USP 60 Testing for Burkholderia cepacia Complex
Pathogen screening for water-based cosmetics, OTC drug products, and household cleaning formulations
THE CHALLENGE |
Why Burkholderia cepacia Threatens Product Safety
In recent years, Burkholderia cepacia complex has negatively impacted the manufacturing process for formulated products, including cosmetics, OTC drug products, and household cleaning products. This gram-negative, rod-shaped group of organisms has been identified as a health concern with exposure to humans. As an opportunistic pathogenic organism, its presence in products must be avoided to protect vulnerable populations, particularly individuals with compromised immune systems or chronic lung conditions.
Contamination events involving B. cepacia have led to costly product recalls, regulatory warnings, and reputational damage for manufacturers. Health authorities worldwide have issued guidance emphasizing the need for robust pathogen screening water-based products to prevent contamination at the source. For quality managers and compliance leads, the question is no longer if screening is necessary, but how to implement effective testing protocols that meet regulatory expectations.
BUREAU VERITAS SOLUTION |
USP 60 Pathogen Screening at
Bureau Veritas Buffalo
The United States Pharmacopeia (USP) released a testing standard, USP 60, that specifically screens for the Burkholderia cepacia family of organisms. Bureau Veritas Buffalo is qualified to perform USP 60 testing using validated methodologies that detect B. cepacia complex in aqueous formulations.
What is USP 60 Testing?
USP 60 Burkholderia cepacia screening is a microbiological test designed to detect the presence of B. cepacia complex in water-based products. The test employs selective media and enrichment techniques to isolate and identify these organisms, providing manufacturers with actionable data to verify product safety before distribution.
How We Perform the Test
Bureau Veritas Buffalo follows the USP 60 protocol using validated selective media and incubation conditions. Samples are enriched to enhance detection sensitivity, then plated on specialized agar. Suspected colonies undergo biochemical and molecular confirmation to ensure accurate identification. Results are delivered with clear reporting that supports regulatory submissions and internal quality assurance programs.
Product Applicability — Water Activity Testing
The USP 60 standard limits applicability to products classified as "water-based." Based on guidelines set by the USP 1112 standard, water activity is defined as a product with a water activity level above 0.60 aw. Through prerequisite water activity testing cosmetics and other formulations, we separate aqueous (water-based) products from anhydrous (non-water-based) products. This allows for targeted screening of the most susceptible products, optimizing testing resources and compliance efforts.
BENEFITS |
Benefits of USP 60 Testing with
Bureau Veritas
Reduce Contamination RiskBurkholderia cepacia testing verifies that products are free from these harmful microorganisms, safeguarding the health and safety of consumers. Early detection prevents contamination events that can lead to recalls, regulatory action, and brand damage. | Support Regulatory ComplianceConducting USP 60 testing helps the supply chain comply with regulatory requirements and standards set by health authorities. Testing documentation supports U.S. FDA submissions, GMP audits, and international market access requirements. | Strengthen Quality AssuranceRoutine USP 60 testing helps verify the effectiveness of chemical hygiene programs within manufacturing facilities. Regular screening provides trending data that supports continuous improvement and validates contamination control measures. |
WHY BUREAU VERITAS |
Why Bureau Veritas Buffalo Lab
Bureau Veritas Consumer Products Services brings over 35 years of testing expertise to support cosmetics, OTC drug, and household product manufacturers. Our Buffalo laboratory is equipped with validated microbiological testing capabilities and staffed by experienced microbiologists who understand the regulatory landscape for pathogen screening water-based products.
35+Years in Consumer Product Testing | 100K+Reports Annually | 12K+Technical Specialists |
Accreditations and Expertise
Bureau Veritas Buffalo operates under validated quality management systems aligned with industry best practices. Our microbiologists are trained in USP methodologies and stay current with evolving regulatory guidance from the FDA and international health authorities.
Note: The Bureau Veritas Buffalo, New York location is not FDA-registered. If your services require FDA registration, our Milford, Ohio and Knoxville, Tennessee facilities are FDA-registered and ready to assist. Contact us for details.
Fast Turnaround and Reliable Reporting
We understand that time-to-market matters. Our streamlined workflows deliver USP 60 Burkholderia cepacia test results with clear, actionable reporting that supports regulatory submissions and internal decision-making. Turnaround times are tailored to meet your production schedules and compliance deadlines.
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GET STARTED |
Request a Quote for USP 60 Testing
Protect your products and your brand with validated Burkholderia cepacia testing. Contact our team to discuss your testing needs, turnaround requirements, and regulatory objectives.