Microbiology Testing

At Synergy Bioscience, we prioritize quality, safety, and compliance in all our microbiology testing services. Our work ensures the integrity of your manufacturing process and helps uphold the highest industry standards. We offer an extensive range of tests that strictly adhere to the guidelines of the United States Pharmacopeia (USP) and are regulated by the Food and Drug Administration (FDA) in the U.S.

 

We deliver a suite of tests that comply with all the USP General Chapters, ensuring the highest standards of microbiological testing for both sterile and non-sterile products. Our mandatory requirements align perfectly with the USP guidelines:

  • Raw Material and Finished Product Microbiology Tests (Stability, Preservative Efficacy, Gram Stains, Microbial Limits Test)
  • Microorganisms Identification (Biochemical and Genotypic) – USP Chapter <1113>
  • Antimicrobial Effectiveness Testing – USP Chapter <51>
  • Biological Indicators-Resistance Performance Tests – USP Chapter <55>
  • Microbiological Examination of Nonsterile Products for B.cepacea (USP Chapter <60>
  • Microbiological Examination of Nonsterile Products- Microbial Enumeration – USP Chapter <61>
  • Microbiological Examination of Nonsterile Products Test for Specific Microorganisms – USP Chapter <62>
  • Mycoplasma Testing – USP Chapter <63>
  • Sterility Testing – USP Chapter <71>
  • Antibiotic- Microbial Assays – USP Chapter <81>
  • Endotoxin Testing – USP Chapter <85>
  • Validation of Microbial Recovery from Pharmacopeial Articles – USP Chapter <1227>
  • Microbial Enumeration Test- Nutritional and Dietary Supplements – USP Chapter <2021>
  • Microbiological Attributes of Non-sterile Nutritional and Dietary Supplements – USP Chapter <2023>
  • Purified Water Testing (Bioburden Testing)
  • Environmental Monitoring (Ambient Air, Compressed Air, Surface Cleaning Validation) – USP Chapter <1116>

 

We also keep our testing processes aligned and in compliance with the USP’s General Information Chapters, including Chapter <1111>, Chapter <1117>, and Chapter <1229.3> for best laboratory practices and bioburden monitoring.

 

Preserving Product Integrity with Antimicrobial Effectiveness Testing

Many products include an antimicrobial to prevent unwanted microbial growth. Synergy Bioscience offers Antimicrobial Effectiveness Testing (AET) to ensure the efficacy of these antimicrobials against targeted organisms. This service applies to injections, topicals, oral products, and antacids packaged in multi-dose containers. Our AET methods, informed by USP <51>, differ based on the unique attributes and intended use of each product.

 

Securing Sterilization with Biological Indicators-Resistance Performance Tests

We employ Biological Indicators-Resistance Performance Tests to confirm the resistance of organisms to sterilization measures. These indicators are thoroughly tested and confirmed for their suitability before they are used.

 

Assuring Safety with Microbial Enumeration Tests

For non-sterile products, we use USP Chapter <61> methods for microbial contamination testing. This includes the Total Yeast and Mold Count (TYMC) and Total Aerobic Microbial Count (TAMC) analyses. By counting the colony-forming units (CFU), we provide a comprehensive microbial count that helps ensure product safety.

 

Maintaining Sterility with Sterility Testing

Our sterility testing confirms the absence of microbial contamination in pharmaceutical products. We employ direct inoculation and membrane filtration methods to detect microbial growth, ensuring your products meet USP standards.

 

Detecting Dangers with Bacterial Endotoxin Testing

Bacterial endotoxins are potentially fatal substances produced by disintegrating gram-negative bacteria. We utilize the Limulus Amebocyte Lysate (LAL) Test, which is recognized by the FDA and USP, to detect the presence of endotoxins in products even when sterility test requirements are met.

 

Choose Synergy Bioscience for your microbiology testing needs. We uphold the highest industry standards while providing effective, efficient, and compliant testing services for your products.

To discuss how Synergy Bioscience can help you, please contact us