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
• Remediation and prevention of Burkholderia cepacia complex (BCC), Cronobacter (Enterobacter) sakazakii and Bacillus cereus
• 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)