White Paper

Qualification And Validation Of Isolator Systems

Source: Bosch Packaging Technology

By J├╝rgen Metzger and Andrey Yermakovich


Manufacturing of high performance pharmaceutical machines and equipment must follow strict guidelines.  There is no room for failure, therefore all involved parties should be aware and must follow relevant norms. Successful qualification and documentation processes start in the planning phase of a project, follow through manufacturing and lifecycle of the equipment.

The user requirements and equipment functions need to be defined in the early state of a project. The specification shall clearly define CQAs and CPPs (Critical Quality Attributes and Critical Process Parameters). The materials, processes (e.g. welding) and assembly must be ensured. Materials properties and influences to certain substances must also be specified. Surface properties and radiuses shall be considered as well. Electrical equipment (e.g. sensors, actuators) and automation platform need to be considered in a Hardware Design Specification. Software and its structure is applicable in Software and Module Design Specs.