Risk Assessment Document for Vial Washing Machine

Following types of risks are mainly identified during risk assessment process:

• Risk related to product contact materials for equipment and containers (eg. Selection of SS grade, gaskets, lubricants etc.)
• Risks related to appropriate utilities and their control (eg. Steam, gases, power source, compressed air etc.)
• Risks related to calibration/ preventive maintenance
• Risks related to protection the environment and health & safety of personnel.
• Risks related to cleaning & sterilization
• Risks related to control system of the equipment
• Risks related to product loss