Salmonella Control Area ( PSCA) Guidelines December 2015 Dr. - - PowerPoint PPT Presentation

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

• rganisms 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

• f 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

• f 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

• peration.
• 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
• f 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
• uter 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

• f 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

• p 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 ??