New York Codes, Rules and Regulations › Title 1 - DEPARTMENT OF AGRICULTURE AND MARKETS › Appendices › Appendix 6

Current through Register Vol. 46, No. 28, July 10, 2024
SANITIZATION
(cf. Part 3)
I. Methods of Sanitization
CHEMICAL
Certain chemical compounds are effective for the sanitization
				of utensils, containers, and equipment. The bactericidal activity of such
				compounds is influenced by temperature, hydrogen-ion concentration (pH), and,
				in some instances, by interfering substances in the water in which they are
				used.
The activity of chemical sanitizers may also be adversely
				affected by ingredients in washing compounds and organic matter carried over
				from the wash solution. Consequently, a rinse between washing and bactericidal
				treatment is important in maintaining the strength of solutions. Similarly,
				deposits of milk solids on utensil surfaces interfere with bactericidal
				activity, and chemical sanitizers cannot be relied upon unless the surfaces to
				be treated are clean.
Temperature, pH and exposure time also influence the corrosive
				action of the chemical bactericides and sanitizers on materials used for
				product-contact surfaces of equipment, containers, utensils, and pipelines.
				Minimum treatment consistent with sanitizing requirements will aid in
				preserving the sanitary finish of surfaces.
Hypochlorites.--Either calcium or sodium hypochlorite (stock
				powder or solution) is a satisfactory chemical sanitizer.
An exposure period of at least 1 minute to at least 50 ppm
				available chlorine should be maintained when the temperature is at least
				75° F (24° C). Under these conditions, an exposure of 1 minute is
				considered adequate for all hypochlorites, including the slower, more alkaline
				compounds. Lower solution temperatures result in slower action; for each
				18° F (10° C) drop in temperature, approximately double the exposure
				time is needed to achieve equivalent bactericidal action with the same strength
				of solution. It is also possible to compensate for lower temperatures by
				increasing the concentration of the bactericide.
Hypochlorite bactericides cannot be relied upon in the presence
				of large amounts of milk or other organic matter. A sharp decline in the
				available chlorine content of a sanitizer following circulation through
				processing equipment is usually regarded as evidence of inadequate cleaning and
				should be promptly investigated. When a spray is used in lieu of circulation or
				immersion, the above specified concentrations of available chlorine should be
				doubled.
Organic Chlorine Compounds.--The bactericidal action of
				chloramine T, the chlorinated hydantoins, the chlorinated isocyanurates and
				other organic forms of chlorine are significantly affected by pH.A
Note.--Trichloromelamine, an organic chlorine, may not be used
				to sanitize product containers and equipment.
For example, with chloramine T solutions, the maximum pH which
				can be tolerated and still provide satisfactory results at 200 ppm available
				chlorine is 7.2; at 100 ppm concentration it is 6.8; and at the 50 ppm level,
				6.4. Thus, satisfactory results with formulations of the chemical based on the
				above equivalent germicidal activities cannot be expected with products which
				ionize in solutions to give pH values higher than 6.4. The practical value of
				chloramine T is limited to situations where long exposure periods are
				practicable, or where a low pH can be provided.
Chlorinated hydantoin formulations giving solutions of pH 7.0
				and below should be satisfactory.
Satisfactory results in chlorinated isocyanuric acid solutions
				of pH values up to 9.5 can be expected.
The marked differences found in bactericidal activity of
				organic chlorine compounds over the pH range illustrate the necessity of
				establishing the conditions of use, including concentration, from experimental
				data.
Quaternary Ammonium Compounds.--Continued field use has
				established that certain quaternary ammonium compounds are effective
				bactericides for the treatment of utensils, containers, and equipment. The
				bactericidal effectiveness of specific quaternary ammonium compounds varies and
				is influenced by the chemical nature and concentration of active agent,
				temperature, pH, exposure time, and by interfering substances present in
				natural waters. It has been established that the interference of natural waters
				is due principally to bicarbonates, sulphates, and chlorides of calcium and
				magnesium. B Ferrous bicarbonate may also interfere to a lesser degree but its
				interference is minimized when the iron is oxidized. Any treatment which tends
				to precipitate, remove or inactivate calcium or magnesium reduces this
				interference as do increased pH and temperature.
