Primary

Salmonella Control Area

( PSCA)

Guidelines

December 2015

Dr. Vandana Gadre

Agenda Historical perspective So what does Salmonella affect ?

Why Guidelines ?

Salmonella control elements - Guidelines

Some processing examples

What is zoning

Zoning concepts

Prevention of cross contamination

Verification program

Questions??

History

NUTS : 1996 (Kraft Foods – Australia) 50 illnesses from Salmonella mbandaka Total cost to the business approximately $20 mn Source: unclean equipment and inadequate storage of

processed nuts at supplier (evidence of bird droppings)

NUTS : 2007 (External Company – USA) 425 illnesses from Sal.tennessee Total cost to the business approx. $50 - 60 Mn Source: moisture inadvertently entering the

production process allowing for growth of Salmonella organisms present at low levels in the product

NUTS : 2008-9 (External Company – USA) 700 illnesses, at least 9 deaths related to S.typhimurium Cost to the business not defined, business filed for bankruptcy liquidation Source: not yet been identified, but gaps in CCP controls & zoning, and release of Salmonella positive material

3

2012 cocoa powder (S. Senftenberg)

Rework stored in unprocessed / raw zone during construction

2013 (2011, 2012) milk powder (S. Agona)

Mezzanine / roof above packing zone hard to clean

(harborage area)

History

4

ConAgra Foods Inc. – Banquet Pot Pies

• 401 people in 41 states sickened in 2007

• Confusing microwave cooking instructions contributed to many of the illnesses

• >75% of the people sickened in the outbreak had reported that the pies they consumed were microwaved

• ConAgra insisted that its pot pies were safe.

• Company claimed consumers who failed to cook the pies properly were to blame for the Salmonella outbreak

• This Case prompted changes in the label instructions and warnings about the importance of thoroughly cooking frozen, not-ready-to-eat foods.

ConAgra Foods Inc. - Peanut Butter

• Salmonella was found in a ConAgra plant in 2007

• Salmonella in jars and plant matched strains recovered from

consumers.

• 425 individuals became ill in 44 U.S. states and 51 hospitalized

• Production stopped at the facility.

• Company officials stated a roof leak and faulty sprinkler head

introduced moisture into the plant which allowed Salmonella

growth.

Peanut Corporation of America - Peanut Products

• Over 691 people from 46 U.S. states got sick in late 2008 and early 2009

• 116 patients hospitalized and 9 deaths • 361 companies involved; > 4400 products containing peanuts,

peanut butter or peanut meal were recalled • Salmonella found in product testing several times since 2007 • Plant had a history of problems:

• Dirt and mold buildup throughout the plant

• Gaps in doors large enough to allow rodents in

• Food and non-food contact surfaces were not cleanable, properly designed, constructed, and used.

• Several food contact surfaces were not properly cleaned and sanitized

• Roof leaks • FDA began a criminal investigation into the actions of the Peanut

Corporation of America, which they said knowingly sold contaminated peanut butter and peanut products to major food makers.

So what does Salmonella affect ?

Cereal / Oats

Raw nuts / almonds

Chocolates

Infant formulae

Seasoned potato chips

Dried coconut

Peanut butter

• A number of outbreaks of salmonellosis associated with the

consumption of ready-to-eat low-moisture products

• Although Salmonella outbreaks from low-moisture products are relatively

rare, they often impact large numbers of people.

• Outbreaks underscore the difficulty in eradicating Salmonella from the

environment of dry product manufacturing facilities and illustrate the

wide diversity of low-moisture products that can be contaminated with

Salmonella and cause illness

• These outbreaks also highlight the need to reinforce industry preventive

control measures through guidance

Why a guideline?

• For an industry-wide guidance, developed through a review of industry

programs and information from the literature

• The guidance is applicable to various products that include, but are not

limited to Peanut butter, cereals, dry protein / dairy products, confections

(such as chocolate), snacks (such as corn chips), spices, animal feeds

(both ingredients and finished products), pet foods and pet treats.

• Depending on the susceptibility of the product to Salmonella, all or

selected practices described in this guidance may be applied.

Salmonella Control Elements

Apply hygienic design principles to building and equipment design.

Building design Sanitary design, layout and maintenance

of equipment Control Moisture

Enhance stringency of hygiene practices & controls in the PSCA.

Requires highest level of hygiene control.

Barriers to separate it from the rest of the facility.

Traffic control : including the movement of Man / materials. Avoid

activities that may lead to contamination

Prevent ingress or spread in the processing facility.

Conduct a hazard analysis for potential sources – Facility/ Man/ Material

movement / Air/ Water /Incoming RM/

Segregate ingredients known to be contaminated

Training

Salmonella Control Elements

Validate control measures to inactivate Salmonella

Determine controls, adequacy, and critical limits Challenge studies / Validate lethal step, / Operation must deliver the critical limits and monitored and met through

in-plant validation,

Establish a raw materials/ingredients control program.

Identify sensitive ingredients Approved suppliers Evaluate supplier Food program

including Env pathogen monitoring , Hold and release etc

Prevent or minimize growth of Salmonella within the facility

Control moisture, check equipment and building for harborage points

Remove water immediately in case of ingress like leakages

Controlled cleaning

Salmonella Control Elements

Establish procedures for verification of Salmonella

controls and corrective actions.

