Containment and Isolation

To protect the operator while handling potent compounds and toxic substances, containment strategies must be implemented to minimize his or her exposure to API, which must be kept below safe limits. Containment is the separation of a hazardous area from a clean one by means of a physical (isolators) or aerodynamic (downflow booths) barrier.

When handling sterile products, the containment process must significantly reduce the exposure of the product to its surroundings and ensure the total safety of the finished product.

An isolator is an enclosed and confined environment whose function is to provide a threefold level of protection. Containment is an issue more and more addressed by authorities and companies in fine chemical and pharmaceutical industries with increasing demand also in energy, aerospace, food and cosmetic applications. Product protection, as well as environment and operator protection, is the driving requirements in new projects or in equipment re-vamping.

FPS offers a complete range of containment systems that satisfies all possible needs and requirements. Our approach to a containment system is to discuss with the end user the specific needs in terms of protection, quality, and productivity in order to identify the equipment that best fits the specifications:

  • Isolators for API and HPAPI Primary Production are available for many applications: Laboratory, Synthesis, Filtration & Drying, Production Reactor Charging, Process vessel discharging, Pilot Milling & Micronisation, Production Milling & Micronisation, Dispensing…
  • Isolators for HPAPI Formulation and Packaging are available for many applications: spray dryers, granulators, extruders, mixers, powder screens, tablet presses, capsules filling and pan coating machines.
  • Isolators for sterile applications are proposed in the form of closed isolators or Restricted Access Barrier Systems.
  • Additional containment solutions as: Laminar flow booths for small volumes protections, Pack-off systems to safely discharge, weigh and pack powders, Cleanrooms as general operation environment and Inert Gas Containment systems

The definition of the proper containment strategy is a necessary requirement for the correct design of the facility and the process equipment. Containment is necessary to reduce the exposure of operators to potent products.
The starting point is the sound knowledge of the products to be handled and their specific characteristics as well as their occupational exposure limits (OEL), the quantities involved and the duration and the frequency of each process to be contained.
Powders are extremely volatile and can be easily inhaled, so it is essential that proper PPEs are worn and a separation system is used to minimize the quantity of product the personnel is exposed to. The choice of such system is mainly based on the potency of the compound: while non-potent products may require equipment as simple as a downflow booth, highly active APIs must be handled within a rigid isolator.
The longer or the more frequently a task is performed, the higher is the potential exposure of the operator to the product. If the substance is potent a rigid wall isolator is essential to minimize the exposure, while less potent products require different containment strategies.
Process equipment not designed for containment can be fully or partly integrated in isolators. A technical evaluation and a close cooperation between the equipment manufacturer and the isolator maker can lead to excellent containment performances.
SMEPAC tests are carried out simulating the whole process using placebo compounds. Specific sensors are installed in the room, close to the breathing area of the operator and on the sensitive areas of the containment systems to measure the total exposure of the operator and verify that the measured value are not exceeding the maximum exposure limits of the APIs.

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