Products containing n-alkyl (C 8-C
				1
								8 dimethyl benzyl ammonium
				chlorides, n-alkyl (C14-C18) dimethyl benzyl ammonium chlorides, alkyl dimethyl
				dichlorobenzyl ammonium chlorides and n-alkyl (C 1
								2-C 1
								8)
				dimethyl ethylbenzyl ammonium chlorides are effective in waters ranging from
				550 to 1,100 ppm hardness without added sequestering agents. Other quaternary
				products such as diisobutyl phenoxy ethoxy ethyl dimethyl benzyl ammonium
				chloride and methyl dodecyl benzyl trimethyl ammonium chloride-methyl dodecyl
				xylene bis (trimethyl ammonium chloride) require compounding with sufficient
				sodium tripolyphosphate to raise their hard water ceiling levels to a minimum
				of 500 ppm hardness at use concentrations. By proper formulation, however,
				levels up to 1,200 ppm are possible. The above products have been found to be
				bactericidally effective when used:
1. At concentrations of 200 ppm or more;
2. At pH levels of 5.0 or higher;
3. At temperatures of 75° F (24° C) or higher;
				and
4. For a 30-second exposure period.
The above-named compounds without sequestering agents are also
				effective within certain limits of water hardness under the conditions of use
				enumerated above however, the level of hardness at which bactericidal activity
				is reduced below that necessary for effective treatment, varies among the four
				named compounds and may be influenced by other ingredients in a proprietary
				formulation. Accordingly, the limiting hardness should be established for the
				use of each quaternary ammonium product. Unless stated on the label,c the
				regulatory agency should request such information from the manufacturer.
Bacteriological data should be used to establish the usefulness
				of the above named quaternary ammonium compounds and sequestering agents and
				any others:
1. At temperatures less than 75° F (24° C); or
2. At a pH below 6.0; or
3. When combined with a compatible sequestering agent in waters
				above 500 ppm of hardness; or
4. Without, or with less than, the specified amount of
				sequestering agent. Suggested methods and criteria are given in a following
				subsection on Other Chemical Sanitizers.
Iodine Compounds.--Another type of halogen sanitizer that has
				been found effective consists of a combination of iodine with certain nonionic
				substances. Although iodine is only slightly soluble in water and is volatile;
				in combination with nonionic wetting agents as an iodophor, it is readily
				soluble in water and is less volatile. When diluted for use, iodophors have a
				low pH which enhances their germicidal qualities. Increasing the temperatures
				of a sanitizing solution containing iodophors also increases its effectiveness,
				but above 120° F (49° C) iodine volatilizes, resulting in a decrease in
				solution strength.
In solution, iodophors are yellow or amber in color and the
				intensity is proportional to the concentration of iodine. Concentrations of
				12.5 ppm when used as a bactericide only and 25 ppm when used as a
				detergent-sanitizer have been found effective. The concentration of iodine can
				be determined by titration with sodium thiosulfate, and color tests for field
				use are available. Since the bactericidal properties of different proprietary
				formulations may vary because of differences in ingredients and pH, their
				effectiveness may be evaluated by the use of a bacteriological test procedure
				such as that proposed by Weber and Black D or the Chambers modification
				thereofE.
Detergent-Sanitizers. --Bactericides are sometimes combined
				with detergents in proprietary formulations for the cleaning and bactericidal
				treatment of containers, utensils, and equipment in a single operation. Such
				use has been reported to be effective under certain conditions for the cleaning
				and bactericidal treatment of dairy farm equipment, milk tank trucks, and
				similar equipment.
The limitations of detergent-sanitizer combinations should be
				understood if they are to be used effectively. Certain sanitizers and
				detergents cannot be combined in solution without impairment of bactericidal
				properties, cleaning properties, or both. In addition, the activity of a
				detergent-sanitizer is likely to be reduced more rapidly by the presence of
				milk solids and other organic matter in a combined operation than when
				bactericidal treatment is a separate process which follows cleaning.
These factors tend to point up the fact that the usefulness of
				a detergent- sanitizer for the combined cleaning and sanitizing treatment of
				product-contact surfaces is dependent on both the composition of the product
				and its intended use.
"Single-step" operations are actually considered most
				dependable when the amount of detergent-sanitizer can be carefully proportioned
				to the exact needs of the equipment involved, assuring effective cleaning and
				sanitizing, while minimizing the chance of residual chemical deposits on the
				equipment treated.
Further, and of equal importance to the above, is the need for
				the protection between treatment and use of all product-contact surfaces so
				sanitized. The application of untreated rinse water; the handling of equipment,
				as in the assembly of milking machines on farms or piping systems in milk
				plants; and the exposure of treated surfaces to airborne contamination through
				extended storage periods all tend to downgrade the values suggested for
				detergent-sanitizers.
These precautions are suggested where detergent-sanitizers are
				used:
1. Equipment to be treated should be thoroughly
				prerinsed.
2. Solutions should be prepared and used according to
				manufacturer's directions.
3. Treated equipment which is exposed to any of the hazards of
				contamination described above should be resanitized prior to use.
