OEB4 Grade Negative Pressure Isolator (Integrated Fengrui De Pulverizer) Full-Process Operating Proc

Standardize the full-process operation of the OEB4-level negative pressure isolator (integrated with a Fengrui De crusher), including equipment startup, permission management, pressure maintenance verification, material transfer through the pass-through window, crushing operation, cleaning and inactivation, material exit, and routine maintenance, to ensure personnel safety, environmental pollution-free, and product quality controllability during the operation of highly active materials (OEL 1-10μg/m³), in compliance with GMP, 21CFR PART 11, and ISO10648-2 standards.

This procedure applies to the crushing operations of high-activity and cytotoxic materials in the pharmaceutical and biological products industries. It covers equipment operators, equipment maintenance personnel, and quality supervision personnel, and involves equipment models that are negative pressure isolators (cabin material SUS316L, operating cabin pressure -30Pa~-100Pa) compliant with OEB4 protection level, integrated powder reducers, and supporting OEB4-level transfer windows (with ultraviolet disinfection and pressure interlock functions).