Sterility Testing and Validation

Sterility assurance stands as a cornerstone of pharmaceutical and medical device manufacturing. Clients require rigorous sterility testing and validation to safeguard patient health, ensure product safety and meet stringent global regulatory requirements. Microbial contamination can compromise product efficacy, trigger costly recalls and jeopardize patient safety. Regulatory agencies worldwide demand robust sterility assurance data as part of product approvals and ongoing compliance. Cambrex’s science-first approach empowers clients to confidently navigate these challenges, leveraging our technical expertise and collaborative approach to deliver reliable, regulatory-ready results.

Comprehensive Sterility Testing Methods

We offer a full suite of validated sterility testing methods, each designed to detect microbial contamination with precision and reliability:

• Direct Immersion – Ideal for liquid and small-volume samples, this method immerses products directly into culture media to detect microbial growth.
• Open Membrane Filtration – Suitable for a wide range of sample types, this approach filters the sample through a membrane, which is then incubated to identify any contaminants.
• Closed Membrane Filtration – Utilizing a closed system, this method minimizes contamination risk and enhances reliability, making it ideal for sensitive or high-risk products.

Our experienced analysts execute all methods in controlled environments, ensuring robust and reproducible results for every project.

Rapid Sterility Testing

Traditional sterility testing requires up to 14 days of incubation, which can hold up product release and impact your timelines. To support time-sensitive programs, Cambrex offers rapid sterility testing services by leveraging Celsis® bioluminescence technology to detect microbial adenosine triphosphate (ATP) with exceptional sensitivity, allowing us to deliver reliable, compliant results in days instead of weeks. This accelerated approach not only maintains the highest standards of quality and regulatory assurance, but also helps you reduce inventory costs, streamline manufacturing and bring products to market faster.

Expertise in Sterility Validation

Cambrex’s sterility validation services confirm the effectiveness and reliability of your aseptic processes and testing procedures. Our capabilities include:

• Biological Indicator Testing – Utilizes resistant microorganisms to challenge sterilization processes, verifying the effectiveness of sterilization methods.
• Media Fills (USP <797>) – Simulates aseptic manufacturing processes to validate the sterility of your production environment and procedures.
• Growth Promotion Studies – Confirms that culture media can support the growth of microorganisms, a critical aspect of method validation.
• Bacteriostasis/Fungistasis (B/F) Testing – Verifies that the test system does not inhibit microbial growth, ensuring the accuracy of sterility results.

These validation studies are essential for regulatory submissions and ongoing quality assurance, ensuring your compliance with global standards.

Accreditation & Regulatory Compliance

Our sterility testing laboratories are FDA-registered, GMP-compliant and ISO 17025-accredited for medical devices, reflecting our commitment to excellence and regulatory compliance. Our methods are validated to USP <71>, EP, JP and other international standards, as well as ANSI/AAMI/ISO 11137-2 and 11737-2, ensuring your data is accepted by regulatory agencies worldwide.

Expertise and Client Support

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