10- 144 C.M.R. ch. 235, § 9

Current through 2024-51, December 18, 2024

Section 144-235-9 - INSPECTION

An annual sanitary survey of each water bottling plant shall be made by the Department to determine its conformance with the U.S. FDA requirements under 21 CFR Part 129, including the following standards:

A. PLANT SURROUNDINGS.

1. Immediate plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies, other insects, and rodents, or which otherwise constitute a nuisance or unsanitary conditions.

2. Surface drainage shall be diverted away from the source well.

3. Source well shall have a sanitary seal and the well house shall be secured with a lock.

4. Source overflow pipes and vents shall be screened with #24 mesh screening.

B. BUILDING AND ROOMS.

1. All rooms shall be of sufficient size to allow for the proper installation of equipment and to facilitate its maintenance.

2. All bottling rooms shall be separated from other plant operations or storage areas by tight walls and self-closing doors to protect against contamination. No storage should be permitted in bottling rooms.

3. Plant buildings shall be insect, bird and rodent proof.

4. Ambient ozone shall be vented to the outside, and the vent shall have a #24 mesh screen. All persons engaged in handling ozonator water disinfection components must be provided with proper Personal Protective Equipment (PPE), and shall use gloves and a chemical cartridge respirator. All such equipment shall be maintained in a clean and serviceable condition in accordance with Occupational Safety and Health Administration (OSHA) and Maine Department of Labor (DOL) standards.

5. Piping system shall be free of excessive leaks or other sources of contamination.

6. Locker and lunch rooms shall be separate from plant operations and storage areas, and have self-closing doors, shall be clean and sanitary, and have refuse containers provided.

C. FLOORS.

1. The floor shall be smooth, impervious, properly drained, and maintained in a state of good repair, and shall be kept clean and free from waste, litter, and extraneous material. Floors in new construction in wet areas shall be pitched one-fourth inch per foot to properly trapped drains.

2. Floors in the bottling room shall be cleaned and disinfected daily in accordance with Section 9.F.3. of these Rules.

3. Wastewater shall be disposed of in accordance with State and Local Plumbing Codes.

D. WALLS AND CEILINGS.

1. Walls and ceilings of bottling areas shall have a smooth, cleanable surface and shall be kept clean and in good repair.

E. DOORS AND WINDOWS.

1. All outside openings into the bottling facility and bottling areas shall be effectively screened with #24 mesh screening and/or otherwise protected against the entry of insects, dust, and airborne contamination.

F. EQUIPMENT FOR COLLECTION, STORAGE AND PROCESSING OF WATER.

1. EQUIPMENT. All equipment shall be of a sanitary design and shall be constructed of non-toxic, non-absorbent material which will withstand sanitization and which will not impart flavors, color or odor to the bottled water.

2. STORAGE TANKS. Storage tanks shall be tightly closed to exclude all foreign matter. Storage tanks shall be thoroughly cleaned a minimum of once per year, in accordance with the manufacturer's specifications and in compliance with Section 9.F.3. of these Rules.

3. CLEANING/SANITIZING PROCEDURE. All product storage tanks, piping, filling equipment, container washers, cappers and other equipment used to store, handle, transport, and package the water shall be inspected, maintained, cleaned, and sanitized according to the following requirements:

(a) Wash surfaces with 100 ppm chlorine water solution at 75[DEGREE] F or higher for not less than 1 minute followed by flushing with operations water or product water (to obtain 100 ppm, add 1.0 oz. of approved chlorine bleach (5.25% chlorine) to 4 gallons of water).

(b) Spray wet surface with 100 ppm chlorine solution at 75[DEGREE] F for not less than 1 minute followed by flushing with operations water or product water. This is to be used on surfaces that are not reached by the above treatment.

(c) Satisfactory results may also be obtained by use of other bactericides such as quaternary ammonium compounds, organic chlorine compounds, and bactericidal agents containing iodine or bromine. As the effectiveness of these agents may be expected to vary with temperature, pH, and with other components of specific formulations, they should not be used unless the Department has approved their usage under specified condition.

(d) An alternative cleaning and sanitizing procedure may be employed in accordance with the chemical manufacturer's recommendations and with prior approval from the Department.

(e) Wastewater shall be disposed of in accordance with State and Local Plumbing Codes.

4. SANITIZING FILTERS. Softeners, charcoal filters, de-mineralizers, etc., shall be sanitized on the basis of recommendations by the manufacturer. Such manuals shall be available for inspection by the Department.

5. MULTIFOODS EQUIPMENT. In order to minimize the potential for microbiological contamination of the finished product, noncarbonated bottled water shall not be transported, stored, processed, or bottled in or through lines or equipment through which milk, fruit juice, or other food products have passed and is likely to contribute nutrients for microbial growth, unless said lines, equipment, or holding tanks have been cleaned in accordance with Section 9.F.3. of these Rules.

(a) Bottled water may be processed through lines or equipment used also for other food products under the following conditions:

1. Before being used for the bottling of water - filling equipment, process lines, including storage tanks and associated equipment which is designed to be cleaned in-place and which is used for filling other food products shall be thoroughly cleansed and sanitized in-place in accordance with the manufacturer's specifications and in compliance with Section 9.F.3. of these Rules.

2. Immediately following completion of filling operations for any food product other than water, the filler shall be thoroughly rinsed internally and externally with potable water.

3. Any alternate cleaning, rinsing, or sanitizing operations or processes not described in this Section shall be consistent with FDA requirements and receive prior Department approval.

