Cytotoxic Lyophilised Vial Scale-Up
Western India · Oncology Care
Overview
Scale-up of a cytotoxic lyophilised injectable from 4,000 to 32,000 vials per cycle in a contained suite, with cycle redevelopment rather than linear scaling.
The challenge
The development cycle had been built on a pilot lyophiliser with a different shelf configuration. Scaled directly, the first trial produced cake collapse in the edge vials and a 9% reject rate, with residual moisture out of trend on the perimeter.
What we did
Shelf mapping and product temperature probes established the real sublimation front at full load, and primary drying was extended with a lower shelf temperature instead of chasing the pilot cycle time. Containment was verified by surrogate monitoring at the breathing zone, and cleaning validation was recalculated to a toxicology-based MACO.
Project data
| Cycle capacity | 4,000 → 32,000 vials |
|---|---|
| Cake collapse / rejects | 9.0% → 0.4% |
| Residual moisture | Within 1.5% across the full shelf map |
| Containment verified | Surrogate monitoring, OEB 4 band |
| Cleaning validation | Toxicology-based MACO, HPLC-verified swabs |
| Scale-up duration | 22 weeks including validation |
Standards applied
- EU-GMP Annex 1
- WHO-GMP
- USP <800> principles
Scope supplied
- Oncology Injectables
- Scale-Up & Process Validation
Related
- Oncology Injectables
- Scale-Up & Process Validation