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Microbiology for the pharmaceutical industry

Microbiological tests are one of the most important tools for safe products in the pharmaceutical and biopharmaceutical industry. Therefore, they are firmly anchored in the standards of the FDA and the arnce books USP and Ph.Eur.

Our team of microbiologists has in-depth, technical expertise and ensures valid test results through the high SGS standards.

If required, we support your question with comprehensive documentation, including validation plan and validation report, as well as with the preparation of a suitable test method. 

Microbiological tests according to USP

  • Microbial purity Ph. Eur. 2.6.12, USP <61>:
    • Determination of total aerobic microorganism count (TAMC).
    • Determination of the total number of yeasts and molds (TYMC)
  • Detection of specific microorganisms Ph. Eur. 2.6.13, USP <62> and <60>:
    • Escherichia coli
    • Pseudomonas aeruginosa
    • Staphylococcus aureus
    • Salmonella
    • Detection of bile salt tolerant Gram-negative bacteria.
    • Candida albicans
    • Aspergillus brasiliensis
    • Clostridia
    • Burkholderia cepacia USP <60>
    • House germs
  • Mycoplasma Ph. Eur. 2.6.7, USP <63>
  • Sterility testing Ph. Eur. 2.6.1,USP <71>
  • Bacteria endotoxins Ph. Eur. 2.6.14 and USP <85>
    • Gel Clot (Method A)
    • Kinetic-turbidimetric (method C)
    • Kinetic-chromogenic (method D)

Germ identification is performed by Gram stain, microscopy (morphology), VITEK® 2, MicroSEQ® or MALDI Biotyper®.

Further microbiological tests with matrix-specific validations and verifications

  • Tests for sufficient preservation
  • Tests for antimicrobial activity
  • Disinfectant studies
  • Cleaning validations
  • Sampling and analysis of:
    • Hygiene swabs
    • Swab samples
    • Airborne germ count determination
    • Air particle determination

Microbiological testing for a wide range of pharmaceutical and biotechnological products

Our accredited laboratories offer microbiological methods for a range of different matrices.

We test:

  • Raw materials and excipients
  • Pharmaceutical media, such as gases, air, water, steam
  • Active pharmaceutical ingredients (API, drug substances), intermediates and finished products (drug products), including
    • Oralia aqueous, non-aqueous
    • Rectalia
    • Ophthalmica
    • Topical Products
    • Transdermal patches
    • For vaginal use
    • Inhalatives
    • Parenteral products (including water for injection, WFI)
    • Antibiotics
    • Cytostatics
    • Anesthetics
    • Vaccines
    • Genetically modified organisms (GMO up to class 2)
    • Herbal extracts and medicinal products
  • Packaging materials
  • Medical devices
  • Preserved products
  • Disinfectants

In addition to the examination of individual products, a qualified, microbiologically monitored production environment is crucial for safe products. For microbiological monitoring of the production environment, we examine surface samples and room air samples. As part of hygiene monitoring, we examine swab and smear samples of personnel clothing, mouth guards and hands.

Contact us

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SGS INSTITUT FRESENIUS GmbH

Tegeler Weg 33
D - 10589 Berlin

Kasteler Straße 45
D - 65203 Wiesbaden

SGS Analytics Germany GmbH

Auf der Hüls 183
52068 Aachen

Schwanthaler Str. 111-115
80339 München

Tegeler Weg 33
10589 Berlin