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Figure 3: Micro swabbing is a common method to test microbial residues
residue level. The detergent manufacturer should be able to assist in this development. While achieving residual cleanliness is
crucial for eliminating hidden contaminants, addressing the microbial threats that can compromise product safety is equally important. This brings us to the last level of cleanliness: ensuring equipment is microbially clean.
3. Microbially clean Microbial contamination caused by bioburden in the equipment is becoming a more significant concern and interest in the cosmetics industry. Clarifying terms is necessary before we explore options to control microbial contamination. Two terms that confuse the global realm – sanitization and disinfection. In US Environmental Protection Agency and United States Pharmacopeial Convention (USP) standards,2,3
reduction of
microbial load is referred to as sanitization, while disinfection is defined as destroying or irreversibly inactivating micro-organisms. For this article, we will use the term sanitization to mean the reduction of microbial load to desired levels, regardless of the geographic location of the application. Once visual cleanliness and residue levels
have been met, there remains potential for microbial residue on equipment that can contaminate a cosmetic product. If microbial contamination is extreme, as in a slimy, discolored area indicating biofilm presence, a visual inspection may detect the issue. Often, microbial contamination is only detected through finished product testing, with high micro counts resulting in batch rejection. Even if history shows no problems
with microbial contamination for products manufactured in a facility, current product trends are moving towards more natural ingredients, which may increase the potential for introducing previously unseen microbial flora. In addition, preservative options are shrinking as the EU delists preservatives
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for use in cosmetic products, meaning less insurance in the formulation to counter microbial growth and contamination. Microbial residues can be measured with
either micro swabs or rinse water sampling, depending on equipment design and condition. There are unique challenges with microbial residue testing primarily related to access to sample points. Often, the areas in the equipment of highest risk for micro growth are areas that are not easily accessed, such as pipes, equipment joints, or, in some cases, equipment surfaces damaged by gouging or pitting. These areas that are difficult to access for sampling are also the most difficult to effectively sanitize, compounding the risk. The primary method of controlling
microbial residue on cleaned equipment is through a sanitization step. Personal care and cosmetics manufacturers have historically used thermal disinfection to reduce microbial residue. Formulation trends mentioned above are increasing the importance of maintaining good microbial control in the manufacturing equipment. Further pressures to control costs and
reduce energy usage result in companies moving from the often-used hot water sanitization to chemical sanitization. Confidence that the thermal process is effective and operating in the validated state highly depends on temperature and time for all equipment contact points. Chemical sanitization is becoming more popular with assured microbiological effectiveness validated using a specific product, concentration, and contact time – often at ambient temperatures and for just a few minutes.
Conclusion Ensuring that personal care and cosmetic products are produced in an environment free from contamination is essential to the health and safety of the consumer. One key step the
manufacturer can take is developing a cleaning and sanitizing programme that effectively removes contamination from manufacturing. Those contaminants may be residues from products (actives or not), detergents, or microbial load. Cleaning to a ‘visually clean’ standard is imperative and non-negotiable as a starting point. Development of the standard – the process, acceptance limits, and training – is critical. We have explored the fact that achieving
‘visually clean’ may not be enough. Residues that are not visible, such as actives residues, detergent residues, or microbioburden, may contribute to contamination impacting product quality. Cleaning and Sanitization programs must address all these residue types rigorously to provide confidence that product quality is not impacted. To ensure your products meet the highest
cleanliness and safety standards, consider partnering with experts who specialize in contamination control. Doing so can safeguard your brand’s reputation, protect consumer health, and stay ahead of regulatory requirements. Don’t wait for a contamination issue—take proactive steps now to implement a robust cleaning and sanitization program.
References 1 Annex 15 of the EU GMP guidelines states “limits for the carryover of product residues should be based on a toxicological evaluation. The justification for the selected limits should be documented in a risk assessment which includes all the supporting references”
2. US Environmental Protection Agency. Pesticide Registration Manual: Chapter 4 - Additional Considerations for Antimicrobial Products. https://www.epa. gov/pesticide-registration/pesticide- registration-manual-chapter-4- additional-considerations
3. United States Pharmacopeial Convention (USP) Chapter 1072
June 2025 PERSONAL CARE
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