Aseptic manufacturing has to be done in sterile environments such as clean rooms and isolators for pharmaceutical applications. A pharmaceutical isolator is more frequently chosen than clean rooms by the pharmaceutical industry due to its performance and cost. This equipment allows bio-decontamination and atmosphere containment. It complies with pharmaceutical safety regulations. Protecting the product, the personnel and the environment are its main roles.

What is a Pharmaceutical Isolator?

An isolator is a sterile containment chamber often used during health product production and testing. This equipment is manufactured in compliance with the requirements of the pharmaceutical industry. It creates a controlled or special atmosphere, free of bacteria, micro-organisms and particles. The sealed enclosure is suitable for aseptic dispensing and many toxic processes.

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Common equipment in an isolator for the pharmaceutical industry:

  • A main isolator for storing products/materials when they need to be handled, stored, packaged, transferred, etc.
  • High-performance decontamination systems.
  • Very high efficiency filters (HEPA or ULPA).
  • Shoulder-length gloves or gloves that allow access to the work area.
  • Transfer systems to bring in and out the elements to be protected, but also to evacuate the waste.
  • Automatic safety devices that isolate contaminants in case of a problem.

As an option, it can be complemented with hooked hanging bars, cooling tanks, welding machines, cleaning equipment and other types of accessories. Depending on the process requirements, integrated options can be customized.

To ensure that pharmaceutical applications are carried out according to the required standards and recommendations, the isolator is cleaned with sterilizing agents such as H2O2 (hydrogen peroxide). Its various features ensure the purity of the enclosure and the continuity of the containment from the beginning to the end of the process.

Why a Pharmaceutical Isolator is the Right Choice

An isolator designed specifically for the pharmaceutical industry is used for handling, transfer, packaging and filling of various pharmaceutical products. It is suitable for sterility tests, handling of pathogens, tissues or biological production systems, defiltration processes, drying and weighing of cytotoxic principles, etc.

The sterile environment of an isolator is superior to conventional clean rooms or production environments. The containment pressures, which may be higher or lower than atmospheric pressure, limit the risks of exposure to contaminants for the operator and the external environment.

An isolator can integrate software and provide options to simplify process control and monitoring. It becomes, for example, easier to control sterility, to set and record temperatures, humidity levels, pressures, hourly leakage levels… This data are required by the organizations in charge of inspecting and controlling this equipment. Installing an isolator for the pharmaceutical industry is more economical than setting up a sterile clean room. Renovation costs will be lower. It is also cheaper to maintain, resulting in a systematic reduction in operating costs.

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