Home > Validation of Cleaning and Sanitation Programs

Requirements for Validation of Cleaning Procedures:

Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the cleaning and disinfection procedures and their frequency shall be validated and records maintained.

What is Cleaning?

• Cleaning is a physio-chemical process involving a number of factors
• Objective – prevent contamination and cross[1]contamination
• Elimination or reduction – hazards
• Variety of hazards to be considered
• Biological, Physical, Chemical and Allergens
• Residuals remaining from detergents

Hazards

• Biological
  • Bacteria, yeasts, moulds, viruses, etc
• Physical
  • Wood, metal, plastic, etc
• Chemical
  • Environmental, process, ingredients, etc
• Allergens

What is Cleaning Validation?

• Validation means Proof that the approved cleaning procedure is capable of producing safe food
• Food businesses by law need to clean and sanitize their facilities. This is required to produce safe and legal food products and remove hazards such as pathogens, allergens and chemicals.
• Food businesses employ Standard Sanitizing Operation Procedures (SSOP) to achieve this.
• In order to ensure that these methods are in fact capable of removing the hazards and reducing the risk to an acceptable level – validation of the cleaning procedure is often required. Particularly for High-Risk unit operations.
• Simply setting up a procedure and checking it a few times (e.g., ATP, swabbing and culturing, residual testing etc.) is not enough to validate a cleaning method as it will not account for the possible variation from employees, chemicals and other parameters. Validation of cleaning methods can be conducted statistically using a capability study.

When is Cleaning Validation Required?

• When risk assessment or legislation requires it
• Critical cleaning, e.g., between manufacturing of one product and another or specific contact surfaces
• Not necessarily for non-critical cleaning, e.g., between batches of the same product or of floors, walls, the outside of vessels

Cleaning Validation Pre-requisites:

• Before any validation can be conducted, you must first put in place certain requirements
• Validation is basically setting up an experiment to prove an hypothesis
• In this example we are looking to prove that a cleaning procedure is in fact capable of achieving the objective of producing safe and legal food
• All this should be documented in a procedure for conducting the validation

Cleaning Validation Procedure:

• Cleaning SOPs for cleaning processes in place
• Cleaning schedules should also be in place
• Cleaning Validation Procedure required:
• • contact surfaces
  • cleaning after product changeover
  • between batches in campaigns
  • categorizing products for cleaning validation and
  • periodic evaluation and revalidation of the number of batches manufactured between cleaning validations.
• Objectives & responsible people
• Cleaning SOP’s
• Cleaning chemicals, concentration, solution volume, water quality
• Time and temperature
• Flow rate, pressure and rinsing
• Number of cleaning cycles
• Description of the equipment – make, model, complexity of design
• Training of operators
• Equipment used for monitoring (e.g., conductivity meters, pH meters)
• Sampling procedures (e.g., direct sampling, rinse sampling, in process monitoring and sampling locations) and the rationale for their use
• Analytical methods
• Acceptance criteria (with rationale for setting the specific limits)
• Revalidation requirements

Cleaning Chemicals

• Solubility of the materials to be removed
• Design and construction of the equipment and surface materials to be cleaned
• Minimum temperature and volume of cleaning agent and rinse solution
• Manufacturer’s recommendations
• Released by quality control and meet food standards or regulations
• Composition known
• Easily removed with rinsing – demonstrated – with acceptable limits defined
• If persistent residues – avoided
• Consider also detergent breakdown

Categorising

• Very similar cleaning procedures for products and processes – no need for individual validation
• “Worst case” may be acceptable and should be justified
• Representative product – most difficult to clean
• Equipment – only when it is similar or the same equipment in different sizes (e.g., 300 l, 500 l and 1000 l tanks).

Cleaning Validation Reports

• The relevant cleaning records – (signed by the operator, checked by production and reviewed by quality assurance) – and source data (original results) should be kept
• The results of the cleaning validation should be presented in cleaning validation reports stating the outcome and conclusion

Equipment

• Cleaning of contact surfaces to be validated. Critical areas should be identified
• Dedicated equipment for:
• products which are difficult to clean,
• equipment which is difficult to clean,
• products with a high safety risk
• The design of equipment may influence the effectiveness of the cleaning process
• Which are the critical areas for sampling?
• What would be considered an appropriate approach for cleaning validation for this piece of equipment?
• What is important about cleaning validation for components / parts of equipment?
• Consider also the different materials, e.g., stainless steel contact surfaces, silicon seals and others

Sampling

• Two methods of sampling:
  • direct surface sampling and
  • rinse samples
• Combination of the two – most desirable
• Resampling
  • May indicate residue presence and poor cleaning procedure

Direct Surface Sampling (direct method)

• Most commonly used method
• Use “swabs” – type of sampling material should not interfere with the test
• Factors to be considered include:
  • supplier of the swab,
  • area swabbed, number of swabs used, whether they are wet or dry swabs,
  • swab handling and swabbing technique
• Other factors include:
  • location from which the sample is taken (including worst case locations)
  • composition of the equipment (e.g., glass or steel)
• Critical areas (hardest to clean)
  • g., in semi-automatic/fully automatic clean-in-place systems
• Use appropriate sampling medium and solvent

Rinse Samples (indirect method)

• Allows sampling of:
  • a large surface
  • areas that are inaccessible or that cannot be routinely disassembled
• Provides an “overall picture“
• Useful for checking for residues of cleaning agents
• In combination with other sampling methods such as surface sampling

Analytical Methods

• Validated analytical methods – able to detect residuals or contaminants:
  • specific for the substance(s) being assayed
  • at an appropriate level of cleanliness (sensitivity)
• Sensitive and specific – may include:
  • ELISA
  • Specific Allergen Testing
  • Non-Specific Testing
• Validation of the analytical method should include:
  • limit of detection (LOD)
  • Reproducibility

Establishing Acceptable Limits

• Limits: Practical, achievable and verifiable
• Rationale: Logical, based on knowledge of materials
• Each situation assessed individually
• There should be no residue from:
  • Previous product
  • Reaction by-products and detergents
  • Cleaning process itself (e.g., detergents or solvents)
  • Remember: Uniform distribution of contaminants is not guaranteed
• The limit-setting approach:
  • be product-specific
  • group products into families and choose a worst case product
  • group products into groups according to risk
• Limits may be expressed as:
  • a concentration in a subsequent product (ppm),
  • limit per surface area (cfu/cm2), or
  • in rinse water as ppm.
  • Visual
• Certain allergenic ingredients and highly potent material should be undetectable by the best available analytical methods

Cleaning Validation Sample Procedure

• No absolute or correct way to do validation
• The following is a good generic example of how a validation may be conducted

For more information, please Chat with us Ask The Expert.