Controlled Environment for Powder-Filled Vial Production
For cytotoxic parenterals, we offer powder-filled vial manufacturing in a safe, contained environment. Integrated clean-in-place and sterilize-in-place practices are used for the powder hopper. The manufacturing process entails 100% fill weight checking or an in-process fill weight check. Visual inspection occurs on the production line.
Initial Sterile Crystallization Process
As a first step in producing powder-filled vials, we perform sterile crystallization of the active pharmaceutical ingredients (APIs) used in cytotoxic products in an explosion-proof environment. To ensure safety, drug compounding, milling and filling take place in Class 100 (ISO 5) negative pressure isolators sterilized with vaporized hydrogen peroxide. Within the isolators, temperature, relative humidity, laminar air flow, differential pressure and nonviable airborne particles are continuously monitored. Final filling of APIs is in single-use polyethylene bags. The bag contents are aseptically transferred into a powder-filling isolator using a sterile rapid transfer port.
Powder-Filled Vial Manufacturing Features
Vial Sizes
6 mL to 100 mL validated volume
30 mg to 5 g fill weight
Filling Mechanisms
Auger filling (volumetric or gravimetric dosing processes)
Finishing
Robot for bulk packaging