Professional Documents
Culture Documents
an Environmental Monitoring
Program
Cleaning
Hygiene GMPs &
HACCP
Preventive
& EMP
Food
Zoning SOPs Controls
Safety
Sanitation
Transition
areas
Basic
GMP
areas
Primary
pathogen
control
areas
Example: Hygienic Zoning
Primary Pathogen
Zone 1 Zone 3 Basic GMP
Control Area
Non-
Zone 2 Transition Zone 4 Manufacturing
Hygienic Zoning - Guidelines
• All manufacturing activities must take place in the appropriate areas or
zones e.g., Zone 1/ 2/ 3/ 4.
• Wherever possible highly sensitive areas should be separated by a
physical barrier to avoid cross-contamination
• Have dedicated employees in each zone(s) to achieve highest food
safety throughout the process
• Determine each zone(s) specific cleaning & monitoring requirements
• Monitor & verify
Hygienic Zoning Levels - Guidelines
• Not all food production plants require
exactly 4 hygienic zones
• Some plants require only 2/ 3/ 4
depending on the nature of the
finished product, HACCP plant, and
risk analysis
Hygienic Zoning - Controlling Traffic Pattern
Controlling raw
ingredient, equipment,
and employee traffic
pattern is key to prevent
cross-contamination
Enterobacteriaceae
Zone
3
• Non-food contact surfaces that are not close to zone 1 surfaces (walls,
floors, drains, ceilings, pallets, etc.)
• Don’t forget to include wheels!
• It is recommended to test zone 3 areas for indicator as well as pathogens
– E.g., Enterobacteriaceae for Salmonella spp.
– Listeria spp. for Listeria monocytogenes
• If zone 3 is contaminated with a pathogen, it could lead to
contamination of zone 2
Environmental Swabs in Zone 3 Areas
Total percentage of
testing from
zone 3 is normally
30-40%
Zone
4
Note: AIB International does not endorse third party products and services
Comprehensive Environmental Monitoring Program (EMP)
• EMP plan:
– Hygienic zones (1-4 zones)
– Water: All water sources
– Air: Collect air samples (E.g., air sampler
100L/min)
– Employees: E.g., Hands, boots, cloth
– Product testing: Raw ingredients &
finished product
Verification
• Periodically verify your written
environmental monitoring procedures
by increased and intensive
environmental sampling of the plant to
assess whether the hygienic sampling
sites are appropriate
(FDA 2017)
Summary
• Prevents cross-contamination
• Eliminates product held-up
• Designing products flow is the key to success
• Reduces the downtime required for an item of process equipment to be
cleaned
• Reduce the likelihood of post-lethality cross-contamination
• Helps in building an effective EMP
• Hygiene zoning helps facility prioritize/ optimize sanitation program
Questions
Thank You