Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning agent for a GMP Cleaning Procedure

Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning agent for a GMP Cleaning Procedure

04/18/2018, 10:30 AM - 11:15 AM

Technical Conference Stage 4, Booth 1477, Exhibit Hall
Language:
English

The recent shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the design, qualification, and monitoring of a cleaning process. Cleaning agent screening is a critical element of the cleaning life cycle approach and the right decision during the design phase can bring significant rewards during the qualification and monitoring stages. Cleaning agent selection is often based on historical practices; manufacturing Site A, uses cleaning agent X, therefore Site B, uses cleaning agent X. This approach is ideal if Site A and B are manufacturing the same product, on the same equipment, and have already successfully already transitioned their cleaning validation program to the life cycle model. If the original cleaning agent selection was made without scientific scrutiny then it could drastically increase cost of compliance and risk to the manufacturing process. This presentation will review different factors to consider in screening a cleaning agent based on a scientific, risk based approach. Some topics to be discussed are: chemistry, performance, rinsability, toxicity, environmental impact, safety, stability, among others.

Contributors

  • Elizabeth Rivera

    Speaker

    Technical Services Manager

    STERIS

    Elizabeth Rivera is a technical service manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. This presentation will review different factors to consider in screening a cleaning agent based on a scientific, risk based approach. 2. Some topics to be discussed are: chemistry, performance, rinsability, toxicity, environmental impact, safety, stability, among others. 3. Cleaning agent screening is a critical element of the cleaning life cycle approach and the right decision during the design phase can bring significant rewards during the qualification and monitoring stages.

Categories

  1. Track
    Risk Management

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