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“Health-based approach” implementation for setting limits in cleaning validation for Vaccines/Biotech (La Vague 54)

Cleaning – Process validation principle

The key point before setting limits in cleaning is that cleaning is now considered as a process on its own subject to the three stage-principle developed in the FDA PV guidance (2), which are:

Stage 1: Process Design & Development
Stage 2 : Process Performance Qualification (PPQ)
Stage 3 : Continued Process Verification (CPV)

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Cleaning Validation for biotechnological substances : What acceptance criteria ? (La Vague 54)

EMA Guideline published in 2014 [1] and PDA TR49 [2] clarify some cleaning validation aspects for therapeutic macromolecules.

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Indirect visual testing is modernizing cleaning validation (La Vague 54)

Visual testing remains a vital operation in a cleaning validation strategy, and is a precondition to initiating this cleaning validation step. This is still too often neglected, the compliance of this visual test gives us a first indication of the efficacy of our cleaning step during a process. It is a pharmaceutical operation in the same way as all the other operations performed during manufacturing or packaging.

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Recovery rate determination is a preliminary and necessary step during cleaning validation. (La Vague 54)

The determination of recovery rate enables the validation of sampling techniques by precise measurement of the amount of contaminant that can be retrieved.
This study demonstrates that residues present on the surface of equipment can be adequately quantified by a combination of the analytical method and the sampling methodology. These studies provide a scientific basis which then allows the use of sampling and analytical methods during a cleaning validation exercise.

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Cleaning control strategy in the manufacture of Pharmaceutical Active Ingredients in development for clinical use (La Vague 54)

During the production of batches of commercial pharmaceutical active ingredients, validation of the cleaning of dedicated facilities is generally carried out. Systematic cleaning controls are not therefore necessary. In the case of the development of new active ingredients for pharmaceutical use, the problem of cleaning must be taken into account starting from the production of the first batches for use in phase I to III clinical trials. This article describes the strategy applied at ORIL Industrie, Servier Group, during the production of these New Chemical Entities (NCE) for clinical trials.

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