Q: We are a small, independently owned food manufacturing company. Is there a resource to assist us in getting compliant with the Global Food Safety Initiative (GFSI) standards and the U.S. Food Safety Modernization Act (FSMA)?
A: Yes. For the past decade, international retailers such as Wal-Mart, Costco, and Target have required that their suppliers achieve certification to one of the GFSI standards. The GFSI standards that are recognized in the United States are:
• British Retail Consortium (BRC) Issue 6
• SQF 2000 (Safe Quality Food) Edition 7
• ISO/FSSC 22000
• International Food Standard (IFS)
GFSI (a non-profit international foundation established to promote food safety) and FSMA (U.S. legislation signed into law in January 2011) have similar goals: to provide consumers with safe food.
The Institute of Environmental Sciences and Technology (IEST) has created recommended practices for cleanrooms and controlled environments. International standards, such as the ISO 14644 series for cleanrooms and controlled environments, and these recommended practices are used by industries regulated by the U.S. Food and Drug Administration (FDA) to meet the guidelines specified in the Code of Federal Regulations (CFR), such as 21 CFR Part 210 for pharmaceutical manufacturing.
Even though the FDA has not released specific guidelines for compliance to FSMA, 21 CFR Part 110, Guidelines for Food Manufacturing and FSMA section 103 have many similarities to the FDA guidelines for the medical device and pharmaceutical industries.
Airborne particulate cleanliness
Both FSMA and GFSI require filtered air zones similar to cleanroom environments for all aseptic filling operations for the juice and bottling industries and all high risk food manufacturing operations.
The first two standards in the ISO 14644 series, Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness (1999) and Part 2: Testing and monitoring to prove continued compliance with ISO 14644-1 (2000), are being updated and proposed revisions were issued in December 2010 as Draft International Standards (DIS). One of the major changes concerns a new principle for selection of cleanroom sample locations. Currently, both the original standards and the DIS versions may be used as trade reference per agreement between customers and suppliers.
Several IEST recommended practices enable end users to meet the requirements of ISO 14644-1 and -2, as described in Table 1.
Table 1. IEST Recommended Practices to meet requirements of ISO 14644-1 and -2. | |
IEST-RP-CC001: HEPA and ULPA Filters | Provides a reference prior to selecting air filters for a cleanroom. |
IEST-RP-CC002: Unidirectional Flow Clean-Air Devices | Reviews products and systems available for directing air flow in a cleanroom. |
IEST-RP-CC006: Testing Cleanrooms | Reviews how to perform particle testing and associated testing to achieve ISO cleanliness classifications. |
IEST-RP-CC007: Testing ULPA Filters | Provides procedures to evaluate ULPA filters used in a cleanroom. |
IEST-RP-CC019: Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and Clean-Air Devices | Provides guidelines for evaluating and selecting subcontractors to test and certify cleanrooms. |
IEST-RP-CC021: Testing HEPA and ULPA Filter Media | Describes test methods for physical and filtration properties and includes a table on filter-testing frequency. |
Additionally, IEST publishes four technical guides to assist cleanroom operators testing for particles:
• IEST-G-CC1001: Counting Airborne Particles for Classifi-cation and Monitoring of Cleanrooms and Clean Zones
• IEST-G-CC1002: Determination of the Concentration of Airborne Ultrafine Particles
• IEST-G-CC1003: Measurement of Airborne Macroparticles
• IEST-G-CC1004: Sequential Sampling Plan for Use in Classification of Particulate Cleanliness of Air in Cleanrooms and Clean Zones
Biocontamination control
Both FSMA and GFSI require development of standard operating procedures and recordkeeping of sanitation activities and environmental monitoring for microorganisms and food residue on surfaces or in the air within the plant operations.
ISO/Technical Committee 209 published two biocontamination control standards in 2000: ISO 14698-1: General principles and methods and ISO 14698-2: Evaluation and interpretation of biocontamination data.
