module07 by xiaoyounan

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									                                                               module	7	•		page	1	of	44




Sanitary Operations: Cleaning and Sanitizing

In Module 5 we outlined the need to design, construct
and use food processing equipment and utensils that are
easy to clean. In this module we will discuss the part of
the GMP that requires you to properly clean that equip-
ment along with the rest of the processing facility.

This module will help you understand the GMP require-
ments for:

•	 General	maintenance	and	sanitary condition of
   buildings, fixtures and facilities.

•	 Proper	selection and use of cleaning and sanitiz-
   ing chemicals.

•	 General	cleaning and sanitizing procedures.

•	 Proper	cleaning and sanitation of food contact surfaces.

•	 Storage and handling of cleaned equipment and utensils.

These requirements are found in Subpart B, Section §110.35 of the GMP regulation.

There are 44 pages, 5 GMP TVs, 10 links to Internet resources, and 6 questions in this
Module. We’ll continue to use the GMP TV to provide some examples of good and bad
practices.
                                                                module	7	•		page	2	of	44




Definitions
The GMP requires that you keep your facility and all equipment, utensils and food contact
surfaces clean and sanitary, but it does not tell you how to do it. So we will begin this
Module with detailed information on how to properly clean and sanitize and then follow
with	a	discussion	of	the	specific	GMP	requirements.

Before	we	discuss	how	to	clean	and	sanitize,	it	is	important	to	understand	the	definitions	
of cleaning, sanitizing, and food contact surfaces.

Cleaning means the removal of dirt, food residue, and any other materials from a sur-
face, utensil, or equipment using detergents or other cleaning aids and either mechanical
or detergent scrubbing actions, followed by rinsing.

Sanitizing means the application of a chemical or heat to a clean surface that will kill
microorganisms.	The	definitions	section	of	the	GMP	regulation	states	that:	Sanitize means
to adequately treat food-contact surfaces by a process that is effective in destroying veg-
etative cells of microorganisms of public health significance, and in substantially reducing
numbers of other undesirable microorganisms, but without adversely affecting the product
or its safety for the consumer.

Food contact surfaces	are	defined	in	the	GMP	as	those surfaces that contact human
food and those surfaces from which drainage onto the food or onto surfaces that contact
the food ordinarily occurs during the normal course of operations. Food-contact surfaces
include utensils and food-contact surfaces of equipment. Because food contact surfaces
represent the highest risk of direct food contamination, they may need to be cleaned and
sanitized more often and more vigorously than other areas of your processing facility.
Food contact surfaces may include employee garments, gloves, and hands in addition to
equipment and utensils.
                                                                module	7	•		page	3	of	44




How To Clean
Remove Soil: Let’s start with cleaning, which is the process of removing the soil from
the plant and processing equipment. The soil that we want to remove can include food
debris made up of fats, carbohydrates, proteins and minerals, dirt, and other undesir-
able material which build up on food contact surfaces and provide nutrients that bacteria
can use to grow and multiply. After cleaning, a sanitizer is applied to destroy microorgan-
isms that may be left on the surface. It is important to remember that a sanitizer will lose
its effectiveness against bacteria unless food debris has been completely removed from
equipment and food contact surfaces.

There are two basic types of cleaning methods: manual and Clean-In-Place (CIP).

Manual Cleaning is not just a brush and bucket! It involves selecting the right cleaners,
using the right method to apply cleaning agents, and then using whatever mechanical ac-
tion is needed to remove the soil from the food contact surface.

Clean-In-Place (CIP) is a method of cleaning enclosed pipes and equipment that uses
re-circulation of cleaning and sanitizing solutions. This method is used for equipment that
cannot be easily broken down for cleaning.
                                                                    module	7	•		page	4	of	44




Use The Right Tools
Whether you use a manual or clean-in place system, developing an effective cleaning and
sanitizing program requires that you have the right tools for the job.

These tools should include:

•	 Plenty	of potable water (both hot and cold water may be needed).

•	 Detergents appropriate for use in food plants.

•	 Acceptable	cleaning tools such as brushes, pads, brooms, foam applicators, and
   sprayers.

•	 Approved	sanitizing solutions that will kill microorganisms but not contaminate food.

•	 Effective	cleaning and sanitizing procedures for your facility and all of its equipment
   and utensils.

•	 Trained employees to conduct cleaning & sanitizing procedures properly.

•	 Monitoring activities to verify that procedures are effective.

Let’s look at each of these items in more detail.
                                                                 module	7	•		page	5	of	44




Water Is Essential For Cleaning
Water Quality: You must have an
adequate water supply to clean soiled
equipment. A desirable water sup-
ply must be free of microorganisms
(clean and potable), have a neutral
pH (near pH 7), and a low mineral
content.	Some	firms	may	have	to	
treat their water to achieve these
qualities. A good water supply in-
cludes both an adequate amount of
hot and cold water and adequate
water pressure.

Water Temperature: The tempera-
ture of the water is also important.
Some cleaners may not be effective
if the water is too hot or too cold.
Check the label on the cleaner that
you use to see if the manufacturer
recommends an appropriate water
temperature. The GMP requirements for delivering hot and cold water to conduct cleaning
and sanitizing activities were covered in Module 4.

Pre-Cleaning: Before you use water for cleaning equipment, you need to remove large
particles and any heavy soil that has built up during food handling or processing. You can
do this by physically removing large scraps of food and by scraping any areas that have
food	debris	that	is	difficult	to	remove.	If	you	don’t	remove	the	heavy	soil,	you	will	end	up	
trying to wash utensils and equipment in a soupy mixture of water, food debris, and deter-
gent - a very ineffective way of cleaning.
                                                                module	7	•		page	6	of	44




Detergents and Their Use
Now that you have determined that you must have an adequate
supply of potable water at a suitable temperature and with enough
pressure, you need to decide on what type of detergent you will
use. This will depend on:

•	 The	type of soil or food debris to be cleaned,

•	 The	type of surfaces that you are cleaning,

•	 The	type	of	cleaning equipment that you will be using, and

•	 The	amount	of	water available and its chemistry (hard or soft
   water).

Detergents have different ingredients that aid in cleaning. Some
reduce the hardness or alkalinity of the water, others tie up metals
in the water, which increases wetting ability, and some make fats
easier to dissolve in water. It is important to check the label instructions and match the
detergent to the type of soil to be removed. There are many different products available
and	you	should	consult	with	your	supplier	to	find	the	right	product	for	your	situation.
                                                                 module	7	•		page	7	of	44




How Detergents or Cleaners Work
In order to select the right detergent for the right job, it
is necessary for you to understand just how detergents
work. Most detergents are composed of a mixture of in-
gredients	that	are	formulated	for	specific	types	of	dirt	or	
food residue.

Basic Ingredients: Certain ingredients in the detergent
make the residue that you are trying to remove dissolve
better in water. Most detergents are designed to work
best in hot or warm water. One ingredient in many deter-
gents is called a surfactant, which binds equally well to
water and fats or oils. These ingredients promote physical
cleaning by helping to wet, foam, and dissolve the food
debris to be removed so that it can be washed away with
water.

