Cleaning validation

Question 1

Cleaning validation is defined as

Answer 1

a process giving evidence that a cleaning operation can routinely meet pre-defined standards i.e. the consistency of the cleaning operation has been demonstrated Cleaning verification is defined as a process giving evidence that a cleaning operation can meet pre-defined standards on a single occasion i.e. the consistency of the cleaning operation has not been demonstrated

Question 2

Cleaning validation Historical expectations:

Answer 2

Total carry over shall not exceed any of the following:
* 0.1% of minimum daily dose of Product A in the maximum daily dose of Product B
* Not more than 10 ppm of Product A in Product B
* No visible residue on any piece of equipment

Question 3

Cleaning validation Current expectations

Answer 3

Limits should be based on a risk evaluation per product i.e. not a one thousandth of the therapeutic dose for everything
 Limit should be based on a “permitted daily exposure” or “health based exposure” calculated on a case by case basis
 Limit should take account of the bioavailability of the administration route

Question 4

Cleaning studies assume

Answer 4

 Residues are uniformly distributed around equipment
 Next product will be uniformly contaminated

Question 5

What are the methods of sampling for cleaning validation

Answer 5

 Rinse Samples
* Until acceptance criteria met
* (But clean until clean is not a viable approach!)
 Swabs
* To confirm cleaning of worst-case areas