cleanroom operations

How to Comply with
FSMA Using
Cleanroom Technology

iest cci

Since the Food Safety Modernization Act (FSMA) was passed in January 2011, FDA has stepped up its inspection and enforcement program. FSMA regulations aim to ensure the safety of the US food supply to reduce food-borne illnesses. The infiltration of pathogens into the food production and packaging process can be controlled through a comprehensive prevention program that targets the environment in which these activities are performed. Principles of cleanroom technology, long used in manufacturing for the critical electronic, medical device, and pharmaceutical industries, can effectively be adopted by processors of food products. This course provides a basic understanding of these principles so attendees can begin to understand how to control their environment to prevent the generation and transfer of such contamination to food products.

Course outline     Who should attend?     Course materials 


Course outline
  • Update of FSMA
  • Designing facilities for food manufacturing – Filtration and HVAC System Requirements
  • FSMA risk-based assessment plan
    • FSMA The Risk-Based Prevention Plan (exempt: juice and low-acid canned foods subject to HACCP)
    • ISO Recommendations for Hazard Analysis/Risk Assessment Plan
    • ISO Operations: GMP program prerequisites to hazard analysis
    • ISO Monitoring – Particle (viable/non-viable) monitoring and how to monitor microbial contamination
    • Suggestions for corrective actions – Particle /microbial removal from controlled environment surfaces
    • Record Keeping of all training, monitoring, maintenance, and installations data
    • Written plan
    • Requirement to reanalyze
  • GMP’s and pre-requisite program
  • Sanitation and disinfection theory
  • Example of SSOP – Facility Housekeeping
  • Environmental monitoring
  • Garments
  • Personal practices and example SSOP
  • Case History – The meat industry and FSM
Who should attend?

You should learn how to comply with FSMA because:
  • You are a plant manager of a facility that may require an FDA inspection
  • You are a quality assurance manager or quality control technician of your facility
  • You are an operations manager of a facility that may require an FDA inspection
  • You are a HR manager for food safety/defense training

Course materials
  • Copy of PowerPoint presentation in a course binder
  • Certificate of course attendance with completion of CEUs
Continuing Education Units: .6 CEUs