Consulting Services

Our team of highly competent and globally-recognized subject matter experts in pharmaceutical microbiology are available to meet your most critical needs.

Our capabilities span a wide range of applications and functions, including, but not limited to:

Manufacturing


  • Contamination control and bioburden reduction strategies for sterile and non sterile fill-finish facilities
  • Fermentation, recovery and purification microbiological control (API, bulk drug)
  • Sterility assurance and aseptic processing
  • US and EU cGMP compliance
  • Environmental monitoring (sterile and nonsterile)
  • Process water monitoring and maintenance
  • Investigations of microbial excursions, presence of objectionable organisms and out-of-specification findings
  • Manufacturing isolator and RABS design, cycle development and microbiological validation
  • Disinfection and sterilization
  • Cleaning validation
  • Process development
  • Manufacturing facility design and qualification
  • Process Analytical Technology (PAT)
  • Audit readiness
  • Rapid microbiological method (RMM) validation and implementation

Microbiology Laboratory


  • Laboratory audits, optimization and management
  • Laboratory design, qualification, optimization and automation
  • Microbiology method suitability testing, including the harmonized Sterility Test and Microbial Limits Test, Antimicrobial Effectiveness testing, USP 1223 and1227
  • Sterility testing (harmonized)
  • Antimicrobial and preservative effectiveness testing
  • Bioburden and microbiological examination of nonsterile products (harmonized Microbial Limits Test)
  • Disinfectant effectiveness validation
  • Environmental monitoring
  • Pharmaceutical-grade water analysis
  • Microbial identification strategies and instrument/method validation, including gene sequencing and MALDI
  • Endotoxin analysis and method validation
  • SOP and protocol development
  • Method validation and technology transfer
  • Pharmacopoeia (e.g., USP, Ph. Eur., JP) interpretation and compliance
  • Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)
  • Sterility test isolator design, cycle development and microbiological validation
  • Documentation and data management
  • cGMP compliance
  • Rapid microbiological method (RMM) validation and implementation

Quality, Regulatory and Product Development


  • Failure investigations and root cause analysis
  • Microbial data deviation investigations
  • Audit response management (e.g., FDA 483, warning letters, consent decree)
  • Regulatory submission support associated with microbiological processes (e.g., NDA, ANDA, IND, BLA, marketing authorization)
  • Pharmacopoeia (e.g., USP, Ph. Eur., JP) compliance
  • Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
  • USP 797 and 800 compliance, pharmaceutical compounding of sterile and nonsterile preparations (compounding pharmacies)
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