Microbiological Services
From method validation to finished product testing, our fully cGMP compliant Microbiological Services Laboratory routinely supports a wide range of services. All testing is performed on-site, which facilitates an extremely fast turnaround time. Our experienced staff ensures that all product quality requirements are met.
Some of these capabilities are:
- Full support of the Manufacturing Services:
- Purified water
- WFI system monitoring
- Environmental monitoring
- Compressed air monitoring
- Microbial Limits Preparatory Testing and Microbial limits Testing conforming to the USP/NF, EP, and JP
- Antimicrobial (Preservative) Effectiveness Testing
- Bioburden evaluation of product containers
- Method validation
- Bacterial Speciation and Fungal Identifications
- Environmental monitoring (on-site and off-site):
- Particulate
- Viable monitoring
- Surface monitoring
- Air monitoring
- Generation of protocols, reports, SOPs and monographs.
- Microbiological Services Equipment
- Incubators
- 20-25oC
- 27-29oC
- 30-35oC
- 35-37oC
- 41-43oC
- 43-45oC
- 55-60oC
- Total Organic Carbon Analyzer
- Milliflex Plus Pump Filtration System
- DUO SAS Super 360 Air Samplers
- MetOne Laser Particle Counter
- Microscopes
- Biological Safety Cabinet
- Beta Star Autoclave
- Balances
- pH meter
- Conductivity Meters
