The sterility control and test isolator is a required piece of equipment in pharmacology, especially for sterile pharmaceutical products to determine their acceptability. Validation and sterilisation testing of products must be safe in order to avoid and limit false results. The use of an isolator is the best way to control the quality of sterility testing.
Why Use a Sterility Testing Isolator?
Sterility testing and control in an isolator is a reliable method of conducting sterility testing. The test and control must be carried out in a controlled aseptic environment. Compared to a clean room, the isolator is more compact and offers a high level of safety for both the environment and the operator. Sources of contamination are immediately detected for the purposes of optimizing the control and testing. The efficiency of the isolator ensures process integrity. In the event of a fault, the negative or positive pressure of the isolator’s hermetic chamber prevents contamination of the external environment or the operator.
What Are the Characteristics of an Isolator?
An isolator has transparent walls and rounded corners for easy cleaning and decontamination. It is equipped with ULPA or HEPA filters to promote air circulation. An isolator can be laminar flow, with unidirectional airflow. This keeps the working and control environment under perfect sterile conditions. The equipment can also be turbulent flow, with multi-directional air flow, where the protection of the environment and the operators is optimal.
Gloves are attached to the walls of the isolator, which allows operators to benefit from better ergonomics during handling. This ensures that sterility control and testing are kept free from any risk of external contamination.
The integrated software and options facilitate the various controls (sterility, leakage), the recording and adjustment of pressures, temperatures, humidity levels, etc.
The isolator’s work surfaces can be locked and lifted to complete the cleaning of the device. An automatic safety system prevents accidental opening of the working surfaces.
Before and after the control and sterility test, the isolator is equipped with a transfer lock to allow the products to pass through.
Jacomex Sterility and Test Isolator
Jacomex can carry out the design and manufacture of an isolator. Specialists in the design and manufacture of glove boxes, we can provide bespoke equipment with a sterile atmosphere for each of the most important stages of your testing processes. Equipped with an effective decontamination system, the isolator is gas sterilized, enabling surface treatment within a controlled environment and limiting microbiological and particulate contamination. The sterility control and test isolator and the accessories and options supplied can be tailored to your specific requirements.