For aseptic applications, pharmacy isolators are the best solution. Known to operate in aseptic air, isolators can also be used in controlled, purified atmospheres with very low humidity and/or oxygen content.

Processes and experiments can be carried out in strict compliance with current standards, whatever the atmosphere reproduced by the isolator and its equipment. The main role of the isolator is to protect the product, the environment and the operator.

Pharmacy Isolators: What are they?

A pharmacy isolator provides a totally secure and hermetic environment. This equipment offers optimal protection for aseptic preparations. Entirely sterile, the main isolator is used to package, handle or store products. Handling gloves, protecting the handler up to the shoulders, are placed on one of the walls of the equipment.

The isolator is equipped with transfer systems, allowing the introduction or removal of products. The disposal of waste can be done while respecting containment and aseptic conditions thanks to these systems.

There is a wide range of isolators on the market. The manufacturing of the equipment can be made to measure with the sole aim of preventing the risks of contamination, ensuring the maintenance of product containment and protecting the personnel during handling.

Pharmacy isolators have different pharmaceutical applications: innovative therapy drugs, dosing and weighing operations, etc.

General Equipment Specifications

In order to ensure the most reliable and safe containment and to guarantee a good operation, the isolator must have the following specificities:

  • The WORKSTATIONS positioned side by side or facing each other,
  • With or without internal storage, just-in-time operation,
  • A negative or positive pressure,
  • Laminar, turbulent or unidirectional flow ventilation,
  • HEPA or ULPA filtration,
  • Secure transfer systems.

Specific elements can also be integrated within the isolator, depending on its purpose. The equipment can thus integrate:

  • Dedicated equipment for powders: sifter, grinder,
  • Various laboratory equipment: precision balance for sample preparation, incubator, centrifuge,
  • Equipment specific to the pharmaceutical industry such as a freeze-dryer.

A pharmacy isolator is specially designed to comply with GAMP5, PIC/S and ISO, GMP, 21 CFR part 11, FDA standards.

What are the Advantages of a Pharmacy Isolator?

An isolator is a modern medical technology, allowing the pharmaceutical industry to benefit from various advantages. Compared to sterile clean rooms, the isolator offers a superior sterile environment with either negative or positive internal pressure.

The operator or the outside environment can be protected from any form of contamination in the event of an anomaly. The isolator provides excellent efficiency for aseptic process validation, procedure and sterility testing.

Integrated options and software make monitoring and control easy. Setting and recording of pressures, humidity, temperatures, etc. are also made easy, as are leakage and sterility checks. In addition, the data collected may be required for inspections by the authorities. In addition, the isolator manufacturer provides documents that must be able to attest to the rigorous traceability of the processes implemented at each stage.

The equipment takes up less space and requires less investment, which reduces renovation costs. Those who acquire it also see their operational costs reduced since the maintenance and upkeep of the equipment is less expensive.

In most cases, pharmacy isolator designers and manufacturers offer customized equipment, with options and accessories that meet process requirements.