Microbial Content Testing Services for Raw Materials and Finished Products
- FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
- DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
- US EPA/NJ DEP Registration# NJD982726648
- ISO/IEC 17025:2017 Accreditation# 80071
Accurate Microbial Testing for Quality, Safety, and Compliance
Microbiological testing of raw materials and finished products is an important part of helping prevent contaminated or adulterated products from reaching consumers. For pharmaceutical, OTC drug, cosmetic, medical device, and nutritional supplement manufacturers, microbial content testing supports product quality, regulatory compliance, and release decisions.
CPT℠ Labs offers microbial testing services using USP, ISO, and other recognized compendial methods.
Our microbiology testing services include microbial enumeration, specified microorganism testing, and method suitability testing for a wide range of product types and formulations.
Microbial Content Tests Performed at CPT℠ Labs
Our Microbiology Division provides compendial and custom microbial testing services using validated methods recognized by FDA and international regulatory authorities.
USP <61> Microbial Enumeration Testing
Quantitative testing for total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) in non-sterile pharmaceuticals, OTC products, cosmetics, and raw materials.
USP <62> Test for Specified Microorganisms
Presence/absence testing for specified and objectionable microorganisms, including Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella, Candida albicans, and bile-tolerant gram-negative bacteria.
USP <60> Burkholderia cepacia Complex Testing
Method suitability and screening for Burkholderia cepacia complex (BCC), a microorganism of concern in water-based non-sterile drug products.
USP <2021> Microbial Enumeration for Dietary Supplements
Microbial enumeration for dietary supplements, botanicals, and dietary ingredients, including TAMC, TYMC, and Enterobacteria Count using the MPN method where appropriate.
USP <2022> Specified Microorganisms for Dietary Supplements
Presence/absence testing for specified microorganisms in nutritional and dietary supplements, using manufacturer-specific or product-specific microbial specifications as applicable.
ISO 21149 and ISO 16212 Cosmetic Microbiology
Microbial testing for cosmetics, including aerobic mesophilic bacteria enumeration, yeast and mold enumeration, and testing for Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans.
Microbial Test Methods and Suitability
The right microbial testing method depends on product type, formulation, microbial load, and the sample matrix. Method suitability testing is an important step before routine testing begins because product ingredients can affect the recovery of microorganisms.
Membrane Filtration
Membrane filtration is often used for dilute or large-volume samples. The sample is filtered to capture microorganisms, which are then recovered and enumerated on suitable media.
Plate Count Enumeration
Plate count testing uses dilution and direct plating on agar media for microbial enumeration. It is commonly used for non-sterile pharmaceuticals, cosmetics, and other products when the matrix supports reliable recovery.
Most-Probable Number (MPN)
MPN is a statistical method used in certain applications where other enumeration methods are not suitable. It is commonly used for Enterobacteria Count testing in dietary supplements when appropriate. It is not used for mold enumeration.
Why Choose CPT℠ Labs for Microbial Testing?
CPT℠ Labs provides microbiological testing services designed to support product quality, contamination control, and compliance with applicable regulatory expectations.
Our testing programs can help manufacturers evaluate raw materials, in-process materials, and finished products across a range of industries. Request a quote today to get started with microbial content testing services.