Supporting compliance with complex regulatory requirements

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Leigh Labs provides a series of microbial and sterility testing services supporting cosmetics and OTC, nutraceuticals and dietary supplements, as well as qualitative and quantitative assessments of non-sterile raw materials and finished products using USP, FDA and in-house methods.

Testing capabilities and services include:

• USP <51> Antimicrobial Effectiveness Testing
• USP <60> Testing for Burkholderia Cepacia Complex
• USP <61> Microbial Enumeration Testing for Non-sterile Products
• USP <62> Test for Objectionable Microorganisms
• USP <2021> and USP<2022> Test for Non-sterile Nutritional and Dietary Supplements

Leigh Labs provides comprehensive environmental monitoring services for facilities that require documented evaluation of their controlled environments, production areas, equipment, and surrounding conditions.

• Viable Air Monitoring – Microbiological air sampling with results reported in CFU/m³.
• Surface & Swab Monitoring – Sampling of equipment, work surfaces, floors, high-touch areas, and other designated locations.
• Non-Viable Particle Monitoring – Airborne particle counting and assessment for controlled environments, including ISO 14644-1 classification assessments.
• Environmental Monitoring Programs – Development of sampling plans based on facility layout, operations, personnel flow, equipment, and areas of increased risk.
• Microbiological Testing – Incubation, enumeration, and identification of microorganisms as applicable to the approved testing scope.
• Routine Environmental Monitoring – Ongoing monitoring programs to establish and maintain environmental conditions.
• Facility Assessments & Qualification Support – Environmental assessments and sampling support for new, renovated, or existing production areas.
• Environmental Monitoring Reports – Detailed reports documenting sampling locations, methods, equipment, results, acceptance criteria, deviations, and conclusions.
• USP Microbiological Testing – Microbial enumeration and specified microorganism testing in accordance with applicable USP requirements.
• Investigational and Follow Up Sampling – Additional environmental sampling to help evaluate excursions, elevated microbial counts, or other environmental concerns.

Leigh Labs provides a complete service from developing the sampling plan and performing onsite sampling through laboratory analysis and final reporting. We can also customize the program based on your facility, products, processes, environmental specifications, and applicable regulatory requirements.