STERILITY ASSURANCE
cGMP sterility assurance of drug product and containers
Cambridge Pharma guarantee the highest levels of sterility assurance using state-of-the-art equipment and processes.
Sterilisation is carried out using in-house double ended Pure steam Getinge autoclave or specialist approved external vendors for other methods (e.g gamma or ETO) as required. Filling is conducted within Grade A barrier isolators with VHP decontamination systems, using controlled transfer and single use systems where possible.
Compatible Batches are filled for terminal sterilisation (over pressure cycles available) or otherwise by aseptic process validated with process simulations (media fills)
- In-house Getinge 540L working capacity over-pressure autoclave
- Grade A isolators with VHP decontamination
- Gamma and ETO sterilisation available
- Single-use systems
- Batch terminal sterilisation
- Batch aseptic processing
