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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Sterile Crystallization

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In addition to lyophilized vial filling, liquid vial filling and ampoule 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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