Safety & Compliance

qPCR-based rapid sterility assay performed for detection of microbial contamination including bacteria, fungi, and mycoplasma in accordance with current GMP expectations and validated laboratory procedures. Includes sample preparation, nucleic acid extraction, amplification, controls, and result reporting.

Quantitative Polymerase Chain Reaction (qPCR)-based sterility testing for the rapid detection of bacterial, fungal, and/or mycoplasma contamination in biological samples, cell cultures, pharmaceutical products, or manufacturing environments. Testing includes nucleic acid extraction, amplification using validated microbial target primers/probes, appropriate positive and negative controls, and quantitative analysis of microbial contamination levels where applicable. Assay performed in accordance with applicable laboratory quality standards and sterility testing guidelines.

Rapid molecular sterility testing performed as a supplemental or alternative microbiological method aligned with the USP <71> Sterility Tests requirements for detection of viable microbial contamination in sterile products. Testing utilizes validated quantitative Polymerase Chain Reaction (qPCR) methodology for detection of bacterial and fungal nucleic acid targets, including appropriate positive, negative, inhibition, and environmental controls where applicable.
Method suitability, detection limits, specificity, sensitivity, and equivalency to compendial sterility methods are established through validation studies in accordance with applicable regulatory expectations and internal quality procedures. Testing may be used for in-process monitoring, rapid release support, investigational testing, or adjunct sterility assessment as permitted by product-specific regulatory strategy.
Samples are processed under controlled laboratory conditions with documented chain of custody, aseptic handling procedures, and data review. Final reports include sample identification, test method, acceptance criteria, control performance, and qualitative and/or quantitative results interpretation.

Rapid qPCR sterility testing aligned with the intent of USP <71> Sterility Tests for detection of bacterial and fungal contamination using validated molecular methods, controls, and documented quality procedures.

qPCR-based rapid sterility testing service aligned with USP <71> Sterility Tests expectations, including validated detection of bacterial and fungal contamination with appropriate controls and reporting documentation.

Quantitative bacterial endotoxin testing is performed using the PYROSTAR™ endotoxin detection system with kinetic turbidimetric Limulus Amebocyte Lysate (LAL) methodology. The assay is designed for the detection and quantification of Gram-negative bacterial endotoxins in pharmaceutical, biologic, and medical device samples. Testing is conducted using FDA-licensed PYROSTAR™ ES-F reagents and microplate reader systems in accordance with applicable USP <85> requirements and validated laboratory procedures.
The PYROSTAR™ ES-F assay utilizes endotoxin-specific LAL reagents formulated with carboxymethylated curdlan to minimize interference from β-glucans and improve assay specificity. Endotoxin concentrations are determined by measuring the increase in sample turbidity over time and comparing results to a validated standard curve generated from Control Standard Endotoxin (CSE). The method supports quantitative detection across validated sensitivity ranges appropriate for product specifications and regulatory requirements.
Testing includes all required system suitability controls, standard curve verification, positive product controls, and negative controls to demonstrate assay validity, recovery, and absence of product interference. Results are reported in Endotoxin Units per milliliter (EU/mL) or EU/device, as applicable.