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SGS Life Science Services is a leader in quality control testing. We offer a wide range of services in microbiology test methods. Various routinely performed services can be found below. If you are in need of additional services, please fill out our online Request for Information form.
Antimicrobial Preservative Effectiveness Tests *
- USP (duplicate plating)
- EP/BP (duplicate plating)
- Parenteral, ophthalmic
- Topical, oral
- USP/BP/EP (duplicate plating)
- Parenteral, ophthalmic
- Topical, oral
- CTFA (6 organisms)
- CTFA (14 day re–challenge)
- Japanese Pharmacopeia
- Additional organisms
- Triplicate plating (per organism)
- A.P.E. Plate Counts by Filtration (per organism, per time point)
- Validation of Plate Count Method used for AE Testing
* Additional fees may be incurred if the initial test parameters are not successful and retesting is required.
Micronial Limits Tests – USP
Preparatory Testing Method Validation
Preparatory testing demonstrates the ability of the test method to recover microorganisms that could be present on a product using 6 representative microorganisms. U.S. Pharmacopoeia – USP requires this type of test to validate the specific test method that will be used in routine microbial limits testing of the product. This is generally required only once per product until a change is made in the product formula or manufacturing process.
Full Preparatory Testing Components
- Aerobic bacteria plate count validation
- Yeast and Mold plate count validation
- E. coli screen validation
- Salmonella screen validation
- S. aureus screen validation
- P. aeruginosa screen validation
Screening Tests
- Aerobic Plate Count, Yeast and Mold, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella and E. coli
- Diagnostic Work on Suspect Organisms (fees are per isolate)
- Gram Stain
- Salmonella suspects – TSI biochemical test
- E. coli suspects – EMB agar morphology
- P. aeruginosa / E. coli / Salmonella suspects – oxidase test
- S. aureus suspects – coagulase test
Microbial Identification
SGS uses a combination of techniques for microbial identifications. An appropriate identification method is selected after gram stain and morphology of unknown bacteria. The bacteria can be identified by the MIDI method, which is based on a fatty acid profile of an extract of the bacteria, or the API biochemical method.
Gram positive rods – MIDI Gram negative rods, Enterobacteriaceae – API
Gram positive cocci – APIGram negative rods, other bacteria – MIDI
Bacteria Identification (MIDI GC with with gram stain, morphology, catalase and oxidase.)
- 1 Organism
- 2 to 5 Organisms
- 6+ Organisms
Bacteria Identification (API with gram stain, morphology, catalase and oxidase.)
- 1 Organism
- 2 to 5 Organisms
- 6+ Organisms
Initial results of some bacteria identification testing may indicate more than one organism as a possible identification. We can report the results of the initial test or perform additional biochemical confirmation testing to distinguish the most probable organism identification.
Individual Identification Tests
- Bacteria Characterization – Biochemical & Morphological
- Yeast Identification – Genus Level
- Mold Identification – Genus Level
- Gram Stain
- Gram Negative Bacteria
- Microorganism Morphology
SGS can provide the necessary supplies for microbiological sampling. Click on Microbial Environmental Monitoring Supplies for more information or fill out our online Request for Information form for additional services not mentioned above.
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