suitability. Our equipment is designed for easy manual cleaning, and our solutions are supported by validation-optimised software for manual formulation, data recording and quality assurance. In this way, we help to continuously increase operational efficiency, enhancing overall equipment effectiveness (OEE) and improving competitiveness.
A reliable partner for quality control and process equipment for the pharmaceutical industry
As a reliable partner of pharmaceutical industry manufacturers around the world, Minebea Intec invests heavily and constantly in testing and certification in accordance with various national and international standards and regulations, such as
- for materials and products: EHEDG / FDA / HACCP / IFS / EAC
- for Ex applications (explosion protection): ATEX / FM / CSA / IECEx / EAC
- for calibration: OIML / NTEP
- for ingress protection (IP): up to IP69k
- for manufacturing: Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) – e.g. to FDA 21 CFR
We also ensure compliance, in relation to electronic records and electronic signatures, with FDA 21 CFR Part 11.
We are thus well prepared to meet the widely varying needs of pharmaceutical industry manufacturers, whatever their product or field of activity – and, of course, to provide the associated quality documentation that might be required for any project.