Microbiological Development and Quality Control Testing Services

We test a wide range of pharmaceutical products with a special focus on high-risk parenteral drugs that are administered directly into the circulatory system. Our experienced scientists work with various dosage forms including injectable and topical formulations. We also evaluate containers, closures, and filtration systems to ensure they maintain sterility throughout your product's lifecycle and prevent microbial contamination.

Get your products to market quickly and safely with our rapid testing solutions and comprehensive quality control capabilities designed to identify potential contamination issues before they impact your business or regulatory standing. 

Rapid Sterility & Quality Control Testing: 

• Sterility and rapid sterility testing - Results in as little as 24 hours for mycoplasma, 7 days for sterility testing 

• Mycoplasma testing - PCR methods with 24-hour turnaround 

• Microbial examination test method development and validation 

• Bacterial endotoxin test method validation and testing 

• Antimicrobial preservative efficacy testing 

• Particulate matter testing 

• Container and closure integrity testing 

• Sterilization cycle development and validation 

• Batch release and stability testing (both development and commercial batches) 

• Filter validation bacterial retention studies 

• Microbiological assays 

• Special research studies 

Pre-Clinical Microbiology Services (CLIA-Certified Lab):

Generate testing data for your IND submissions and investigational compound development with our CLIA-certified lab services, featuring >500,000 well-characterized isolates. 

• Antibacterial/Antifungal spectrum and potency testing 

• Resistance studies and kill-curve methods 

• Synergy and drug interaction studies 

• Methods development and quality control studies 

• Bacteriophage assays and special isolate collections 

Address your complex microbiology challenges with our tailored approach to method development and validation, ensuring your products meet the highest quality standards throughout their lifecycle. 

Rapid Microbial Methods 

We enable therapeutics and products to be delivered to patients within short shelf-life timeframes. Unlike traditional methods, our Rapid Microbial Methods provide results in as little as 24 hours. We use BacT/ALERT® 3D Dual-T, the first fully automated, growth-based, dual-temperature microbial detection system. Our comparability studies conform to USP <1223>. 

At Element, we work with you to determine which method fits your needs while aligning with your shelf-life schedule. 

Our scientists are experienced across a range of drug products and dosage forms, including parenteral and topical products. We operate under all current Good Manufacturing Practices (cGMPs), and our microbiology labs are regularly inspected by the Food and Drug Administration (FDA). Find your nearest testing location on our Locations Page.