Can the level of the surrounding environment be reduced when working with the isolator?

A GMP environment generally must pay attention to good operating practices to ensure the safety of product production. Often, it is applied to the aseptic preparation of medical products, which is essential for sterile products. If a medical product cannot be terminally sterilized, for example, protein products cannot withstand high temperatures or radiation, then preparation in a sterile environment is the best option. In the past few years, sterile isolators have been considered the highest level of safety for aseptic preparation, but are also understood to be equivalent to laminar flow cabinets and weighing hoods and restricted access isolation systems (RABS). The cost is more expensive.

Now due to advances in materials technology, it is possible to produce relatively low-cost isolators, such as our QUBE series. Bioquell QBUE offers a Class A/ISO 5 aseptic environment that is significantly less expensive than traditional stainless steel and glass materials. Consider saving purchase costs. If you use an isolator, does the surrounding environment require Class A or Class B? Can C or D be satisfied? This problem is particularly acute considering the operating costs of a Class A environment rather than a Class C environment. Increasingly stringent environmental reviews and sustainable business development have the potential to reduce the space of large, high-level cleanrooms. There is no doubt that the isolator is suitable for low-level environments, but it must be combined with a good wiping process to ensure product safety. Clear standard operating procedures, proven isolator technology and routine environmental monitoring can help increase safety levels while reducing GN shop operating costs.

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