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Author:gly Date: 2024-09-30
Established in the 1960s and operating from its own premises in Yorkshire, the company specialises in the design and manufacture of special-purpose machines, jigs, fixtures, gauges and precision tooling assemblies.
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.
"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.
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.
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.
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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.
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.
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.
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).
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This enhancement has ensured high process accuracy and stability, crucial for producing precision medical components used in the Intrafix Safeset for infusion devices.
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.
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.
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.
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.
A Worcestershire-based precision plastic and injection mouldings business has been acquired out of administration. P J S Mouldings fell into administration on August 11 2023, with administrators from Grant Thornton UK LLP subsequently concluding a sale of the business as a going concern to S M Automotive Division. P J S Mouldings, which is based in Redditch, was founded in 1993 and provided precision plastic and injection moulding services to a range of sectors, with a particular focus on serving the automotive market. The acquisition, overseen by joint administrators Rob Parker, Jon Roden and Helen Dale of Grant Thornton UK LLP, sees P J S Mouldings’ business and assets sold to Solihull-based S M Automotive Division as a going concern. S M Automotive Division is a subsidiary of West Midlands mouldings group Stechford Mouldings, which has been operating in the region for more than 80 years. The acquisition of P J S Mouldings’ business and assets sees all operations transfer to the new owner and secures more than 70 jobs. In P J S Mouldings’ most recent accounts at Companies House, for the year ending March 31 2022, the firm reported fixed assets valued at slightly over £0.5 million and current assets at £1.8 million. At the time, the firm owed creditors around £1.7 million within one year and £370,723 after more than one year, leaving its net assets at £241,838. Commenting on the sale, joint administrator Rob Parker said: “We are very pleased to have completed a going concern sale of the business, which secures the continued employment for a loyal workforce in these challenging economic times. S M Automotive Division Limited appears to be a great fit for the business and well placed to serve its customers in the future”. Distressed acquisitions can deliver enormous value - but it is vital to undertake a thorough due diligence process
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.
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