Our pharmaceutical microbiology laboratory is a stand-alone facility equipped with current technologies to analyze raw materials, active pharmaceutical ingredients, and finished products in accordance with Pharmacopoeial or customer supplied methodologies.
Our staff is fully versed in USP, EP, and JP Pharmacopoeial methodologies or can develop and validate company/product specific methods. We provide dependable and cost effective testing in a cGMP compliant and a FDA inspected laboratory.
Microbiological testing capabilities include:
- Method Development and Validation
- Microbial Examination <61> <62>
- Antimicrobial Effectiveness Test <51>
- Endotoxin <85>
- Gel Clot
- Sterility Testing <71>
- Barrier Isolator
- Particulate Matter <788>
- Microscopic Particle Count
- Microscopic Examination of Unknown Substances
- Microbial Identification System
- Antibiotic Assays <81>
- non-USP testing, e.g.
- hold time studies
- kill rate studies
- Water Activity
- Water Testing and Water System Validations
- Environmental Monitoring
- Disinfectant Qualification
- Cleaning Validations
Our highly experienced and knowledgeable microbiologists can provide advice on compendial testing, regulatory issues, investigative studies, and scientific evaluation on safety and efficacy data.