Cleaning Monitoring Benchmark: Visual Inspection and Surface Cleanliness Monitoring

Cleaning Monitoring Benchmark: Visual Inspection and Surface Cleanliness Monitoring

07/16/2020, 11:15 AM - 12:00 PM

Stage 4, Booth 2276, Exhibit Hall
Language:
English
The presentation goal is to compare the current practices for visual inspection/control and surface cleanliness monitoring amongst several pharmaceutical manufacturers. The presentation discusses the manufacturer practices against the current regulatory requirements for cleaning validation (EU Annex 15, ICHQ7, US FDA guideline on cleaning validation, EMA HBEL guideline, etc.). In this regard, a survey performed on more than 35 manufacturers around Europe will be shared. The goal is to discuss the survey results and compare practices regarding visual inspection after cleaning of process equipment, and procedures put in place to monitor and control the surface cleanliness (non-, direct, indirect product contact surface). Finally, the presentation shares decision trees and best practices developed and observed during the past years.

Contributors

  • Walid El Azab

    Speaker

    Technical Service Manager

    STERIS

    Walid El Azab is an Industrial pharmacist and a Qualified Person (QP). He is a Technical Services Manager for the Life Sciences Division of STERIS...

Objective

  1. Objective 1. 1. Understand the current benchmark regarding visual inspection and surface cleanliness monitoring. 2. 2. Understand the regulatory requirements for cleaning validation and monitoring. 3. 3. Be able to develop an adequate cleaning monitoring strategy based on the type of surfaces.

Type of Session

  1. Type of Session
    Session

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