PCI offers customized aseptic fill finish manufacturing for Phase I clinical trials in Australia.
From our dedicated and fully audited facilities in Melbourne, Australia we provide specialized sterile technologies that ensure flexibility, accuracy and speed-to-market.
- Aseptic/sterile fill for Phase I clinical trials
- Full randomisation/blinding and delivery to Phase I site “ready to use”
- Prefilled syringes and vials
- Infusion bags and syringe pumps
- Peptides, NCEs, biologics
- Complex peptide formulations
- Single use Millipore systems
- USP sterility and endotoxin testing
- Filter integrity testing (bubble point)
- Continuous particulate testing
- In process Assay, pH, Appearance
- Grade C formulation suite
- HEPA filtered pass throughs
- Grade B filling suite with Grade A laminar flow
- Dedicated microbiology personnel
- Trained staff in aseptic processing
- Full time environmental monitoring staff
