Aseptic & Containment Isolator Equipment is critical for maintaining the sterility of a complex process. These devices can be complex and require precise sequencing. Some of the most important factors to consider are the temperature of the isolator’s external surface and internal points. The correct operation of gas drivers is also vital.
Negative Pressure Compounding Aseptic Isolator
A Negative Pressure Compounding Aseptic Isolator (NPAI) provides a sterile environment for compounding aseptic preparations. It is designed to operate in either positive or negative pressure mode and features a recirculating airflow scheme. It also meets the requirements for international cGMP standards. It is capable of achieving a negative pressure of -15Pa in two minutes.
Depending on the type of compounding aseptic isolator, different designs are available. Each has a different design, operating characteristics, and uses. These differences will impact aseptic techniques, material transfer, and staging. Each design also differs in the characteristics of the supply airflow. A recent study suggests that users should avoid turbulent airflow CAI designs.
Closed Aseptic Isolator Systems
There are two types of enclosed isolators available: open and closed. Open isolators are often used in filling areas and are designed to allow continuous ingress and egress, but still maintain a high level of protection from contaminants. Closed isolators, on the other hand, maintain a closed atmosphere throughout their operation, and are the most suitable containment option.
Closed isolators provide containment for hazardous materials and a microbiologically controlled environment. They can be either gloved or glove-less, and they provide a barrier between the working area and the contaminated area. Closed isolators can be configured to be fully automated or manually operated. An increasing number of companies are using isolation systems to improve product quality, increase productivity, and reduce operating costs.
Open Aseptic & Containment Isolator Systems
Using open isolator systems for aseptic and contained equipment can help you achieve a number of goals. These include reducing the risk of contamination and minimizing the need for PPE, which can be costly. Moreover, they are more comfortable for operators and decrease the environmental impact of PPE disposal. The need to meet Annex 1 safety and regulatory requirements has led to a rise in inquiries about isolator technology.
A common use for open isolator systems is in the manufacturing of drugs and other toxic hazard products. They are designed to provide sterile, clean environments, and operate at an air concentration of below one microgram per m3. They can also be used for sterile product manufacturing, compounding, and sieving.
Containment Isolation Surfaces Exposed to Validated Process
Validated processes require the use of containment isolation equipment. This equipment is designed to provide isolation from the room and maintain an ISO Class 5 level of cleanliness under dynamic operating conditions. Surfaces exposed to validated processes should be cleaned at least once per day and contaminated items should be changed frequently. Particle counters should be located as close to the transfer door as possible.