Equipment Cleaning in DSP

This activity presents the fundamental objectives of cleaning in biopharmaceutical environments, explaining why mastering methods such as CIP (Cleaning-In-Place) and SaIP (Sanitization-In-Place) is essential. It details the types of contamination, the responsibilities of various stakeholders, and the key steps required to ensure that equipment is clean, safe, and compliant with cGMP requirements.

This activity explores best practices in cleaning preparation, the selection of cleaning agents, and the validation of a cleaning process. It introduces the execution steps—cleaning, rinsing, sampling—the acceptance criteria, and the precautions and controls necessary to secure the safe requalification of equipment.

This activity simulates an operational cleaning procedure on a DSP line, following each step of the protocol: equipment check, initiation of the CIP sequence, sampling, and batch record documentation. It includes deviation and investigation scenarios related to cleaning quality, helping reinforce understanding of best practices.