Minebea Intec (Germany) - Press Release: In accordance with the new chapter 2.1.7 of the European Pharmacopeia (EPC), Minebea Intec is now offering the required certification for scales, which is specifically required for the pharmaceutical industry as per the updated standards, to meet GMP requirements. As a leading provider of weighing and inspection solutions, the company also has a suitable selection of high-precision scales in its product portfolio.
The introduction of chapter 2.1.7 of the European Pharmacopeia represents an important step towards laying down standards for weighing in the pharmaceutical industry within Europe and towards assessing the certification of the scales used with regard to accuracy and suitability for the intended weighing process. The chapter deals with the requirements that the analytical scales and precision scales used in the pharmaceutical industry must meet, and has been in force since January 2022. The service team from Minebea Intec can certify scales that have already been calibrated in accordance with the new standard Ph.eur.2.1.7.
High standards for precise measurements: a new chapter:
The ‘General chapter 2.1.7’ places three key requirements for precise weighing when manufacturing medicinal products. Analytical and precision scales must be calibrated at the intervals specified and regular performance checks must be conducted, in order to assess any incidental errors (precision of scales) as well as systematic errors (accuracy of scales). Defining criteria for these tests ensures that potential errors with the scales are kept to a minimum.
With the new chapter, pharmaceutical companies in more than 38 countries are obliged to show a corresponding certificate at the biennial GMP production audits, which documents that the weighing solution has been used in accordance with the prescribed values. Should this document not be available, this breach can make it difficult to continue using the scale. To avoid this, Minebea Intec is on hand as a reliable partner to assist pharmaceutical producers. Furthermore, the company also offers the documentation required in the USA in accordance with the United States Pharmacopeia (USP).
Signum Supreme: high-precision scale for exact weighing:
As well as the necessary certifications, Minebea Intec also offers precision scales, which are suitable for a variety of applications in the pharmaceutical sector. The weighing solutions in the Supreme series offer reliable overload protection and are based on monolithic weighing technology with electromagnetic force compensation (EMFC). Its high resolution guarantees precise measurement results and thus less product loss or errors. An integrated calibration weight adjustment ensures consistent precision. Bench scales like the Signum Supreme are ideally suited for the pharmaceutical sector, for mastering tasks such as sample analysis or formulation. The combination of high-precision weighing solutions on one hand and comprehensive service on the other makes Minebea Intec a top-performing and reliable partner for customers from the pharmaceutical industry whose long-term experience is the basis for innovative solutions.
Minebea Intec has around 170 years of experience in industrial weighing and inspection technology – a store of knowledge which ensures a strong service offering for customers. From initial consultation to installation, right through to commissioning, Minebea Intec is on hand to assist its customers – and always has its finger on the pulse with new offerings such as certification in accordance with Ph.eur.2.1.7. “Being able to label precision scales in accordance with Ph.euro.2.1.7 is an important opportunity for us, which should help to drive forward the latest market developments,” says Katrin Sichau, Product Manager Service at Minebea Intec. “The new chapter of the European Pharmacopeia is a step towards establishing a binding set of rules for the European market in line with the USP. We are helping our customers from the pharmaceutical industry to comply with these regulations. In combination with our high-precision scales, we ensure that both producers and consumers are shielded from the negative consequences of using unsuitable measuring equipment.” By updating its service offering, Minebea Intec is demonstrating that its customers are also ideally prepared for future challenges.