Microbiology

Microbiological testing is an important factor in ensuring a product’s safety, efficacy and timely project completion. At USA Pharmaceuticals & Sports Science, we provide clients with more than 30 years of microbiological expertise developed from serving the pharmaceutical, beverage and dietary supplement industries.

Our core strengths include non-sterile product evaluation (microbial limits testing), sterile product testing, preservative effectiveness, environmental monitoring support and disinfectant qualification studies. We pay strict attention to every detail as we methodically test and/or monitor the conditions of our clients’ GMP manufacturing environment and the quality of products produced.

Our offerings include compendial microbiological testing per the USP, EP / PhEur, JP, BP:

• Analysis of non-sterile products
  
  • Microbial limits test
    
  • Microbial enumeration and validation
    
  • Tests for specified organisms
    
  • Microbial identification
    
  • Water activity testing
    
• Sterile product testing
  
  • Method suitability – bacteriostasis / fungistasis
    
  • Sterility testing by membrane filtration and direct transfer with barrier isolator technology
    
  • Antimicrobial effectiveness (preservative efficacy) validation and testing
    
• Environmental monitoring & facility support
  
  • Disinfectant efficacy / disinfectant qualification studies
    
  • Microbial identification
    
  • Incubation and enumeration of settling plates
    
  • Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)
    
  • Biological indicator total viable spore count, purity and post-exposure testing
    
• Container closure integrity testing
  
  • Container closure integrity by dye ingress
    
  • Container closure integrity by microbial ingress