A medical isolator can easily replace conventional environments in aseptic production and various medical processes. The equipment meets the standards and regulations imposed by the medical sector. The need to perform sterility testing, manufacturing and aseptic filling in a confined and sterile environment justifies its use. The environment within an isolator is controlled and protected from the various forms of possible contamination. Thus, this medical isolator allows the pharmaceutical processes to be carried out and safety rules to be respected.
Functions of a Medical Isolator
An isolator used in the pharmaceutical industry is “equipment that uses tight physical barrier techniques to effect the separation between a controlled internal and external environment, between process and personnel”. It serves as a separator between the aseptic environment and the external environment. The enclosure is perfectly sealed, aseptic and confined to protect the product during aseptic dispensing and sterility testing.
A medical isolator incorporates decontamination devices that eliminate microbes and particles using agents such as hydrogen peroxide or H2O2. Also, it has very high efficiency filters HEPA or ULPA for optimal protection. The user can intervene physically by using gloves that go up to the shoulders or cuff gloves attached to one of its walls. The isolator is most effective when its hourly leakage rate is equivalent to 0.1 to 0.5% of its volume. Everything is designed to limit the risks of contamination linked to the production environment or to humans.
Operators can safely handle products or materials, fill injectable products and infusions within the enclosure of an isolator. At the same time, this equipment protects them from potentially dangerous or toxic products. It also prevents the spread of these products into the external environment. In the pharmaco-medical sector, it plays an essential role in production processes, controls of health products, certain risk preparations, etc.
Advantages of a Pharmaceutical Isolator
The pharmaceutical isolator is undeniably an excellent alternative to sterile clean rooms for several reasons. The equipment offers a reduced sterile volume, therefore easier to control before, during and after processes. It is convenient to use. It is less expensive to set up and operate.
The design of an isolator for pharmaco-medical use requires compliance with specific specifications. These specifications refer to pharmaceutical regulations, ISO standards and GMP (Good Manufacturing Practices) requirements. Thanks to these standards, the isolator guarantees better sterility than clean rooms. The different steps of a process are carried out without breaking containment. Even in the event of leaks or abnormal reactions, safety systems help protect human operators and the production environment.
The addition of accessories, connectors and software integration are possible with a medical isolator. The use, control and monitoring of all the equipment is facilitated. All the more so since the competent organizations perform regular control tests.