Borealis collaborates with Plastisud, Sumitomo (SHI) Demag, and HEKUMA in creation of new manufacturing cell for high-volume pipette tip production

The challenge

Pipette tips may not be the most prominent of medical diagnostics consumables, but they are among the most important. Because the tip is crucial to ensuring the integrity of the sample contained within, it must fit the pipette perfectly. It must permit no leakage, but at the same time allow for easy removal. Pipette tips must thus be produced with perfectly consistent dimensions and flawlessly even surfaces.

Polymer materials of the highest quality and state-of-the-art manufacturing equipment are required to achieve these demanding specifications. In Europe, pipette tips will be subject to more stringent regulatory schemes once the In Vitro Diagnostic Regulation (IVDR) takes effect in May 2022. A new challenge has arisen during the Covid-19 pandemic, as testing on a massive global scale has led to an explosion in demand for diagnostic consumables, including pipette tips. Healthcare industry partners must find a way to accelerate the rapid and efficient production of millions of high-quality pipette tips in order to fulfil acute demand.

The solution

Recent co-operation between Borealis and several value chain partners has yielded a new production cell designed for the manufacture of highly precise diagnostic consumables such as pipette tips on a large scale. Borealis partnered with Plastisud, a leading mould maker specialising in the engineering and manufacturing of high-precision multi-cavity moulds for the injection moulding process; Sumitomo (SHI) Demag Plastics Machinery, leading manufacturer of injection moulding machines; and HEKUMA, specialist for highperformance automation systems for the production of plastic products in medical diagnostics, among other areas. The new manufacturing cell comprises Plastisud’s 64-cavity mould (which boasts an innovative, two-injection-point concept) along with Sumitomo’s highly-precise machine technology. HEKUMA provided a side entry robot with optional downstreaming processes like contact-free camera inspection, mixed or cavity separated insertion in racks and packaging. Borealis supplied Bormed™ BJ868MO, a member of the Bormed™ portfolio of PE and PP medical grades dedicated to the meeting the stringent requirements of the healthcare industry. Taken together, these components enable the efficient production of industrial volumes of high-quality healthcare applications like pipette tips - for which the margin of error in production is nearly zero.

The results

Collaboration was essential to the successful implementation of this high-tech production cell. Combined, the advantages each partner brought to the table resulted in a cleaner, faster and quieter system capable of producing diagnostic consumables with extremely narrow tolerances, and in very high volumes. The cell is also designed to accommodate the special requirements posed by a pipette tip weighing only 0.26 gr. And thanks to the unique characteristics of Bormed BJ868MO – which was designed for use in diagnostic applications, among others – the production process itself has been improved. Thanks to a very high melt flow rate of 70 g/10 min., easier filling of the 64-cavity mould is possible. From a processing perspective, the required injection pressure is lower. The melting temperature of 166 °C also speeds up cycle times.

Bormed™ BJ868MO: the medical grade designed to enable compliance with future MDR and IVDR

Like other members of the Bormed family, Bormed BJ868MO was developed for use in rigid and flexible healthcare products. The grade enables our customers to achieve compliance with increasingly stringent safety regulations, including the future MDR and IVDR for medical and diagnostic devices.

As a regulated grade and member of the dedicated Bormed™ portfolio of PE and PP grades, Bormed BJ868MO offers clear advantages to both manufacturers and end users:

• High impact resistance – minimises risk of breakage for the end user and ensures good drop performance of final device in varying conditions (at refrigerator, deep freezer and sub-zero temperatures);
• Superior high flow – enables fast and easy mould filling; flow-length-to-wall-thickness-ratios of up to 300 provide for very good dimensional stability;
• Lower holding pressures, lower processing temperatures and faster cycle times – all enhance sustainability thanks to reduced energy consumption and CO2 emissions.

Thanks to our Bormed Concept, Borealis and Borouge customers can rely on a long-term security of supply due to a rigorous change control procedure and two-year pre-notification period combined with last call volume. It also guarantees superior product quality and consistency, as well as long-term product traceability thanks to retention of Quality Control data and samples. Additional Bormed services include regular external testing of Ph. Eur., USP and ISO 10993 as well as extractable profiles with analysis reports that can be shared upon request.