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CleanControlling Medical GmbH & Co. KGParticulate 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?

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.

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Tests as part of the validation of instructions for the preparation...

Manufacturers and distributors of medical deviceswhich are designed for reuse, must provide information for their products and instructions for processing of the products in order to guarantee th...

Tests as part of the validation of instructions for the sterilizatio...

In the same way as with processing of medical devices (cleaning and disinfection) the manufacturer or the distributor must describe and provide a suitable sterilization method if the medical device is...

Particulate cleanliness in medical technology

In-vitro cytotoxicity test (as per DIN EN ISO 10993-5)

The ability of a substance to damage cells or tissue is referred to as cytotoxicity. The test for cytotoxicity is one of the most important test methods within the scope of the biolog...

Determination of bioburden including validation (as per DIN EN ISO 1...

The objective of determination of bioburden is to determine the population of viable microorganisms (bacteria and fungi) on or in a product or its packaging. The determination of this number is...

Endotoxin test (as per USP 85 and Ph. Eur. 2.6.14)

Endotoxins (ancient Greek endo: "inside", "within", toxins, "the poisonous substance") are part of the outer cell membrane of gram-negative bacteria, which can lead...