Contrast Media Fill-Finish Transfer, 100 ml Bottles
Western India · Diagnostic Imaging
Overview
Transfer of an iodinated contrast formulation from the customer's own plant to our large-volume aseptic line, with particulate performance as the gating criterion.
The challenge
The customer's existing line could not hold sub-visible particulate limits consistently at 100 ml fill volume, and rejection at automated inspection was running at 6.8%. Viscosity at fill temperature was also causing dosing variation across the filling heads.
What we did
Fill temperature and in-line filtration train were re-established on our equipment during three engineering batches rather than copied from the sending site. Dosing was re-qualified per head with weight checks at frequency. Particulate rejection settled at 1.1% and the three PPQ batches met specification with margin on osmolality, assay and BET.
Project data
| Fill volume | 100 ml bottles, large-volume aseptic |
|---|---|
| Engineering batches | 3 before PPQ |
| Inspection rejection | 6.8% → 1.1% |
| Batch size achieved | 1,200 L |
| Transfer to PPQ complete | 19 weeks |
| Stability | Zone IVb long-term ongoing, accelerated passed 6 months |
Standards applied
- WHO-GMP
- Schedule M
- ICH Q1A(R2)
Scope supplied
- Contrast Media
- Technology Transfer
Related
- Contrast Media
- Technology Transfer