Microbiology

Routine and custom-designed programs for your sampling and testing requirements

We offer a complete line of services that includes GMP/GLP-analytical microbiology services and specialty services. Our experienced team of pharmaceutical microbiologists can provide you with method development support, consulting, and problem-solving skills, and analytical flexibility. You can choose testing our Routine Analytical Testing methods or request a program designed specifically to your sampling and testing requirements.

Catalent Benefits

To ensure your project’s success, we are committed to providing:

  • Quality testing services
  • Rapid data turnaround
  • Effective communications 
Catalent Services
  • Specialty Services
    • Barrier isolation testing
      • Sterility testing for release 
      • Vaporized hydrogen peroxide sterilant 
    • Ribotyping testing 
      • DNA-based microbial identification 
      • Bacterial ID 
      • Genotypic method 
  • Compendial testing
    • USP, EP, JP, BP 
    • Microbial attributes of non-sterila products
      • Microbial enumeration tests and validation
      • Tests for specified organisms and validation
      • Microbial identification 
    • Inhibition/enhancement qualifications
      • Gel clot 
      • Kinetic chromogenic 
    • Sterility tests
      • Method suitability resting (bacteriostasis/fungistasis) 
      • Membrane filtration methods 
      • Direct transfer techniques 
    • Antimicrobial effectiveness testing
      • Method qualification 
      • Preservative challenge 
    • Pharmaceutical water testing 
    • Total organic carbon 
    • Environmental monitoring
      • Consulting and training 
      • On-site sample collection 
      • Microbial identification 
      • ISO Classification
      • Trending
    • Container closure integrity evaluation
      • Dye intrusion 
      • Microbial ingression 
      • Customized methods 
      • Process validation
      • Stability testing
    • Facility/Utility validation
    • Pharmaceutical (purified, WFI, clean steam) water validation and routine testing
    • Biological indicator testing
    • Endotoxin indicator preparation and testing
    • Disinfectant efficacy testing and consulting
    • Environmental monitoring consulting and ISO classification
    • Cleaning validation support and testing
    • Media fill support
      • Incubation
      • Inspection
      • Container closure integrity
      • Growth promotion
Facilities
  • RTP, North Carolina, U.S.A. - Center for Development and Analytical 
    • General stats
      • Over 330+ Personnel in 200,000 sq. ft. of laboratory space
      • 9,500+ sq. ft. of GMP Manufacturing for CTMs
    • Project Director Based Work Teams
      • Effective resource design including:
        •  Project management
        • Project directors
        • QA
        • Scientific staff supported with administrative assistants
    • Special material handling
      • DEA-controlled substances
      • Cytoxics
      • High potency
      • Light-moisture-oxygen sensitive compounds
      • Cephalosporin/penicillin
      • BSL 2/3
      • Hormonals
      • Radioactive licenses
    • Laboratory facilities
      • 6 buildings in Southport Business Park
      • 200,000 sq. ft. laboratory space
      • 22,750 cu. ft. ICH stability
    • cGMP manufacturing
      • 9,500 sq. ft. 
      • Respiratory
      • Sterile (liquid/lyo)
      • Phase I/II scale
    • Operational excellence
      • Visual management of workload 
      • Metrics driven
      • Value-stream approach
  • Swindon, United Kingdom
    • 158,000sq
    • EMEA, FDA, ANVISA, Turnkey MOH & AEO Approved; CT-PAT approval for Catalent US
    • Featured Technologies:
      • Zydis® fast-dissolve technology
      • Development and clinical technologies
      • Regulatory consulting services
    • Analytical Testing Services:
      • Raw material and finished product release testing
      • QP Release
      • Method Development and Validation
      • Compendial testing
      • Stability testing and storage