Aseptic Fill Finish Processing
PCI Clinical Services can offer customised manufacturing of aseptic fill finish treatments for conducting all of your 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 1 Clinical Trials
- Full randomisation/blinding and delivery to Phase I site “ready to use”
- Prefilled syringes & Vials (2ml, 5mL, 10mL, 20mL)
- Infusion bags and syringe pumps
- Manufactured in excess of 200 batches
- Peptides, NCEs, biologicals
- 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
- Full time microbiologist
- Trained staff in aseptic processing
- Full time environmental monitoring staff
