Powder Filled Vials
For cytotoxic parenterals, Baxter offers filling of powder filled vials at our highly experienced Halle/Westfalen, Germany facility. In addition to continuous monitoring of temperature, relative humidity, laminar air flow, differential pressure and non-viable airborne particles in the isolator, we feature:
Sizes and options:
- Clinical to commercial scale
- Starting from 1 kg of powder
- Vial sizes from 6 to 100 mL validated
- Fill weight: 50 mg/vial to 5 g/vial
- 1 – 8 filling heads
Advanced processing:
- Class 100 (ISO 5) isolator
- Isolator sterilization by vaporized hydrogen peroxide (VHP)
- CIP/SIP of powder hopper
- 100% fill weight check or in-process fill weight check
- Auger fillers designed for precise powder dosing
- Online visual inspection
- Vial printing
- Packaging robot for bulk packaging of drug product vials
- Meets FDA, JP and EU regulatory standards
