C
Section 7.5.1.2.1 states: If product is cleaned in accordance with a) or b) above, the requirements contained in 6. 4 a) and 6. 4 b) do not apply prior to the cleaning process.
How does this apply to our production setting?
Do 6.4 a and 6.4 b apply?
What would be the extent of documented controls needed?
Our company supplies components to the Medical Device manufacturer they are cleaned by us in an ultrasonic cleaner and in some cases passivated by our certified supplier then sent to the the customer. All sterilization takes place after shippment. We use controls for handling after cleaning takes place by use of protective gloves to keep device components in a clean condition.
How does this apply to our production setting?
Do 6.4 a and 6.4 b apply?
What would be the extent of documented controls needed?
Our company supplies components to the Medical Device manufacturer they are cleaned by us in an ultrasonic cleaner and in some cases passivated by our certified supplier then sent to the the customer. All sterilization takes place after shippment. We use controls for handling after cleaning takes place by use of protective gloves to keep device components in a clean condition.