Sterile Crystallization
In addition to lyophilized vial, liquid vial 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)
- 80 – 600L compounding volume
Advanced processing:
- Class 100 (ISO 5) isolators for powder milling and filling
- Negative pressure isolator for compounding process, designed for operator safety
- Isolator sterilization using vaporize hydrogen peroxide (VHP)
- Continuous monitoring of temperature, relative humidity, differential pressure and non-viable airborne particles in the isolator
- Aseptic transfer into powder filling isolator: final transfer of API bags using sterile RTP port
- EX (explosion) proofed area
- Final filling of API into single-use PE bags
- Use of organic solvents including methanol, ether, ispropanol
- Meets FDA, JP, and EU regulatory standards
