FDA expects manufacturers to measure and characterize the microbial quality of their pharmaceutical substances as well as of their final drug products. 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.
More products from SGS Group Management SA
Nitrosamine Impurities Testing
SGS Life Sciences has considerable expertise in the method development of nitrosamine determination in pharmaceutical products. SGS has established a specific method for NDMA which can be applied to various different matrices. Alternatively, a platform method, based on trace-level detection by LC-MSMS, is als...More info
Extractables & Leachables
Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Regulatory bodies such as the US Food and Drug Administration (FDA) and The ...More info
Quality Control Testing
Bringing a compound from the laboratory to the market is a long and winding road with a great number of scientific, safety and regulatory challenges. SGS has been offering high quality analytical testing and clinical research services to support drug research, registration and production.
Life-saving medicines are heavily regulated during development, manufacture and distribution. To fulfill regulatory requirements, the biopharmaceutical industry is increasingly looking for independent service providers who can deliver comprehensive characterization solutions on one site.
Viral Safety Testing
SGS’s global center of excellence for cell bank
characterization & virus testing is located in the United Kingdom and provides
services with ultimate reliability, highest GLP/cGMP quality & scientific
For any of your biologics, we help you comply with the global regulator...
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