Objectives:

• Implementing cleanroom principles and practices that comply with USP Chapter <797> and <800> requirements and other industry best practices
• Understand the Engineering controls and airflow science
• Ensures competency of all personnel involved in sterile compounding, validation, staff training and documentation.
• Understand the Principles associated with workflow, cleaning, environmental sampling, validation, and documentation.

Sterile Compounding Certificate Program Structure

Reading USP 797 and USP 800
 

  1- Self-study module Available online (2 weeks)

       Successful completion the post-test of self -study module with 80% passing rate (3 attempts permitted)

   2- Practical module On-site (Discussion and Practice) (2 weeks)

• Media fill test (result will require 14 days)
• Fingertip sampling
• Successful hands-on demonstration under supervision of expert pharmacist (3 attempts permitted)

Sterile Product Preparation Certification (SPPC)