Personal and home care product manufacturing sites are not required by regulatory agencies to establish comprehensive quality systems and environmental monitoring (EM) programmes, which measure the state of control of their manufacturing and ensure data integrity.
So, how can you ensure product quality if you aren't in control of your manufacturing environment?
The real value of a microbiological monitoring programme lies in the ability to create a baseline understanding of your manufacturing environmental conditions.
Environmental monitoring gives you the power to easily identify areas for quality improvement, respond quickly and proactively to changes in the microflora of your environment, and maintain an overall contamination control strategy.
Regulators recommend routine environmental monitoring and data trending as best practices. EM is a fundamental aspect of current good manufacturing practice (cGMP) compliance and is a proven strategy for contamination risk mitigation for cosmetic and home care product manufacturers.
For each monitored location and material source, alert and action levels can be created from the established microflora baseline. An alert level of microorganisms indicates a potential drift in microflora growth from normal operating conditions. An action level is the second tier of notification where, if reached, indicates a significant drift from normal operating conditions and an investigation should be done to understand the cause of the change.
By routinely sampling and identifying organisms, you can detect possible contaminants and identify sites where there is risk of contaminating the product.
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