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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Sterile Crystallization


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.

Sizes and options:

  • Poly Ethylene bags (1 - 5 kg)
  • Typical ranges from 80 up to 600 L compounding volume

Advanced processing:

  • 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 FDA, JP, and EU regulatory standards
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