Accelerating Product Release Through Advanced Microbiology Testing Solutions Best-in-Class Turnaround Times | ISO/IEC 17025:2017 Accredited Laboratories
Microbial Detection Testing RUO and GMP Sterility Testing
Bioburden Testing
Enables safe product release through USP <1223> validated methods equivalent to USP <71> requirements
Measures pre-sterilization microbial levels per USP <61> and ISO 11737-1 requirements
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Automated aerobic and anaerobic culture monitoring with continuous detection of positive results
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Rapid - 5 or 7 days*
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Standard - 14 days
Microbial enumeration using membrane filtration methods Test Method Suitability Study (TMSS) performed prior to testing
Bacteriostasis & Fungistasis (B&F) study performed prior to testing
Tissue Recovery Testing Confirms tissue meets microbial safety requirements in accordance with AATB standards
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Accelerated detection and realtime culture monitoring for efficient tissue processing and timely release
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Expedited reporting of definitive presence/ absence determinations
*Incubation times will be determined based on B&F study results. Turnaround times apply to negative results only. Positive results may require additional processing time for identification.
Offers advanced methods to support product safety and regulatory compliance for biopharma, medical device, tissue and cleanroom manufacturing industries
Microbial Identification and Qualification Species-level microbial identification and method qualification enabling accurate detection and dependable results Identification
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Bacterial identification using MALDI-TOF mass spectrometry Fungal identification using gene sequencing
Qualification
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Growth promotion testing to verify culture media supports microbial recovery and detection Aseptic Process Simulation (APS) to qualify aseptic manufacturing processes prior to clinical or commercial production
Environmental Monitoring Supports cleanroom and controlled-environment compliance through advanced microbial detection
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Comprehensive surface and air monitoring using contact and settle plates
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Automated imaging and analysis throughout incubation for continuous oversight
Why Choose QualTex Laboratories?
Fast turnaround times
Advanced automation technology
Accurate result delivery
High-volume testing capacity
Provides validated supplies
Certifications and Accreditations The QualTex microbiology laboratories are FDA-registered and hold TGA and CLIA certifications, as well as ISO/IEC 17025:2017 accreditation. Its quality management system is compliant with ISO 9001:2015.
6211 IH 10 West San Antonio, TX 78201 888-789-5227 customerservice@qualtexlabs.org QualTexLabs.org
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