Microbial Cleanliness

The Microbial Cleanliness test is performed to estimate the population of viable microorganisms on or in a personal protective equipment, component, raw material or package (in this case, a medical face mask). In practical use, microbial cleanliness is often referred to as bioburden.

Considering the market and consumer concerns about the quality and safety of face masks, STEMart has invested additional cutting-edge test facilities and provides faster, flexible and professional microbial cleanliness according to EN and ISO standards.

Applicable Standards

• EN 14683 Medical Face Masks - Requirements and Test Methods
• EN ISO 11737-1 Sterilization of Medical Devices - Microbiological Methods - Determination of A Population of Microorganisms on Products

Standard Procedures

• Extract the full medical face mask in an extracting liquid.
• Filter the extraction liquid with a 0.45 μm membrane filter.
• Put the membrane filter above the TSA plate for the total viable aerobic microbial count and above SDA for fungi enumeration.

Microbial Cleanliness Test can be used in a number of situations as part of:

• Validation and revalidation of sterilization processes;
• Routine monitoring for control of production processes;
• Monitoring of raw material, components or packaging;
• Assessment of the efficiency of cleaning processes;
• An overall environmental monitoring programm.

STEMart provides microbial cleanliness test to help manufacturers monitor the production process of face masks. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.