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CleanControlling Medical GmbH & Co. KG

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CleanControlling Medical GmbH & Co. KGTests as part of the validation of instructions for the preparation of medical devices (according to

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 the clean processing results required for patient safety. These also include some medical devices for single use which are sold non-sterile but are designed for use in a clean, disinfected and, if necessary, sterile condition.

As per DIN EN ISO 17664 at least one automated process must be described in these instructions, unless the medical device is not suitable for such a process. In this case a manual process must be described. These instructions must contain specifications for cleaning (with precleaning as applicable), disinfection and sterilization of the products. As per the specification in DIN EN ISO 17664 these product-related instructions have to be validated, i.e. laboratory tests must be carried out to verify that the specifications in the instructions genuinely result in the product having a cleanliness condition with which it can be safely re-used on patients.

The tests within the validation of the instructions is performed by applying a defined test contamination to the product (e.g. a mixture of blood and bacteria), with areas of the product which are difficult to access being afforded particular attention, and subsequently cleaning and disinfecting the product follows exactly in accordance with the specifications in the product-related instructions. The specifications of the instructions must be so exact that as far as possible the party performing the test cannot influence the results.

The success of the cleaning step is tested by measuring the reduction of protein contamination on the product. The success of disinfection can be determined from the reduction of a test organism suitable for testing disinfection.

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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

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...