Chemical Agents: Other ingredients are either alkaline
or acidic, and are designed to chemically remove certain
types of soil or food debris. For example, alkaline ingredi-
ents like strong caustic soda or potash, or milder agents
like phosphates are used to remove fatty material. They
bind to fat to form soap, which can then be washed away
with water. Other detergents that contain weak or strong
acids dissolve mineral deposits, which can then be washed
away with water.

Special Additives: Additional ingredients may be added to some products to make them
more	effective	for	specific	types	of	cleaning.	Foods	like	milk	that	are	high	in	protein	can	be	
very	difficult	to	remove—especially	if	they	have	been	heated.	Specially	formulated	deter-
gents that are alkaline, contain wetting agents, or ingredients like enzymes may be need-
ed to dissolve or break down proteins.
                                                              module	7	•		page	8	of	44




Biofilms and Detergents
Biofilms: Sometimes, no matter what you do to clean, some
types of bacteria can produce a substance that protects them
from their environment and helps them to stick to food contact
surfaces.	These	bacterial	communities	are	known	as	biofilms.	If	
a	biofilm	develops	on	a	food	contact	surface,	it	cannot	be	eas-
ily	seen	or	detected	and	it	is	very	difficult	to	remove.	Harmful	
bacteria	can	be	dislodged	from	the	biofilm	during	processing	and	
contaminate food products.

Removing Biofilms: Specially formulated detergents that con-
tain an oxidizing agent such as chlorine or peroxide, in addition
to	other	ingredients,	may	be	needed	to	remove	these	biofilms.	
There are many different cleaning products available for use in
food processing plants. You should talk to your supplier to de-
termine what products will be most effective for your particular
needs. Once you determine what products to use, it is important to remember to follow all
manufacturers directions when using them and make sure that they are stored properly.
                                                                module	7	•		page	9	of	44




Choose An Effective Cleaner That Won’t
Damage Equipment
While it is important to use a detergent that will
remove all dirt and food debris, you also need to
consider the type of surface you are trying to clean.
Caustic alkaline or acidic cleaners may be effective
in removing food debris, but they can also be cor-
rosive to softer metals such as aluminum, copper, or
lower grades of steel. Stress cracking and clouding
can also occur when hard plastics are exposed to
corrosive cleaning agents for prolonged periods of
time. Higher grades of stainless steel are likely to be
more resistant to corrosion over time, which is why
it is a preferred material for handling foods that are
acidic, salty, or high in fat or water.

If cleaning agents cause the surfaces that are being
cleaned	to	deteriorate,	it	will	be	much	more	difficult	to	keep	them	clean.	For	this	reason	
it is important to use cleaning agents that are effective and get the job done, but are not
so aggressive that they pit, crack, rust, corrode or otherwise damage your food contact
surfaces.




                   Contaminated food is eaten by customers



                Foodborne illness occurs and customers get sick
                                                               module	7	•		page	10	of	44




Cleaning Basics
For both manual and CIP cleaning, there are several factors that need to be considered
including: contact time, temperature, concentration, and scrubbing. Let’s review
them.

Contact time: Detergents or cleaners do not work instantly. It takes time for them to
penetrate the soil or food debris on the food contact surface that you want to clean. That
is why a dirty pan is easier to clean after it has been soaked in warm soapy water. You
need to consider how cleaning agents will be applied, and how long they need to stay in
contact with the item to be cleaned. The “directions for use” on the label of your cleaning
agent should outline recommended dilutions and contact time. You should always refer to
these directions when using any cleaner.




Soaking: If you need to extend contact time, the most common way is to use a soak tank
or sink for portable items such as utensils, pans, cutting boards and other small pieces of
equipment.	Each	item	can	be	soaked	in	a	solution	of	the	detergent	and	warm	water	for	as	
long as necessary. This is one reason why most state and local regulatory agencies require
a two or three compartment sink equipped with hot water so that one of the compart-
ments is dedicated to washing the equipment or utensils.

However, not all equipment can be submerged in a detergent solution. Larger pieces of
equipment, walls, and other vertical surfaces which require an extended contact time
might need to be cleaned using a foam application - which will be discussed later.
                                                             module	7	•		page	11	of	44




Cleaning Basics
Temperature: As discussed earlier, each
detergent has an optimum temperature
at which it performs the best. If the water
temperature is too cold, the detergent may
not work properly. If the temperature is too
high, soil could be baked onto equipment.
Some detergents tend to degrade at higher
water temperatures.

Concentration: There is an optimal concen-
tration of detergent for each cleaning task.
Again, check the “directions for use” on the
container when deciding how much to use.

Scrubbing: Manual cleaning requires water,
a detergent, and a physical scrubbing action
in order to release the food debris that your
detergent has loosened. It is not enough just to pour water with detergent on the surface
of the equipment to be cleaned. You must also use some sort of brush, pad or other tool
and physical labor!
                                                                module	7	•		page	12	of	44




Cleaning Tools and Scrubbing
Scrubbing is Essential: There are no detergents that are ideal for every situation. Ap-
plying the right detergent for the recommended time can loosen or begin to dissolve dirt
and	food	debris,	but	scrubbing	is	usually	necessary	to	finish	the	job.	This	is	especially	true	
if the soil has dried or been cooked onto the surface. For most situations you will need to
scrub the item or surface to be cleaned with a brush, pad or other cleaning tool to loosen
all of the dirt and food debris so that it can be washed away.

Types of Cleaning Tools: There are many different types of cleaning tools. Let’s look at
two of the most common types, and some of the things to consider when deciding which
tools to use.

Brushes should be designed for use in food operations and constructed of a material that
is easy to clean and will not be damaged by the detergents that you are using. When se-
lecting brushes you should consider how they will be used. Brushes with stiff bristles may
be	appropriate	for	flat	or	difficult	to	clean	surfaces.	Softer	bristles	may	be	needed	to	clean	
curved surfaces or things that may be susceptible to scratching.

Pads are popular cleaning aids. They can be used for many different tasks because they
readily conform to the surface being cleaned and may only require light pressure to loosen
food debris. They are also useful for cleaning utensils and hard to reach areas such as un-
der the lip of a processing table. Pads should be designed for use in food establishments
and made of a synthetic material that will not be damaged by cleaning chemicals. It is
important to use pads that are designed for the type of material to be cleaned.

Avoid Damage: Pads, brushes, or other cleaning tools that are too abrasive can cause
damage such as scratching and rusting. This damage could increase the chance that
bacteria	will	attach	to	the	surface	and	form	a	biofilm,	which	could	then	contaminate	food	
products over time with harmful bacteria or other microorganisms.
                                                                module	7	•		page	13	of	44




Cleaning Tools
Design Considerations: Since scrubbing is such an
important part of the cleaning process, you should
also consider how easy your cleaning tools are to
use. For some cleaning tasks, brushes with long
handles can make scrubbing easier and for others
more	difficult.	Cleaning	tools	that	are	awkward	or	
cause user fatigue may decrease your employee’s
motivation to clean as thoroughly as possible.

Tools to Avoid: Some cleaning tools such as
sponges, wiping cloths and mops should never
be used for routine cleaning in food plants. These
items	are	very	difficult	to	clean	and	sanitize.	They	
also retain moisture and water which will promote
the growth of bacteria that could contaminate the
surface or item that you think you are cleaning. Disposable, single-use paper towels
should be used if surfaces need to be wiped.

