The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. FDA expects manufacturers to measure and characterize the microbial quality of their pharmaceutical substances as well as of their final drug products.
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Our microbiologists have a wealth of experience in applying USP, Ph. Eur. and other international methods to a wide variety of biologics and traditional pharmaceuticals. Recognized as the global benchmark for quality and integrity, we are committed to providing you with the best-in-class services.
Our teams of microbiologists help determine your needs and expectations to satisfy regulatory requirements. Our scientific approach is supported by our technical knowledge and expertise in microbiological testing. With extensive method validation expertise, our team of microbiologists ensures the quality and integrity of all test results.
Our facilities meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators are available for microbial evaluation.
Biological and Microbiological Testing Services
Our biological and microbiological testing services include:
- Microbial limits tests (microbiological examination of non-sterile products)
- Sterility testing
- Microbial contaminant identification
- Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms) and microbial challenges
- Mycoplasma testing
- Microbiological assessment of antibiotics
- Bacterial endotoxins testing
- Sampling and analysis of water for pharmaceutical microbiology
- Chemical disinfectant testing and cleaning studies
- Environmental monitoring
- Microbiological attribute studies (e.g. barrier testing for packaging, condoms and medical gloves, and hygienic and antibacterial testing for contact lenses, personal care products, and more.)
- Non-viable particulate testing
To discuss your biological and microbiological testing requirements, contact us today.