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Safety in Pharmaceutics and Medical Engineering

CASE STUDIES
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Since the surface roughness of injection molded components may influence the functionality of medical products, one of the leading pharmaceutical companies uses InfiniteFocus to perform enhanced quality assurance. The use of the high resolution form and roughness measurement system results in safer administration of medications and minimizes the risk of injury for hospital staff.

Roughness measurement of injection molding components

A surface roughness that is either too high or too low might affect a medical product’s proper functionality. InfiniteFocus is used to verify surface finish of these items and thus helps to achieve error free functionality. This enhances the patient comfort and the hospital saves money.

What is measured

Polymer components which are used in devices and combination products

These products offer, apart from the administration of medications, diverse safety features. Among other things they include syringes with an additional needle protection device made of polymer. This protection is put over the syringe after the injection in order to prevent needlestick injuries by contaminated needles. The polymer’s surface roughness being too low could, in the worst case, even lead to a leaking contact between needle protection and needle. Protection against an infection caused by a contaminated needle would no longer be provided then.

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Roughness measurement by InfiniteFocus is performed in combination with form measurement. By measuring the syringe’s form or/and glass cone on the syringe, the matching sealing plug’s perfect fit is verified.

Where else InfiniteFocus is used

Incoming goods inspection

Until the purchase of InfiniteFocus, the company had to “rely on the manufacturer’s specifications”, says the enterprise about past practice. In exceptional circumstances external labs were assigned to do tactile roughness measurements which were both, time-consuming and expensive. Today InfiniteFocus serves as an optical surface measurement device which, besides providing area based roughness measurements, also offers additional parameters such as form measurement or color. It provides quality assurance with dependable information about the surface state faster and easier.

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What the operator thinks

“In the past, roughness was traditionally measured profile based. The results were correspondingly uncertain and of no great significance since profile-based roughness measurements only deliver information about a small segment of a surface. Due to the area based roughness measurement with InfiniteFocus, we now gain reliable feedback regarding the product’s secured functionality. On top of that we benefit from the great user friendliness and the intuitive handling. The easy handling allows several employees to use the system in varied areas only shortly after a quick introduction.” Cédric Gysel, Associate Scientist in pharmaceutical development

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