Keep Your Cleaning Tools Clean: Damaged or dirty brushes, pads or brooms can actu-
ally be a source of contamination if they are not routinely cleaned and sanitized. Cleaning
tools	should	also	be	dedicated	to	a	specific	job.	For	example,	brushes,	brooms	or	squee-
gees	used	to	clean	the	dirtiest	areas	of	your	plant	such	as	floors	or	drains	should	never	
be used on equipment or food contact surfaces. Using different colored cleaning tools for
different jobs can be an effective way to make sure that the right tool is used for the right
job.	This	concept	will	be	discussed	in	more	detail	in	Module	8.
                                                            module	7	•		page	14	of	44




Cleaning Tools
GMP TV: Click on the images in the GMP TV below for additional information on cleaning
tools.
                                                                module	7	•		page	15	of	44




Foam Application Systems
Not all equipment can be washed or soaked in a sink. If you are cleaning large pieces of
equipment	like	processing	machinery,	tables,	coolers,	conveyors,	floors	and	walls,	that	re-
quire a longer contact time for detergent to work, a foam application system can be used.

How Foamers Work: A foam application system combines air with a foaming detergent
that has the consistency of shaving cream when it is applied. The foam tends to cling to
vertical surfaces to allow enough contact time for the detergent to do its work. This type
of application can also produce a consistent detergent concentration, and is highly visible
to ensure that you have uniform coverage of the surface to be cleaned.

Use Foam Detergents Properly: It is important to follow manufacturer directions. Us-
ing too much of the cleaning product or leaving it on surfaces too long can make clean-
ing	more	difficult	and	damage	your	equipment.	Some	important	things	to	consider	when	
using foam detergents is that you need an applicator, the foam needs a certain amount of
contact time, and you may still need to manually scrub the equipment for the detergent
to be effective. Again, all of this information is typically found in the “directions for use”
on each detergent container label. Let’s take a look at some foam application systems in
the GMP TV on the next page.
                                                            module	7	•		page	16	of	44




Foam Application Systems
GMP TV: Click on the Photos in the GMP TV below to learn more about different types of
foam applications.
                                                              module	7	•		page	17	of	44




Clean-In-Place Systems
For some types of cleaning jobs, neither manual or
foaming application of a detergent would be effec-
tive. This is usually the case for closed processing
systems such as heat exchangers, valves, pipes or
fluid	lines	used	to	convey	milk	or	other	liquid	food	
products. These types of food processing systems
are typically cleaned without disassembling each
section using the second method of cleaning that
was	briefly	mentioned	before	-	a	Clean-In-Place or
CIP system.

For CIP systems, specially formulated low foaming
detergents are usually required for cleaning. These
detergent solutions are pumped through equipment
lines at pre-determined intervals for routine cleaning. It may be necessary to periodically
disassemble the entire system for more thorough cleaning. It is important to follow manu-
facturers directions for these systems and select the proper cleaning and sanitizing chemi-
cals to prevent product contamination.
                                                                  module	7	•		page	18	of	44




Other Types of Cleaning Equipment and
Pressure Washing
Cleaning Machines: Some food processing facilities may use special types of cleaning
equipment such as automated dishwashers, tote washers, rack washers, or other types of
cleaning cabinets. This equipment should be operated according to the manufacturers direc-
tions and properly maintained so that it cleans your equipment adequately without damaging
it.	The	FDA	Food	Code	and	most	local	and	state	regulations	have	specific	requirements	for	
the installation and operation of equipment such as dishwashers.

Pressure Washers: Pressure washers are widely available and it is tempting to consider us-
ing them for cleaning food processing areas to remove dirt and food debris. However, pres-
sure washers should not be used because of the potential for re-contaminating cleaned
areas. Cleaning in food processing areas generally starts from the top down (walls to equip-
ment	to	floor).	When	a	high	pressure	spray	hits	the	floor,	a	mist	will	be	created	that	contains	
the water, dirt, food debris and harmful bacteria like Listeria	that	are	likely	to	be	on	the	floor.	
These contaminants will then settle on and re-contaminate the surfaces that have already
been	cleaned.	This	problem	will	be	even	worse	if	high	pressure	is	directed	at	or	near	floor	
drains, which are likely to contain harmful bacteria.

Summary: Whether you are using a manual or CIP system, you need to choose the right
detergent and application system for the types of soils and equipment at your facility. You
should always check the directions on the label of your detergents to make sure that you are
using the proper amount, the right water temperature, and an effective application method.
You also need to make sure that your detergents are properly labeled and stored so that they
will not contaminate the food you are receiving, storing or processing.
                                                                module	7	•		page	19	of	44




Sanitizing or Disinfection
After cleaning, you need to apply a sanitizer to kill
any bacteria or other microorganisms that may still be
present. Remember, sanitizers are less effective when
food debris is present. Food contact surfaces must be
completely free of food residue before sanitizers are
applied.

Traditionally the words disinfect and disinfectants
were used to respectively describe the procedures and
agents used to kill microorganisms and reduce their
numbers to a safe level. In the GMP regulation, and in
this course, the word sanitize has the same meaning
as disinfect, and the disinfectants or agents used to kill
harmful microorganisms are called sanitizers.

Microorganisms can be destroyed by heat, chemicals, ultraviolet (UV) light, or radiation.
Two of these options, heat and chemicals, are commonly used in food processing or stor-
age facilities. Heat may be an option for sanitizing certain pieces of equipment or utensils,
but	is	not	appropriate	for	large	pieces	of	equipment,	or	the	floors,	walls,	ceilings	and	other	
parts of the plant.
                                                                        module	7	•		page	20	of	44


Choosing A Sanitizer
Using Sanitizers: Just like detergents, there are also many different types of sanitizers that can
be used in food processing facilities. By law, you can only use chemical sanitizers that have been
approved	for	use	in	food	facilities,	and	specific	requirements	or	regulations	may	vary	from	state	to	
state. As always, it is essential that you follow directions provided on the manufacturers label, and
that the chemicals are stored properly. If not used properly, sanitizers could make the food you
produce unsafe and harm your employees.

