During and after the manufacture of medical devices, cleaning is an important aspect to avoid hazards for patients. Therefore, the manufacturer or distributor of medical devices must demonstrate the cleanliness of the products and ensure it during the ongoing process.
In addition to biological residues, this also involves avoiding particulate or filmic-chemical residues from the manufacturing process on the end product by cleaning the materials and products in a targeted manner. To ensure effective cleaning, the cleaning process, which is based on the risk assessment, must be validated and monitored.
CleanControlling Medical makes an important contribution to this with laboratory tests as part of the validation or monitoring of the cleaning of medical devices.
Typical applications:
|
Final cleaning of medical devices before delivery
|
Typical test methods:
|
In vitro cytotoxicity test, TOC/THC determination, bioburden determination, endotoxin (LAL) test, particle analyses
|
Samples:
|
Products and materials, liquid samples
|