Focus on implementing a

robust environmental

monitoring program

Environmental monitoring generally

conducted on non-product

contact surfaces, samples taken primarily in the

PSCA

Product contact surface testing may be done as

part of corrective actions for an environmental

positive.

COA may also dictate the need

for finished product testing.

Whenever finished product

testing is performed, the

tested lot should be isolated,

practice Hold and release

If a product sample tests positive for

Salmonella, the tested lot is considered

adulterated and should not be released into commerce.

Retesting should not be conducted for the purpose of negating the

initial test results

Corrective actions must be

taken when Salmonella is

detected in an environmental monitoring or

finished product sample.

Hygiene Zoning or PSCA

What is Zoning about ??

Zone: An area or a region distinguished from adjacent parts by a distinctive feature or characteristic.

Zoning concepts

• Separation of one manufacturing area from another is generally done to

minimize contaminant transfer from one area to another, e.g., wet to dry

areas, “dirty” (relatively speaking) to clean areas, raw materials to finished products, or a basic hygiene area to a high hygiene

• PSCA - where handling of ingredients and product requires the highest

level of hygiene control

• Product with pathogen inactivation treatment, the PSCA is the area

subsequent to the terminal lethality step.

• Where no inactivation step is employed, e.g., dry-blend mix, the entire

process area may become the PSCA.

Zoning concepts • Stringent hygiene control in the PSCA depends on effective hygiene

control in the rest of the processing area of the facility, which for

comparison are designated the basic GMP area and, if one is established,

the transitional area.

• PSCA also referred to as the high hygiene zone or the high risk area (e.g.,

in Europe) or ready-to-eat area, the critical side, or the dry side of the

operation.

• The basic GMP area is also referred to as the basic hygiene area, the non-

critical side or wet side of the facility

• Non processing areas – Plant entrance, hallways, locker areas, cafeteria,

bathrooms.

Zoning concepts • Compartmentalization or segregation of the facility - common practice

• The separation of the Plant into areas of different hygiene levels with

separate PSCA is key in controlling Salmonella

• Number of hygiene areas may vary : depending on the product / process /

intended consumer (e.g., general public, infants)

• Stringency of hygiene control increases from the basic GMP area to the

transitional area to the PSCA.

• Emphasis on control measures for (physical) separation, passage

of traffic (personnel, equipment, materials, etc.), air flow, cleaning

processes (whether or not wet cleaning is permitted) and how water is

used and verification

Zoning concepts

• Barriers are placed between the different hygiene areas to restrict traffic

and prevent vectors (potential sources of Salmonella) from passing

between the basic GMP area to the PSCA.

• What are common vectors??

• Examples of physical barriers are walls, doors, split conveyors, filters,

etc.

• Examples of other barriers are pallet exchange, shoe-change, removal of

outer bag packaging, marked limits on floors, etc.

• Ideally, no direct connection between PSCA and basic GMP area. Access

through a buffer area : vestibule or anteroom, hygiene juncture where

• Critical is hygienic facility design and plant layout to direct the flow of

personnel and traffic

• The air supply to the PSCA should be suitably filtered to prevent

airborne contamination, ideally, under positive air

Zoning concepts

How does one determine an area as PSCA?

Some common practises to prevent cross contamination

•Survey facility & operations

•Identify areas basis risk, nature of operation, dry vs wet : color code

•Define PSCA basis risk assessment

•Nature of Operation : Process area type and numbers

Establish designated areas

with different levels of

hygiene controls

•Best form of control. •Barriers at entrance and exit •eg Closed system like tanks, pipelines, walls •Review drains location – always from processed to raw

Establish barriers for the PSCA.

Milk Processing Plant – Example of color coding

Nut Processing Plant – Example of closed system

Milk Processing Plant – Example of Separation

Spray drier

Ground floor 1st floor

Some common practises to prevent cross contamination

Control traffic

• Restrict man, material movement

• Ideally no movement of man, material, tools equipments from raw to PSCA

• Entry with appropriate change overs / hand wash

• Dedicate man, equipment, tools, palettes for the area

Prevent or minimize dust

• Barriers : wall – no gaps / crevices

• Air filtrations – EU 5 / 7 or HEPA ,

• Positive air pressure

• Consider air used for product transport

Master sanitation schedule

• Adhere to frequency & effectiveness

• Wet or dry cleaning as appropriate (include complete cleaning and sanitizing cycles)

• Partial wet cleaning without sanitizing : avoid

• If water is introduced ensure thorough cleaning followed by sanitizing and drying

Some common practises to prevent cross contamination

• Identify for PSCA and GMP areas

• Typically PSCA dry cleaning, Buffer/vestibule area : dry and controlled wet cleaning

• No drains in PSCA preferred ; if there are drains ensure floor slope

• Crack free / damage free floors

• Address hollow, difficult to clean areas / equipments

Appropriate cleaning and

hygiene procedures

• Product accumulation : walls, ceilings, conveyor belts, lids and tank walls , mixing tanks, bottom of a bucket elevator)

• Important for hygroscopic products or in high humidity

• Poor equipment design may lead to residue accumulation and should be corrected

Focus on

Area Evaluation and Verification

Routine Pre op and Op

checks

Hygiene

monitoring of

Air / Water /

Equipment

Path Env Monitoring

GMP audits

• Evaluate and verify segregation program to ensure effectiveness.

Thank you for your Attention!!

Questions ??