Sterile Filling Isolator

The Advantages of Isolators in Sterile Filling Processes

Sterile filling isolators are essential equipment in the field of sterile filling due to their ability to create a working environment that is completely isolated from the ambient air. This isolation protects products from microbiological and particulate contamination, two issues that are critical in the production of injectable medicines and other sensitive products. Unlike traditional clean rooms, this isolator requires less monitoring. In fact, the volume of air to be sterilised is much smaller, which reduces operating costs while increasing reliability.

The isolator also offers great flexibility. It can be used for different types of products, including liquid, freeze-dried and powdered medicines. This allows pharmaceutical manufacturers to adapt to changing market needs and optimise their production lines. Finally, this equipment is generally equipped with integrated cleaning and sterilisation technologies, such as CIP (Clean-In-Place) and WIP (Wash-In-Place) systems, which ensure rapid and effective decontamination between each production cycle.

How does an Isolator Work to Ensure a Sterile Environment?

The isolator works by maintaining a physical barrier between the external environment and the workspace, which is continuously sterilised. This is achieved through a HEPA (High Efficiency Particulate Air) ventilation and air filtration system, which removes particles and pathogens from the air. The air inside the isolator is thus constantly recycled and filtered, ensuring a clean and stable atmosphere, which is essential for aseptic filling processes.

It should be noted that operators work through gloves integrated into the isolator, allowing them to handle products without coming into direct contact with the sterile environment. The equipment is also often equipped with transfer locks to introduce and remove products without compromising the sterility of the system. This allows for safer management of raw materials, finished products and instruments used during production.

Another special feature of this type of system is the integration of cleaning and sterilisation technologies. These include, among others, automatic hydrogen peroxide vapour (VHP) disinfection systems. These technologies ensure complete decontamination of the isolator without the need for dismantling or lengthy interruptions to the production process. This guarantees optimal performance and reduces the risk of contamination.

EREA Pharma: Recognised Expert in the Manufacture of Isolators for Sterile Filling

If you are looking for a leader in the design and manufacture of isolators for sterile filling, EREA Pharma can meet your needs. With many years of experience in the field of aseptic production, we offer tailor-made solutions adapted to the specific needs of laboratories and pharmaceutical manufacturers. Our isolators meet safety and quality standards, ensuring sterile environments in all circumstances.

In addition to supplying high-quality isolators, we also support our customers throughout the entire process, from the design phase to installation, including training teams in the use of the equipment. We also specialise in the integration of cleaning and sterilisation technologies, including CIP and WIP systems, which facilitate the maintenance and management of isolators without compromising the quality of the products manufactured. Thanks to our technical expertise and ability to innovate, we are an essential partner for pharmaceutical companies seeking to guarantee the sterility of their production processes while optimising their efficiency.

Are you considering installing a sterile filling isolator in your company? Contact our experts to benefit from the best solutions.