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General Microbiological Testing

MICROBIOLOGICAL ENVIRONMENTS conducts expert CGMP testing according to compendial guidelines or to your protocols. We also have extensive experience in method development and validation for new or difficult to test products.

We offer the following routine services; please contact us if you require a service not listed:

• Incubation and Analysis of Environmental Monitoring Samples

• USP <797>Pharmaceutical Compounding -Sterile Preparations
• USP <1116> Microbiological Evaluations of Clean Rooms
• ISO 14698 Cleanrooms & Associated Controlled Environments- Biocontamination Control

• Microbial Identification - Bacterial and Fungal

• Fatty Acid Analysis
  • MIDI Sherlock System
• Biochemical Methods
  • BBL Crystal
  • API Systems

• MLT- Microbial Limit Testing/ Total Microbial Content

• USP <61> & <62> Microbiological Examination of Non Sterile Products
  • Microbial Enumeration Tests
  • Tests for Specified Microorganisms
• USP <2021>Microbial Enumeration Tests- Nutritional & Dietary Substances
• USP <2022>Absence of Specified Microorganisms- Nutritional & Dietary Substances
• CTFA-M1 Determination of the Microbial Content of Cosmetic Products
• CFTA-M2 Examination for S.a, E.c. and P.a

• Biological Indicator Testing

• Direct transfer- Impregnated Spore Strips and Steel Disk Carriers
• Total Viable Spore Count
• Log Reduction
• Self Contained
• Within Product
.
• AET- Antimicrobial Effectiveness Testing

• USP <51> Antimicrobial Effectiveness Testing
• CTFA M3 Determination of Preservation Adequacy

• Pharmaceutical Water Testing

• USP Purified Water

• Antibiotic Residue Testing - Beta-Lactam Residue Detection

• Disinfectant Efficacy Tests

• AOAC - Germicidal Spray Test
• Use Dilution Test
• Disinfectant Neutralization Test
• Cleaning Validation

• Inoculated Product Test

• Product Inoculation
• Inoculated Product Sterility
• Liquid Sample Population Confirmation

• USP <87> Biological Reactivity Tests - In Vitro

• Time/ Kill Study

• Minimum Inhibitory Concentration Test - MIC

• Minimum Lethal Concentration Test - MLC