Controlling Microbial Risk in Sterile and Non-Sterile Products
Microbial control is essential for pharmaceuticals, biologics, and medical devices. Testing at every stage—from raw material qualification to finished product release—ensures freedom from contamination. Non-compliance can result in recalls and patient harm.
Our cGMP-compliant microbiology laboratories perform compendial testing per USP and Ph. Eur. We conduct release testing and environmental monitoring to maintain cleanroom integrity.
Services include Sterility Testing (USP <71>) for injectables and devices, and Microbial Enumeration (Bioburden) (USP <61>) for non-sterile products. Partnering with BQCIS ensures a documented, globally compliant microbial-risk management program.
Key Compendial Microbiology Services
Key Benefits of Microbiological Testing
Regulatory Assurance
Complies with USP <61>, <62>, <85> and Ph. Eur. 2.6 series to meet FDA and EMA expectations.
Enhanced Cleanroom Control
Environmental Monitoring (EM) data supports trending, root-cause analysis, and preventive actions.
Product Safety Assurance
Early detection of contamination prevents costly batch rejections and recalls.
Strengthened Quality Systems
Supports QRM frameworks and GMP readiness for regulatory audits and certifications.
Success Story
Environmental Monitoring Program Prevents Sterility Breach
Rising microbial counts in a Grade B cleanroom signaled a potential sterility failure risk for a medical device manufacturer.
BQCIS performed targeted EM sampling and genetic sequencing to trace the contaminant to a defective HEPA filter, then supervised its replacement and procedural updates.
Microbial levels returned to compliance within 24 hours, avoiding product quarantine and maintaining uninterrupted sterile manufacturing status.