Microbial Limit Testing and Validation
When a new product is submitted for Microbial Limits Testing (MLT), the method of choice must first be verified to ensure it is fit for purpose for the new product
Once the test method has been verified and deemed fit for purpose this test method can be used to test the product for routine analysis for Microbial Limits Testing.
Our Microbial Limits Test consists of two main requirements:
This examines the Bioburden levels of the product/s by determining the number of Total Aerobic Microbial Count (Bacterial) and the Total Yeast and Mold counts (Fungal) present in the product/s.
This examines the absence and presence of “Objectionable Organisms” in the product/s. Objectionable organisms include:
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Bile Tolerant Gram Negative Bacteria
- Candida albicans