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Berkey Creamery
Table of Contents:
HACCP Team and Product Statement with Process Flow Diagram……………………… pg.3
8 SSOPs………………………………………………………………………………………………………………….. pg.9
Page 2 of 25
Orange
Juice
Concentrate
Received and
University Water
stored under
Supply
(-20°F)
Mixing
Drums thawed and
(balance tank of Water Softener
stored under 45°F
HTST)
Pasteurization
1 gal bottles
(CCP#1)
Pasteurized
½ gal Verification of Brix
Storage at or (11.8-12.2%)
bottles
below 45°F
Quart
In line metal
Packaging detector
(CCP#2)
bottles
Confirmatory
Pint bottles Test for
Protein
Storage and
Distribution
(under 45°F)
Page 3 of 25
Evaluation of Product and Process YES No If Yes, describe Food Safety Are modifications of
Implications the HACCP plan of
Hazard Analysis
required?
Product description change?
Formulation change?
Ingredient change?
Packaging change?
New consumption or storage methods?
New suppliers?
Process Change?
Added or changed equipment?
Finished product description change?
Evaluation of Product Safety History
Excessive CCP deviations? Any
product recall?
Any new or emerging hazards? Any
food safety consumer complaints?
Evaluation of CCPs, Critical limits, Monitoring, Corrective actions, CCP Verification, Record keeping
Do the CCPs control the hazard? Are
the CCP critical limits adequate? Do
monitoring methods and their
frequency adequately identify
deviations?
Are record keeping procedures
adequate?
Do verification activities include the
calibration of process monitoring
instruments?
Does verification include review of
consumer complaints?
Does verification include the review of
records?
Are the prerequisite programs and/ or
SSOPs identified in the hazard analysis
as reducing the likelihood of hazards still
effective?
Page 4 of 25
Page 5 of 25
Penn State Berkey Creamery Juice HACCP 201
Document
actions
Page 6 of 25
Orange juice is prepared from a concentrate, pasteurized, and then packaged for wholesale and retail
distribution.
MATERIALS
1. Supplies
a. Sanitizer
b. Swabs that detect milk protein
c. Orange juice concentrate
d. Brix refractometer
e. Chart paper
f. Record of manufacture form
2. Hazards
a. Burns from hot water and hot metal.
b. Corrosive damage to eyes and skin from sanitizer. Wear goggles and gloves when
using the concentrate. Avoid breathing the vapors.
PROCEDURE
1. Pre‐production sanitation
a. Discard the sanitizing solution that was held in the filler bowls, allowing it to flow
through the filler tubes and onto the floor.
b. Prepare at least 300 gallons of sanitizing solution in a mixing tank. Test the
concentration and record the result on the sanitation test record.
c. Pump the sanitizing solution through the lines leading to the HTST, through the HTST,
and then to the tank that will be used for orange juice production. Finally, pump the sanitizing
solution from the orange juice production tank through the lines to the fillers, allowing it to
overflow the bowls and to flow through all of the filler tubes and then onto the floor.
d. Start the HTST and pasteurize some water. Run this water through the lines leading to
the tank that will be used for orange juice production, then through the lines to the fillers. Allow
the pasteurized water to overflow the bowls and to flow through all of the filler tubes and then
onto the floor.
e. Swab food contact surfaces. If results indicate the presence of milk protein residues
repeat the sanitation procedure.
Page 7 of 25
RECORDKEEPING
1. Each day that orange juice is prepared a record of manufacture form should be filled out. This will
specify the ingredients used, the volume of juice made, and the results of the milk protein residue test.
2. Charts should be used to record the pasteurization conditions as well the temperature of the
pasteurized storage tank.
3. Record the results from the sanitizer concentration assays on the weekly sanitation test form.
4. Retain all records for at least two years.
REFERENCES
1. Penn State Berkey Creamery Juice HACCP Plan (most recent version).
2. SOP 005 Chart Usage
The following individual is responsible for implementation of this SOP and has the overall authority on‐site:
Page 8 of 25
Water is critical for food production and plant sanitation. Potable water, cooling water, steam and ice
must be safe and it must be available in sufficient quantities, at suitable pressures and temperatures, to meet
operational requirements.
