Harvesting, isolation and purification
Article 74
1. Harvesting steps, either to remove cells or cellular components or to collect cellular components after disruption, shall be performed in equipment and areas designed to minimise the risk of contamination. 2. Harvest and purification procedures to remove or inactivate the producing organism, cellular debris and media components (while minimising degradation, contamination, and loss of quality) shall be adequate to ensure that the intermediate or active substance is recovered with consistent quality. 3. All equipment shall be properly cleaned and, as appropriate, sanitised after use. Multiple successive batching without cleaning may be used if intermediate or active substance quality is not compromised. 4. If open systems are used, purification shall be performed under environmental conditions appropriate for ensuring product quality. 5. Additional controls, such as the use of dedicated chromatography resins or additional testing, may be appropriate if equipment is to be used for multiple products. Introduction of those methods is subject to risk assessment.