Microbiological Analysis

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Microbiological Analysis


The sophisticated ChemicalAnalysis testing lab operates as an extension of yours - minus the headaches and overheads – offering a prompt, cost-effective and seamless service. With our commitment to our staff and analytical equipment, we are able to provide the highest level of service for sterile, Endotoxin (LAL) and non-sterile Microbiological Testing.

Sterility Testing

Employing the most advanced technologies, ChemicalAnalysis utilises closed system sterile testing within the highly controlled, closed environment of an isolator. These concurrently used closed systems significantly reduces the risk of false positive sample results.

Samples in various packaging (ampoules, syringes, collapsible bags, vials, etc.) can be tested including -

  • Solids
  • Liquids
  • Creams / ointments
  • Medical Devices
  • Cytotoxics
  • Antibiotics
  • Samples with antimicrobial agents added

Endotoxin (LAL) Testing

We have the ability to utilise either kinetic turbidimetric or chromogenic assay techniques to quantify very low endotoxin concentrations in a wide range of sample types. We utilise the latest technology from Associates of Cape Cod, with their PyrosKinetix Flex endotoxin detection system.

Non-sterile Microbiological Testing

  • Microbiological quality of pharmaceuticals: Categories 1-4
  • Microbial bioburden assesment during shelf life of pharmaceutical products
  • Tablet and capsules, creams and ointments, solutions and transdermal patches
  • Pre Phase I to Phase II pharmacokinetic data
  • Pharmacopeial guidelines relevant to microbiology and non-sterile manufacturing
  • Validation of test methods to international monographs (USP-BP-EP)
  • Testing includes;
    1. Total viable aerobic counts
    2. Pseudomonas spp.
    3. Staphylococcus spp.
    4. Bacillus spp.
    5. Escherichia coli
    6. Salmonella
    7. Bile-tolerant Gram negative bacteria
    8. Preservative efficacy testing

Please contact us for more information or if the analysis you require is not listed.

Chemical Analysis is Australia's most advanced analytical laboratory outsourcing service, offering leading edge technology and intelligence when you need it.