The Required D-Value: Evaluating Product Preservation in Relation to Packaging and Consumer Use/Abuse

Cosmetic and pharmaceutical products are subject to microbial contamination and spoilage during use. In 1970, Halleck published the recommendations of the Preservation Subcommittee of the Toiletry Goods Association Microbiology Committee, which stated that preservation studies should consider product formulation, manufacturing conditions, packaging, product stability and continued effectiveness of the preservative system during the intended use by consumers.¹ Eiermann reported that data obtained from suveys during U.S. Food & Drug Administration inspections of cosmetic manufacturers indicated that microbial contamination of cosmetics during manufacturing was no longer a major regulatory issue.² However, the question of whether cosmetic products remain uncontaminated when used by consumers had not been resolved.