Isolators and Their Use in Sterile Manufacturing

Isolators are very useful in sterile manufacturing where microbial contamination and cross contamination is a major problem.

An isolator can best be defined as an arrangement of physical barricades which are incorporated to a degree that the isolator is capable of being sealed; so as that it can undertake a scheduled leak tests that are based on pressure, to attain stated limits.

Internally, isolators provide a working space that is detached from the surrounding environment. Hence, manipulation can be executed within space from the outside without the integrity being compromised.

In the pharmaceutical industry, the word isolator covers a wide range of equipment. In one set of equipment, it has the chief aim of providing containment in the handling of hazardous supplies either aseptically or not. In another set, it has the chief objective of the provision of a micro- biologically controlled environment, within which aseptic operations can be undertaken out.

For example, containment isolators do employ negative internal air pressure and the isolators that are exposed in this situation i.e. aseptic processing do employ positive pressure. The sporadic process, which is often delivered by gas, may be applied to help in microbiological control.

For some situations, specific large-scale isolators, do provide for an opening i.e. a mouse hole that allows for a continuous ejection of sealed products. But for other types, they do remain closed in the course of the production and operations period. This capacity for the isolators to be enclosed thus permits for the operation to be carried out in a controlled gaseous environment e.g. anaerobic state.

One should note that enclosed isolators are always positively pressurized units with High Efficiency Particulate Air (HEPA) filters that do supply ISO 5 airflow in a unidirectional manner to the interior. Air is generally re-circulated and cleaning may be automated or manual. 

Moreover, bio-decomposition occurs via an automated cycle that generally utilizes vaporized hydrogen peroxide. For one to access an isolator, they need to embark through glove compartments and sterilized transfer systems. These isolators can be placed in an ISO 8 area or even better environment location.

Isolators are increasingly becoming significant in the pharmaceuticals industry and in the advancement of product quality, reduction in operating costs and in the enhancement of production runs capability. This has rendered them to have a marginal advantage compared to the convectional clean room production. 

Therefore, advanced filling lines necessitate the need for compartment management of the interaction encompassing the billing machine, the isolators systems and the subsequent machines e.g. over seal capping machines. The challenges faced include the safe performance of the interfaces, the simplification of the overall control system and the easing of operations to the specific compartments.

Those Processes that entail a need for active ingredients containment, then the containment isolators are built with precisions that are ideal with localized specific applications e.g. a bespoke design that permits for numerous special characteristics to be included. This features may be for example a polished stainless steel chamber or hatches, inflatable seals etc. For sterility test isolators, which are generally a range of two glove and four glove isolators; they are specifically built for sterility testing and are designed for sterility testing of pharmaceutical products.