The Berkey Creamery uses treated water from well fields owned and maintained by The Pennsylvania
State University. These wells provide water for the University Park Campus of Penn State and are the state
approved source of all water needs, including the cleaning and rinsing of equipment.
FACILITIES
Page 9 of 25
1. The University maintains documentation on the water tests conducted for chemical,
microbiological, turbidity and radiological parameters.
2. Microbiological test results of the water supply that are conducted by Penn State are
maintained in the Office of Physical Plant.
3. All other results from the analysis of the potable and cooling water supplies are maintained at the
Berkey Creamery for at least two years.
The following individual is responsible for implementation of this SSOP and has the overall authority on‐site:
INTRODUCTION
Clean and sanitized processing equipment and utensils are essential to the manufacture of safe food
products. Processing equipment is cleaned after each day’s run and sanitized immediately prior to the next
use. Most equipment in a dairy plant is cleaned‐in‐place (CIP) using a computer controlled multi‐step system.
Items that cannot be cleaned with the CIP system must be cleaned and sanitized after each use by hand or in a
COP (cleaned out‐of‐place) tub.
MATERIALS
1. Supplies
a. Cleaning and sanitizing agents
b. Cleaning equipment such as gloves, brushes, buckets, and foam sprayers
c. COP tub
d. Sanitation test records
2. Hazards
a. Burns from hot water and hot metal parts
b. Chemical burns to the skin and eyes from exposure to cleaners and sanitizers. Wear
gloves and goggles when using the concentrated chemicals. Avoid breathing the vapors.
1. Utensils and items that cannot be adequately cleaned with the CIP system must be hand washed.
2. These items are dismantled and pre‐rinsed with water to remove the heavy soil, then hand
scrubbed using a chlorinated alkaline detergent, and rinsed again with water. Wire screens must be
autoclaved following hand washing.
3. The cleaned items are reassembled and sanitized prior to use using the CIP sanitizing circuit if
possible or dipped in a sanitizing solution.
1. The pasteurized CIP circuit is used to clean the all of the pasteurized storage tanks, filler lines,
and the bottle and bag filling equipment.
2. If needed, the equipment is pre‐rinsed with water to remove most of the residual product.
3. The necessary line connections are made and the pasteurized CIP program is activated.
a. The first step is a water rinse
b. Then water is heated and a chlorinated alkaline detergent is added. This solution is
circulated throughout the circuit while valves and agitators are periodically pulsed to aid in
soil removal.
c. The wash cycle is followed by a water rinse which cools down the circuit.
d. Finally an acid sanitizer is added, circulated throughout the circuit, and allowed to
drain to the floor.
e. The line connections are returned to their original configuration.
4. Prior to the equipments next use a CIP sanitation step is performed using an acid sanitizer.
1. The HTST CIP circuit is used to clean the bowl, homogenizer, separator, and pasteurizer, all of the
lines connecting these pieces to equipment, as well as the lines and valves leading to the pasteurized
storage tanks.
2. If needed, the equipment is pre‐rinsed with water and the bowl is allowed to overflow with water
in order to remove most of the residual product.
3. The necessary line connections are made and the HTST CIP program is activated following the
required initial ten minute delay.
a. The first step is a caustic rinse using an alkaline cleaner. This solution is circulated
throughout the circuit while valves are periodically pulsed to aid in soil removal. It is also
allowed to overflow the bowl.
b. The caustic rinse cycle is followed by a water rinse.
Page 12 of 25
1. The ice cream mix tanks are cleaned using the pasteurized CIP circuit described above.
2. The flavor vats and ice cream freezers are rinsed with water following each use. Then a solution
of hot water and chlorinated alkaline detergent is circulated through this equipment and the lines
connecting them. Following the cleaning step the equipment is rinsed with water.
