By Michael Vileikis
Manually executed cleaning techniques and procedures have been utilized to wash small change parts and equipment since the inception of oral solid dosage manufacturing. As processes, procedures and perceptions have matured the apparent risks associated with manual cleaning have become a frequently discussed topic throughout the pharmaceutical industry.
Why haven’t companies completely transitioned to automated parts washing? Capital cost is a consideration that limits some companies from an upgrade to a cabinet style parts washer. Along with the cost of the equipment and the facility modifications, specific washing racks must be designed and maintained for each set of designated components. Another consideration is that cleaning validations must be performed as new products and materials are introduced into the facility. And after your capital investment and your time and effort to complete a cleaning validation, there is still a manual element of loading the washer, which can be considered a risk.
There are many challenges and risks associated with manual cleaning, including but not limited to: Cross Contamination, Consistency, Quality and Material Handling. Consistency, or the ability to demonstrate control of your cleaning procedure, is the largest challenge associated with a manual cleaning operation.
To ensure a repeatable washing operation, all potential operators must be trained to execute the same scrubbing patterns, soap/detergent application, cleaning procedures and drying procedures. They must consistently execute required soaking or rinsing for a designated length of time, and under the same temperature of water. Also, all operators need to be trained and continually monitored to identify “visually clean” surfaces accurately.
In addition to the inherent variability in human performance, the risk of cross-contamination during manual cleaning is highly dependent on the suitability and effectiveness of the room design and material handling methods employed. Operators must physically segregate soiled components from areas in the room used for cleaning and drying to ensure that clean, dry materials will not be contaminated by dirty equipment. Manual cleaning operations in multiproduct facilities should be performed in segregated washing paths to prevent mix-up and product-to-product carry over.
A trend is emerging in the industry showing movement towards semi-automated cleaning methods. This is mainly driven by the demands of cleaning potent compounds. The total elimination of manual cleaning is not anticipated in the near future. If implemented correctly, manual cleaning can be effective and repeatable. To provide their operators with the best chance to succeed, organizations must develop sound procedures, define cleaning goals, train personnel, optimize wash room design and select proper material handling methods.
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