Sterile Crystallization

Halle/Westfalen facility in Germany, where sterile crystallization for cytotoxic products is performed

In addition to lyophilized vial filling and liquid vial filling of cytotoxics, Baxter also offers sterile crystallization of cytotoxic active pharmaceutical ingredients in a closed system at our highly experienced Halle/Westfalen, Germany, facility.

A step in the sterile crystallization manufacturing process


  • Poly Ethylene bags (1 - 5 kg)
  • Typical ranges from 80 up to 600 L compounding volume
Worker engaged in the sterile crystallization manufacturing process


  • EX (explosion) proofed area
  • Use of organic solvents including methanol, ether, isopropanol
  • Negative pressure isolator for compounding process, designed for operator safety
  • Isolator sterilization using vaporized hydrogen peroxide (VHP)
  • Class 100 (ISO 5) isolators for powder milling and filling
  • Final filling of API into single-use PE bags
  • Aseptic transfer into powder filling isolator: final transfer of API bags using sterile RTP port
  • Continuous monitoring of temperature, relative humidity, differential pressure and non-viable airborne particles in the isolator
  • Meets US, EU, and JP regulatory standards