Isolator for Sterile Conditioning

Pharmaceutical and medical products must be packaged in a sterile environment such as a isolators used for sterile conditioning. The purpose of this equipment is to either ensure the safety of the operators, particularly in processes where active pharmaceutical ingredients are used, or to protect the operations to be carried out in the enclosure in a sterile environment or under a controlled environment. The isolator also prevents the spread of harmful substances in the environment and protects both the pharmaceutical laboratory and pharmacy staff.

 

Functions of an isolator for sterile conditioning

 

The isolator for sterile conditioning is a bacteriologically sealed enclosure used to isolate an area. It is specially designed to prevent human or environmental contamination of the internal area. Its atmosphere can be controlled. If potentially hazardous intravenous formulations, compounds or agents are required to be handled, a vacuum isolator can be used. This is widely used in pharmaceutical laboratories. As a separator chamber for sterile packaging, the confined isolator meets the requirements of ISO Class 5 standards and the high standards imposed in the pharmaceutical industry.

This device has a dual function in the packaging of pharmaceuticals and potentially hazardous substances:

1. Containment

The isolator integrates a sterilization device to enable space containment during antiblastic and chemotherapeutic preparations, weighing or handling of pharmaceutical compounds, transfers of pharmacy materials or equipment, etc. The enclosed volume can be sterilized by means of a sterilizing agent.

2. The transfer of products or materials

The isolator, which is hermetically sealed, aseptic and separated from the external environment, can be used for products as well as packaging, tools and pharmacy equipment. For maximum protection, it is equipped with communication systems allowing the insertion and removal of the elements to be protected without breaking the containment.

 

The design of the isolator

 

The corners of the confined isolators are systematically rounded and seamless to optimise the cleaning and decontamination of the enclosure and to avoid the risk of cross-contamination. HEPA or ULPA filters allow the exchange of air between the isolator and the outside environment. In the case of laminar flow, these filters also ensure air circulation is in the same direction, generally vertically, which avoids the transfer of contaminating agents to the outside and keeps the atmosphere under controlled particulate cleanliness (ISO 14644-1 standard). In the case of an isolator operating in turbulent flow under vacuum, priority is given to the protection of the operators, their environment and the sterilization of the enclosure.

To give the operator access to the workstation, one or more pairs of gloves are attached to the transparent walls of the workstation. These gloves are standard size and multi-purpose most of the time. The light and transparency of the walls are used to optimize visibility. In this way, the operator can work while remaining outside the containment area, and thus protected against (micro)biological risks.

The isolator is also equipped with lockable, flip-up work surfaces. These allow the cleaning of the isolator following a pre-cleaning to be completed and the instrumentation to be loaded or unloaded with ease. A built-in safety device prevents accidental opening of the panel to prevent any risk. This is why operators choose to opt for tailor-made isolator models instead of the standard models available on the market. Nevertheless, manufacturers also provide modular highly confined isolators to meet the increasingly high demands of the industry.

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