The perspective of Anne Wagner, PhD, Technology and Market Development Manager for Charles River's Microbial Solutions division.
Environmental monitoring provides the tools needed to effectively address contamination risks.
Manufacturing consumer care products is complex and requires a maximum level of efficiency and productivity. The process is constantly threatened by invisible invaders: microorganisms. Imagine this scenario. Before a shampoo goes to market, microbial limits are tested and you discover out-of-specification microbial growth (OOS) on your plates.
What should you do next?
You can think of your manufacturing facility as a rail system (see ill.). SKU shampoo is produced on the red railway line. Your finished product is complete at stop D.
The first step is to determine which microorganism has contaminated your product. You probably stained Gram and then identified the recovered microbial isolate at the species level. You identify the microbe as Pluralibacter gergoviae. This organism is classified as a Gram-negative opportunistic pathogen, resistant to preservatives and ubiquitous in nature. Without a baseline of your environment, each contamination event puts you in square one to identify the root cause. This microbial contaminant can come from anywhere.
Let's go back to our analogy with the train. We can see that the contamination occurred on the red line. Imagine that this is a slippage. If you only clean the manufacturing tank, corrective action may not be enough to fix the problem as there are many other sources of contamination. In addition, the red line route is connected to all other railway lines, directly or indirectly, which means that the contamination risk points in a final product are expansive. New trains arrive every few minutes and you could see recontamination occur again on the red line if you can't confirm the initial source of the introduction of pathogenic bacteria into the environment.
Was it a contaminated raw material, improperly worn PPE, or problems with the water purification system? Did construction work or moving vehicles create dust? You need to test all these environmental sources to find the origin of the microorganism. In this example, you determine that the microbial source is at stop J of the pink line. The microbial origin can be a leaking pipe, a failure of the water purification filter or even an air conditioning problem. No cleaning of the tank will solve this problem. If the source is a raw material shared between different manufacturing sites, you can potentially have microbial contamination in multiple facilities. The scope of contamination may be even greater than expected.
Biocontamination tests to the rescue
But hope is not lost! You can regain control of your manufacturing environment with Environmental Monitoring (EM). The SE is a risk assessment control strategy that involves performing biocontamination testing in your manufacturing environment, under the direction of your CQ micro-laboratory. This strategy should be considered for all equipment, personnel, materials, procedures, processes and facilities. Here's how the process works. Places and materials are sampled and plated on culture media to look for the growth of microorganisms. Colonies of microorganisms are counted, registered and organisms identified. For each location and material, alert and action levels are created from the established base amount of manufacturing microbiota. If the number of microorganisms reaches the alert level, this indicates a potential drift from normal operating conditions. If the level of action is reached, this indicates a significant deviation from normal operating conditions and an investigation should be conducted to understand the reason for this change.
The benefits of environmental monitoring are clear
The SE provides you with the tools to quickly assess, mitigate risks and resolve contamination events efficiently and accurately. With action and alert limits in place, even if your manufacturing plant is complex and rapidly evolving, you can potentially discover contamination before it reaches your final product, protecting customers and saving time and money.
Without the use of ES, the risk of a contamination event is higher. Microbial contamination of a batch cannot be remedied or cancelled once it has occurred, and the product must be destroyed. Then the entire equipment train is stopped, including the batch manufacturing skid, storage tanks and filling line. You have lost production capacity, income and time. You have increased the costs and the risk of recall. If the product has been placed on the market, these events are often brought to the attention of consumers through publicly announced recalls by regulators. Product recalls not only pose a risk to consumers, but result in additional costs and lost revenue, create negative regulatory status and a loss of consumer confidence in the brand.
Consumer product companies aim to manufacture a product that is sought after by the consumer. The product must have all the characteristics of a consumer product – effective, pleasing to the eye and, above all, safe for the user. Products must be free of harmful microorganisms that can cause disease or have a negative impact on the product. Environmental monitoring provides a basic profile of the microorganisms present in the manufacturing environment. Implement environmental monitoring with accurate microbial identifications to track microorganisms and trends and manage risks to help your manufacturing site make proactive decisions. The value of environmental monitoring depends on the quality, accuracy and reproducibility of these identifications. Monitoring and analyzing trends in your manufacturing microflora helps you identify areas at risk of contamination and demonstrates that the procedures implemented to prevent contamination are effective.