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Microbiology Testing

QualTex Laboratories offers comprehensive microbiology testing and specialized assays to support product safety and compliance across the biopharmaceutical, tissue, and cleanroom manufacturing industries. Fast turnaround times and reliable, high‑quality results are achieved through state‑of‑the‑art automation and advanced technical expertise.

Services

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  • Microbial Detection
    • Sterility: RUO, GMP - USP <1223> in accordance with <USP> 71
    • Bioburden: RUO, GMP - USP <61> and ISO 11737-1
    • Recovery testing
  • Microbial Identification
    • Aerobic bacteria
    • Anaerobic bacteria
    • Mold/Fungi
    • Yeast
    • Gram stain
  • Microbial Qualification
    • Growth promotion
    • Testing for Aseptic Process Simulation (APS)
  • Environmental Monitoring
    • Surface microbial (contact plate)
    • Air microbial (settle plate)
  • Additional Testing
    • Endotoxin LAL
    • PCR-based Mycoplasma
    • Residual Moisture

Beyond routine and specialized testing, QualTex Laboratories offers custom assay development and R&D capabilities, delivering flexible solutions tailored to unique client needs.

Laboratory Technologies Include

  • BACT/ALERT® 3D
    • Continuous, positive microbial detection for rapid contamination monitoring
  • MALDI‑TOF mass spectrometry
    • Swift, accurate organism identification
  • BD Kiestra™ ReadA
    • Automated plate imaging and incubation for faster, consistent culture results
LEARN MORE ABOUT OUR SERVICES

QualTex’s Microbiology Laboratory is FDA registered and holds ISO, TGA, and CLIA certifications.

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Certifications
View list of U.S. and international accreditations, certifications and registrations.
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