Comprehensive Microbiological Testing & Validation
- Bioburden testing and validation (ISO 11737-1)
- Sterility testing and validation (ISO 11737-2)
- Bacterial endotoxin testing and validation (USP <85> & USP <161>)
- Sterility assurance level (SAL) testing (EN 556-1, ANSI/AAMI ST67)
- Microbiological barrier testing (ASTM F1608)
- Preservative efficacy testing (PET) (BP/USP)
- Antimicrobial efficacy testing of devices (ISO, ASTM, EN)
- Environmental monitoring services (ISO, ICH, WHO)
What microbiological tests do you offer?
We offer bioburden, sterility, endotoxin, PET, antimicrobial efficacy, and environmental monitoring services.
Do you provide validation services for microbiological testing?
Yes, we perform validation for bioburden, sterility, and endotoxin testing as per regulatory standards.
What is sterility assurance level (SAL) testing?
SAL testing evaluates the probability of viable microorganisms remaining after sterilization.
Do you support environmental monitoring?
Yes, we provide environmental monitoring services for controlled manufacturing environments.
Are your methods compliant with global standards?
Yes, our testing aligns with ISO, USP, ASTM, EN, ICH, and WHO guidelines.
Microbial Control. Trusted Outcomes.
Microbiological testing is essential to ensure product sterility, safety, and compliance across pharmaceutical, medical device, and healthcare applications. At Accuprec, we provide comprehensive microbiological testing and validation services aligned with global regulatory standards.
Our capabilities include bioburden testing, sterility testing, endotoxin analysis, preservative efficacy testing, and antimicrobial effectiveness studies. We also offer environmental monitoring and microbiological barrier testing to ensure controlled and compliant manufacturing environments.
With expertise across ISO, USP, ASTM, and WHO guidelines, we deliver accurate, reliable, and audit-ready results to support regulatory approvals and quality assurance.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
