As the name suggests the compounding aseptic Isolators are designed and created for compounding a range of Pharmaceutical Ingredients. As you might be aware, an isolator is industrial and laboratory equipment that can separate the test samples or the preparations from the adjoining surroundings so that no microorganisms can negatively affect the process of laboratory and microbiological testing of pharmaceutical production.
Air Purification
Compounding aseptic isolator exchanges purified air with the surroundings. The air is purified through the use of HEPA or High-Efficiency Particulate Air filter, which is a kind of retentive filter that can remove the microbes and pathogens by retaining them.
Removal of Exhaust Air
The exhaust air of the system is removed actively through building ventilation, which is specifically designed for the testing and filtering process and is used only in industries producing Pharmaceutical or other goods and products that require a high degree of purity and sterility. This ventilation is highly important in pharmaceutical production areas where volatile pharmaceutical preparations and drugs are being produced.
Containment of Contamination during Material Transfer
As materials are transferred in and out of the production and testing systems, it is important that the whole process is free of contaminants, pathogens, and harmful bacteria and virus. The material transfer channels and processes are specifically designed to meet these ends.
Air Pressure Stability
It is important that the process of preparation of sterile Pharmaceutical products is in line with air pressure. Incorrect air pressure differential can cause the inflow of microorganisms and pathogens from the surrounding environment. Hence it is ensured that the pressure does not vary during external or glove manipulations or during the course of the normal operations. The pressure stability of the equipment used is also validated by the manufacturing company. In the case of compounding aseptic isolators, the net or final displacement of the air is outwards or away from the isolator, and it is mandatory to maintain positive air pressure of a minimum of 0.1.
Isolator Placement related Specifications
The room where the isolator is placed should provide for gowning and hand washing, and should also have adequate size to provide for storage of materials and support operations like cleaning. The size of the room should on also be in line with the hazard potential of the drugs that are being compounded in the vicinity. The ISO class 5 standard is maintained during the transferring of materials and while the operating conditions are following. In some instances where certain conditions are not met, the compounding aseptic isolator should be kept in ISO class 7 rooms.
Isolators are not some kind of magic box but are carefully created and calibrated equipment for controlling and reducing contamination, and should all always be worked under the supervision of a qualified pharmacist.
A good quality isolator will comply with the existing legal norms as well and will provide for sterile and safe operations. Prompt and regular servicing ensures that the processes are always well controlled and only sterile and safe products are produced.