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
- 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)