The containment isolator is part of the process equipment often found in pharmaceutical laboratories. Sterile packaging of potentially harmful pharmaceutical compounds and products cannot be done in an exposed environment. This equipment is. therefore, a practical solution to ensure the safety of operators and products as well as being more economical than setting up a clean room.
What is the Purpose of an Isolator?
The isolator is a hermetically sealed enclosure used to sterilize an environment and confine sterility. It is adapted to the handling and packaging of materials, products and toxic or dangerous active agents in pharmaceutical environments. Thanks to this system, operators do not come into direct contact with the sterile zone, but can still perform their tasks during the process. The target elements are also protected from contamination with the added advantage that contaminants are not likely to escape into the external environment.
In pharmaceutical laboratories, a vacuum containment isolator is most often used. The equipment must comply with Class A, ISO and pharmaceutical industry standards. It forms a physical barrier between the toxic agent and the operator and plays two very important roles
Confining the atmosphere
All isolators are equipped with sterilization and air treatment systems to decontaminate the closed volume and maintain its sterility. The aseptic environment created is suitable for handling and weighing pharmaceutical compounds or active agents, anti-plastic preparations, chemotherapy preparations… Thanks to the containment technology, there is a greatly enhanced level of safety control.
Transferring products or materials
The application of a containment isolator also makes it possible to transfer products and equipment between the sterile enclosure and the external environment. It uses communication systems for the operator to move them in and out without breaking sterility. As the atmosphere is controlled, the risk of contamination is minimized.
Components of a Containment Isolator
A containment isolator typically has translucent walls with covered corners and no seams. Because the area is at negative pressure relative to atmospheric pressure and protected by HEPA or ULPA filters, there is very little risk of contaminants escaping to the external environment during air exchange. These filters provide air treatment and are coupled with sterile gas decontamination systems.
Shoulder-high glove ports are present on the isolator shell. This makes it easier for the operator to intervene in the work area, as these gloves or sleeves are adapted to all sizes and are multi-positional. In addition to the transparency of the walls, the enclosure is illuminated to improve visibility.
The presence of communication systems such as transfer chambers is essential for sterilization, product input and output. The same goes for automatic safety devices and regulation elements to control the machine and prevent the risk of incidents. There are also waste evacuations. The components of an isolator can be configured depending on the needs and constraints of the process by adding various accessories: printer, welding machine, cooling tank, etc.