Free Fda-2399.p65 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

SAMPLE COLLECTOR AND TITLE

MILK SAMPLE COLLECTOR EVALUATION REPORT DAIRY PLANT SAMPLING ­ RAW AND PASTEURIZED MILK
EVALUATION BY AGENCY

LOCATION

DATE

X = DEVIATION N/A = NOT APPLICABLE

EQUIPMENT
1. Thermometer ­ Approved Type ............................................................. a. Accuracy ­ Checked against reference thermometer every 6 months (±1°C (2°F)); adjustment made; correction factor recorded ................ b. Date checked and checker's initials attached to case .......................... 2. Agitation a. Use odor-free, pressurized filtered air or electrically driven stirring or recirculatory equipment as required; all equipment sanitized before use in each successive tank (where applicable)................................... 3. Sample Transfer Instrument a. Clean, sanitized, or sterilized ............................................................... b. Seamless metal tube ........................................................................... c. Or metal dipper with long handle; capacity at least 100 ml (4 oz.) ................................................................................................. d. Or single-service paper or plastic sampling tube ................................ e. Or sanitized sampling cock ................................................................. f. Or from an approved in-line sampler .................................................. g. Or other means for removing sample aseptically ................................ 4. Sampling Instrument Case a. Proper design, construction and repair .............................................. 5. Sample Containers a. Clean, properly sanitized, or sterilized ................................................ b. Àdequate supply, properly stored and handled ................................... 6. Sample Storage Case a. Rigid construction, suitable design to maintain samples at 0°C 4.4°C (32°F - 40°F); protected from contamination; racks provided............................................................................................... 7. Cleaning and Sanitizing of Equipment a. Sampling instruments, clean and dry .................................................. b. For sanitizing stirrer, sampling tube, or dipper between samples: 1. Rinse first in one container of clean cold water connected with a continuous flowing source ............................................................. 2. Then submerge in water maintained at 82°C (180°F) for at least 1 min. ............................................................................................. 3. Or submerge in a hypochlorite solution at 200 ppm for at least 1 min. (or other bactericidally equivalent solution) ........................ 4. Strength of sanitizing solution determined with applicable test kit ...................................................................................................

SAMPLING PROCEDURES
8. General Sampling Procedures ­ Plants, Raw and Pasteurized Milk Sampling a. Hands washed, clean, and dry during sampling ............................. b. Milk temperature determined and recorded at all sampling locations .......................................................................................... c. Temperature control sample provided at first sampling location and labeled with time, date, temperature, and collector identification ................................................................................... d. Sample containers legibly identified at collection point .................. e. Sample containers and closures handled aseptically ...................... f. Sample container not held over milk when transferring sample into container .................................................................................. g. Sampling instrument protected from contamination before and during sampling ..............................................................................

h. Fill sample container not more than ¾ full ........................................ i. Immediately place samples into sample case containing ice ............ 9. Raw Milk for Pasteurization ­ Milk Tank Trucks and Plant Storage Tanks (Refer to Item 8 for applicable procedures) a. Agitation time determined as required .............................................. b. Collect sample aseptically from tank opening (manhole)................... c. Or from pipeline ................................................................................ d. Or from balance tank prior to pasteurization .................................... e. Or from sanitized sampling cock ...................................................... f. Or from an approved in-line sampler ................................................ g. Manual hand-disc agitator not used to mix milk in large storage tanks or trucks ................................................................................. h. Sample dipper, when used, rinsed at least two times before transferring sample ......................................................................... i. Dipper should extend 6 to 8 inches into milk to obtain a representative sample ................................................................................... j. Sample dipper rinsed in safe tap water after each use and replaced in sanitizing solution ........................................................................ 10. Pasteurized Milk and Milk Product Samples (Refer to Item 8 for applicable procedures) a. Samples collected while product still in possession of processor ....... b. Representative samples, randomly selected ..................................... c. After thoroughly mixing product, aseptically transfer representative portion to sterile sample container ............................................ d. Collect sample directly from milk dispenser spigot without sanitizing or flushing ........................................................................ 11. Pasteurized Milk and Milk Product Containers and Closures (Refer to Item 8 for applicable procedures) a. In the case of single-service containers and/or closures used for packaging milk and milk products, collect a randomly selected sample set from each manufacturing line (process)......................... ­OR­ In the case of multi-use containers used for packaging milk and milk products, collect at least four randomly selected containers ............... Regarding both of the above cases: 1. Lip or interior of bottles or containers not contaminated ............. 2. Milk or water prevented from dripping into empty milk containers: filler valves by-passed ................................................ 3. Containers sealed or capped with line equipment ........................ 4. Laboratory sterilized closures, when used, aseptically applied to containers .................................................................................... 5. Containers delivered to laboratory without rinse solution, properly protected from crushing or damage .............................. 6. Single-service containers not stored or shipped in refrigerated cases ........................................................................................... 12. Sample Storage and Transportation a. Ice or other refrigerant maintained slightly above milk level in sample container; sample not frozen ............................................... b. Sample protected against contamination; ice water no higher than milk level in sample containers; do not bury tops of containers in ice..................................................................................................... c. Samples and sample data promptly submitted to laboratory ............ d. Use tamper proof shipping case with top labeled "This Side Up" (when using common carrier shipping) ...........................................

REMARKS (If additional space is required, please place information on the back of this Form or on a separate page.)

FORM FDA 2399 (10/08)

FRONT

(PREVIOUS EDITIONS ARE OBSOLETE)

PSC Graphics (301) 443-1090

EF

MILK SAMPLE COLLECTOR EVALUATION REPORT
REMARKS (Continued)

FORM FDA 2399 (10/08)

BACK

(PREVIOUS EDITIONS ARE OBSOLETE)