CleanControlling Medical GmbH & Co. KG Products and services

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

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 caus...

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...

Hygiene in times of COVID-19 (Testing of microbiological cleanliness...

Hygiene is an important commodity at all times, but especially in the current crisis situation. Despite the fact that restrictions are beginning to be released, strict compliance with hygiene measures...