3. Prior to each days operations the pasteurized lines, flavor vats, freezers, ingredient feeder, half‐
gallon and three‐gallon filling equipment, as well as all the lines connecting this equipment are sanitized
with a chlorine sanitizer. Residual sanitizer is flushed out of the lines by pumping approximately three
gallons of ice cream mix through the circuit and draining it onto the floor. On days when the Dixie cup or
pint filling equipment is used it is likewise sanitized prior to use with a chlorine sanitizer which is allowed
to drain to the floor.
4. After each use, the filling equipment is rinsed with water to remove most of the residual product.
Then it is hand washed with a chlorinated alkaline detergent and rinsed with water again. Additionally, at
the end of each week the filling equipment that has been used is washed using a self foaming chlorinated
alkaline detergent and rinsed with water.
1. The filling lines and equipment are cleaned and sanitized using the pasteurized CIP circuit
described above.
2. On days when dairy products are packaged the following additional cleaning and sanitizing
steps are preformed.
a. Prior to packaging the acid sanitizer which was retained in the filler bowls is drained
through the filler tubes and onto the floor. The nozzle heads are also sprayed with an acid
sanitizer.
Page 13 of 25
Page 14 of 25
VALIDATION
1. Cleaned equipment and utensils are visually inspected to determine if they are free of residue and
foreign material.
2. Periodic swabbing of cleaned equipment with ATP bioluminescence swabs is used to monitor food
contact surfaces for the presence of residual soil.
3. Swabbing with milk protein detecting swabs prior to the manufacture of non‐dairy drinks is
used to monitor for possible cross‐contamination.
4. Samples are automatically collected from the various cycles within each CIP program. These are
titrated to determine their chemical concentration. If the concentrations are not consistently within an
acceptable range the chemical injection time will be adjusted.
RECORDKEEPING
1. Results from the chemical titrations of cleaning and sanitizing solutions are recorded on the
sanitation test records. These tests are performed to determine the concentrations of cleaning and
sanitizing solutions used in both the CIP system and the COP tubs.
2. Results obtained from ATP bioluminescence swabs are recorded on ATP monitoring forms.
3. Results obtained from milk detection swabs are recorded on the records of manufacture for
non‐dairy drinks.
The following individual is responsible for implementation of this SSOP and has the overall authority on‐site:
Name: ____________________________ Title: __________________________ Date: _______________
Page 15 of 25
INTRODUCTION
During processing there are numerous ways that a product can become contaminated with a microbiological
hazard. The three most common means of cross‐contamination are contact with unclean equipment, mixing
pasteurized with raw products, and environmental contamination.
PROCEDURE
1. Periodically monitor equipment such as silo tanks, valves, agitator shafts, shielding and venting
for cracks and crevices. Improper welds and irregular surfaces are difficult to clean and sanitize properly
and thus can become a harborage for microorganisms.
2. Product handling:
a. Minimize the amount of a food products handling, environmental exposure,
and time / temperature abuse following pasteurization.
b. Discard any product that has been mishandled, not protected from
contamination, or not maintained at 45ºF (7.2ºC) or less.
c. When reclaiming products, re‐pasteurization is required, using higher temperatures
and /or longer holding times. All equipment involved in the reclaiming process should be
cleaned and sanitized daily.
d. Isolate returned products and outdated products from all other plant operations.
3. Cleaning supplies:
a. Eliminate the use of absorbent items such as rags and sponges in processing areas, as
well as porous materials such as wooden handled tools and brushes. Use impervious materials
such as metal or plastic instead.
b. Brushes should be segregated; raw and pasteurized, internal and external surfaces.
c. Brushes should be maintained in good condition, sanitized between uses, and stored
properly when not in use.
4. Utilize shielding over food and food contact surfaces to minimize contamination with
condensate, aerosols, dust, and other airborne hazards.
5. Monitor the cleanliness of overhead shielding, conveyors, conveyor belts, chain rollers and
supports. Maintain a cleaning and sanitizing regimen for all conveyors.
6. Air blow and agitation equipment should be monitored for cleanliness. These are not usually
cleaned adequately by CIP methods and therefore should be dismantled, cleaned manually, and
sanitized daily.
