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How to Establish a
Pathogen Environmental
Monitoring (PEM) Program
           By Ivy Cho
        ivyc@abcr.com
Questions to ask

• What are the environmental
  sources of spoilage organisms?
• Where is the presence of
  foodborne pathogens or their
  indicators in the environment
  and on the equipment?
• How effective are the cleaning
  and sanitation practices?
• How frequent should the
  cleaning and sanitation be
  practiced?
Facility environment

• Pathogens can enter as raw materials,
  ingredients, pests, or by people.
  – Persist in niches and hot spots and moves
    through the facility by traffic flow, dust,
    and condensation


  Perfect recipe for
  contamination!
Microbiological concerns

• Pathogens
  – Salmonella spp.
  – Listeria spp.
  – E. coli 0157:H7
• Indicator organisms:
  non-
  pathogenic, indicat
  ors for
  contamination
  – Aerobic plate count
  – Coliforms
  – E. coli
PEM zoning concept – Zone I

• Zone I: direct or indirect product
  contact surfaces after the lethality
  or microbial reduction step and
  before the
  product is
  sealed in the
  primary
  package
PEM zoning concept – Zone II



          • Zone II: non-
            product
            contact sites
            adjacent to
            Zone I
PEM zoning concept – Zone III

• Zone III: non-
  product contact
  sites adjacent to
  Zone II, areas of
  cross-
  contamination
  risk
PEM zoning concept – Zone IV


          • Zone IV:
            areas remote
            from Zone I
PEM zoning concept examples

                   Zone I – slicers, conveyors,
                      peelers, strip tables,
                   utensils, work tables, racks,
                   employee hands, pumps,
                          hoppers, fillers

                       Zone II – exterior of
                   equipment, refrigeration
                 units, framework, equipment
                            housing
            Zone III – phones, air return covers, hand
               trucks, forklifts, walls, floors, drains


Zone IV – cafeteria, locker rooms, halls, warehouse, loading dock
Sampling methods for PEM

• The use of proper sampling methods is
  crucial for ensuring reliable and
  defensible data.
  – Surface sampling: sponges and swabs
  – Product residue scraping and dust
    samples
  – Water and rinse samples
  – Air samples
Establish your baseline

                 • Investigational sampling is
                   intensive to establish a
                   baseline.
                    – It is not uncommon to sample
                            25-50 target areas in each
                                 zone everyday for a
                                      month.


• By determining the baseline counts, it will be
  established what is unacceptable and acceptable
  under normal operating conditions.
• Move to routine sampling; rotate sites and test each
  site 4 times a year.
Sampling Diagram
                                                          Minimum
Zone       Sampling site      Microbiological analyses    sampling   Number of
                                                         frequency    samples
  I      Direct product        Indicator organisms       Weekly         Line
          contact site        and pathogens under                    dependent
                                 special situations


 II      non-product                Pathogens            Weekly        10-15
         contact sites
       adjacent to Zone I
 III      non-product               Pathogens            Weekly        10-15
          contact sites
       adjacent to Zone II,
         areas of cross-
       contamination risk

 IV    areas remote from            Pathogens            Monthly       5-10
             Zone I
How valuable is a PEM program?

• It is more dependable and concrete to
  monitor the environment than to depend
  on finished product testing only.
  – Can help identify and eliminate harborage
    niches and hot spots.
  – Can demonstrate food safety competence
    to visitors (auditors, buyers, regulators).
  – Verifies that sanitation, GMP’s, and pre-
    requisite programs are working in
    competence.
Related information
Video instructions on how to perform environmental sampling

        The dos & don'ts of environmental sampling




      Video instructions on how to sample water & ice

         How to sample for laboratory water testing
Questions?


For additional
information, please
contact us at
352.372.0436 or visit our
website at abcr.com

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How to establish a pathogen environmental monitoring program

  • 1. How to Establish a Pathogen Environmental Monitoring (PEM) Program By Ivy Cho ivyc@abcr.com
  • 2. Questions to ask • What are the environmental sources of spoilage organisms? • Where is the presence of foodborne pathogens or their indicators in the environment and on the equipment? • How effective are the cleaning and sanitation practices? • How frequent should the cleaning and sanitation be practiced?
  • 3. Facility environment • Pathogens can enter as raw materials, ingredients, pests, or by people. – Persist in niches and hot spots and moves through the facility by traffic flow, dust, and condensation Perfect recipe for contamination!
  • 4. Microbiological concerns • Pathogens – Salmonella spp. – Listeria spp. – E. coli 0157:H7 • Indicator organisms: non- pathogenic, indicat ors for contamination – Aerobic plate count – Coliforms – E. coli
  • 5. PEM zoning concept – Zone I • Zone I: direct or indirect product contact surfaces after the lethality or microbial reduction step and before the product is sealed in the primary package
  • 6. PEM zoning concept – Zone II • Zone II: non- product contact sites adjacent to Zone I
  • 7. PEM zoning concept – Zone III • Zone III: non- product contact sites adjacent to Zone II, areas of cross- contamination risk
  • 8. PEM zoning concept – Zone IV • Zone IV: areas remote from Zone I
  • 9. PEM zoning concept examples Zone I – slicers, conveyors, peelers, strip tables, utensils, work tables, racks, employee hands, pumps, hoppers, fillers Zone II – exterior of equipment, refrigeration units, framework, equipment housing Zone III – phones, air return covers, hand trucks, forklifts, walls, floors, drains Zone IV – cafeteria, locker rooms, halls, warehouse, loading dock
  • 10. Sampling methods for PEM • The use of proper sampling methods is crucial for ensuring reliable and defensible data. – Surface sampling: sponges and swabs – Product residue scraping and dust samples – Water and rinse samples – Air samples
  • 11. Establish your baseline • Investigational sampling is intensive to establish a baseline. – It is not uncommon to sample 25-50 target areas in each zone everyday for a month. • By determining the baseline counts, it will be established what is unacceptable and acceptable under normal operating conditions. • Move to routine sampling; rotate sites and test each site 4 times a year.
  • 12. Sampling Diagram Minimum Zone Sampling site Microbiological analyses sampling Number of frequency samples I Direct product Indicator organisms Weekly Line contact site and pathogens under dependent special situations II non-product Pathogens Weekly 10-15 contact sites adjacent to Zone I III non-product Pathogens Weekly 10-15 contact sites adjacent to Zone II, areas of cross- contamination risk IV areas remote from Pathogens Monthly 5-10 Zone I
  • 13. How valuable is a PEM program? • It is more dependable and concrete to monitor the environment than to depend on finished product testing only. – Can help identify and eliminate harborage niches and hot spots. – Can demonstrate food safety competence to visitors (auditors, buyers, regulators). – Verifies that sanitation, GMP’s, and pre- requisite programs are working in competence.
  • 14. Related information Video instructions on how to perform environmental sampling The dos & don'ts of environmental sampling Video instructions on how to sample water & ice How to sample for laboratory water testing
  • 15. Questions? For additional information, please contact us at 352.372.0436 or visit our website at abcr.com