Cleaning Validation is a prolonged and costly process. There are several types of cleaning techniques which are popular in the biopharmaceutical and medical device industries:
• Manual cleaning
• Soaking / immersion
• Agitated immersion
• Spray / jet washing
• Ultrasonic bath
• Clean in place (CIP)
• Clean out of place (COP)
Cleaning efficacy is influenced by the “TACT” parameters related to the cleaning (process/utilities/materials):
• Action (immersion, agitation, scrubbing, spraying etc.)
Cleaning validation should be performed after a cleaning method is tested and established. Usually cleaning validation is performed as post-cleaning studies, in the case of a new facility, equipment or process, and/or during validation of an existing cleaning procedure for an existing facility or process.
The cleaning agents used should be considered in the cleaning validation, including testing for cleaning agent residuals after cleaning or in the product next manufactured with the same equipment.
In order to meet cleaning validation challenges, prior to purchasing new process equipment, a sanitary design should be defined in the equipment URS (User Requirement Specifications). We must apply GMP principles to process equipment to assure that effective cleaning and storage methods are used to meet the acceptance criteria that are defined in the cleaning validation protocols.
In order to avoid validating every single piece of equipment on the production floor for cleaning, a grouping strategy may be defined in the validation plan, prior to writing the cleaning validation protocols.
A grouping strategy is defined as a method of grouping together similar or equivalent equipment (based on IQ and OQ) to reduce the number of validations required. A grouping strategy should be based on cleaning materials, cleaning methods and technologies, cleaning parameters, products to be cleaned and engineering characteristics of the equipment (size, shape, materials or content, geometry, etc.)