Whitepaper: Manage Your Risk: Monitoring the Environment of Aseptic Processes

Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

The risk assessment of particle and microbiological contamination of the product and its components should take into account the following aspects:

• Highest risk of contamination of the product and its components (study of the airflows and exhaust grid)
• Personnel operations
• Material and personnel flows
• Cleaning and sanitizing of environments and equipment