Choosing A Sanitizer: The following table describes the advantages and disadvantages of com-
mon sanitizers that are approved for use in food processing facilities. Click here to print out this
chart	for	future	reference.	(24k	pdf)



Type of Sanitizer                 Advantages                            Disadvantages
Chlorine                          Kills most microorganisms             May corrode metal & weaken rubber
                                  Effective	at	low	temperature	         Irritating to skin, eyes & throat
                                  Test strips determine concentration   Unstable, dissipates quickly
                                  Relatively inexpensive                Loses strength with organic material
                                  Does	not	form	films                   May be unstable at high temperature
Iodine                            Kills most microorganisms             May stain plastic & porous materials
                                  Less affected by organic material     Inactivated	above	120ºF	(49ºC)	
                                  Solution color indicates activity     May be unsuitable for CIP
                                  Dissipates slowly & leaves residue
Quaternary Ammonium               Non corrosive                         Inactivated by most detergents
Compounds                         Residual activity if not rinsed       Ineffective for certain microorganisms
(Quats or QAC)                    Less affected by organic material     Effectiveness	varies	with	formulation
                                  Test strips determine concentration   May be inactivated by hard water
                                  Can be applied as foam                May be unsuitable for CIP
Chlorine Dioxide                  Kills most microorganisms             Unstable and cannot be stored
                                  Stronger oxidizer than chlorine       Potentially explosive and toxic
                                  Less affected by organic material     Relative high initial equipment cost
                                  Less corrosive than chlorine
Ozone                             Kills most microorganisms             More expensive than many sanitizers
                                  Stronger oxidizer than chlorine &     Unstable and cannot be stored
                                      chlorine dioxide                  May corrode metal & weaken rubber
                                                                        Potentially toxic
                                                                        Inactivated by organic material
Peroxy Compounds                  Works	well	on	bacteria	in	biofilms    More expensive than some sanitizers
                                  Kills most microorganisms             Inactivated by some metals
                                  Relatively stable in use              May corrode some metals
                                  Effective	at	low	temperature          Not as effective against yeast & molds
                                  Suitable for CIP


                                                                                          Continued
                                                                           module	7	•		page	20	of	44




Hot Water                          Kills most microorganisms               May	form	films	or	scale	on	equipment
171 to 190ºF (77 to 88ºC)          Penetrates irregular surfaces           Potential burn hazard for employees
                                   Suitable for CIP                        Contact time sensitive
                                   Relatively inexpensive                  Inappropriate for general sanitation
Carboxylic Acid                    Kills most microorganisms               Inactivated by some detergents
                                   Sanitize and acid rinse in one step     Less effective than chlorine at low
                                   Low foaming, suitable for CIP           temp.
                                   Stable if organic material is present   May damage some materials
                                   Less affected by hard water             Less affective against yeast & molds
                                                                           pH sensitive
Acid-Anionic Sanitizers            Sanitize and acid rinse in one step     Effectiveness	varies	by	microorganism
                                   Very stable                             More expensive than some sanitizers
                                   Less affected by organic material       May corrode some metals
                                   Can be applied at high temperature      Unsuitable for CIP due to foaming
                                   Not affected by hard water



Adapted from Sanitation Control Procedures Manual, National Seafood HACCP Alliance, Florida Sea Grant Re-
port	No.	119,	Gainesville,	FL,	2000.
                                                                                 module	7	•		page	21	of	44




Using Sanitizers Correctly
Just like detergents, sanitizers must be used and applied properly or they will either be
ineffective in killing microorganisms or cause damage to the plant, processing equipment,
or employees.

Concentration: First, you must use the right sanitizer at the right strength or concentra-
tion. If the sanitizer concentration is too low, you will not kill microorganisms. If the con-
centration is too high, you could make the food you produce unsafe, damage equipment,
or	even	harm	employees.	The	federal	regulations	for	sanitizing	solutions	in	21CFR	Part	
178.1010	give	the	maximum	amount	of	active	sanitizer	that	should	be	used	in	food	pro-
cessing establishments. The following table gives the maximum concentration allowed and
the most commonly used concentration range for common sanitizers.

Sanitizer Concentrations Commonly Used in Food Processing Facilities

Sanitizer                     Concentration                 pH                            Minimum Temp.
Chlorine                      50 ppm                 8	or	less                            75°F	(24°C)
                              100 ppm                10 or less                           55°F (13°C)
                              Maximum	200	ppm	
                              for FCS
Iodine                        12.5	to	25	ppm	        5 or less              75°F	or	24°C
                              Maximum	25	ppm	
                              for FCS
Quats                         Minimum concentra- Follow manufacturer 75°F	or	24°C
                              tion per manufac-        directions.
                              turer directions       Water hardness must
                              Maximum	200	ppm	 be 500 ppm or less
                              for FCS
Chlorine dioxide              100	to	200	ppm
                              Maximum	200	ppm	for	FCS
Peroxy Compounds              Minimum and Maximum amounts of hydrogen peroxide, acetic
                              acid, peroxyacetic acid, peroxyoctanoic acid and other ingredients
                              as	specified	for	approved	formulas	in	21	CFR	178.1010

Maximum	and	minimum	concentration	values	for	Food	Contact	Surfaces	(FCS)	are	specified	in	approved	sanitizer	formulas	
in	21	CFR	178.1010,	Sanitizing	Solutions.	pH	and	minimum	temperatures	are	from	the	2001	FDA	Food	Code.	Contact	time	
is at least 1 minute. Table adapted from FDA Food Code and Sanitation Control Procedures Manual, National Seafood HACCP
Alliance, Florida Sea Grant Report No. 119, Gainesville, FL, 2000.
                                                                module	7	•		page	22	of	44




Use The Right Amount of
Sanitizer
Concentration: Sanitizer concentration is measured in ppm
or parts per million. This is an extremely small amount of ac-
tive sanitizer. To help you appreciate just how small this is, 100
parts per million would be equivalent to:

•	 8	1/3	feet	in	16	miles;	or	

•	 1	hour	and	40	minutes	in	2	years;	or

•	 6	¼	pounds	in	64,000	pounds;	or

•	 One	$100	dollar	bill	in	a	stack	of	10,000	$100	dollar	bills;	or

•	 100	cars	in	a	bumper-to-bumper	traffic	jam	from	Cleveland	
   to San Francisco.

Making Sanitizer Solutions: To make solutions that have
the proper amount of sanitizer, you need to carefully follow the
directions for use provided on the sanitizers’ label. Because the
amount you need is so small, if even a little mistake is made
when these solutions are prepared, the concentration could be
too high or too low. That is why you need to check the concen-
tration of your sanitizing solution with a test strip each time it is
prepared and periodically during use to make sure that you have the right concentration
so that the sanitizer will work properly.
                                                                  module	7	•		page	23	of	44




Measuring Sanitizer Concentration
Test Strips or Kits: Your chemical supplier should be able to provide an appropriate test
strip or kit for the sanitizer that you are using. Test strips are available for chlorine, iodine,
Quats, peroxide and other sanitizers. When these test strips are dipped in the solution
that you have prepared for a certain amount of time, they will change color based on the
amount	of	the	active	sanitizer	in	the	solution.	The	final	color	of	the	strip	is	compared	to	a	
color	chart	on	the	container	to	tell	you	the	amount	of	sanitizer	in	the	solution.	Each	sani-
tizer will need a different test strip. For example, test strips for chlorine will not measure
iodine or Quats. You should also make sure that the strips you use are capable of mea-
suring in the concentration range that you are working with. For example, if you need to
measure	chlorine	in	the	100	to	200	ppm	range,	the	strip	you	use	should	not	measure	in	
the 0 to 10ppm range.

GMP TV: Click on the GMP TV below to learn more about test strips that can be used to
measure sanitizer concentrations.
                                                                module	7	•		page	24	of	44




Using Sanitizers Properly
Sanitizers, just like detergents, aren’t effective if they are not used properly. You need to
consider contact time, water, organic material or the amount of soil present in the
solution, and their application. Let’s look at each of these factors.

