Flexible Isolators The Exorcist: How Flexible Isolators Ban Danger for Plant, Product and Personnel

Author / Editor: Gabriela Mikhaiel / Dipl.-Ing. (FH) Tobias Hüser

When handling hazardous substances at certain levels of toxicity (OEB 4-5), isolation is simply a must. Containment is not only required to protect the operator but also to preserve product quality, essential in aseptic environments. Here you can read when flexible solutions are best applied for closed processes and what advantages and disadvantages they have in comparison with fixed systems.

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Dispensing-Isolator with a integrated cleaning system and a tablet press
Dispensing-Isolator with a integrated cleaning system and a tablet press
(Picture: DEC)

Thanks to high-quality and proven performance, flexible technology serves widely the pharmaceutical industry, for example under controlled nitrogen atmosphere for oxygen reduction, for sterile processing and quality control or for the handling of toxic substances. Also the bio-pharmaceutical sector uses such systems for cell culture processes from laboratory to industrial scale operations. Flexible systems can be designed, depending on the process conditions, both over- or underpressure, as multi-chamber systems with the appropriately designed air flow control and filtering technology.

The inward transfer of material and sampling equipment, removal of waste products and materials is achieved in a variety of ways from simple airlocks through to high specification rapid transfer ports. If necessary, these relatively simple and low cost systems can also be equipped with connections for air samplers and particle counter systems.

Benefits of Flexible Isolator Systems

The main advantages of flexible containment systems compared to solid systems are the lower acquisition cost, the ability to rapidly replace damaged film material and the possibility to reduce or to remove cleaning validation. This can be very important in an R&D environment when only few details of a compound´s toxicity level are known. Both standard and customized units offer not only fast, but also cost-effective solutions. Flexible systems are easier to optimize for ergonomics and can therefore, in some instances, allow for easier use.

This is reflected in the good all-round visibility and simplified height adjustment through module frame design. Lightweight, portable construction and quick installation are further significant benefits to allow great operating flexibility. Another advantage of disposable systems, particularly for aseptic applications, is the fact that depending on the process they require reduced cleaning efforts which in turn leads to considerable cost savings.