- Aerobic Plate Count (APC/TAMC): A test that measures the total number of aerobic bacteria in a product. It is used to evaluate overall microbial cleanliness.
- Bioburden: The total number of microorganisms present in a raw material, in-process sample, or finished product before preservation or sterilization.
- Burkholderia cepacia Complex (BCC): A group of waterborne bacteria associated with serious infections and product recalls in non-sterile products.
- CFU (Colony Forming Unit): A unit used to estimate the number of viable microorganisms in a sample based on colony growth on agar.
- Challenge Test (Preservative Efficacy Test): A study that evaluates how well a product’s preservative system controls microbial growth over time after intentional contamination. Also referred to as USP <51>.
- Contamination: The unintended presence of microorganisms in a product, raw material, or manufacturing environment.
- Environmental Monitoring: Testing of air, surfaces, and equipment to assess microbial control within a manufacturing or laboratory space.
- Objectionable Organisms: They are specific bacteria that must not be present in certain products due to safety risk, such as Salmonella, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, E. coli, and Burkholderia cepacia complex.
- ISO 17516: An international standard that defines acceptable microbiological limits for cosmetic products.
- Microbial Limits Test: A regulatory test that determines whether microbial levels in a product meet established acceptance criteria.
- USP <51> (Antimicrobial Effectiveness Test):
A standardized challenge test used to evaluate how effectively a product’s preservative system controls microbial growth throughout its shelf life. - USP <60> (Burkholderia cepacia Complex): A USP chapter focused on detection of Burkholderia cepacia complex, an objectionable organism of concern in non-sterile pharmaceutical, cosmetic, and personal care products.
- USP <61>: United States Pharmacopeia method for microbial enumeration testing.
- USP <62>: United States Pharmacopeia method for testing specified objectionable organisms.
- Water Activity (Aw): A measurement that indicates how much free water is available to support microbial growth.
- Pathogen: A microorganism capable of causing disease in humans.
- Preservative System: Ingredients added to a formulation to prevent microbial growth throughout shelf life.
- Sterility Test: A test that confirms complete absence of viable microorganisms in products required to be sterile. Also known as USP <71>.
- Total Yeast and Mold Count; Fungal Count (TYMC): A test that measures combined yeast and mold populations in a product.