Contact Time: Just like detergents, sanitizers must be in contact with the cleaned surface
long enough to kill bacteria and other microorganisms. In general, sanitizers like chlorine,
iodine, and Quats need at least 1 minute of contact time with the cleaned food contact
surfaces in order to be effective. Some sanitizer formulas may have different suggested
contact times, and you should follow the directions on the sanitizers’ label. Sanitizers like
Quats may provide residual sanitizing activity over a longer period of time if the surface is
not rinsed after the sanitizer has been applied.

Water Chemistry and Temperature: The effectiveness of some sanitizers may be af-
fected by the pH (acidity or alkalinity) or the hardness of the water that is used to make
up the sanitizer solution. For example, chlorine is especially affected by pH and it will lose
its effectiveness if used in very basic (alkaline) solutions. Again, it is important to check
the directions for use on the label and prepare your sanitizer accordingly. For most appli-
cations,	room	temperature	water	at	approximately	75°F	(24°C)	should	be	used	to	make	
up sanitizer solutions.
                                                               module	7	•		page	25	of	44




Using Sanitizers Properly
Organic material: Sanitizers like chlorine
will react with the organic material in food
debris that contains protein, fat or carbo-
hydrate and make the sanitizer unavailable
to kill bacteria and other microorganisms.
That is why it is necessary to clean food
contact surfaces to remove this soil before
they are sanitized. If sanitizers are used
in solutions where employees are dipping
their hands, the amount of available sani-
tizer also decreases as organic material
builds up. For this reason you need to pe-
riodically check the concentration of these
solutions during the work day and change
them as often as necessary.

Application: Just like detergents, you may
also need to consider how you will apply a sanitizer solution to food contact surfaces,
equipment,	floors	and	walls	after	cleaning.	For	utensils	and	portable	items,	it	is	easy	
to immerse them in a sanitizing solution after cleaning. For large pieces of equipment,
walls	and	floors	it	may	be	necessary	to	spray	the	sanitizer	solution	onto	the	surface	in	
a way that will ensure that it is in contact with the surface for at least 1 minute or for
the time suggested by the manufacturer. Options can include portable sprayers or even
in-line metered systems that mix the proper amount of sanitizer and water. Application
methods and tools can often be provided by your chemical supplier.
                                                              module	7	•		page	26	of	44




Additional Resources
If you would like to learn more technical details about cleaning and sanitizing chemicals,
how they work, and how to use them, click on the links below to university fact sheets.
More information is also available from trade associations, university or extension food
safety specialists, and government agencies. Click on the buttons below to review these re-
sources. Use your browsers BACK button at the top of the screen to return to this module.




There are many different chemical suppliers. Most of them have a national network of dis-
tributors. One way to locate a chemical supplier would be to check your yellow page list-
ings under food processing or restaurant equipment and supplies. For additional informa-
tion, Click on the following links which contain directories of many different chemical and
cleaning suppliers across the U.S.
                                                                module	7	•		page	27	of	44




Basic Cleaning and Sanitizing Procedure
So far this module has discussed the things you should consider when selecting cleaning
and sanitizing products. Now you need to develop and implement a procedure for clean-
ing and sanitizing everything in your processing facility. To do this you should start with a
basic procedure for proper cleaning and sanitizing, and then identify any variations that
may	be	needed	for	various	areas	of	the	plant,	specific	processing	or	storage	equipment	
like refrigeration units, and portable equipment and utensils. Let’s look at the basic steps
that should be included in a complete cleaning and sanitizing procedure.
                                                               module	7	•		page	28	of	44




Developing Your Cleaning and Sanitizing
Procedures
General Components: You can use the information provided in this Module to develop
effective cleaning and sanitizing procedures for your operation to meet GMP requirements.
The GMP requires you to have effective procedures but it does not currently require that
they	be	written	down.	Each	procedure	should	include	how and what you will clean and
sanitize, where and when this will be done, and who will do it.

Basic Procedures: The basic 10 Step procedure described on the previous page can
be used to help you develop a procedure that describes how you will clean and sanitize.
Some operations may only need one or two procedures. For example, one procedure for
cleaning	all	equipment	and	fixed	items	like	tables,	conveyors,	and	processing	machines,	
and another procedure for portable items and utensils using a three-compartment sink.
More complex operations may need to develop separate procedures for different areas of
the plant, for different pieces of equipment, or for different processing systems. You will
also need procedures for cleaning and sanitizing cleaning tools like brushes, pads, scrap-
ers, brooms, and squeegees.

Customized Procedures: For each procedure you must decide which cleaning agents
and sanitizer will be used, the concentration that is needed, and how they will be applied.
You may need different cleaners, sanitizers, and application methods for different parts of
the facility or pieces of equipment. These different procedures should be included in your
sanitation procedure to be sure that employees who do routine or periodic cleaning and
sanitizing tasks know exactly how to clean and sanitize each utensil, piece of equipment,
or processing area.
                                                             module	7	•		page	29	of	44




Developing Your Cleaning and Sanitizing
Procedures
Set Up A Schedule: You must also
decide when and how often you need
to clean and sanitize your facility and its
equipment and utensils. At a minimum,
it is likely that all food contact surfaces
will need to be cleaned and sanitized at
least once per day, and those areas that
become dirty during processing may
need to be cleaned and sanitized more
than once per day. Some areas or equip-
ment such as refrigerated coolers, freez-
ers, or dry storage areas may only need
to be cleaned and sanitized periodically.
Your procedure should describe when
each routine and periodic task should be
completed. The goal of the GMP require-
ment is to make sure that you protect
food	from	being	contaminated	with	filth	and	harmful	bacteria	on	unclean	food	contact	
surfaces.

Assign Tasks: Finally, your cleaning and sanitizing procedure should indicate who is
responsible	for	cleaning	and	sanitizing	tasks.	Some	firms	may	have	a	dedicated	clean-
ing crew who conducts these tasks after food handling or processing stops at the end of
the	shift	or	workday.	Others	may	assign	specific	cleaning	and	sanitizing	tasks	to	produc-
tion	employees	that	must	be	completed	at	the	end	of	their	shift.	Each	employee	who	has	
a cleaning and sanitizing responsibility must be trained to understand why their task is
important and how to do it properly.
                                                              module	7	•		page	30	of	44




Monitoring The Effectiveness of Your
Procedures
Monitoring: Because cleaning and sanitizing is so
important to protect the food you are processing
from contamination, you should monitor these ac-
tivities. At a minimum, a supervisor or other des-
ignated person should visually inspect equipment,
utensils and other food contact surfaces to make
sure that they are clean before food is handled
and processed each day. Cleaning and sanitizing
tasks should also be monitored routinely to make
sure that the procedures you have developed are
being conducted properly.

Monitoring Tools: Because visual inspections are
subjective, you may also want to periodically measure how effective your procedures are.
Several types of tools are available to help you measure the effectiveness of your cleaning
and sanitizing procedures. However, the GMP only requires that your sanitation procedures
be effective, it does not require testing. Since these monitoring tools can be expensive,
each	firm	must	decide	whether	or	not	they	are	needed	and	how	to	use	them.

