1- Points to be considered to minimize the risk
2- Production in clean areas
3- Appropriate standard of cleanliness
4- Filtered air supplied
5- Airlocks for entry : Personnel and/or equipment
6- Materials
7- Separate areas for operations
8- Component preparation (containers and closures)
9- Product preparation, filling, sterilization, etc.
10- Premises
- Design
- Changing rooms designed as airlocks
11- Effective flushing with filtered air
12- Separate rooms for entry and exit desirable
13- Hand washing facilities
14- Interlocking system for doors
15- Visual and/or audible warning system
16- Use filtered air supply to maintain pressure cascade
17- Pressure differential approximately 10 to 15 Pascales
18- Zone of greatest risk – immediate environment
19- Equipment
- Water treatment plants and distribution system
- Design, construction, maintenance
- Operation and design capacity
20 Environmental Monitoring
- Microbiological
- Physical parameter testing
21- Sanitation
22- Personnel
23- Processing
24- Sterilization
18(hours)