Microbiology Services

Coldstream Laboratories’ FDA-inspected facility offers full-service independent contract microbiology laboratory testing of drug substances and drug products. We are skilled and specially equipped to handle the unique challenges associated with toxic and potent products. When you trust your microbiological testing needs to us, you can be assured that we will deliver reliable, accurate and timely results. Contact us today to learn more about our microbiology services.

List of Microbiology Services:

Non-Sterile API, Excipient and Raw Material and Finished Product Testing:

  • Harmonized Microbial Enumeration Testing and Testing for Specified Organisms – USP <61>, <62>
  • Bacterial Endoxtoxins Testing – USP <85>
  • Antimicrobial Preservative Effectiveness – USP <51>
  • Pre-filtration Bioburden Testing – USP <61>
  • Vitek 2 Compact Organism Identification

Sterile Finished Product Testing:

  • Pre-filtration Bioburden Testing – USP <61>
  • Sterility Testing in Class 100 Isolator – USP <71>
  • Bacterial Endotoxins Testing – USP <85>
  • Particulate Matter in Injections – USP <788>
  • Container Closure Integrity Testing using Dye Immersion – ASTM D 4991-07, PDA TR 27
  • Vitek 2 Compact Organism Identification

Method Development and Suitability:

  • Bioburden Recovery – USP <61>
  • Recovery of Specified Microorganisms – USP <62>
  • Bacteriostasis/ Fungistasis – USP <71>
  • Bacterial Endotoxin Inhibition/ Enhancement – USP <85>
  • Neutralization of Antimicrobial Substance – USP <1227>

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