PharmCo Microbiology

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PharmCo (GLP & GMP Compliant)

Details
Parent Category: ROOT

Deibel Labs is proud of its recent venture into Cosmetic and United States Pharmacopeia (USP) testing.  Deibel Labs has more than 30 total combined years of USP and Cosmetic testing experience in the PharmCo Division.  With this core group of experts, we have developed a Quality Plan that is being incorporated into all of our Labs, nationwide!

We provide a growing range of Microbiological analyses using our Standard Operating Procedures (SOPs) referencing current standards such as the USP, Personal Care Products Council (PCPC), Federal Drug Administration Bacteriological Analytical Manual (FDA BAM), and Standard Methods for the Examination of Water and Wastewater (SMWW).  Routine Microbiological testing includes a full range of screenings, enumerations, identifications, and microbial challenges.

Around the corner, Dietary Supplement and more specific Cosmetic testing will soon be implemented.

OUR TESTS INCLUDE

  • USP Microbial Enumeration Tests <61>
  • - Aerobic Plate Count
  • - Total Yeast and Mold Count
  • - Preparatory (Suitability) testing

 

  • USP Microbial Limits test <62>
  • - Salmonella sp
  • - Bile-Tolerant Gram-Negative Bacteria (Enterobacteriaceae)
  • - Pseudomonas sp
  • - E.coli
  • - S. aureus
  • - Preparatory (Suitability) testing
  • - Clostridia sp.
  • - C. albicans
  • - Other objectionable organisms

  • USP Antimicrobial Effectiveness test <51>
  • - Standard 5 USP suggested challenge organisms
  • - Additional organisms upon request, Client supplied or from a Culture Collection (ATCC)

  • Water testing
  • - Total Aerobic Plate Count (Direct Count)
  • - Total Aerobic Plate Count (Membrane Filtration)
  • - Coliform - 10 tube MPN
  • - Coliform - membrane filtration
  • - Trending reports and analysis

  • Environmental Monitoring
  • - Monitoring of environmentally controlled areas by Deibel Associates
  • - Sampling performed by Deibel Associates
  • - Sampling performed by client
  • - Trending reports and analysis

  • Microbiological characterization / Identification
  • - Microscopic Examination (Gram Stain, Spore Stain, etc.)
  • - API Biochemical characterization
  • - Phenotypical Differentiation
  • Consultation services
  • - Environmental monitoring
  • - Cleaning Validations

 


 Discounts received for routine sample submissions, and large scale projects

 

Deibel Labs is not currently registered for drug/active ingredient testing with the FDA

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