Modular cleanrooms have the advantage of scalability, enabling modular cleanrooms to be installed quickly to meet demand when additional production areas are needed. Modular cleanrooms with standard layouts can be used to support some of the verification activities. Another advantage of modular clean room design is the physical isolation of the operating rooms resulting from modularity.
An isolation system, such as an isolator or restricted access isolation system (RAB), is another option to prevent contamination. The advantage of the isolator is that it provides a high quality sterile environment and protects both the operator and the product. However, it is possible that isolators may not be appropriate in the manufacture of some cell therapy products for several reasons.
1.The time to prepare and start the isolator is longer than the permissible waiting time for cell culture.
2. Operators need to be trained and have good operation skills to skillfully carry out production operation activities through gloves.
3. If a long isolator purification cycle is required, it will be an obstacle to prevent production process and transfer. If the chemicals used for decontamination enter the material for cell culture, they may inhibit cell growth or affect the material, unless the outer packing is impermeable to prevent the invasion of the gas used for decontamination.
5. If the cell material is not maintained at the correct temperature and environment for a long time, it may cause potential cell death.
6. Isolator systems are expensive, process changes increase the complexity and cost of reconfiguring isolators, and product or system changes cause reconfiguration of isolators and may increase the cost of validation.