When it comes to product analysis, ensure compliance
Ensuring microbial control in your product and manufacturing environment is critical for maintaining safety, efficacy, and regulatory compliance. Biolabs provides precise and validated testing services for the detection and quantification of microbial contaminants, including bioburden and endotoxin, in a wide range of pharmaceutical and biotechnology products.
Our microbiology team adheres to ISO/IEC 17025:2017 and USP <61>, <62>, and <85> standards to deliver reliable, defensible data that supports batch release, routine monitoring, and validation studies.
- Bioburden, Membrane Filtration
- Bioburden, Pour Plate
- Endotoxin Kenetic Chromogenic
- Specified Microorganism
- Compendial Method Verification
- Incubation of Media Filled Units (Sterility)
OUR TESTING SUPPORT
Bioburden and Endotoxin Testing at Biolabs
Our bioburden testing quantifies the total viable microbial count in non-sterile products, components, and process samples. We employ validated membrane filtration or pour plate methods tailored to your sample type.
Endotoxin testing detects bacterial pyrogens derived from Gram-negative bacteria using the Limulus Amebocyte Lysate (LAL) assay. Biolabs offers all three recognized LAL methods — gel-clot, kinetic turbidimetric, and chromogenic — ensuring compatibility with both water-based and complex sample matrices.
All results are reviewed under a robust quality management system that complies with GMP and ISO/IEC 17025 standards.