Dispensing Isolator
DISPENSING ISOLATOR
compliant FDA CFR21 Part. 11
#negativepressure #safetymanipulation
#isolationtechnology
DISPENSING ISOLATOR: Il progetto nasce per realizzare un'area con contenimento in banda OEB4 (OEL 1-10µg/m3) per il dispensing di API ; l'isolatore sarà certificato in Classe 2 secondo quanto previsto dalla ISO 10648-2, ISO 14644:7. Il sistema prevede precamera (mm 700x800x900h) per l'introduzione dei materiali e camera di lavoro (mm 1800x800x900h). Automazione completa conforme FDA CFR21 Part. 11, Cicli CIP, Backup Restore, Audit trail.
DISPENSING ISOLATOR: The project was created to create an area with containment in OEB4 band (OEL 1-10µg / m3) for the dispensing of API; the isolator will be certified in Class 2 according to the provisions of ISO 10648-2, ISO 14644: 7. The system includes a pre-chamber (700x800x900h mm) for the introduction of materials and a working chamber (1800x800x900h mm). Complete automation compliant FDA CFR21 Part. 11, CIP cycles, Backup Restore, Audit trail.
#pharmacyisolator #pharmaceuticalindustry #highpotentactiveingredients #processing #isolationtechnology#smepac #OEB5
#cphiworldwide2020 #containmentisolator #negativepressure #safetymanipulation #isolationtechnology #CFR21