Filter Testing

Filter testing and qualification play a critical role in maintaining patient safety and product quality by ensuring that sterilization processes are robust and compliant with regulatory requirements. These tests are essential for sterile drug manufacturing and medical devices that require sterility, supporting regulatory submissions and market approval.

Comprehensive Filter Testing Services

Cambrex is an industry leader in pharmaceutical and medical device testing, leveraging our experience and technical expertise to help clients meet strict regulatory standards and achieve successful market entry. Our specialized capabilities include:

• Bacteria Filter Retention Testing – We validate that filters used in sterile manufacturing can effectively retain bacteria, preventing microbial contamination. This gold-standard test directly demonstrates a filter’s ability to maintain product sterility and regulatory compliance, ensuring the integrity of pharmaceutical and medical device products.
• Filter Integrity Testing/Bubble Point Testing – Our team performs bubble point testing to verify that sterilizing-grade filters function correctly. By measuring the pressure required to force air through a wetted filter, we confirm that the filter’s pore size is appropriate for microbial retention. This is vital for routine quality control and process validation.
• Forward Flow Testing – We use forward flow testing to assess filter integrity by measuring the flow of air or liquid through the filter under pressure. This confirms that the filter is intact and provides the necessary barrier against microbial ingress.

Cambrex’s proven track record and collaborative teams ensure that clients receive reliable, science-based solutions for their filtration validation needs, supporting regulatory compliance and market success.

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.