The disinfectant qualification process ensures cleaning and disinfectant protocols effectively eliminate site-specific microbial isolates found in pharmaceutical and medical device manufacturing environments. Regulatory agencies require documented evidence that disinfectants used in cleanrooms and controlled environments are effective against the facility’s unique microbial flora, making this process essential for maintaining product safety and quality, mitigating contamination risks and supporting continuous improvement as facility conditions evolve. By challenging disinfectants with organisms commonly recovered from classified areas, disinfectant qualification confirms that selected reagents can reliably control contamination. Routine qualification also ensures that changes in disinfectant products or facility flora do not compromise microbial control, reducing the risk of recalls or regulatory actions.

Disinfectant Qualification Excellence: Customized Protocols, Regulatory Compliance and End-to-End Support

Cambrex delivers industry-leading disinfectant qualification services, leveraging deep expertise and advanced microbiology labs to validate cleaning protocols against site-specific microbial isolates. We support clients in various scenarios, including:

• Initial disinfectant qualification – When a new cleanroom is being validated and you need proof that chosen disinfectants work.
• Additional surfaces – If new equipment, flooring or wall materials are introduced, and you need to confirm the disinfectant is still effective on them.
• Extending expiration dates – Re-qualifying disinfectants if you want to use them beyond the manufacturer’s labeled shelf-life.
• Verifying contact times/disinfectants – Ensuring that the current disinfecting procedures (e.g., 5-minute wet contact time) are sufficient, or you’re testing new disinfectants if you change suppliers.
• Environmental isolate challenges – Testing disinfectants against microbes unique to your facility, not just lab strains, to demonstrate site-specific effectiveness.

Our team develops tailored protocols that address your facility’s unique contamination risks, ensuring full regulatory compliance with FDA and GMP standards. From risk assessment and protocol development to execution, analysis and documentation, Cambrex provides comprehensive environmental monitoring support to safeguard product quality and maintain a compliant, controlled facility.

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.