By Alexa Tatarian, B.S., Project Coordinator
According to Good Manufacturing Practice (GMP) regulations and increased regulatory demand, testing in regard to the cleanliness of a medical device after the manufacturing and cleaning process needs to be completed and documented. Residual oils, lubricants, polishing compounds, detergents, and other contaminants from the manufacturing and cleaning process can affect the function and safety of medical devices.
For example, too much residue can cause an implant to not adhere properly within the body. Biological and microbiological contamination can also cause damage if they remain during patient contact.
Nelson offers a variety of test options to help show the cleanliness of a device after the manufacturing and cleaning processes – tests to quantify the residues remaining as well as tests to document other harmful contaminants. Earlier this year, a guidance document was published (ASTM F2847) which outlines test options and reporting of residues on single use implants.
Tests offered to quantify residues remaining on the surfaces of medical devices include: the quantification of extractable residue by gravimetric analysis (ASTM F2459), total organic carbon (TOC), detergent residual analysis by UV/VIS, and particulate testing.
There are currently no regulatory limits that dictate what the residue levels should be, therefore it is recommended to pair the above tests with additional supporting tests to examine other concerns about the residues.
A cytotoxicity test (MEM elution) is helpful when paired with the above tests to show whether the residues obtained are cytotoxic or not. If microbiological contamination is a concern, bioburden and LAL (endotoxin) tests can provide additional data to claim a clean device.
Not every test suggested above needs to be completed for each validation. Depending on the device, process, and potential contaminants everyone may have a different test plan based on their needs.
This testing is important because if not completed, a potentially dangerous device could be placed on the market. It is absolutely vital to ensure the quality and safety of devices before they are distributed, and these cleaning validations can help provide data related to the overall cleanliness of newly manufactured/single use medical devices.