Analytical flexibility for specialty services and customized capabilities
We offer a complete line of services that includes GMP/GLP-analytical microbiology services and specialty services. We have an experienced team of pharmaceutical microbiologists who can provide you with method development support, consulting and problem-solving skills, and analytical flexibility. You can choose testing via our Routine Analytical Testing Methods or request a program designed specifically to your sampling and testing requirements.
Catalent Benefits
- Quality testing services
- Rapid data turnaround
- Effective communication to ensure your project’s success
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-sterile products
- Microbial enumeration tests and validation
- Tests for specified organisms and validation
- Microbial identification
- Bacterial endotoxin tests (LAL)
- Inhibition/enhancement qualifications
- Gel clot
- Kinetic chromogenic
- Sterility tests
- Method suitability testing (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
- 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
- Microbiology
- Stability testing and storage
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