Section 5-6.7 - Production, equipment and packaging

5-6.7 Production, equipment and packaging. All bottled water production, including transporting, packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for chemical contamination, undesirable bacterial or other microbiological growth, toxic formation, deterioration or contamination of the finished product.

(a) Bottles must be mechanically filled and closed.

(b) Fillers, piping, pumps and other process equipment used in the production of bottled water products may not be used for the production of milk, and/or dairy products. Other beverage production that may impart deleterious substances to bottled water produced in the same equipment or cause microbiological contamination of the bottled water, may also be prohibited when the contamination is confirmed by two documented cases.

(c) All equipment shall be of sanitary design and shall be constructed of nontoxic, nonabsorbent material which will not impart flavor, color or odor to the bottled water. All equipment shall be installed and maintained to facilitate the cleaning of equipment and of all adjacent spaces. All material used in the design, construction and repair of the water transmission and/or production piping in a bottled or bulk water facility must be lead free. For this Subpart, lead free shall mean solder or flux which contains no more than 0.2 percent lead and pipes, pipe fittings and any appurtenances which contain no more than eight percent lead.

(d) Storage tanks used for bottled water production shall be:

(1) Tightly closed to exclude all foreign matter and vented through inverted air filters.

(2) Without connections to sources of water not approved in writing, by the State or the governmental regulatory agency having jurisdiction over facilities located outside the State.

(3) Protected from cross connection and equipped with backflow prevention devices approved by the State or the governmental regulatory agency having jurisdiction over facilities located outside the State.

(4) Equipped with linings or coatings conforming to the listing of acceptable linings for process and potable water tanks from the State or the governmental regulatory agency having jurisdiction over facilities located outside the State.

(5) Used only for water and not for storage of any other food product or non-food substance.

(e) There shall be no cross connections between finished product water lines and any other water pipelines.

(f) Hoppers shall be provided with covers.

(g) Fillers shall have the inlet so designed as to prevent the entrance of condensation. Filling valves shall be equipped with a condensation diverting apron.

(h) Containers and packaging shall, at a minimum, meet the following requirements:

(1) Packaging processes and materials shall not transmit contaminants, or objectionable toxic or deleterious substances to the bottled water.

(2) Containers and closures for bottled water shall be in compliance with those requirements contained in Food and Drugs 21 CFR.

(3) Only sanitary, nontoxic lubricants shall be used on container contact surfaces.

(4) Bottles shall be provided with a tamper-evident seal or cap.

(5) Screw, snap and crown caps shall be new.

(6) Screw, snap and crown caps must be sanitized unless protected and received clean and kept free from bacterial contamination.

(7) When sanitized bottles cannot be filled immediately, they shall be closed or covered immediately when removed from packages. When they are to be filled, such closed bottles shall be opened, resanitized, filled and closed immediately in one continuous operation.

(8) All cleaned bottles shall be protected from dust, dirt, insects, debris and other forms of contamination.

(9) Each container of bottled drinking water shall be identified by a clear and conspicuous production code indicating, in English, the day, month and year of production. The production code shall identify a particular batch or segment of a continuous production run. The plant shall record and maintain information as to the kind of product, volume produced, date produced, production code used and the distribution of the finished product to wholesale and retail outlets to which the plant directly supplies product.

(10) Multi-use containers shall have the production date code affixed to the primary container. Cap coding is not acceptable unless the dispenser system retains the cap with the multi-use container, after opening.

(i) The plant shall have on file a written recall plan which shall detail procedures for recall of any particular batch as identified by the production code.
 

Effective Date: 
Wednesday, June 19, 1991
Doc Status: 
Complete