Are you monitoring your water system?

Published: 10-Jun-2024

One of the most common reasons for a product recall is microbial contamination. It’s easy for microorganisms to get into your manufacturing facility and a lot more difficult to get rid of them especially once they make it into a finished product

To make it even more challenging, microorganisms are adapting and thriving in harsher conditions. Their adaptations can include antimicrobial resistance or even promoting growth as they adapt to a product’s environment. There are the usual suspects of microorganisms that are known to be harmful to people such as pseudomonas aeruginosa, which has been found in cosmetic creams and eyedrop recalls and have had significant health effects to exposed consumers. There are more lurking opportunistic microorganisms that are gaining visibility recently as seen in FDA recalls and new guideline requirements in the pharmacopoeia for microbial testing that will affect the cosmetics industry as well.

One of those is a family of closely related microorganisms called the Burkholderia cepacia complex (Bcc). There are also other microorganisms that are becoming resistant to antimicrobials and have been recent pests to the cosmetics industry, specifically pluralibacter gergoviae. All these microorganisms have varying degrees of pathogenicity (harmfulness), but they have one thing in common, they are all categorised as opportunistic pathogens and thrive in water. To get ahead of these rapidly evolving microorganisms, cosmetic manufacturers need to be aware of how these bacteria grow and how to keep them from impacting the manufacturing process.

It's in your water

Water is the top route that microorganisms use to make their way into cosmetic manufacturing. While cosmetics have some of the most varied product formulations, the most common ingredient is water. The quality of your cosmetic products is deeply rooted in the quality of your water. Despite this relationship, the regulations regarding water quality are not clear or very specific. Cosmetic regulations for products manufactured and/or sold in the US, as they stand, are primarily governed by the FD&C Act that states a cosmetic product must be safe for consumer use and not “adulterated” or misbranded in any way. The Modernization of Cosmetics Act of 2022 (MoCRA) expands the authority of the FDA beyond the FD&C Act to allow for increased oversight into the manufacturing and evaluation of quality of cosmetics. Even with this new regulation, water quality is not specifically called out, but is still
covered because the product must be safe for use and free from harmful microorganisms like pseudomonas aeruginosa, Bcc, and pluralibacter gergoviae.

Without the regulations specifying water quality, manufacturers have the ability to choose which water purity grade they want for personal care products. One of the most common water grades used in cosmetics is purified water but even that can have a range of quality. Some cosmetic manufacturers may be using USP-grade purified water, which is required for non-sterile drugs including over the counter (OTC) drug products, but not a requirement for cosmetics. For manufacturers that produce a diverse portfolio, it is easier to use USP-grade purified water across all manufactured products to avoid confusion and mitigate any regulatory issues. As defined by USP <1231> and the purified water monograph, purified water is defined as “water obtained by a suitable process” and must comply with corresponding geographical water regulations.

Testing your water’s microbial quality

Although routine water system monitoring is not required in cosmetics, it is important that you are testing your water system using validated methods on a regular basis.  ISO 21148:2017 issues a water quality warning stating “Water processed through an ion exchanger (deionised) may have a high microorganism content; it is therefore advisable not to use such water without verifying that the microorganism content of the water is low.” Routine testing and monitoring of your water purification process paired with accurate microbial identification of recovered microorganism isolates are essential to your water and product quality. Consider your water use at every stage of your process. Water is used not just as a raw material in the formula but for cleaning purposes as well. Monitoring of microorganisms in your water allows manufacturing to be proactive to reduce routes of microbial exposure during the manufacturing process.

A routine schedule for collecting microbial data is a best practice to maintain a state of control in your manufacturing environment. Lack of data regarding the quality of your water system poses a potential risk of missing fluctuations of objectionable microorganisms that could be getting into your products. If the contamination arose from your water system, no amount of cleaning the manufacturing vessels will remediate the microorganisms because that is not the source. Assessing manufacturing quality is not a one-time event. Take into consideration seasonal variability when defining the periods of time to do additional sampling for identification. A facility should be requalified periodically, especially after any changes to equipment, facility, personnel, and/or processes. Requalification provides the opportunity to critically evaluate microbiological data. Identifications made during this process are just as important as checking the final product to assess and maintain quality in your manufacturing. Being able to review a database of previous results provides a history of your microbial environment. This is the basis of tracking and trending, which is key to making proactive decisions in your manufacturing facility. Without
tracking and trending, it is difficult to show that procedures put in place for preventing contamination are truly effective.

The importance of accurate identification

Detecting microbial contamination in your facility is only one facet of contamination control. Accurate identifications are necessary to understand microbial risk to your products. These IDs can provide direction for appropriate cleaning and disinfecting strategies and determining potential microbial high-risk areas and points of entry. An accurate species level identification can help provide a link to the microorganism source. The relative cost of accurate microbial IDs is small especially compared to the loss of profits from quarantined vessels and product.

Accurate microbial identifications are dependent on the method, how that method is executed, how the data is analysed, and the quality of the microbial database. There are many technologies utilised to characterise and identify microorganisms from manufacturing environments, being aware of the limitations of these technologies are vital. Basic characterisation, such as a Gram staining, gives general information about the contaminant, but more detail may be required to fully understand the risk to your products. Gram staining is often the first step in microbial identification in personal care product manufacturing, and an inaccurate Gram stain can lead to erroneous results with lost time and lost profits.

Different methods of microbial identification have varying levels of accuracy. For example, it has long been recognised that DNA sequencing is the gold standard for microbial identifications, providing the highest confidence in accuracy and precision versus commercial phenotypic methods (e.g., Gram staining). However, this method can be costly and work intensive. An alternative to DNA sequencing identification is MALDI-TOF (Matrix-Assisted Laser Desorption Ionisation – Time of Flight) mass spectrometry technology, which has become widely accepted as reliable microbial identification method with the benefits of fast sample preparation and testing time. The MALDI-TOF system provides accurate, rapid, and cost-effective IDs. Both DNA sequencing and MALDI-TOF methods provide higher accuracy than the conventional phenotypic methods. You can reduce risk to your products when you rely on a more accurate identification method. However, an identification system is only as powerful as the microbial database that supports it. If your method doesn’t have a database that includes microorganisms relevant to your industry, it could result in no ID or a completely inaccurate identification. Inaccurate data leads to faulty risk assessments. Many commercial databases were created for clinical purposes and may not include microorganisms related to home and personal care manufacturing.

Personal care and cosmetic product manufacturing is complex and fast paced, and contamination events have significant impact. One of the most common sources of microbial contamination is through water systems. How, when, and where you monitor will depend on your risk assessment – some areas like your purified water system may need more frequent testing than others. Risk levels can fluctuate over time in your manufacturing sites and may require reassessment. By routinely monitoring your water’s microbial quality through tracking and trending, using an effective method of identification, and maintaining a controlled environment, you can mitigate and remediate contamination quickly.

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