Microbiological quality is critical for patient safety, sterile barrier integrity and regulatory compliance. Accuprec provides comprehensive microbiology services for medical devices, combination products and cleanroom-controlled manufacturing environments—aligned to ISO/USP/EP/WHO expectations.

Core Testing Services

• Bioburden (ISO 11737-1): Total viable counts, method suitability/recovery efficiency, product-specific validation.
• Sterility Testing (ISO 11737-2 / USP <71>): Membrane filtration/direct inoculation, negative controls and media growth promotion.
• Bacterial Endotoxins Test — LAL (USP <85> / EP 2.6.14): Gel clot, kinetic turbidimetric/chromogenic methods; MVD/interference validation.
• Preservative Efficacy Test (PET) / Antimicrobial Effectiveness (USP <51>): Challenge organisms, log-reduction criteria, time-point profiling.
• Microbial Limits (USP <61> / <62>): TAMC/TYMC, specified microorganisms identification.
• Water & Utilities: Purified/WFI monitoring, endotoxin, TOC and conductivity support.

Environmental Monitoring (EM) Programs

• Cleanroom classification & routine EM — active air, settle plates, contact plates and surface swabs.
• Compressed gas monitoring and personnel hygiene checks.
• Alert/action levels, trend reports and contamination investigations (CAPA inputs).

Validation & Documentation

• Method suitability and product interference studies (bioburden, sterility, LAL).
• Qualified culture collections, positive controls and growth promotion records.
• GMP/GLP-compliant protocols, raw data, CoAs and regulator-ready reports.

Outcome: Defensible microbiological evidence to support sterility assurance levels, release decisions and global submissions (EU MDR, USFDA 510(k)/PMA).