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