Cleaning of Equipment

a. Types of cleaning processes (manual/semiautomated/automated): The direct cleaning of equipment by a trained operator is considered manual cleaning. Among the critical parameters involved in manual cleaning are volumes of cleaning agents and rinse water, temperature of wash and rinse solutions, duration of washing cycle, concentration of detergent used, and so on. In semiautomated cleaning, various levels of automatic control are also included. This may also be considered as a blend of manual and automated cleaning, for example, manually removing gaskets and fittings before automated CIP or dismantling a pump prior to cleaning in an automated COP system. The automated system usually comprises programmable cycles and does not include personnel intervention.

b. CIP/COP: As discussed in the sections above, CIP generally refers to the automated circulation system. Some of the critical aspects of the CIP system that need to be considered are the certainty of preventing backflow and of assessing the suitability of recirculated cleaning solution for subsequent use. CIP parameters such as flow rate, pressure, and spray ball patterns must also be qualified prior to use.

c. Equipment design considerations: Care must be taken in designing equipment to minimize the risks of cross-contamination and microbial contributions to the equipment. Preferably, equipment should be constructed of a nonreactive material. If the cleaning agents seem to be reactive with sealants, plastics, or filters, then design specifications and preventative maintenance procedures must be carefully looked into.

d. Equipment storage after cleaning: It is necessary to protect equipment from cross-contamination between the period of cleaning completion and reuse for the next product manufacture. Areas must be allocated for this purpose where possible cross-contamination may be controlled. In the meantime, records must also be maintained showing equipment numbers, date and time of cleaning, and names of persons who cleaned and inspected it.

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