TECHNOLOGY | MEDICAL
Right: The Netstal Elion Med: with the numerous options of the MED kit, manufacturers can have their machines individually equipped up to cleanroom class ISO 5
Below: Test preparation: automated assembly of 96-well
analysis plates
Engel and Hack Formenbau collaborate closely on many projects, with a focus on high-precision applications for medical technology. In the future, the mould and system solution will not be used exclusively for coronavirus test swabs. The compa- nies are also jointly developing complete systems for the production of swabs for influenza tests or gynaecological examinations, for example. The production of disposables for medical diagnostics is among the most demanding injection moulding applications, according to Wolfgang Zangerle, Head of Business Development Netstal at KraussMaffei. “The area of diagnostics is indispen- sable in today’s medical sector,” he says. “What do you treat if there is nothing for you to analyse? Our products help the field’s leading manufacturers produce items like blood collection tubes, pipette tips, vials, tubes and plates. These products, the so-called disposables, are now made of plastics. They are single-use items that have to meet the highest standards. Several customers that produce the disposables for the new coronavirus mass test from Roche (Virus and Antibody detection) are currently using Netstal machines.” He continues: “In diagnostics, purity and cleanli- ness always come first. For example, the items have to be absolutely free of RNA and DNA when used for genetic testing, for example PCR (polymerase chain reaction) testing for the coronavirus. For us, this means that we have to ensure that it is very easy to clean the machine and the entire plant. All surfaces have to be designed in a way that prevents germs from forming as much as possible, which means that we also have to select inert materials. Not taking into account any of these things could lead to the contamination of the disposable and, ultimately, an incorrect or delayed test result or, even worse, the incorrect treatment of a patient.” However, as diagnostics has developed in
recent years, this has changed the requirements of
injection moulding machines. “Disposables for analytics keep getting smaller since modern testing methods only require small samples,” says Zanger- le. “This means that we have to build machines that, on the one hand, deliver top precision and on the other, offer a performance that allows for the controlled injection moulding of products that keep getting thinner. Not only that, but these machines also have to produce large quantities of them while meeting a zero-fault requirement. It’s a classic field for our Netstal Elion series.” Controlled processing of medical grade polymers is essential to avoid material degradation, he says, and the company offers plasticising units that allow for the polymer to be strained as little as possible while providing the maximum level of homogenisation. One example, in particular in the area of PCR analysis, is the optical analysis of the light emission that passes through the disposable and the highly doped lysis and is crucial for an accurate result. This would not be possible without perfect homogenisation, dispersion and without preventing material degradation. The new fully automated test from Roche is now making it possible to quickly analyse a large number of samples for the presence of the coronavirus. The plastic consumable materials required for this are produced under cleanroom conditions on machines from the Elion series. A test kit for the fully automatic Cobas 6800 and 8800 diagnosis systems was developed by Roche within a short period of time. Following an expe- dited process, the company obtained approval for the new quick test from the FDA. In Europe, Roche completed a self-certification process on the basis of the data used for the USA. Hundreds of these systems worldwide are being used to test millions of patients per month to determine whether they have caught Covid-19. Roche is now aiming to deliver as many tests as possible and is pushing its
30 INJECTION WORLD | September 2020
www.injectionworld.com
IMAGE: KRAUSSMAFFEI
IMAGE: KRAUSSMAFFEI
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