General

Reducing the cost of production or research processes has recently become a very important factor in any process. A great answer to this challenge are  flexible isolators with a very wide scope of application. They occur in all areas in which classic fixed isolators are used. They are characterized by simple installation and handling, with flexible isolators retaining the essential properties of fixed designs. They are a welcome and suitable solution in processes that require frequent product changes (e.g. in several process systems). Adjustments are possible both in the design area and in the area of  modular elements, which ensures the corresponding functionality of the device. To ensure protection, the flexible insulator is hermetically sealed from the outside and at the same time  important elements are integrated for the required conditions and a smooth operation.

The decisive advantage of flexible isolators is not only the content but also the price. The production of a flexible isolator is significantly cheaper than the cost of conventional isolators for an equivalent technological operation. The aspect of cleaning validation is also important, which is not required in the case of flexible one-time use.

Advantages

  • Lower investment costs
  • Shorter delivery times
  • Easy installation
  • Cleaning validation is not required
  • Upgrading existing equipment
  • FDA and ATEX conformity according to regulations
  • Mobile version
  • Ergonomic shape

Operating principle

Flexible isolators basically consist of a flexible part made of PU foil and a supporting structure to which the flexible part is attached. The supporting structure may be part of an existing device or it may be a self-contained narrow structure, usually made of stainless material, which maintains the shape of the flexible part. The foil, from which the flexible part is made, complies with FDA standards and may have dissipative properties (ATEX suitability).

The shape and configuration of the isolator are adapted to the used technological process. The complexity of the process that takes place in a flexible isolator also defines the complexity of the design and the inclusion of individual modular elements. To design the system, standard modules are used - elements (material pass-through, ventilation, filtering, sealing, cleaning, cable access, airtight zipper, different sizes and shapes of gloves) that have been developed and tested to provide a sufficient level of protection (OEB). The preliminary test of important functionalities in the technological process (mock-up) can also contribute significantly to improve the functionality of the device, which helps to define the final shape, dimensions and arrangement of the elements according to the intended process and user needs.

Components of flexible isolators:

  • AH module with regulation of the pressure conditions and air exchange in the isolator
  • Pre-filtration (G4, F8 ...)
  • Absolute filtration (H13, H14, ...)
  • Dismantling of the modular supporting structure made of stainless material
  • Base plate in various shapes with fasteners for flexible part and supporting structure
  • Additional connection system (dosing, waste, reactor ...)
  • Endless bag system
  • Airtight inserts for cables and pipe connections
  • Possibility of openings on customer request
  • Gloves made from different materials
  • Airtight zipper (different lengths, different shapes)
  • H2O2 decontamination

Use

Flexible isolators are an alternative to conventional metal isolators and are intended to protect the user, the environment and the product when handling highly active substances. Their use is very diverse, as they are intended for research and development work in the laboratory as well as for protection during the implementation of production processes in the regular production. They are used for handling and weighing hazardous substances, taking samples, emptying barrels, changing filters and many other different tasks.

A wide range of  combined components of flexible isolators enables you to cover complex and demanding technological processes in different combinations.

In practice, flexible designs of isolators are very often used for a variety of solutions, such as:

  • Changing a filter
  • Weighing
  • Sampling
  • Sterile work
  • Access to the reactor

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