7. Do not break or slash containers over top a vat.
8. Exercise care when handling packing materials, especially where open containers are conveyed
through non‐processing areas.
9. Heating, ventilating, and air conditioning systems:
a. Should maintain positive pressure in areas where food products are exposed.
b. Minimize air flow from potentially contaminated areas to processing and packaging areas.
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The following individual is responsible for implementation of this SSOP and has the overall authority on‐site:
Name: ____________________________ Title: __________________________ Date: _______________
Page 17 of 25
INTRODUCTION
The production of safe food begins with proper sanitation. In addition to clean food processing
equipment, the facilities that are associated with food production areas must be clean and properly
maintained.
MATERIALS
FACILITIES
Page 18 of 25
INTRODUCTION
Food, food packaging materials and food contact surfaces must be protected from adulteration with
physical or chemical hazards. Contaminants may include water, cleaners, sanitizers, lubricants, pesticides,
metal, rubber and plastic. The inclusion of unintended ingredients and undeclared allergens is also considered
to be product adulteration.
a. Review all piping to ensure that products are not being contaminated.
a. Look for lines where products, or cleaning and sanitizing solutions could become trapped.
b. Examine drain lines to make sure they are draining freely except during use.
c. Monitor for cross‐connections between raw and pasteurized lines, between product lines
and
cleaned‐in‐place (CIP) circuits.
2. Inspect the sweet water system and any equipment that utilizes sweet water for leaks and
cracks. Monitor the water for harmful contaminants.
3. When alterations are made in the process piping or equipment, change the blueprints to
reflect those alterations.
4. As part of a routine preventative maintenance program examine air valves, screens, gaskets,
seals, o‐ rings, and other metal, rubber and plastic parts on processing equipment for wear.
5. Change the filters on the air blow system frequently.
6. Use extreme caution when reworking products.
a. Ensure that all reclaimed products have been pasteurized before reuse.
b. Make certain that reclaimed product is not used in the same lines or processing
equipment as pasteurized product unless they have been cleaned and sanitized between
uses.
c. Do not reclaim products from damaged or dirty containers.
d. Do not reclaim products that are beyond the normal shelf life.
e. Do not reclaim products that have been held at elevated temperatures.
f. Do not reclaim products that have been exposed to chemical or biological contamination.
Page 19 of 25
RECORDKEEPING
1. Records of manufacture list all ingredients and packaging materials as well as their lot numbers.
These are retained for at least two years.
2. Certificates of analysis for ingredients and packaging materials should be obtained from suppliers.
3. Record the results from the cleaner and sanitizer concentration assays on the weekly test form
REFERENCES
The following individual is responsible for implementation of this SSOP and has the overall authority on‐site:
Page 20 of 25
SANITATION STANDARD OPERATING PROCEDURE – Labeling, Storage, and Use of Toxic Chemicals
INTRODUCTION
Toxic chemicals are routinely used in all aspects of the food manufacturing process. Proper labeling,
storage and use of these chemicals minimize the chance of finished product contamination as well as
enhance employee safety.
MATERIALS
1. Supplies
a. Gloves
b. Goggles
c. Spill containment supplies
2. Hazards
a. Chemicals can cause damage to skin and eyes.
b. Chemicals used in the manufacturing and sanitation processes are approved for use
in the food industry.
PROCEDURE
1. Labeling:
a. All chemicals, including mixed chemicals, should be properly labeled.
b. Chemical wastes should be labeled with red tags supplied by Environmental Health
and Safety (EHS).
2. Chemical storage:
a. Chemicals should be stored and handled in an area that is dry, well ventilated, and
separate from food handling areas.
b. All chemicals are to be stored so that incompatibles are not next to each other.
c. Chemical wastes should be stored in primary containers that are compatible with the
waste and leak proof. These primary containers should be held in secondary containment in
an approved accumulation area.
d. Stored chemicals must be inventoried annually.
e. Chemicals no longer in use or past their expiration date must be manifested to EHS for
disposal.
3. Chemical usage:
a. Chemical agents, including detergents and sanitizers, should be used in a manner
that prevents contamination of food, packaging materials, and food contact surfaces.
b. Chemicals should be mixed and stored in clean, labeled containers.
