Manual cleaning processes continue to play a role in the pharmaceutical industry. Some equipment and parts are not easily adapted for CIP or COP.
Because of the human element, the variability of manual cleaning is the primary concern when validating the cleaning process. The easiest way to address variability is to develop a cleaning process that is more rugged than needed for the product residues, and to clean residues to levels well below the cleaning SL.
Individuals involved in manual cleaning must be adequately trained on the cleaning process(es). This includes detergents, aqueous utilities, and cleaning aids (e.g., brushes, pads, wipes). Thorough training is also necessary on the individual equipment cleaning procedures. Personnel need to know the extent of disassembly of each piece of equipment to allow adequate cleaning of all parts of the equipment.
Personnel must be familiar with the cleaning process parameters for manual cleaning. While detergent concentration and water temperature might be less critical, the minimum cleaning time for each piece of equipment needs to be followed in order to minimize individual variability as much as possible. Appendix 6 presents a case study on setting parameters for a manual cleaning process.
Qualification of individual cleaning personnel is recommended. Qualification can be done for each equipment group (e.g., tanks) or for a representative complex piece of equipment (e.g., tablet press). Qualification is another way to ensure an adequate and more consistent level of manual cleaning on all equipment. During cleaning validation, different personnel should be used to mitigate the assumption of variability.
Of particular concern is manual cleaning of product residues with low HBEL cleaning limits. For these residues, consistency is critical. A low HBEL cleaning allows no room for error based on variability since a piece of equipment could be visibly clean but still fail the HBEL cleaning limit. In addition to qualified cleaning personnel, implementing frequent monitoring is advisable after cleaning validation is complete.
The validation requirements for a manual cleaning process are the same as for any cleaning process. What differentiates manual processes from CIP and COP processes is the ability to measure the Critical Process Parameters (CPPs) for cleaning. Automated systems routinely record and control temperature, conductivity (detergent related) and time where manual cleaning relies on operator documentation of these parameters.
Read also: Cleaning Parameters and CPPs