Microbiology Testing Services
Microbiology Testing You Can Trust, Delivered in the United States
Cormica provides a full suite of microbiology testing services to support the development, manufacturing, and release of pharmaceuticals, medical devices, and combination products across the United States. Our FDA-registered facilities operate under ISO/IEC 17025 accreditation for pharmaceutical microbiology, helping you demonstrate regulatory compliance and maintain product safety.
We work with leading innovators developing solid oral dose forms, injectables and parenterals, pre-filled syringes, on-body and wearable systems, wound care technologies, respiratory drug products, surgical devices, and more. With strong technical expertise we deliver rapid and reliable testing that supports confident market release.
Microbiology Testing Services Aligned with USP Standards
Nonsterile Product Microbial Enumeration
Microbial enumeration testing aligned with USP <61> to determine total aerobic microbial count (TAMC) and total yeast and mould count (TYMC) in non-sterile products.
Nonsterile Product Test for Specified Microorganisms
USP <62> testing to confirm the absence of objectionable organisms including E. coli, Pseudomonas aeruginosa, Salmonella spp., Staphylococcus aureus, and Candida albicans.
Antimicrobial Preservative Efficacy
USP <51> antimicrobial effectiveness studies to evaluate preservative performance over time.
Biological Indicator Enumeration
USP <55> based enumeration of biological indicators used in sterilisation validation and routine control.
Sterility Testing
Sterility testing & rapid sterility testing in accordance with USP <71> to support manufacturing validation and release of sterile pharmaceuticals and devices.
Endotoxin Testing
USP <85> endotoxin analysis using LAL methods for parenteral and implantable products.
Microbial Identification
Rapid microbial identification using biochemical profiling and genetic sequencing technologies including Vitek 2 and MicroSEQ. Results help confirm contamination sources and support product safety decisions.
Environmental Monitoring
USP <1116> & <797> support to demonstrate contamination control in cleanrooms and critical manufacturing areas. Services include incubation, enumeration, characterization, trending, and alert or action level notification.
United States Testing, Delivered With Confidence
Our FDA-registered and ISO/IEC 17025 accredited laboratories provide the trusted microbiology support that US manufacturers rely on. As part of the Cormica Group, Focus Labs delivers proven technical capability and a strong regulatory track record, including zero 483 observations during our most recent FDA audit.
With facilities located in Allentown, Pennsylvania and Palm Harbor, Florida, we help pharmaceutical and medical device organisations maintain microbiological control and bring safe products to patients.
- Testing confidence built on strong regulatory performance
- Direct support from our US microbiology specialists
- Fast turnaround times and responsive communication
Your Cormica Team
Rob States
VP of technical services
Isha Brooks Sanders
Business Development Manager
Anthony Grilli
Focus Labs General Manager
