A Premier CDMO. FDA Registration #1210580.
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Microbials

Microbial

With a combined 25 years of experienced staff, we will be able to provide with high quality customer service and assistance with regulatory guidance with microbiological needs or questions for your products.

Denison values its partnerships with clients and provides exceptional on-time service

Denison strives to meet customer needs and expectations while upholding all applicable regulatory requirements through constant quality improvement and communication.

Denisons microbiological contract services will provide verification and guidance on regulations of Over-The-Counter pharmaceuticals (OTC), dietary supplements, and cosmetics using a wide range of services.

Denison will provide you with assurance that your products are safe for consumer use and meet all applicable regulatory microbial requirements.

All testing is conducted under a quality system overview and follows current Good Laboratory Practices (GLP) and current Good Documentation Practices (GDP). Testing is run to current USP rules and regulations to ensure proper safety and reporting guidelines are met.

Testing Includes:

Pharmaceutical/OTC Products

  • USP 60 - Selection of B.cepacia complex
  • USP 61 - Microbial Enumeration
  • USP 62 - Screening of Pathogens
  • USP 51 - Antimicrobial Effectiveness Testing
  • Suitability testing for above procedures
  • Rapid Methodology for USP 60/61/62

Dietary Supplements

  • USP 2021 - Microbial Enumeration
  • USP 2022 - Screening of Pathogens
  • USP 60 - Selection of B.cepacia complex
  • Suitability for above procedures
  • USP 51 - Antimicrobial Effectiveness Testing
  • Rapid Methodology for USP 2021/2022/60

Cosmetics and Personal Care

  • Total Aerobic Count
  • Total Yeast & Mold Count
  • Preservative testing
  • Selection of Pathogens
  • Rapid methodology

Environmental Monitoring

  • Plate Reads.
  • Water testing
  • Swab analysis

Rapid Method Testing

  • BioBurden (USP 61/62)

Bacterial and Yeast Identification

Learn More About our Analytical Services

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