Follow
In order to have efficient cleaning methods, the following strategy is required. The cleaning strategy of a diagnostic company should be to minimize the risk of product quality. Cleaning validation is directed towards situations or process steps where the potential for carry-over poses the greatest risk to product quality and patient safety. In some cases, the element of reproducibility is limited, cleaning verification may be performed. Cleaning process applies to both cleaning verification and validation activities as described below:
Cleaning Verification
Cleaning verification typically involves only one lot trial run to demonstrate the effectiveness to release the equipment for further use. Cleaning verification requires the following:
a. All equipment used to manufacture the product must be evaluated to determine the types of residues to be removed (this includes product, previous product, raw materials. microbial residues, intermediates, anti-foaming agents, cleaning agents, lubricants etc.)
b. Proper selection of cleaning agents
c. The equipment configuration and materials of construction must be evaluated to determine the appropriate cleaning methodology
d. Sampling techniques and sites must be determined
e. Test Method must be validated and appropriate to use
f. Justification for acceptance criteria must be documented
g. Cleaning procedures must be documented which must include appropriate process parameters
h. Personnel carrying out the cleaning procedures must be adequately trained
i. Failure to meet acceptance criteria must be investigated
j. The failure must be reported through a CAPA system
Cleaning Validation
Initial cleaning validation requires a minimum of three consecutive successful operations demonstrating its effectiveness as well as reproducibility. In addition to cleaning verification described above, cleaning validation requires the following described below:
a. Acceptance criteria must be documented prior to execution of the cleaning process
b. Validation of cleaning procedures must reflect normal equipment usage pattern
c. Personnel carrying out the cleaning validations procedures must be adequately trained
d. Failure to meet acceptance criteria must be investigated
e. The failure must be reported through a CAPA system
f. Validated cleaning procedures must be monitored at appropriate intervals using analytical and visual testing to ensure that cleaning procedures remain effective.
Written justification should be provide for the monitoring program as the test method and number of samples that is different that used in cleaning validation
