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Cleaning validation is an important regulatory component of industrial manufacturing. It ensures that a standard and reliable protocol is followed forthe removal of residual chemicals from equipment between batches. Clean equipment is important for process validation because consistent products cannot be synthesized without consistent starting points. However, cleaning validation is about more than just equipment cleaning. Attention must be paid to other parts of the manufacturing process including employee education, building and facility maintenance, equipment calibration and maintenance, control of raw materials, up-to-date standard operating procedures, clear communication between all employees, and accurate reporting of data and processes.

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Equipment cleaning validation

Industry guidelines demand that written protocols are readily available for reference. These protocols contain detailed information about the methods and materials used to clean and maintain equipment. This also includes information explaining the proper disassembly and reassembly of equipment that may require deep cleaning. During the cleaning process all priorbatch labels must be removed. The solvents used for cleaning must be validated and documented. The solvents should always be examined thoroughly to determine if they themselves leave a chemical residue on the equipment. Analytical methods such as test swabs are routinely used to quantitatively measure the chemical composition and amount of residue on the equipment following the cleaning procedure. Additionally, there should be protocols in place to protect clean equipment against contamination during idle time. There can even be regulations about the amount of time that equipment can sit unused between batches.

 

Instrument Calibration

Equally important is the routine calibration of instruments and equipment. There should be written calibration procedures in place, and the work should be completed by trained employees at scheduled intervals. There should also be plans for how to recover from unforeseen events such as equipment malfunction, deletion or loss of data, an unplanned computer crash or restart, and system updates or changes. The quality and reproducibility of the manufactured product is directly tied to the consistency of the equipment used to process it and the existence of backup plans. If adequate attention is not paid to routine calibration there could be devastating consequences such as product recall, loss of trust in the company, or even endangerment of consumer welfare.

 

Management of raw materials and finished product

Another important piece of the cleaning validation puzzle is the storing, handling, and testing of  raw materials. Even validated cleaning procedures can fail if the raw materials are contaminated and leave an unexpected chemical residue to contend with. All raw materials need to be sampled and tested for quality, and should pass inspection before entering into the manufacturing process. The storage of raw material should also be validated to ensure that quality is maintained and to reduce the risk of spills and environmental contamination. Of course, after manufacturing is complete, the final product needs to be packaged and handled with consistency in order to guarantee  quality throughout its journey out of the manufacturing plant and into the hands of the consumer.

 

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Lluis M. Martínez | SEPMAG Chief Scientific Officer

Founder of SEPMAG, Lluis holds a PhD in Magnetic Materials by the UAB. He has conducted research at German and Spanish academic institutions. Having worked in companies in Ireland, USA and Spain, he has more than 20 years of experience applying magnetic materials and sensors to industrial products and processes. He has filed several international patents on the field and co-authored more than 20 scientific papers, most of them on the subject of magnetic particle movement.

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