Aplikácie: Farmaceutický priemysel

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

Minebea Intec has many years of experience in the development and manufacturing of innovative production and quality assurance equipment for weighing and foreign body detection purposes. Much of this experience has been in pharmaceutical industry applications, where quality control plays a vital role in ensuring product safety and quality while also maximising the efficiency and cost-effectiveness of production processes. 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.

Goods In and engineering

Equipment for checking incoming materials and for engineering applications

Ensuring that all materials that will be used in the production process are exactly as ordered is the first step in production quality control. And engineering and development of new pharmaceutical products and solutions also requires great precision, especially in terms of establishing and reproducing the exact quantities of individual contents used.

Minebea Intec’s wide range of high-precision weighing equipment includes solutions for every such application – solutions that are efficient, reliable and fully compliant with the pharmaceutical industry’s strict quality and safety standards.

Processing

Precise quantity control during processing

Processing in the pharmaceutical manufacturing industry requires precise control of quantities – both during production of active ingredients or drugs in primary processing, and, in secondary processing, during conversion of the active drugs into products suitable for administration. Minebea Intec’s range of weighing equipment, which includes bench and floor scales, and digital and hygienic solutions for weighing process vessels, has been optimised for such applications in any cleanroom environment.

Packaging

Checking and control during the packing stage
During packaging, the amount of finished product in individual packages and single products must often be checked for quality control purposes, and it may be sensible to check for contaminants, e.g. using x-ray inspection equipment.
Minebea Intec’s numerous checkweighing and inspection solutions have been optimised to meet the needs of drug manufacturers in their packaging operations, ensuring that the product leaving the factory will satisfy final customers’ expectations. Systematic recording of the details of all production steps can be transferred into the company’s quality control system and provide invaluable information in the event of a customer complaint or a product recall.

Goods Out

Final checking before delivery
Following packaging, pharmaceutical products can be stored until required and then transferred to Goods Out for delivery to customers. Here, reliable control and documentation of the product transfer is important for commercial and risk-avoidance reasons.
Completeness of orders must be confirmed, and over-delivery of product should also be avoided – checks which are especially important where secondary packaging is additionally required, or where multiple product types or package sizes are combined in a single delivery. Minebea Intec’s range of weighing and inspection solutions can meet all such demands, efficiently and cost-effectively.

Naše riešenia pre farmaceutický priemysel