Isolators are a common means for protecting operators when handling highly potent compounds, although this practice is used less for aseptic applications where the use of cleanrooms are more common as the only protection barrier.
However, owing to increased regulatory requirements, open systems have their limits in terms of the risks inherent with human intervention and therefore the need to implement closed systems has become a logical answer.
It is still widely believed in the industry that the cost of installing closed systems such as RABS or isolators will increase the cost of the plant, but there are many examples of well-designed, closed systems that substantially decrease the costs of operation and validation compared with traditional cleanrooms and ensure pay back in a very short period of time.
Some of the major advantages of using closed systems versus open operation in cleanrooms are:
• smaller workspace; isolator-based aseptic facilities are 30–50% smaller than standard cleanrooms
• decrease of cleanroom classification
• reduced costs owing to less gowning, cleaning and staffing requirements
• less product waste and risk of cross contamination
• reduced monitoring costs
• quicker turnaround of product change.
Dec Group has developed isolator systems combined with its powder handling technology, allowing an interface of the processes and therefore removing the need for separated process rooms and intermediate containers. The productivity of such isolators is largely increased as they are fully automated with limited staff requirement and can be CIP and SIP, allowing a very fast changeover of product.
Dec’s isolators, whether standard or customised complex systems, enable ergonomic and flexible working in a safe environment.
Dec Group, +41 21 694 20 40, www.dec-group.net.