Microbiology Testing Services

Our Testing Laboratory can provide you with the expertise developed over the years for microbial method development and validation, and performance of methods used to monitor the conditions of your GMP manufacturing environment and the quality of manufactured products.

We offer

• Method development and method validation
• Testing of formulations, Active Pharmaceutical Ingredients (APIs) and excipients; finished products; in-process and stability samples
• Flexible service arrangements customized to your methodologies
• Support for new products from concept to filing
• Consulting services to guide testing needs based on relevant regulations
• Trouble-shooting of product or in-plant contamination problems

Capabilities

• Compendial Microbiological Method Validation
• Protocol Generation and Microbiological Method Development and Validation for Non-Compendial/Custom Methods
• Water System and Environmental Validation Testing
  
• Microbial Limits Testing
• Antimicrobial (Preservative) Effectiveness Testing
  
• Full Monograph Testing of Pharmaceutical Water
  
• Container Closure Integrity Testing by Dye Immersion and Microbial Ingress
• Disinfectant Qualification Studies by AOAC, including Direct Inoculation and Surface Methods
  
• Environmental Monitoring Support
  
• Equipment Validation Support
  
• Cleaning Validation Support