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 US, EU, and JP regulatory standards