Other Chemical Sanitizers. --Bactericides other than those
				described in the previous sections are also available which are suitable for
				use on milk equipment. Compounds containing bromine and iodine have been found
				to be effective for bactericidal treatment. In addition, other types of
				chemical agents are being compounded into proprietary formulations for the
				bactericidal treatment of milk equipment; however, their bactericidal
				effectiveness varies with specific formulations. Such compounds should be safe,
				and the recommended conditions of usage should provide bactericidal treatment
				at least equal to that given by 50 ppm of chlorine as hypochlorite at pH 10.0,
				at a temperature of 75° F (24° C), and with an exposure period of 1
				minute.F
Sanitizing solutions should be prepared at a concentration such
				as to provide bactericidal effectiveness (for circulation and immersion
				applications) equivalent to that of hypochlorite solutions at a concentration
				of 50 ppm of available chlorine.
The bactericidal efficiency of chemical compounds may be
				evaluated without direct comparison to chlorine. Suitable data may be obtained
				by use of a bacteriological test procedure such as that proposed by Weber and
				BlackD, or the Chambers modification thereof E. These tests provide better
				comparative data at an endpoint somewhat less than total kill of the test
				cultures. Therefore, the test time is less than 1-minute exposure period
				prescribed in Section 7 of this Ordinance. Bactericides which, in recommended
				concentration, produce a 99.999-percent kill of 75-125 million E. coli ATTC
				11229 and of 75- 125 million M. pyogenes var. aureus ATCC 6538, within 30,
				seconds at 70°-75° F (22°-24° C), should be considered
				satisfactory. Swab tests of treated equipment do not furnish sufficient data
				for this purpose. Valid data can be obtained only when stock cultures and
				suspensions of the test organisms are prepared in a manner that uniformly
				maintains their normal level of resistance to germicidal action. Periodic
				checks to determine the consistency of test results, using a well known
				chemical such as phenol, are helpful in this regard. The importance of adhering
				strictly to the composition of mediums and manner of transplanting cultures
				specified in the test procedures cannot be overemphasized.
II. Sanitization of Assembled Equipment
STEAM
When steam is used, each group of assembled piping shall be
				treated separately by inserting the steam hose into the inlet and maintaining
				steam flow from the outlet for at least 5 minutes after the temperature of the
				drainage at the outlet has reached 200° F (94° C). (The period of
				exposure required here is longer than that required for individual cans, etc.,
				because of the heat lost through the large surface exposed to the air.) Covers
				must be in place during treatment.
HOT WATER
Hot water may be used by pumping it through the inlet if the
				temperature at outlet end of the assembly is maintained to at least 170° F
				(77° C) for at least 5 minutes.
CHEMICALS
When chlorine or another chemical solution is used, the
				solution appearing at the outlet end shall show in excess of the minimum
				required strength. The chemical solution shall be pumped through the entire
				equipment for at least 1 minute. Unions and other connectors should be slightly
				loosened to permit treatment of gaskets and threads, except on lines
				cleaned-in-place. Surfaces which are not reached by the chemical solution shall
				be treated with steam as previously described, spray application of chemical
				solution or by other acceptable means. Header ends and connecting piping of
				cabinet coolers should not be overlooked, since condensation from them may
				enter the collecting trough. Chemical sanitizing solutions should be prepared
				fresh for each use.
TREATMENT OF EQUIPMENT
The treatment of milk cans, coolers, packaging machines, other
				equipment, and all parts thereof, requires special consideration. Large
				equipment may be treated by thorough swabbing with a bactericidal solution of
				adequate strength, allowing the solution film to remain at least one
				minute.
III. Sanitizer Strength and Water Hardness Tests
TESTS FOR CHLORINE CONCENTRATION
Three types of field tests are satisfactory for chlorine
				concentration determinations:
Starch-Iodide Method (iodometric).--This test makes use of the
				fact that chlorine displaces iodine from potassium iodide in an acid solution
				(low pH). See general discussions in the latest edition of Standard Methods for
				the Examination of Water and Wastewater, published by the American Public
				Health Association. Iodine, plus starch, forms a blue color which is removed
				(decolorized) by the addition of standard sodium thiosulphate. The quantity of
				standard sodium thiosulphate required to remove the starch-iodine color is a
				measure of the chlorine present.
Field kits are available which give satisfactorily accurate
				readings of available chlorine. In some of these kits, the starch and potassium
				iodide are mixed in dry form for convenience of handling. Some use a liquid
				acid while others employ, for convenience, a crystalline one, such as sulphamic
				acid. The sodium thiosulphate is unstable unless a preservative is added. Some
				test kits make use of a preserved standardized sodium thiosulphate so that one
				drop of solution is equivalent to 10 ppm of available chlorine. Test kits
				should be checked periodically against standardized chlorine solutions.