6. DEDICATED EQUIPMENT. Bottled water shall not be transported or stored in bulk tanks, or processed or bottled through equipment or lines used for any non-food product.

G. CLEANING AND SANITIZING CONTAINERS.

1. MULTI-USE CONTAINERS. All multi-use containers shallbe thoroughly cleaned by washing with an effective, approved cleansing solution, having a temperature of not less than 120[DEGREE] F, followed by application of a bactericidal solution as described in the following sections.

(a) Method A: Clean by exposing all surfaces with not less than 21/12 % approved caustic solution at a minimum temperature of 120[DEGREE] F for not less than 1 minute where high velocity jets are used and for not less than 3 minutes where soaker type container washers are used, followed by a thorough rinsing with operations water or product water.

(b) Method B: Sanitize with 100 ppm chlorine water solution at 75[DEGREE] F for not less than 30 seconds, followed by a thorough rinsing with operations water or product water.

(c) Method C: Sanitize with 200 ppm approved quaternary ammonium water solution at 75[DEGREE] F for not less than 2 minutes, followed by a thorough rinsing with operations water or product water.

(d) An alternative cleaning and sanitizing procedure may be employed in accordance with the tank manufacturer recommendations and with prior approval from the Department.

2. QUALITY ASSURANCE/QUALITY CONTROL. Containers shall be protected from contamination between washers and filters. Used containers shall not be stored in the area provided for the storage of sanitized containers. Containers shall be inspected by visual and olfactory means (at a minimum) to prevent the use of contaminated bottles.

H. FILLING AND CLOSING CONTAINERS:

1. CONTAMINATION PREVENTION. Filling and closing operations shall be conducted to prevent contamination of water being bottled.

2. FILTER RESERVOIR. The filter reservoir shall be kept covered at all times and the inlet designed to prevent entrance of condensation.

3. FILLER. Filling valves shall be equipped with a condensation-diverting apron to prevent any outside condensate from dripping into the container being filled.

I. CROSS CONNECTIONS:

1. CROSS CONNECTIONS ARE PROHIBITED. No cross-connections shall exist between the product water supply lines and any other sources of water. Where operations water from a municipal or other regulated source is supplied to washers and may be used for flushing, the use of separate lines, valves, and pumps shall be employed for each water source.

J. PERSONNEL-CLEANLINESS:

1. HAND WASHING. Hands shall be thoroughly washed before commencing plant functions, and as often as may be required to remove soil and contamination, and upon returning from the toilet room.

2. CLOTHING. All personnel shall wear clean outer garments, and wear hairnets, headbands, caps or other hair restraints.

3. JEWELRY. Employees shall remove all insecure jewelry to prevent contamination of product or equipment, excluding wedding bands.

4. SICK EMPLOYEES. No person infected with any disease in a communicable form, or while a carrier of such disease, and no person with an infected cut or lesion shall work in any processing area in any capacity where there is a likelihood of such person contaminating product-contact surfaces with pathogenic organisms.

5. CONTAMINATION PREVENTION. Employees shall take necessary precautions to protect against contamination of product, product-contact surfaces, or product-packaging materials with microorganisms or foreign substances including, but not limited to: perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

6. EDUCATION AND TRAINING. Product handlers and supervisors shall receive appropriate training in proper principles, techniques and practices of plant and production sanitation and shall be informed of the public health dangers of poor personal hygiene and unsanitary practices.

7. SUPERVISION. Responsibility for assuring compliance by all personnel with all requirements of Section 9 of these Rules shall be clearly assigned to competent supervisory personnel.

K. TOILET FACILITIES:

1. TOILETS. Toilets shall be adequate for the number of employees, and toilet rooms shall have self-closing doors not opening directly into any rooms used for manufacturing, processing or packaging. Toilets and all hand washing facilities shall be maintained in a clean and sanitary condition. The toilet room shall be ventilated to the outside, kept free of odors, and be in good repair. Washable receptacles shall be provided for disposal of hand drying articles or waste material. A covered waste receptacle must be provided in toilet rooms that are used by women.

2. WASTEWATER DISPOSAL. All plumbing shall comply with the State and Local plumbing codes.

L. HANDWASHING FACILITIES.

1. Hot and cold, running water, soap, and individual sanitary towels shall be provided.

2. Hand washing facilities shall be kept clean and shall be conveniently located to the bottling area and toilet facilities.

3. Employee hand wash remindersigns shall be posted at each hand washing facility.

M. STORAGE OF SINGLE SERVICE CONTAINERS.

1. Appropriate clean, dry storage facilities shall be provided for single service containers, closure materials, paper for wrapping, adhesives and other production materials to provide protection from splash, insects, dust, and other contamination.

2. The materials shall be stored on pallets 6 inches above the floor and 18 inches away from any wall to facilitate cleaning and further provide protection from contamination.

3. Partially used cartons of single service glass, plastic bottles, caps or other closures material shall be resealed between uses.

N. ANIMALS.

1. No animals or fowl shall be kept or allowed in any bottling works or other place where bottled waters are produced. Effective measures shall be taken to prohibit contamination, in or on the premises by animals or insects.

O. TEST KITS.

1. SANITIZING SOLUTIONS. Test kits shall be kept at the bottling plant for purposes of checking the strength of the various sanitizing solutions.

2. DISINFECTION. Test kit(s) shall be kept available at the bottling plant for purposes of checking ozone or chlorine-finished product residuals.

10- 144 C.M.R. ch. 235, § 9