HAR §11-37-65. adulterated

Material scheduled for rework shall be identified as such. (6) Frozen ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the ingredients from becoming adulterated. (7) Liquid or dry ingredients received and stored in bulk form shall be held in a manner that protects against allergen cross-contact and against contamination. (8) Ingredients that are allergens, and rework that contains allergens, shall be identified and held in a manner that prevents allergen cross-contact. (9) Water used as an ingredient shall be: (A) Of a defined quality; (B) Unaffected by materials used in the water treatment equipment; (C) Tested or monitored regularly to verify that it meets applicable chemical, physical, and microbiological specifications for quality; and (D) Supplied by a system set up to avoid stagnation and risks of contamination that is routinely cleaned and sanitized according to an appropriate SOP that ensures no biofilm build-up. (c) Manufacturing operations. (1) Equipment, utensils, and containers shall be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning. (2) All manufacturing, processing, packing, and holding shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination, and deterioration. (3) Crude extract, manufactured hemp products, and components that can support the rapid growth of undesirable microorganisms shall 37-73 3622 §11-37-65 be held at temperatures that will prevent the crude extract, manufactured hemp product, or component from becoming adulterated during manufacturing, processing, packing, and holding. (4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling a_w that are taken to destroy or prevent the growth of undesirable microorganisms shall be adequate under the conditions of processing, manufacture, handling, and distribution to prevent crude extract, manufactured hemp products, or components from being adulterated. (5) Work-in-process and rework shall be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms. (6) Effective measures shall be taken to protect finished crude extract or manufactured hemp products from allergen cross-contact and from contamination by ingredients, other components, or refuse. When ingredients, other components, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contamination of crude extract or manufactured hemp products. Crude extract, manufactured hemp products, or components transported by conveyor shall be protected against allergen cross-contact and against contamination as necessary. (7) Equipment, containers, and utensils used to convey, hold, or store crude extract, manufactured hemp products, components, work-in-process, or rework shall be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against 37-74 3622