MANUFACTURING
Spotless standards: mastering contamination
Susan Youngquist - Ecolab Life Sciences
Imagine that a single lapse in your cleaning procedure tarnished your brand’s reputation in just a matter of days. From what seemed to be a simple misstep in your cleaning and sanitization (C&S) procedure, you are now faced with a product recall and press release to warn consumers, a formal root cause analysis, and a corrective action plan, among many other responsibilities. The financial and reputation costs are
staggering, with, in the United States at least, potential Food and Drug Administration (FDA) findings adding to the burden. You have now dedicated hours, days, or even weeks to rectify an issue that could have been easily prevented with proper C&S controls. In the world of cosmetics, ensuring spotless equipment is not just about compliance—it is about safeguarding consumer trust and health. For the most part, regulations worldwide
require that personal care and cosmetics products not be adulterated or contaminated. The manufacturer must meet these regulations by controlling critical steps in the manufacturing process to ensure that contamination does not occur. Various controls can be put in place in the manufacturing and packaging processes, cleaning processes, employee hygiene, plant hygiene, raw material controls and employee training, to name a few. The release of the draft Current Good
Manufacturing Practices (cGMPs) of the Modernization of Cosmetics Regulation Act (MoCRA) is still pending, and with that comes speculation about what will or will
not be required. The international standard of GMPs for cosmetics, ISO 22716:2007, can be referenced as an indication of potential guidelines that may influence the draft language of the MoCRA GMPs. For example, ISO 22716:2007 – 4.10.3
& 4.10.4 requires specific cleaning and/ or sanitizing agents that are verified in effectiveness and are selected and applied according to the specific needs of each facility area. In other words, various areas of your facility may require different cleaning SOPs, and each SOP must be verified in effectiveness. As another example, ISO 22716:2007 – 7.2 outlines the importance of documentation,
traceability, quality checks, and batch management, among other requirements. This outlines the push for the industry to move towards ‘first time right’ (FTR) ideologies, ensuring operations are audit-ready and products are manufactured and delivered in spec. Ultimately, these cGMP guidelines
help mitigate contamination risk and give companies confidence that they are delivering safe and quality products to their consumers. It must be acknowledged that any new GMP can be intimidating at first. Considering that C&S is a key component of GMPs, this article will walk you through – at a high level – the risks and best practices associated with cleaning procedures for critical processing equipment.
The cost of dirty equipment In the digitally connected world we live in, within days, a company’s brand can be negatively impacted via social media when product ‘defects’ make it into the consumer’s hands. Similarly, reports of regulatory audit findings or a recall can damage brand image. These defects or audit findings could
have many causes, including residues carried over from the previous production due to inadequate cleaning or flavors and viscosity changes due to microbiological contamination. Ultimately, manufacturers clean to minimize the risk of product contamination. Types of contamination include product
Figure 1: Establish a repeatable and clear procedure to ensure you accurately pass your visually clean assessment across different operators
www.personalcaremagazine.com
cross-contamination, actives cross- contamination, microbial contamination, or
June 2025 PERSONAL CARE
59
Credit: ymd2881/
shutterstock.com
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