B. Braun, a medical technology manufacturer, has successfully integrated the digital assistance system iQ weight control from ENGEL into their production process for roller clamp housings.
ENGEL
B. Braun Melsungen
This enhancement has ensured high process accuracy and stability, crucial for producing precision medical components used in the Intrafix Safeset for infusion devices.
Enhanced manufacturing process
The roller clamp housings, produced in millions annually by B. Braun, require high precision and a stable manufacturing process. Since last summer, production has been carried out using the ENGEL iQ weight control system, which compensates process fluctuations in real-time, ensuring consistent component quality. This dynamic process control has successfully passed the validation process according to EN-ISO and FDA specifications, which is a first for B. Braun.
Christian Münch, project engineer at B. Braun's Melsungen site (Germany), explained that the roller clamp housing production is now independently regulated via inline controls within the process window. This automation eliminates manual readjustments by operators, reducing production-related rejects. The iQ weight control system, a software-based support tool, adjusts process parameters in real-time during the injection moulding cycle, ensuring consistently high quality. Deviations in injection volume and material viscosity are detected in fractions of a second, and the system automatically adjusts the switchover point, injection profile, and holding pressure shot by shot.
Digital transformation in manufacturing
ENGEL
"Digitalisation is a must nowadays," emphasises Münch. B. Braun's investment in digital assistance systems aligns with their strategy to enhance process capability and efficiency. With around 40 injection moulding machines in their medical division, the integration of iQ weight control into their production processes represents a significant advancement and commitment to Digitalisation.
The initial contact with ENGEL occurred at a trade fair, where B. Braun expressed willingness to use iQ weight control in a validated process. The EN-ISO for Europe and FDA regulations for the USA require detailed documentation during the entire process planning and production phase. Critical production processes that cannot be verified by subsequent monitoring must be validated. Integrating the iQ weight control system into the validation process required defining process windows without altering existing parameters. The validation followed a structured approach, including Design of Experience (DOE), Operational Qualification (OQ), and Performance Qualification (PQ).
Validation process
The validation process involved four steps. During the DOE, limits were tested in a statistical plan, forming worst-case combinations within permissible tolerance ranges. These were stored as parameters for defined process limits in the CC300 control system of the e-mac injection moulding machine. The IQ (installation qualification) step was omitted since it was already completed at the start of production. OQ focused on testing the predefined process limits in trials, confirming that the worst-case settings could still produce parts meeting specifications. The final step, PQ, tested the results over 24-hour periods, ensuring stable process sequences and valid production environments.
Münch highlights the importance of stable processes during this phase. The validation process in injection moulding technology follows an established pattern internally at B. Braun, which handles various processes, including extrusion, injection moulding, assembly, and packaging. Millions of roller clamp housings leave the factory in Melsungen annually, fully assembled and packaged.
High-volume production
Production runs on an ENGEL e-mac 1065/160 injection moulding machine, utilising three moulds with 48 cavities each, producing polystyrene housings with a total shot weight of 170 grams. These moulds, including a recently acquired twin of the existing ones, are used on various ENGEL injection moulding machines. Preliminary tests by ENGEL confirmed the advantages of iQ weight control in maintaining constant component weight. Significant improvements were achieved in the measured deviation with the assistance system compared to production without it.
The medical technology sector faces cost pressures, and iQ weight control helps maintain high production quality while reducing reject rates. Increasing the number of cavities to boost output is a trend in the industry, and ENGEL supports this with machines offering higher clamping forces for cleanroom production. Rising energy prices, material costs, and cleanroom space expenses drive the need for efficient production. B. Braun currently operates six days a week in three shifts, and increasing the number of cavities is seen as an effective way to handle volume increases. The compact design and high plasticising performance of the e-mac series were key factors in choosing this model.
Future applications
B. Braun plans to extend the use of ENGEL's assistance systems to other products in their extensive portfolio. The engineering team sees all of ENGEL's assistance systems as advantageous, and they will be considered in future contract award discussions.
In conclusion, B. Braun's successful implementation of the iQ weight control system from ENGEL highlights the importance of digitalisation and advanced process control in medical manufacturing. This achievement sets a new standard for precision and efficiency in the industry, ensuring consistent high-quality production while addressing cost pressures and increasing output.
B. Braun
As a medical technology company, B. Braun sells over 5,000 products worldwide. For over 180 years, the family-owned company has made a name for itself in the healthcare sector with innovations and investments. This innovative strength is still the driving force behind B. Braun's success today, combined with the declared aim of improving clinical results, care costs and patient benefits.
Over 66,000 people in 64 countries and more than 300 subsidiaries create and produce intelligent solutions for a wide range of therapies. By networking products, services and consulting, the company improves treatment processes and provides concepts to increase efficiency. In 2021, the B. Braun Group generated sales of €7.9 billion.