Associated recommended practices that assist cleanroom operators in achieving the principles in these ISO standards are:
• IEST-RP-CC013: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Cleanrooms and other Controlled Environments
• IEST-RP-CC023: Microorganisms in Cleanrooms
Cleanroom design and construction
ISO 14644-4: Design, construction, and start-up provides guidance for cleanroom designers, contractors, purchasers, and suppliers. A useful tool for cleanroom installers is the construction protocol included in IEST-RP-CC012: Considerations in Cleanroom Design, which addresses the design and installation of cleanroom production equipment and includes a table on cleanroom classifications, airflow velocities, and recommended number of air changes per hour.
These two documents enable operations to meet both FSMA and GFSI requirements for construction and validation for building and manufacturing equipment upgrades.
Cleanroom operations
Food manufacturing facilities seeking to develop standard operating procedures, monitoring, and recordkeeping required to meet FSMA and GFSI requirements can reference IEST recommended practices to support the basic requirements outlined in ISO 14644-5 – Operations. Table 2 lists recommended practices for sanitation of equipment and manufacturing areas, personnel hygiene, and practices, as well as laundering and control of protective apparel.
Table 2. IEST Recommended Practices to meet requirements of ISO 14644-5. | |
IEST-RP-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments | Provides guidance for the selection of garments to protect both product and personnel from contaminants. |
IEST-RP-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments | Provides guidance for the evaluation of wipers used to clean surfaces of the product and the cleanroom. |
IEST-RP-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments | Provides guidance for the selection of gloves to protect both product and personnel from contaminants or hazardous materials. |
IEST-RP-CC018: Cleanroom Housekeeping—Operating and Monitoring Procedures | Provides practical information regarding cleaning techniques, equipment, cleaning compounds, housekeeping checklists, and methods for auditing housekeeping. |
IEST-RP-CC020: Substrates and Forms for Documentation in Cleanrooms | Provides methods for assessing the cleanliness of items such as paper, labels, forms, and similar materials. |
IEST-RP-CC026: Cleanroom Operations | Provides guidance to maintain the integrity of the cleanroom during operation. |
IEST-RP-CC027: Personnel Practices and Procedures in Cleanrooms and Controlled Environments | Reviews behavior requirements for personnel working inside the cleanroom. Includes gowning requirements. |
IEST-RP-CC032: Flexible Packaging Materials for Use in Cleanrooms and Other Controlled Environments | Provides guidance for the selection of packaging to protect product integrity. |
Surface cleanliness
Food microbiologists, food chemists, and the food industry have developed novel instrumentation and techniques to determine surface cleanliness, such as the determination of surface cleanliness using luminometers that detect the presence of adenosine triphosphate (ATP).
Part 9 of the 14644 series, Classification of surface cleanliness by particle concentration, available as a Final Draft International Standard, describes the classification of particle contamination levels on solid surfaces and recommends testing and measuring methods. Part 10, Classification of surface cleanliness by chemical concentration, is being prepared for initial release as a Draft International Standard.
IEST-STD-1246: Product Cleanliness Levels and Contamination Control Program, a standard for testing of surfaces for contaminants, provides guidance for the selection of the test methods to demonstrate the cleanliness level required. IEST has two recommended practices under development on this topic:
• IEST-RP-CC043: Surface Molecular Contamination will describe the types of surface molecular contamination (SMC) that may affect critical surfaces and processes, sources of SMC, and measurement and control methods.
• IEST-RP-CC040: Cleaning of Equipment Surfaces in the Cleanroom and Controlled Environments will provide a framework for developing an effective cleaning program for equipment surfaces.
The author would like to thank the IEST staff, Roger Diener, and tutorial speakers Stacy Street and Shawn Windley for their contributions to this article.
Jan Eudy has technical expertise for cleanroom, food, and healthcare garments and products. At Cintas, she directs the quality system and ISO registration for cleanrooms and supports validation and sterile services. She is President Emeritus and Fellow, Institute of Environmental Sciences and Technology.
This article appeared in the October 2012 issue of Controlled Environments.