Aseptic Manufacturing
In recent years, the sterile drug industry has experienced several recalls, shortage of several critical drugs and agency issued citations primarily due to numerous weaknesses within the manufacture of sterile injectable drugs have been identified. As a result, nearly one-third of the industry's sterile injectable manufacturing capacity is off line. Over 90% of such quality issues are caused by cross contaminations and non-sterility matters caused by human interventions. Risk based approach for sterile manufacturing has always been one of the highest priority for aseptic manufacturing environment. Terminal sterilization is not feasible always due to thermal instability of majority of the drugs commonly used today. Whenever, terminal sterilization is not a viable solution, sterile parenteral drugs are manufactured using aseptic technologies. Aseptic manufacturing Sterility is best achieved through sterile filtration of the bulk using a membrane filter (0.2 μm or less) in sterile container closure systems and working in a clean area.
Aseptic processing using isolation systems separates the external clean room environment from the aseptic processing line and minimizes its exposure to personnel. A well-designed positive pressure isolator, supported by adequate procedures for its maintenance, monitoring, and control, offers tangible advantages over traditional aseptic processing, including fewer opportunities for microbial contamination during processing.
Our Restricted Access Barrier Systems (RABS) and isolators are carefully thought, designed and custom constructed. The RABS technology is aimed to overcome the limitations and disadvantages of conventional cleanrooms.
- Conventional cleanrooms with gowned operators in Grade A areas with simple machine guards as separation to critical process equipment is no longer considered best practice.
- Separates the external cleanroom environment from the aseptic processing line and minimizes its exposure to human interaction
- Fewer opportunities for microbial contamination during processing
- Uses vaporized hydrogen peroxide (VHP/ vH202) at greater than 6 log sporicidal reduction for a high level of surface disinfection