Sanitation test kits are available to measure the amount of organic material (food de-
bris and bacteria) on a surface. This type of test involves swabbing a food contact surface
that has been cleaned and sanitized. The swab is then exposed to an enzyme solution that
reacts with a particular chemical in food debris and soil to produce light. The amount of
light produced is measured by an instrument that indicates how much organic material
was picked up on the swab. Other quick test kits can detect protein or sugars on food con-
tact surfaces. A food contact surface is swabbed and the swab is immersed in a solution
that reacts with the protein or sugar on the swab to produce a color that shows how well
the surface was cleaned.

These measurements do not distinguish between living bacteria and food debris, but
provide a general estimate of cleanliness. Several different companies manufacture instru-
ments or test kits to measure cleanliness. Check with your sanitation supplier or search
the Internet using the terms ATP Testing or Luminometers.
                                                               module	7	•		page	31	of	44




Monitoring The Effectiveness of Your Proce-
dures
Bacterial Testing: In some situations, you may
want to know if bacteria have survived the cleaning
and sanitizing process on surfaces. Test kits, such
as contact plates, are available for some types of
bacteria. These plates are touched to the surface to
be tested and stored at the proper temperature for
one or more days. The plates are visually checked
to estimate the number of bacteria that were on
the surface. For some food products, there may be
specific	requirements	for	testing	for	certain	types	
of bacteria like Listeria, E. coli, or Salmonella. Food
testing laboratories can provide the necessary sup-
plies to take appropriate samples and determine if
these bacteria are present.

Resource Information: One useful resource for information on commercial test kits for
different types of bacteria can be found on the Internet in the Compendium of Fish and
Fishery Product Processes, Hazards, and Controls at the University of California at Davis.
For information on testing for different types of bacteria click here. When you get to this
site, click on the organism or test of interest in the Biological Hazards section, and then
click on commercial test kits.
                                                               module	7	•		page	32	of	44




GMP Requirements for Cleaning and
Sanitizing
Now that you have a basic understanding of how to clean and sanitize your facility and
measure the effectiveness of your program, complying with the GMP requirements should
be easy. Let’s take a look at those requirements and what you can do to meet them.

GMP Requirement: General maintenance. Buildings, fixtures and other physical fa-
cilities of the plant shall be maintained in a sanitary condition and shall be kept
in repair sufficient	to	prevent	food	from	becoming	adulterated.	Cleaning and sanitizing
of utensils and equipment shall be conducted in a manner that protects against
the contamination of food, food-contact surfaces, or food packaging materials.

Maintenance:	The	first	part	of	this	GMP	requirement	says	that	not	only	your	building,	but	
also everything in the facility must be kept in a sanitary condition to prevent the food that
you receive, process or store from getting contaminated.

The control strategies that we reviewed earlier for the maintenance of your facility, its
equipment, and your employee’s practices in Modules 3, 4, 5 and 6 are included in the
GMP to make sure that you can maintain your facility in a sanitary condition. To comply
with this part of the GMP you also need to have procedures to clean and sanitize those
parts of your facility that may not come in direct contact with food, but may eventually
lead to food or food contact surface contamination if they are not kept in a sanitary condi-
tion.

Cleaning and Sanitizing Equipment and Utensils: The second part of this GMP re-
quirement says that you must clean and sanitize your equipment and utensils in a way
that will protect your food and anything that comes into contact with food from contami-
nation. This will require that the procedures that are routinely used to clean and sanitize
equipment and utensils will not contaminate any food in your facility. For example, this
is why it is necessary to remove all food products from the area before you begin your
cleaning procedures.
                                                               module	7	•		page	33	of	44




Sanitation of Food Contact Surfaces
GMP Requirement: Sanitation of food contact surfaces. All food contact surfaces, in-
cluding utensils and food contact surfaces of equipment, shall be cleaned as frequently
as necessary to protect against contamination of food.


Food Contact Surfaces: This part of the GMP focuses on all of the things in your opera-
tion that will come into contact with food. These food contact surfaces include things like:
cutting boards, food preparation tables, conveyor belts, processing machinery, knives,
spoons, other utensils, pans, tubs, totes, ice and any other item that will come in direct
contact with food during handling, processing, or storage.

Frequency of Cleaning: This GMP requirement says that all food contact surfaces must
be cleaned as frequently as necessary to prevent contamination. There is no rule for
deciding how often it is necessary to clean all of the different pieces of equipment or uten-
sils in your plant that may come in contact with food. Most food contact surfaces should
be cleaned at a minimum of once a day depending on the food being processed. In some
cases equipment and utensils may need to be cleaned after every use. Also, if a piece of
equipment is accidently contaminated by the plant environment itself, it would need to be
cleaned.	For	example,	if	someone	uses	a	high	pressure	hose	to	clean	the	floor,	and	the	
water	from	the	dirty	floor	splashes	onto	cleaned	food	contact	surfaces,	those	food	contact	
surfaces would need to be re-cleaned and re-sanitized before they are used.

Factors that Effect Frequency Can Include:

•	 The	type	of	food.

•	 Whether	the	processing	environment	is	wet	or	dry.

•	 The	ambient	temperature	in	the	processing	area.

Every	operation	must	determine	how	often	cleaning	and	sanitizing	is	necessary	based	on	
their processing activities, the types of equipment used, and most importantly on the food
that is being processed. For example, if you are processing a ready-to-eat product (a food
that will not be cooked before it is eaten) then cleaning and sanitizing may need to be
done more frequently to prevent these foods from being contaminated by harmful bacteria
like Listeria.
                                                              module	7	•		page	34	of	44




Special Requirements for Low Moisture
Foods and Wet Processing
GMP Requirement: Food contact surfaces used for manufacturing or holding low
moisture food shall be in a dry, sanitary condition at the time of use. When the
surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried
before subsequent use.

GMP Requirement: In wet processing, when cleaning is necessary to protect against
the introduction of microorganisms into food, all food contact surfaces shall be
cleaned and sanitized before use and after any interruption during which the
food contact surfaces may have become contaminated. Where equipment and uten-
sils are used in a continuous production operation, the utensils and food contact
surfaces of the equipment shall be cleaned and sanitized as necessary.

The GMP has special requirements for two different types of food that can help you decide
both how and how often food contact surfaces should be cleaned and sanitized.

Low moisture foods are foods like grain or cereal products, baked goods, and dried
foods that have a low amount of moisture. Because there is not enough water available in
these foods, harmful microorganisms cannot grow. We will discuss the appropriate mois-
ture content for these foods further in our review of process controls in Module 10. This
part of the GMP requires that equipment, utensils or other items that come in contact with
these foods must be dry to prevent these foods from absorbing moisture. It also states
that if this equipment is wet cleaned, it must be thoroughly dried before it is used.

Wet processing activities are generally used for foods like seafood, meat, poultry, fruits,
and vegetables. Because it is much easier for contaminants like bacteria and other micro-
organisms to contaminate food contact surfaces in a wet environment, this GMP require-
ment	says	that	firms	that	receive,	store	or	process	these	foods	must	clean	and	sanitize	
equipment, utensils and any other food contact surface before it is used and after any
interruption in processing activities that could have caused them to get contaminated. For
continuous operations, the GMP requires processors to use good judgment to decide how
often it is necessary to clean and sanitize equipment to prevent contamination.
                                                            module	7	•		page	35	of	44




Non-Food Contact Surfaces of Equipment
GMP Requirement: Non-food contact surfaces of equipment used in operation of food
plants should be cleaned as frequently as necessary to protect against the contami-
nation of food.

