Location

Productivity and Quality Institute - Alexandria

Objectives

• • Help manufacturers meet the requirements when manufacturing sterile drug and biological products using aseptic processing

Outcomes

• Identify sources of contamination in aseptic operations• Explain methods for contamination control• Describe the major requirements for design, renovation, and operation of a sterile manufacturing facility• Discuss the fundamentals of aseptic clean room design• Understand the importance of monitoring critical parameters: temperature, humidity, air velocity, differential pressure, airflow patterns, non-viable particle counts, and microbial counts• Design a systematic process for aseptic facility layout

Course Contents

Sterile and Non-Sterile Manufacturing systemsMaster Batch & completed batch recordsProductions & process controlsDispensing & weighing controlsGMP & prevention of cross contaminationHVAC systemsHVAC equipmentHVAC designBuildings and Facilities - Critical Area - Supporting Clean Areas - Clean Area Separation - Air Filtration  Membrane  High-Efficiency Particulate Air (HEPA) - DesignReprocessed & reworked materialsFilling operations, controls & environmental monitoringIn-process & finished goods packaging operations & controlsLabelling operations & controlsFilling & packaging records