***** PREMIUM

CleanControlling Medical GmbH & Co. KG

Service Provider

CleanControlling Medical GmbH & Co. KGParticulate cleanliness in medical technology

Particulate cleanliness in medical technology

Particulate contamination of the products is also becoming increasingly important in medical technology. Some questions however remain without sufficient answers. Exactly what damage do particles cause in the body?

Partikelextraktion vom Medizinprodukt mit flüssigem Extraktionsmedium mit DosiereinheitStereomikroskop zur automatischen Partikel-Vermessung und -Zählung mit Auswertesoftware im Bildschirm

What particles are especially harmful in which organs? What effect does the material have?

Among the many standards for medical technology there are various individual standards for the examination of particulate contamination on surfaces which, however, only relate to specific products or product groups in each case. In some standards the procedure for testing particulate contamination is described rather imprecisely, making a comparison of test results from different laboratories impossible. In other cases, the conditions are so rigidly specified that differing product geometries, materials and surfaces are not taken into account.

Due to the lack of standardized specifications the pharmaceutical standard USP 788 has been established as a frequently used standard for testing injection liquids in the medical product sector. USP 788 has the benefit that it specifies limit values. On the other hand, it does not describe a method for the extraction of particles from the test object as the limit values relate to liquid quantities, which then has to be translated in suitable manner for the assessment of solid objects. USP 788 favors the analysis of particles by way of a direct count in the liquid, using an optical particle counter. USP 788 also describes a microscopic method.

CleanControlling Medical GmbH & Co. KG has established the method favored in medical technology, using an optical liquid particle count based on USP 788, as an accredited analysis method. This test is particularly suitable for the validation and monitoring of cleaning processes.

Microscopic particle analyses based on DIN EN ISO 14644-9, which is established in the field of clean room technology, and in turn refers to ISO 16232 and VDA 19.1as applied in industry, lend themselves to the examination of particles and particle sources in the manufacturing process. These particle analyses can be called upon for further tests (e.g. REM-EDX, FT-IR) for material determination of particles. For microscopic particle analyses CleanControlling Medical GmbH & Co. KG calls upon the many years of experience of CleanControlling GmbH in the field of technical cleanliness.

More information

 

CleanControlling Medical GmbH & Co. KGAll showrooms

> Diese Kategorien könnten Sie interessieren

Become a member of the “World Center for Medical Technology“

Become a digital exhibitor yourself in the online portal of the largest and best-known MedTech cluster region in Germany and inform the world of medical technology about your products and services as well as about news, events and career opportunities.

With an attractive online profile, we will help you to present yourself professionally on our portal as well as on Google and on social media.

Become a member
cd