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Lifecycle Approach Wipes Away Cleaning Validation Concerns

September 2019

Cleaning validation is a perpetual undertaking for multiproduct drug manufacturing companies, particularly those with dynamic product profiles and frequently changing commercial needs. With rising demands for complex molecules and highly potent drugs, manufacturers now must continuously invest in new technologies such as containment systems, which offer protection to both operators and finished product (1). This results in manufacturers relying on multiple types of production equipment and manufacturing lines, ranging from production facilities with antiquated technologies (i.e., legacy equipment) to facilities with newer technologies, e.g., isolators or restricted access barrier systems (RABS).