Antimicrobial Effectiveness and Antibiotic Testing

Antimicrobial and antibiotic testing are critical microbiological evaluations that confirm whether products can reliably control harmful microorganisms throughout their shelf life and use. Among these, antimicrobial effectiveness testing (AET) plays a central role, ensuring that preservative systems in multi-dose formulations meet strict requirements. Together, these tests provide manufacturers with the data needed to safeguard patient safety, maintain product quality and achieve global regulatory compliance.

Comprehensive Antimicrobial Effectiveness Testing (AET) Services

At Cambrex, we deliver a suite of AET services designed for pharmaceutical and medical device manufacturers who must demonstrate preservative efficacy as part of regulatory submissions and ongoing quality assurance. Our expertise includes:

  • Antimicrobial Effectiveness Testing (USP <51>) – Validating preservative performance across a broad panel of challenge microorganisms.
  • Formulation and Shelf-Life Support – Evaluating preservative systems to optimize stability and extend product lifecycle.
  • Custom Testing with Environmental Isolates – Assessing preservative effectiveness against facility-specific microbes to strengthen contamination control.
  • Zone of Inhibition Studies – Measuring antimicrobial activity directly to validate performance of drug formulations and devices.

Additional Antibiotic & Antimicrobial Testing Services

Beyond AET, Cambrex provides antibiotic and antimicrobial testing services to support product development, quality and regulatory compliance:

  • Antibiotic Testing and Assays (USP <81>) – Potency and effectiveness evaluations using standardized methods.
  • Antibiotic Susceptibility Testing (AST) – Determining microorganism sensitivity to antibiotics for development and contamination investigations.

With deep technical expertise and advanced microbiology labs, Cambrex helps clients ensure compliance, mitigate risk and maintain the highest standards of product quality and patient safety.

Accreditation & Regulatory Compliance

Our testing laboratories are FDA-registered and GMP-compliant, reflecting our commitment to excellence and regulatory compliance.  This comprehensive framework ensures we deliver accurate, reliable and regulatory-ready results to support your product safety and successful regulatory submissions.

Expertise and Client Support

Cambrex’s team of experienced analysts and microbiologists deliver high-quality services with quick and reliable turnaround times. Clients benefit from direct access to a dedicated account manager, who coordinates with our technical experts and operations teams to ensure proactive risk mitigation, project alignment with client goals, clear communication and prompt issue resolution.

We also offer courier services for sample pickup and delivery within a 150-mile radius of the Agawam, MA facility, ensuring sample integrity and convenience for clients.