Cleaning Validation – Different approaches to limit setting for detergents

Cleaning Validation – Different approaches to limit setting for detergents

04/17/2018, 11:30 AM - 12:15 PM

Technical Conference Stage 4, Booth 1477, Exhibit Hall


Cleaning validation projects involve a lot of different departments and resources within pharmaceutical manufacturing. One of the most critical steps within these projects is to define acceptable limits for the cleanliness of the system. This is because all decisions concerning pass and fail during the validation phase are based on the predefined acceptance criteria. In both the 1993 "FDA Guide to Inspections Validation of Cleaning Processes" and in the 1999 "PIC/S Recommendations on Validation Master Plan Installation and Operational Qualification non-Sterile Process Validation Cleaning Validation (PI 006)" they outline defined criteria such as "default" levels like 10 PPM or dose-based limits that are 1/1000th of the normal therapeutic dose. Recently, The European Medicine Agency workshop on the generation and use of health-based exposure limits (HBEL) [EMA/410936/2017] pointed out that limits are set at 1/1000th of the minimum therapeutic dose. Acceptance limits that are set based on a fraction of the API therapeutic dose cannot be applicable for cleaning agents because cleaning agents have no therapeutic dose in humans. Furthermore the "FDA Guide to Inspections Validation of Cleaning Processes" outlines that the basis for any limits should be scientifically justifiable. The purpose of this presentation is to provide guidance to end users on cleaning agents and help them establish a strategy and rationale to set acceptance limits for cleaning agents that are in line with a harmonized approach based on scientific rationales. Different methods of limit setting for cleaning agents within the context of cleaning validation will be discussed, and example calculations will be conducted to compare the results and evaluate the risk using different approaches. In addition to discussing the methodology of limit setting, this presentation will also detail the requirements on cleaning agents that should be considered prior to any limit calculation performed in order to get a robust set-up for cleaning validation globally.


  • Thomas Altmann



    Ecolab Life Sciences

    Thomas is working in the Life Sciences division of Ecolab as Global Technical Manager and is coordinating the International Customer Service for the...

  • Emily Russell


    Marketing Communications

    Ecolab Life Sciences

    Life Sciences - Senior Marketing Communications

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. 1. Understand that limit setting is an essential part of cleaning validation projects 2. 2. Understand the different ways and reasons to set limits for cleaning agents 3. 3. Discuss the requirements for cleaning agents so that they are applicable in Pharmaceutical operations


  1. Track
    Risk Management

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