The design of isolator systems for aseptic processes involving the simultaneous handling of toxic substances places high demands on construction, layout and operation. In addition to ensuring product protection requirements in accordance with aseptic process management, effective containment must be ensured to protect operating personnel.
The presentation begins by defining the term ‘toxic’ in a regulatory and toxicological context. Building on this, the key design challenges are described, particularly with regard to containment concepts, material selection, pressure cascades, interfaces and interventions during operation. A practical solution is presented using an ADC filling line.
In addition, the topic of cleaning the isolator and machine parts will be addressed.
The presentation will conclude with the topic of SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration). It will explain how SMEPAC tests are used for the quantitative evaluation of containment performance and how they support the verification of operator safety.