Introduction to Isolation Technology

Isolation techniques generally use closed devices, such as Isolators (Isolators), RABS (Restricted Access Barriers), and glove boxes, which are increasingly used in sterile drug production, pharmaceutical research, and laboratory applications. There are three main considerations for the application of isolation technology: 1. To protect sterile drugs from cross-contamination or the external environment during the production process; 2. To protect personnel from highly active, highly sensitizing and toxic substances (for example: penicillin) 3. Protect the environment from the spread of highly active, highly sensitizing and toxic substances under uncontrolled conditions.

Modern isolation barrier technologies fall into three main categories:

1. Simple barriers or partitions;

2. Restricted Access Barrier System (RABS);

3. Isolation barrier system (ISOLATOR).

An isolator as a barrier must be completely sealed so that it can be easily controlled and handled aseptically. A complete operating process may require a system of several isolators to completely separate the entire process from possible sources of contamination (such as surrounding equipment and operators).

Isolation in a production environment is for two reasons: to protect the process or to protect the environment (operators). Adjusting the pressure level within the isolator to meet the requirements for different purposes is a key factor. If it is necessary to protect the environment and staff, the isolator should always maintain a negative pressure state, so that even if the isolator cracks, harmful substances will not leak; and when protecting the process, the isolator should maintain a positive pressure state.

An isolator is a completely closed environment that controls potential sources of contamination (through filters, transfer devices, etc.) while also isolating personnel. To achieve this, by using a forced ventilation system to maintain the differential pressure inside and outside the isolator compartment (adjusted to positive or negative pressure as needed), the airflow remains turbulent enough to maintain a sterile or safe state or environment. (Turbulent flow: airflow flows freely without a fixed direction; laminar flow: airflow flows unidirectionally in two parallel layers without interference.) Laminar flow (which is expensive to generate and maintain) can be very useful in certain situations to ensure that areas of focus are Particles are quickly removed (in one direction), for example, the operator in the isolator needs to use some materials or mechanical tools, and these materials or tools may generate particles during use, thereby contaminating the operation process, this Laminar flow should be selected.

Sterile Isolation System

RABS (Restricted Area Isolation System) provides a protective barrier to the product within a specific area, preventing any form of contamination of the product. Personnel can operate the products in the isolation area through the "mouse hole" (special sterile channel) through special material gloves, so as to achieve free access to the sterile space. All contact parts of the system are cleaned and sterilized. The closed operation process of the isolator can completely prevent secondary pollution and ensure a high clean and sterile environment during the entire transportation process.