Home > A2 Barrier Isolator > What is a Barrier Isolator?

What is a Barrier Isolator?

In January 2004, USP 797 changed the way facilities that prepare compound sterile preparations (CSPs) approach their work. As the first official and enforceable requirement for CSPs, USP 797 deals with policies and practices for preparing CSPs. It applies to all facilities that prepare CSPs, including clinics, hospital care units, and main and satellite pharmacies. As facilities that prepare CSPs evaluate and change their procedures to meet USP 797 requirements, they are finding that barrier isolators provide an ideal alternative to more costly cleanrooms.

According to the Food and Drug Administration, a barrier isolator is "a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel." What this means is that by installing a barrier isolator, you can obtain cleanroom conditions within a contained workspace. Barrier isolators provide a Class 100 environment for product preparation, with work occurring inside a closed, pressurized environment accessible only via sealed gloves that reach into the work area.

Choosing a Barrier Isolator

In the United States, barrier isolators are a relatively new solution to providing a clean work environment in the pharmaceutical industry. Consequently, there are no uniform industry standards for manufacturing barrier isolators, and there are significant design differences between manufacturers. A well-designed isolator that will significantly reduce microbial contamination should meet the following minimum standards:

• Uses unidirectional or turbulent airflow to remove contaminants from the unit. A unit with unidirectional airflow showers the work zone with a continuous supply of filtered air that sweeps contaminants out through the air exhaust system. With turbulent airflow isolators, filtered air mixes with airborne contaminants and is flushed out through the exhaust system.
• Uses positive air pressure to keep external airborne particles out of the isolator.
• Is easy to clean and disinfect inside and out.
• Has a double-glove system so a leak or tear in the glove does not compromise the environment within the isolator.
• Includes a pass-through system that isolates the interior of the unit from the room when materials are transferred in and out.
• Is made of durable material that is easy to clean, such as stainless steel, glass, and high-performance, scratch-resistant plastics.
• Includes height adjustors to make the work environment as comfortable as possible.

The A2 Pharmacy Isolator

The A2 Pharmacy Isolator is an excellent example of a well-designed barrier isolator, meeting all of these standards and more:

• It uses a turbulent airflow system and has both positive and negative air pressure options.
• It is constructed of one piece of long-lasting stainless steel with rounded corners for easy sterilization.
• It includes an air-lock transfer chamber with a ventilation system that cleans the air in the chamber up to class 100 quality.
• All inside surfaces can be easily reached from the glove ports for routine sanitization. In addition, the low height and roller base frame make the external surface of the isolator easy to clean.
• Electronic controls open and close the doors and easily adjust the height. Other electronic controls monitor negative and positive pressure, the air change rate, the integrity of vacuum systems, the electrical supply, and leaks.

In addition, the A2 Pharmacy Isolator includes an Uninterruptible Power Supply (UPS), making it safe and reliable.