Microbiological Services

EXCELLENCE THROUGHOUT

Our vast knowledge and experience in microbiological testing provide our customers with an extensive portfolio of compendial testing that accommodates product development, product validation, and product compliance to regulatory requirements. The microbiology department comprises three laboratories: Sterile Laboratory, Bacteriology Laboratory, and Biotechnology Laboratory. Below list the test services offered by the Microbiology Department.

Microbiological Testing

Sterile Laboratory
- Rapid Scan RDI® (Rapid Sterility)
- USP<71> Sterility
- BacT/Alert Sterility Test
- USP<85> Bacterial Endotoxins
- USP<85> Method Validation
- USP<788> Particulate Testing
- USP<789> Particulate Testing
- USP<790> Visual Particulate Testing

Bacteriology Laboratory
- USP<51> Antimicrobial Effectiveness
- USP<51> Method Suitability
- USP<60> Burkholderia cepacia complex (Bcc)
- USP<60> Method Suitability
- USP<61> Microbial Enumeration
- USP<62> Objectionable Organisms
- USP<61>/<62> Method Suitability
- USP<71> Method Suitability
- USP<922> Water Activity
- USP<1231> Water for Pharmaceutical Use
- Rapid Scan RDI® Method Suitability
- BacT/Alert Method Suitability
- Biological Indicators (USP<55>, direct inoculation)
- Growth Promotion of Media
- Post Media-Fill Growth Promotion Test
- Incubation and Evaluation of Media-Filled Units

Microscope fluorescent images from ScanRDI Samples

Biotechnology Laboratory
- HCG by ELISA
- Protein quantification by ELISA
- Microbial Identification (16S/ITS/whole genomic sequencing)
- qPCR Testing for Protein Quantification
- Gel Electrophoresis
- Microbial Identification Growth in Media-Filled Units – Genetic and Phenotypic (Gram stain and BlueMount)

Laboratory Testing and Services Pricing

OUR LABORATORIES

Eagle’s cutting-edge 35,000-square-foot facility and laboratory are equipped with advanced technologies and specialized segregated laboratory spaces to meet the diverse needs of our clients. This behind-the-scenes video provides you with an opportunity to witness testing while touring our laboratory.

RELATED SERVICES

Research and Development Services

Chemistry Department

Microbiology Team

The microbiology department consists of dedicated scientists who are committed to providing expert qualitative and quantitative assessments of sterile and non-sterile products for our customers.