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 vial powder-filling
• Starting from 1 kg of powder
• Vial sizes from 6 to 100 mL validated
• Fill weight: 30 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 US, EU, and JP regulatory standards