The GMP also requires that the parts of equipment that do not routinely come in con-
tact with food must also be cleaned as often as necessary to prevent contamination. This
requirement is included because of the potential for dirty water and harmful bacteria or
other microorganisms to be easily transferred to the parts of the equipment that do come
in contact with food when it is being used.

Each	operation	must	evaluate	the	equipment	that	they	use	and	determine	how	and	when	
non-food contact parts of equipment need to be cleaned. For some items such as knives,
both food and non-food contact parts are likely to be cleaned and sanitized at the same
time. For large pieces of processing machinery it may be necessary to clean or sanitize
food contact surfaces once or more per day, but other parts that do not come in direct
contact with food may only need to be cleaned and sanitized every few days or once per
week, depending on how they are used and the likelihood of contamination.
                                                               module	7	•		page	36	of	44




Storage of Cleaned Equipment & Single
Service Articles
GMP Requirement: Storage and handling of cleaned portable equipment and utensils.
Cleaned and sanitized portable equipment and utensils should be stored in a lo-
cation and manner that protects food contact surfaces from contamination.

GMP Requirement: Single service articles (such as utensils intended for one time use,
paper cups and paper towels) should be stored in appropriate containers and shall
be handled, dispensed, used, and disposed of in a manner that protects against
contamination of food or food contact surfaces.

These two parts of the GMP are included to make sure that equipment, utensils, and other
food contact surfaces are stored properly after they are cleaned and sanitized so that they
do not become contaminated before they are used. Disposable or single-use items must
also be stored properly to prevent contamination that could be transferred to food.

Proper Storage Conditions: Cleaned equipment and utensils should be stored in a lo-
cation that will allow them to dry and prevent them from getting contaminated by work
activities or the plant environment. At a minimum, cleaned items should never be stored
on	the	floor,	which	is	likely	to	be	the	dirtiest	part	of	the	plant.	Cleaned	items	should	be	
stored in a way that will prevent water from splashing or dripping on them. For reference,
the FDA Food Code requires cleaned equipment, utensils, single use items, and laundered
linens	to	be	stored	at	a	minimum	of	6	inches	above	the	floor.	Items	that	have	been	wet	
cleaned should be stored in a dry environment, turned upside down or otherwise allowed
to drain and protected from dust.
                                                          module	7	•		page	37	of	44




Equipment Storage
GMP TV: Click on the GMP TV below to learn more about proper storage of cleaned equip-
ment, utensils or other items that come in direct contact with food.
                                                                module	7	•		page	38	of	44



What You Can Do
To meet the general GMP requirements for cleaning and sanitizing food contact surfaces,
equipment, utensils, and non-food contact surfaces in the plant environment as necessary
you need to:

    Develop sanitation procedures for equipment, utensils, containers, processing areas,
    and all other plant facilities as necessary. These procedures must be effective but the
    GMP does not currently require that they be written down.

    A complete sanitation procedure should describe:

    •	 What	areas	of	your	facility	and	what	equipment	and	utensils	need	to	be	cleaned	
       and sanitized.

    •	 How	each	item	or	area	will	be	cleaned	and	sanitized	including:
       •   The chemical cleaning and sanitizing products to be used.
       •   Instructions on how to prepare cleaning and sanitizing solutions properly and
           test or verify their concentration.
       •   Instructions on how to apply these solutions.
       •   The cleaning tools to be used for each task.
       •   Instructions for each of the steps in the procedure and their proper order or se-
           quence.
       •   Instructions for proper storage of cleaned equipment.
    •	 When	each	cleaning	and	sanitizing	task	will	be	done.
    •	 Who	will	conduct	each	task.

    Different types of procedures may be needed. For example, some operations may
    need	one	procedure	for	cleaning	and	sanitizing	the	tables,	walls	and	floors	for	their	
    entire	plant	at	the	end	of	the	day.	Other	firms	may	need	one	procedure	for	the	area	
    of the plant that handles raw products, and a different procedure for the area of the
    plant	where	finished	products	are	packaged.	You	may	also	need	different	procedures	
    for different pieces of equipment that are cleaned and sanitized in place, and for por-
    table items and utensils that are cleaned and sanitized in a three-compartment sink.

    Implement each of the cleaning and sanitation procedures that are needed. Imple-
    mentation includes purchasing the necessary chemicals and equipment to complete
    all tasks, placing these items in the proper location, and storing them properly.

    Train employees who have cleaning and sanitizing responsibilities to make sure that
    they understand what tasks must be completed and how to conduct them properly.

    Monitor cleaning and sanitizing activities to make sure that they are conducted prop-
    erly and consistently. Monitoring could include testing to verify that the procedures
    developed are effective.
                                                             module	7	•		page	39	of	44




How To Monitor
Periodic checks of the condition of the
facility, equipment and utensils should
be conducted as described in Modules
3, 4, 5 and 6 to make sure that they
are in acceptable condition. Cleaning
and sanitizing activities should be rou-
tinely checked to be sure that they are
conducted properly and at the proper
time as described in your sanitation
procedure. This may include monitor-
ing the proper use of detergents and
cleaning aids, sanitizers, and cleaning
and sanitizing procedures. Additional
periodic checks using monitoring tools
for	cleanliness	and/or	tests	for	specific	
types of bacteria should be conducted
as needed or required by regulations
for certain types of food products. Although the current GMP does not require monitoring
records, you may want to keep a record of the results of your observations for your own
use. If any corrections are necessary to correct problems, those actions should also be
noted on a written record.
                                                                 module	7	•		page	40	of	44




Use Safe and Effective Cleaners and
Sanitizers
GMP Requirement: Sanitizing agents shall be adequate and safe under conditions of
use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment
and utensils if it is established that the facility, procedure, or machine will routinely render
equipment and utensils clean and provide adequate cleaning and sanitizing treatment.



GMP Requirement: Substances used in cleaning and sanitizing. Cleaning compounds
and sanitizing agents used in cleaning and sanitizing procedures shall be free
from undesirable microorganisms and shall be safe and adequate under the con-
ditions of use.	Compliance	with	this	requirement	may	be	verified	by	any	effective	means	
including	purchase	of	these	substances	under	a	supplier’s	guarantee	or	certification,	or	
examination of these substances for contamination.

These two sections of the GMP require that the sanitizing agents used in food establish-
ments be effective and safe to use and that you have some type of documentation that
the products that you are using are acceptable and free of contamination from undesirable
microorganisms.
                                                                           module	7	•		page	41	of	44




Use Safe and Effective Cleaners and Sanitizers
Use Approved Sanitizers:	There	are	specific	regulations	that	identify	what	sanitizing	so-
lutions	are	acceptable.	This	regulation	is	found	in	Part	178	of	Title	21	of	the	Code	of	Fed-
eral	Regulations.	Part	178.1010	states	that:

Sanitizing solutions may be safely used on food processing equipment and utensils, and
on other food contact articles within the following conditions:

a: Sanitizing solutions are used, followed by adequate draining, before contact with food.

b: The solutions consist of one of the following, to which may be added components that
   are generally regarded as safe or components which are permitted by prior sanction
   or approval. The remaining section of this regulation describes 46 different acceptable
   sanitizing solutions and the minimum concentrations of active sanitizer that are needed
   for each type.

