Extensive microbiology and sterility testing to support bio/pharmaceutical and medical device product and patient safety from SGS.
Characterizing pharmaceutical ingredients in bio/pharmaceutical and medical devices is essential for ensuring final product quality, preventing harm to the patient and avoiding product spoilage.
All regulatory authorities expect manufacturers to characterize the microbial quality of their pharmaceutical substances, both active and excipient. Pharmaceutical manufacturers are also required to characterize their drug products’ manufacturing and handling processes to control or eliminate chances of contamination.
SGS can help you meet regulatory requirements and protect patient safety.
Our microbiologists have a wealth of technical knowledge and the expertise to develop and apply USP, Ph. Eur. and other international methods to a wide variety of biologics, traditional pharmaceuticals and medical devices. They will help you to ensure product quality and safety, from development through final product launch and post market support.
Why choose microbiology testing services from SGS?
As a world leading provider of testing services and a leader in services for the health science sector, we offer a global network of GMP laboratories that meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators are available for microbial evaluation.
Our microbiology testing services include:
- Sampling and analysis of water for pharmaceutical microbiology
- Sterility testing under aseptic conditions in accordance with the European Pharmacopeia 2.6.1 and USP <71> for pharmaceuticals and CFR 610.12 for biologics
- Ames test according to ISO 10993-3/0ECD471
- Antibacterial potency testing using zone of inhibition or turbidity assessment against reference materials
- Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms), microbial challenge and susceptibility testing
- Bacterial endotoxins testing
- Chemical disinfectant testing and cleaning efficacy and validation studies
- Environmental monitoring
- Facility qualification
- Microbiological attribute studies (e.g. barrier testing for packaging, condoms and medical gloves, and hygienic and antibacterial testing for contact lens and personal care products.)
- Microbiological testing methods according to Chinese Pharmacopoeia such as microbial limits, sterility, endotoxins, etc.
- Microbial limits tests (microbiological examination of non-sterile products) according to USP <61>/USP <62>
- Microbial isolation and identification (Vitek, API strips, Microseq, MaldiTof)
- Mycoplasma testing through both culture and PCR testing
- Non-viable particulate testing
- Preservative efficacy testing
- Sampling and analysis of water for pharmaceutical microbiology
- Sterilization and filtration verification according to PDA TR26 and ASTM F838
- Sterility testing under aseptic conditions in accordance with the European Pharmacopeia 2.6.1 and USP <71> for pharmaceuticals and CFR 610.12 for biologics