Page 21 of 25
RECORDKEEPING
REFERENCES
Page 22 of 25
INTRODUCTION
Good manufacturing practices (GMP’s) are established by the Food and Drug Administration and
detailed in the Code of Federal Regulations to protect against contamination of food. GMP’s shall be
followed by all Creamery employees, students, and visitors.
MATERIALS
HYGIENIC PRACTICES
1. Hands are to be thoroughly washed with soap and warm potable water and dried at the following
times, and as needed:
a. When reporting to work
b. After a break period
c. After smoking, eating, or drinking
d. After using toilet facilities
e. At other appropriate times as needed to maintain good sanitation
2. Eating, drinking, and gum chewing are prohibited in food processing areas.
3. Proper hair restraints must be worn
a. Hair restraint must cover entire head, including the front and back
b. Beard restraints must be worn by all employees with more than one day’s growth of
facial hair, including beards, goatees, and sideburns.
c. Mustaches that grow below the lip line must be covered with a beard restraint
4. Fingernails must be properly groomed; clean, cut to an appropriate length, with no polish
or artificial nails.
5. No watches or jewelry, except wedding rings without sets, are permitted in the processing rooms.
6. Smoking and the use of other tobacco products are prohibited, except in designated outdoor areas.
7. Clean uniforms are to be worn at the start of each shift, and left on the premises at the end of each
shift.
a. Uniform shirts and lab coats must have snap closures and no pockets above the waistline.
b. Shoes / boots must remain on the premises and sanitized in a foot bath when appropriate.
c. Hats / bandanas that are worn over hair restraints must be clean and remain on the
premises at the end of the shift.
8. Gloves used in food handling shall be maintained in an intact, clean and sanitary condition.
They should be made of an impermeable material.
9. Personal belongings and street clothing should be stored in an area separate from food handling
areas.
Page 23 of 25
1. Employees affected with any disease capable of being transmitted to others through the
contamination of food, food‐contact surfaces, or food‐packaging materials shall be excluded from any
operations which may be expected to result in the contamination of finished products until the condition
is corrected.
2. Personnel shall report such health conditions to their supervisors.
1. Employees with open sores, bleeding cuts, burns, or skin infections will not be permitted in the
processing rooms.
2. Some hand injuries may be covered with disposable gloves, provided hand washing
procedures are followed.
1. Access of personnel and visitors to processing, packaging, and finished product storage areas
should be controlled to prevent contamination.
2. All personnel and visitors must abide by the employee good manufacturing practices listed in the
sections above.
3. All necessary precautions need to be taken to prevent contamination, including the use of foot
and hand sanitizing systems.
1. OSHA requirements for confined spaces allow access by employees to confined spaces, when
necessary, for matters related to the operation of the processing facility.
2. OSHA rules on injury protection include the installation of devices, such as guards and shields, to
protect personnel from injury. Hearing protection in areas with high levels of operational noise will
reduce hearing related injury.
3. Interior air quality requirements. Adequate ventilation and proper storage of chemicals will
prevent unnecessary airborne exposure to hazardous materials.
REFERENCES
The following individual is responsible for implementation of this SSOP and has the overall authority on‐site:
Page 24 of 25
INTRODUCTION
A commercial pest control company is contracted to provide pest control services. They provide pesticide
applications on a routine basis for the treatment of insect infestations. Additionally, they perform rodent
control procedures in the building exterior areas as well as areas such as the trash disposal bins and recycling
dumpsters.
MATERIALS
Equipment, supplies, and pesticides are completely under the care, custody, and control of the pest
control company. Pesticides are approved for use in the food industry and the handler is certified and holds
an applicator’s license.
PROCEDURE
Service is performed on a monthly basis. Emergencies are handled promptly and modern equipment is
used. Trained professionals perform services in a safe manner. Concerns and needs are readily addressed and
there are periodic reviews of the pesticide application program.
RECORDKEEPING
The following individual is responsible for implementation of this SSOP and has the overall authority on‐site: