Microbiology Testing

Microbiology Testing
Product Description

At SGS, we are leaders in microbiology testing services for quality control, providing a complete array of services for the bio/pharmaceutical industry.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. 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.


SGS Group Management SA

  • CH
  • 2020
    On CPHI since
  • 5000+
    Employees
Company types
Other
Primary activities
Analytical Services
Specifications
  • Supplied from
    Belgium; Canada; China; France; Germany; India; United States

SGS Group Management SA

  • CH
  • 2020
    On CPHI since
  • 5000+
    Employees
Company types
Other
Primary activities
Analytical Services

More Products from SGS Group Management SA (13)

  • Extractables & Leachables

    Product 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 T...
  • Quality Control Testing

    Product 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. 
    SGS leve...
  • Biosafety Testing

    Product Biosafety Testing

    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. 
    SGS’s glo...
  • Viral Safety Testing

    Product 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 expertise.

    For any of your biologics, we help you comply with the global regula...
  • Biologics Charaterization

    Product Biologics Charaterization

    A full package of Biologics testing services to cGMP standards from early phase characterization including Biosafety to Quality Control release testing enabling you to outsource your biologics.
  • Impurities and contaminants analysis

    Product Impurities and contaminants analysis

    Impurities and contaminants analysis in biotechnology products from SGS – a range of services providing impurities and contaminants characterization in biotechnology derived products and microbial contamination control.To help you meet ICH Q6B guidelines, you need accurate impurities and contaminants analy...
  • Analytical Chemistry Services

    Product Analytical Chemistry Services

    Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced metho...
  • Stability Testing

    Product Stability Testing

    From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
    When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 2...
  • Package and Container Testing

    Product Package and Container Testing

     SGS realizes that the package or container that carries your product is vital to its safety and efficacy: a weak container, or one that allows contamination of your product, could put the health of your customers and your reputation at risk. SGS package and container testing services offer a ran...
  • Cell bank and virus seed characterization

    Product Cell bank and virus seed characterization

    As a world leader in biopharmaceutical testing services, we offer you a comprehensive range of biologics safety testing , including virology, cell and molecular biology, as well as microbiology and electron microscopy. As a result, we can help you to ensure product safety and meet your regulatory requireme...
  • Bioanalysis Testing

    Product Bioanalysis Testing

    SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). 
  • CDMO Services

    Product CDMO Services

    CMC CONSULTANCY PRE-CLINICAL FORMULATION SCREENING FORMULATION DEVELOPMENT ANALYTICAL SERVICES GMP CLINICAL MANUFACTURING COMMERCIAL & SPECIALS MANUFACTURING CLINICAL TRIAL SUPPLY

SGS Group Management SA resources (13)

  • News SGS Joins Oxford University Consortium Led by the Jenner Institute to Develop COVID-19 Vaccine

    In a consortium led by the Jenner Institute, Oxford University, SGS has joined forces with specialists in infectious diseases, research and innovation, and pharmaceuticals to rapidly develop, scale-up and produce a potential vaccine called ChAdOx1 nCov-19
  • Brochure Analytical Testing and Quality Control Solutions

    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. 
    SGS leverages its conveniently located network of laboratories and clinical trial facilities present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. 
    Our experts provide effective and efficient testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research services. We perform a variety of tests that are bespoke, client-specific and support the full clinical development, from Phase I First-in-Human trials in our Clinical Pharmacology Units to Phase II and Phase III studies in patients.
  • News SGS Signs Analytical Testing Agreement with AstraZeneca for COVID-19 Vaccine Candidate

    SGS is pleased to announce the signing of an agreement with AstraZeneca for the provision of safety, quality control and analytical testing services in support of AZD1222 – a COVID-19 vaccine candidate co-invented by the University of Oxford and its spin-out company, Vaccitech and licensed by AstraZeneca.
  • Brochure Nitrosamine Impurities Testing Solutions

    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 also available and provides rapid and simultaneous determination of up to ten different, targeted nitrosamines. Although with more limited application, the SGS network is also able to support specialist methodologies such as GC-MSMS. Our experience in optimizing extraction procedures allows application of these methods to drug products, API’s, and raw materials. 

  • News Managing Your Life Sciences Quality Management System Remotely

    Telecommuting and online commerce has been with us for some time and works seamlessly in many industries, but the current state of events has forced companies to apply remote management to other areas that have historically been considered "hands-on" job functions.
  • Brochure Biologics Testing Services

    A full package of Biologics testing services to cGMP standards from early phase characterisation including Biosafety to Quality Control release testing enabling you to outsource your biologics.
  • News Vaccine Testing to Ensure Successful and Faster Vaccine Research and Development

    Following its emergence earlier this year, the novel coronavirus (SARS-CoV-2) has spread rapidly and snowballed into a pandemic. Everyone – citizens, businesses, and governments – yearns for life to go back to normal soon.
  • Brochure Analytical Chemistry Services

    Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced methods and instrumentation.


    SGS leverages its conveniently located network of laboratories present in North America, Europe and Asia-Pacific, to deliver harmonized solutions to local markets as well as international pharmaceutical and biotechnology firms.

    Our recognized experts assist in providing effective and efficient solutions for R&D, analytical development, and quality control testing, helping to expedite the molecule to market.
  • Brochure Bioanalysis Testing Solutions

    SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). CONTINUOUS
  • Brochure Biosafety Testing Solutions

    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. 
    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 expertise. 
    As trailblazers in the development of the biosafety testing industry, our team in Glasgow have developed and validated novel nucleic acid technologies, such as real-time PCR, RAPD, Sequencing, Non
    radioactive Southern Blotting, Next Generation Sequencing (NGS). For any of your biologics, we help you comply with the global regulatory guidelines and testing requirements.
  • Video VIDEO: SGS vs COVID-19: Biologics Characterization Services

    SGS' integrated network of laboratories provides a wide range of essential services to support the fight against COVID-19. We provide established expertise and resources for all aspects of biopharmaceuticals characterization, from physico-chemical properties, to primary, secondary, and tertiary structures, as well as aggregation.
    For more information, contact [email protected] or visit: https://www.sgs.com/lifescience.
  • Video VIDEO: Extractables & Leachables Studies

    Watch to find out more about how our 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, to ensure patient safety and drug product efficacy. 
    Visit https://www.sgs.com/en/life-sciences/ to find out more.
  • Video VIDEO: Nitrosamine Impurities Testing Services

    The presence of the #nitrosamine N-nitrosodimethylamine (#NDMA), in certain sartan APIs has resulted in several regulatory warnings and recalls of contaminated products. We have considerable expertise in the method development for detecting the presence of NDMA and other nitrosamines to help you to ensure product safety and comply with USFDA and EMA requirements.

    For more information, contact [email protected] or visit: https://www.sgs.com/lifescience.

    #Nitrosamine #DrugSafety #DrugDevelopment