The	U.S.	Environmental	Protection	Agency	(EPA)	also	has	regulations	related	to	sanitizers	
in	Part	180	of	Title	40	of	the	Code	of	Federal	Regulations.	This	regulation	describes	EPA	
tolernace exemptions for active and inert ingredients for use in anti-microbial formula-
tions.	Food	contact	surface	sanitizing	solutions	can	be	found	in	section	180.940.

Click on the buttons below to see these regulations. Use your browsers BACK button at
the top of the screen to return to this module.


FDA-Approved	Sanitizers	in	21	CFR	Part	178														EPA-Tolerance	Exemptions	40	CFR	Part	180



Use Effective Procedures: These GMP requirements also say that the procedures,
equipment or service that is used for cleaning and sanitizing must be acceptable, and
that you need assurance that they will routinely provide adequate cleaning and sanitiz-
ing.	Standard	cleaning	and	sanitizing	procedures	identified	in	reference	information	from	
government, university, or trade associations should be acceptable if implemented prop-
erly. One such standard procedure was provided earlier in this Module. When using special
sanitizing equipment, you may need technical information or a statement from the manu-
facturer indicating that it provides adequate cleaning and sanitizing consistent with cur-
rent regulations if used according to instructions.
                                                              module	7	•		page	42	of	44




What You Can Do
To meet the GMP requirements to use safe and effective cleaning and sanitizing agents
that are free from harmful microorganisms you need to:

    Evaluate all cleaning and sanitizing agents used in your facility to determine if they
    are approved for use in food establishments.

    Obtain written documentation from the manufacturer or supplier of your cleaning
    and sanitizing chemicals to verify that these products meet current regulations and
    are approved for use in food establishments.

    Check your procedures to verify that they are consistent with manufacturer rec-
    ommendations and label directions for the proper use of all cleaning and sanitizing
    products including test kits to verify sanitizer concentration.

    Monitor chemical deliveries to verify that the proper products are received,
    that	the	proper	documentation	is	on	file,	and	that	the	instructions	for	use	have	not	
    changed.

How To Monitor
Keep appropriate records from your supplier to show that the cleaning and sanitizing
chemicals that you use are approved and adequate when used properly. Monitor clean-
ing and sanitation procedures daily to be sure that they are conducted properly. Use test
strips	to	confirm	that	you	have	the	appropriate	sanitizer	concentration	each	time	that	
sanitizing solutions are prepared. Although the current GMP does not require monitoring
records, you may want to keep a record of the results of your observations for your own
use. If any corrections are necessary to correct problems, those actions should also be
noted on a written record.
                                                                module	7	•		page	43	of	44




Checklist Questions for GMP Requirements
in Module 7
In Module 7 we reviewed the GMP requirements for: the sanitary condition of the building
and	facilities;	selecting	and	using	cleaning	and	sanitizing	chemicals;	proper	cleaning	and	
sanitizing	procedures	for	food	contact	surfaces,	equipment,	utensils	and	facilities;	and	the	
proper storage and handling of cleaned and sanitized equipment and utensils. We have
compiled	the	items	from	the	What	You	Can	Do	sections	of	this	Module	into	a	simplified	se-
ries of questions to help you create a list of things that you may need to do to meet these
GMP requirements.

Use this list to remind yourself to:

•	 Evaluate	the	status	or	condition	of	your	existing	facilities	or	systems,	and	to	develop	a	
   plan to make any changes that are needed.

•	 Create	new	procedures	or	change	existing	procedures	if	necessary.

•	 Develop	new	monitoring	procedures	or	change	your	existing	procedures.

To	download	the	Checklist	below	as	a	PDF	file	that	you	can	print,	click	on	the	button.


Download Module 7 Checklist and Internet Resources


Cleaning and Sanitizing Procedures

     Do you have cleaning and sanitizing procedures for all food contact surfaces, equip-
     ment, utensils, processing lines, conveyors, storage units, and non food contact sur-
     faces and facilities that describe:

     •	 What	cleaning	and	sanitizing	chemicals	will	be	used?

     •	 How	the	proper	solutions	will	be	prepared	and	the	concentration	will	be	checked?

     •	 How	cleaning	and	sanitizing	solutions	will	be	applied	and	what	cleaning	tools	
        should	be	used?

     •	 The	proper	sequence	of	steps	for	each	cleaning	and	sanitizing	procedure?

     •	 When	these	procedures	will	be	conducted?

     •	 Who	will	conduct	these	procedures?
                                                             module	7	•		page	43	of	44




   Do you need to develop any new procedures or use new chemicals, delivery methods,
   or	cleaning	tools	or	modify	any	existing	ones?	If	so,	how	will	you	make	the	necessary	
   changes	and	where	will	you	get	the	necessary	chemicals,	equipment	or	tools?	What	
   resources are available to help such as sanitation suppliers, university specialists, or
   trade	associations?

   Do you train employees who conduct cleaning and sanitizing activities to make sure
   that	they	understand	how	to	conduct	procedures	properly?	Do	you	need	to	add	new	
   training	programs,	modify	existing	ones,	or	conduct	them	more	frequently?

   Do you routinely monitor the effectiveness of cleaning and sanitizing procedures us-
   ing	visual	inspections	and	testing	if	necessary?	Do	you	need	to	develop	new	monitor-
   ing	procedures	or	modify	existing	ones?

Cleaning and Sanitizing Agent

   Do you have documents from suppliers of cleaning and sanitizing chemicals that
   demonstrate that they comply with all current regulations for use in food establish-
   ments	and	are	safe	to	use?	If	not,	what	documents	are	needed	and	how	can	you	
   obtain	them?

   Do you have written or label instructions that describe how to use and store all clean-
   ing	and	sanitizing	chemicals	properly?	If	not	what	information	is	needed	and	how	can	
   you	obtain	it?

   Do you have procedures to check all deliveries of cleaning and sanitation chemicals to
   make sure that they are what were ordered and that all of the necessary instructions
   and	documentation	are	on	file?	If	not,	what	procedures	are	needed	and	how	will	they	
   be	developed?
                                                                module	7	•		page	44	of	44




Check Your Knowledge
This concludes the study material for Module 7. You now need to review the 6 ques-
tions	for	this	Module,	find	the	correct	answer	to	each	question,	and	submit	your	answers	
while you are logged into the course with your Username and Password.

Each	of	the	following	pages	has	a	single	question	that	will	appear	on	your	screen.	Click	
on the answer you think is correct. You will see a text box that will tell you if this answer
is	correct	or	wrong	and	why.	When	you	find	the	correct	answer,	be	sure	to	write	down	the	
question number and the correct answer. Then move on to the next question.

Click	on	the	Forward	button	at	the	top	of	this	page	to	go	to	the	first	question.

								
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