GMP Benefits of Isolator in Aseptic Processing
There are many benefits to using isolator technology for aseptic processing. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. Separating the operator from the process/product results in greater product quality and operator safety.
Sporicidal agents delivered into the isolator as part of a validated system provide a much higher sterility assurance than in a cleanroom, which is typically disinfected manually.
The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling.
The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel. The room should also have temperature and humidity control.
Autoclaves (steam sterilizers) used to sterilize components/media for manufacturing/sterility testing were interfaced with isolators to keep the entire process under isolator conditions. Additional uses for aseptic isolators include component transfers, charging of sterile powders, and interface isolators for filling machines, depyrogenation ovens, and lyophilizers.
Advantages of Isolators are: Lower cost on long run, easily assembled/disassembled, lightweight, good visibility, good flexibility for glove ports and most important its operation in increases confidences in Sterility Assurance Level. Turbulent flow can be acceptable within closed isolators, which are normally compact in size.
Disadvantages of Isolators are: Large capital investment, difficult to leak test, subject to punctures, canopies need replacing, limited resistance to chemicals, adsorption and permeation of Hydrogen Peroxide, hard to validate or operate.
Conclusion: While the initial purchase of an isolator system is a large capital expense, isolators are less expensive to operate versus a cleanroom. Areas in which isolators save money versus cleanroom technology include: No gowning/de-gowning requirements save time and gown costs. Smaller HVAC system saves in utility costs. Less filtration saves in filter change costs. Small volume results in shorter decontamination times saving labor costs. Elimination of false positives results in no investigation costs. Minimum direct human intervention in operation. Therefore, isolators is best choice for liquid and freeze dried injectable products rather than dry powder filling operation.
Kuldeep Yagik (Alere Inc.)