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Medical devices come into contact with various process auxiliaries during their manufacturing process. This can result in the development of critical substances that are hazardous to health. These hazardous substances accumulate, for example, in surface structures and blind holes, they adhere as a thin film to product surfaces or penetrate plastic parts.
With the new medical devices regulation (MDR), the demands placed on manufacturers are increasing. With our targeted cleanliness tests, you can provide efficient and meaningful evidence of the cleanliness of your medical devices.
Mit der neuen Medizinprodukte-Verordnung (MDR, Medical Device Regulation) steigen die Anforderungen an die Hersteller. Mit unserer gezielten Sauberkeitsprüfungen erbringen Sie den Nachweis der Sauberkeit Ihrer Medizinprodukte effizient und aussagekräftig.
HOW CLEAN IS YOUR MEDICAL DEVICE?
As a rule, the exact chemical composition of the process auxiliaries used is not known. There is insufficient detailed toxicity data available. For this reason, targeted cleanliness tests must be carried out to determine whether critical process auxiliary substances from the manufacturing process remain on the medical devices after final cleaning or packaging, which could lead to undesired effects when used by patients.
Among the known critical process auxiliaries are:
- Lubricating oils
- coating materials, for example in titanium plasma coatings
- Cooling lubricant emulsions
- cleaning agents (solvents, acids, alkalis, tensides)
- Polishing pastes
- Rinse water residues
- Residues of manual handling (hand cream, grease, etc.)
- Blasting media
- Degradation products, e.g. from gamma-sterilisations
- Passivation solutions
- Leachables of packaging
THIS IS HOW YOU BENEFIT WITH OUR TARGETED CLEANLINESS INSPECTION
- Cleanliness tests in accordance with ISO 19227
- Accredited laboratory
- Clear test reports
- Efficient concepts
- Fast delivery time
- Simple contract award process
WHICH RESIDUES ON MEDICAL DEVICES DO YOU HAVE TO DETECT?
Regular cleanliness tests of the medical devices with regard to inorganic and organic compounds or particulate residues ensure a constant product quality.
Niutec AG offers highly efficient analysis packages so that the selected analysis method can be used to determine the broadest possible spectrum of process auxiliaries (substances). This enables us to determine the maximum amount of residue that is potentially hazardous to health.
Cleanliness test for inorganic residues
Inorganic compounds are water-soluble and are used as passivation agents or cleaning agent additives in the manufacture of medical devices.
Cleanliness test for organic residues
Organic compounds such as fats, oils, tensides or alcohol can be soluble or insoluble in water. The compounds are called Total Hydrocarbons (THC) or Total Organic Carbon (TOC). Such organic compounds can be found in a variety of process auxiliaries.
Cleanliness test for particulate residues
Particulate residues from process auxiliaries arise in the manufacturing process, for example during sandblasting or milling, or they get onto your medical devices as a result of cross contamination from the production environment. Depending on the intended use of the medical device, such particle residues can have serious effects on the health of patients in terms of both quantity and size.
Cleaning validation & process validation
New or modified manufacturing processes as well as new facilities must be checked for their safety with appropriate validations. With our highly efficient cleanliness tests, you can check your medical products specifically and professionally document them for critical process auxiliaries that are hazardous to health.
Prove by specific contamination with process auxiliaries that all residues can be removed by your intermediate or final cleaning. Niutec AG carries out clearly defined contamination in the laboratory and sends you the medical devices for cleaning. The products you have cleaned can then be subjected to another cleanliness test in our laboratory. With this before and after comparison, you can convincingly prove the cleaning efficiency of your facilities.
Chemical test methods cannot replace a microbiological cleanliness test, nor can microbiological cleanliness tests replace a chemical cleanliness test, as the approaches differ. Only a combination of the two methods provides the necessary verifiable safety for your products.