Fresenius Kabi is digitalising quality control for infusion and transfusion bag manufacturing with help from Aimtec

The project began with a highly detailed and extensive assignment for selecting a supplier of software for quality control in the manufacturing of transfusion technology at Fresenius Kabi’s Czech plant. The main task was to transfer the keeping of production records – which ensure the traceability of the materials used – and records on quality control checks from paper documents to a digital form, while also giving users maximum freedom to configure the system used for creating production records. One integral part of the project was maximum utilisation of existing data available in digital form in the company’s currently deployed software systems such as ERP and in other data sources from machines on the manufacturing lines. Until now the company has filled out and recorded documents for each batch of the products physically/on paper, which is demanding in terms of both the process and the archival of manufacturing documentation. Therefore in 2018 Fresenius Kabi contacted potential suppliers to provide systems and digitalisation for these processes. And the Pilsen-based Czech firm Aimtec won out in this selection process.

“We were seeking a stable company offering a MES system that could help us to move our company ahead in digitalisation. We chose Aimtec due to its information system, with which it has years of experience in the area of manufacturing – despite their being a supplier without major medical experience. The main decision criterion was the proposed application’s flexibility, with its key users being empowered to fine-tune the sequencing and criteria for individual manufacturing steps themselves, without the need for intervention from an outside company. We also appreciated that the system was open and could be expanded later with new information and computer systems and new outputs from manufacturing equipment. Because our company is subject to the medical industry’s strict regulations, we also double-checked the appropriateness of deploying an information system from Aimtec in cooperation with a firm of independent experts. From the very first negotiations, we could constantly confirm the experience, professionalism and innovative approach of the Aimtec representatives, which are very important aspects for the project’s future problem-free operation,” explains Jozef Rusinko, project head at Fresenius Kabi.

Digitalisation as evidence of regulatory compliance

In April 2020, the two companies launched the first phase of this joint project at the first of Fresenius Kabi’s workstations; expansion to other stations and products is planned by the end of the year. Aimtec’s DCIx system is responsible for collecting data from the machines and keeping a downtime register, and above all a quality control register. This register is, due to the customer’s line of business, complex – and critical for compliance with all the relevant standards. “Our solution digitalises the quality control records and automatically stores this data in the information system, where it is available for later use. The QMS is configured based on rules so as to make automatic checks occur in various phases and periods of the production cycle. A quality control technician then enters the results of the check on a touch screen, and these are again automatically recorded into the system. Demanding manual completion of forms has thus been eliminated, and the whole process has been digitalised,” says Aimtec’s Sales Manager Michal Karim of the project’s details.

The solution overall helps Fresenius Kabi to comply with the requirements of the certification authorities for the Electronic Batch Manufacturing Record (EBMR) – that is, to work through manufacturing-process records batch-by-batch. It also supports them in obtaining GAMP 5 certification, which is essential for the health care and pharmaceutical industries. Aimtec could and did harness its automotive experience when designing this solution; auditing and certification requirements in automotive are also very demanding, and Aimtec welcomes the chance to benefit from this in another field.

Fresenius Kabi

Fresenius Kabi is a global specialist in the manufacturing and distribution of medical products and technologies for infusions, transfusions, and clinical nutrition. Its products and services are used to care for critically and chronically ill patients.

fresenius-kabi.com