Orthotolidine Colorimetric Comparison.--This test is based on
				the fact that orthotolidine, which is colorless, forms an orange-brown colored
				compound when added to chlorine. The depth of color is a measure of the amount
				of chlorine present. A concentration of 20 ppm of available chlorine causes a
				precipitate. Consequently, solutions which are concentrated must be diluted,
				usually at least 1:10 with chlorine-free water. Specific directions and color
				standards for comparison are included in test kits. Such test kits are
				available commercially. Color develops more slowly with alkaline hypochlorites
				than with the less alkaline compounds. Chloramines are considerably slower than
				alkaline hypochlorites in color formation, usually requiring at least 5
				minutes.
Indicator Paper Test.--The indicator paper test is widely used
				in situations where a high degree of accuracy is not required. It is a
				convenient, rapid, and generally a useful screening device. Ranges of chlorine
				concentration are indicated by the color developed on the test paper (usually
				starch-iodide impregnated) as it is immersed in the solution being
				tested.
Indicator papers are subject to rather rapid deterioration,
				especially if they are stored in a damp or chemically adverse environment.
				Their accuracy also suffers when they are handled excessively, especially if
				the operator's hands have been exposed to detergents, sanitizers, or other
				chemically active substances.
TESTS FOR QUATERNARY AMMONIUM COMPOUNDS
Test kits are available which give satisfactory accurate
				readings within the range of recommended quaternary ammonium compound
				concentrations.
In some, the reagents are tableted for convenience of handling;
				others make use of test papers. Where the sanitizing solution is essentially
				clear and free from organic contamination, the above chemical test procedures
				will measure the amount of bactericidally active quaternary ammonium compound
				present during or after use. Where organic contamination is apparent, as
				evidenced by cloudiness in the sanitizing solution, the test sample should be
				heated to boiling for at least 5 minutes, and the supernatant liquid made up to
				volume with water and then removed for testing by pipetting or decantation in
				order to differentiate between the total amount of quarternary ammonium
				compound present and the amount bactericidally active G. If there is reason to
				verify the concentration of the stock quaternary ammonium compound solution
				from which the standardized solutions are made, a laboratory procedure such as
				that of Furlong and Elliker may be used.H
TESTS FOR WATER HARDNESS
The water to be used for preparing solutions should, if
				pertinent, be within the range of hardness in which the proprietary formulation
				to be used is effective. Hardness may be determined by either the Hardness by
				Calculation Method or the Versenate Test (EDTA, titration method, ammonium
				buffer procedure), as described in the latest edition of Standard Methods for
				the Examination of Water and Wastewater, published by the American Public
				Health Association.
TESTS FOR HYDROGEN-ION CONCENTRATION
Hydrogen-ion concentration (pH) has a pronounced effect on the
				activity of sanitizing solutions. Consequently, solutions must be maintained in
				the pH range within which the bactericidal agent is effective. In most cases,
				the pH of the solution is dependent upon the buffering action of the compound
				used. The pH of bactericide solutions can best be determined electrometrically,
				using the glass electrode. However, for a field test, colorimetric methods are
				more applicable. Two types of test kits for such determinations are available
				commercially. Colorimetric readings should be made immediately, because of the
				tendency toward oxidation and decolorization of the indicator. Such indicators
				as bromthymol blue, cresol red, thymol blue, or others are satisfactory,
				depending upon the pH range desired.
References
A Ortenzio, L. F., and Stuart, L. S., The Behavior of
				Chlorine-Bearing Organic Compounds in the AOAC Available Chlorine Germicidal
				Equivalent Concentration Test. Journal of the Association of Official
				Agricultural Chemists. August 1959.
B Chambers, Kabler, Bryant, Chambers, and Ettinger, Bacterial
				Efficiency of Q.A.C in Different Waters. Public Health Reports, 70:545-554.
				June 1955.
C Bactericides shipped interstate are subject to the provisions
				of the Federal Insecticide, Fungicide, and Rodenticide Act and their labels
				must be registered with the U. S. Environmental Protection Agency.
D American Journal of Public Health, 38:1405-17, 1948.
E Chambers C. W., A Procedure for Evaluating the Efficiency of
				Bactericidal Agents, Journal of Milk and Food Technology, 19:183-187, July
				1990.
F Criteria for the Selection of Germicides, American Journal of
				Public Health, 51:1054-60, July 1961.
G Law, McNulty and Rakus, Development of a Procedure for
				Chemical Assay of the Bacterially Active Ingredient in Quaternary Ammonium
				Sanitizing Solutions, Manufacturing Chemist and Aerosol News. November 1964.
				Lautier Fils Ltd., London.
H Journal of Dairy Science, 36:225-234, March
				1953.