Preventing product contamination throughout the process
Recent years have shown steady growth in manufacturing sterile, highly potent products in the pharmaceutical industry. Antibiotics for intravenous or intramuscular injection in powder form, IV preparation or plasma fractionation need to be produced under sterile conditions.
New EU/FDA legislation outlawing irradiation of products makes the issues of sterile powder handling a current topic of increasing relevance for a wide range of applications.
Non-compliant facilities still using open aseptic processing systems (including open RABS) are not able to ensure consistent contamination prevention and present a major and persistent risk of sporadic contamination. It is strongly recommended to run a fully closed operation under strictly controlled conditions.