Incubation Studies

Incubation studies are a critical component of pharmaceutical and medical device microbiology, providing the controlled conditions necessary to detect and evaluate microorganisms. From sterility testing and biological indicator evaluation to microbial enumeration and disinfectant qualification, incubation supports process validation and ensures that products meet stringent regulatory standards for safety and sterility assurance. By allowing microorganisms the opportunity to grow under defined conditions, these studies deliver reliable data that validate sterilization processes, confirm media performance and safeguard product quality.

Cambrex’s laboratories leverage advanced incubation protocols and technical expertise to validate processes, ensure product safety and support regulatory compliance at every stage of development. Our incubation studies include:

• Media Fills (USP <797>) / Process Simulations – Simulates aseptic manufacturing by filling containers with sterile media and incubating them to detect contamination introduced during processing.
• Biological Indicator Testing (BI) – Validates sterilization cycles by exposing biological indicators containing known quantities of resistant microorganisms to the sterilization process, then incubating them for 14 days in compendial media under defined conditions to check for survivors.
• Growth Promotion Studies – Assesses the suitability of culture media to support the growth of specific microorganisms, ensuring media reliability for sterility or bioburden testing.
• Environmental Monitoring Samples – Quantifies facility microbial load through controlled incubation of environmental monitoring plates.
• Additional Services – We also provide disinfectant qualification and hold-time studies to validate microbial control effectiveness through sample incubation.

Expertise and Client Support

Cambrex’s team of experienced analysts and microbiologists deliver high-quality microbiology testing 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.