Cleaning validation

Cleaning verifies the importance of good cleaning results

• Reduce the risk of cross-contamination
• Make the product contaminated scrap the possibility of the smallest
• Patients have the least chance of negative effects
• Reduce the incidence of product complaints
• Reduce the health department or other institutions failed inspection
• risk
• Extend equipment life

Cleaning Verify the type of device cleaning

• Manual cleaning
• Cleaning by operator or by high-pressure hose
• Automatic cleaning
• Wash by automatic control until dry
• Semi-automatic cleaning
• Combination of the above two cleaning process

Cleaning Verify the type of equipment

• Divided by product or importance of equipment.
• Special equipment - to produce a product
• Non-special equipment - produce several products or for several processes
• The main equipment - the main equipment in the production process
• Secondary Equipment - Instruments and Appliances

Cleaning validation The basis for cleaning validation

• The type and number of products made
• Product prescription / material characteristics
• Equipment characteristics
• Equipment in the production process
• Evaluate the potential problems of the cleaning process

Clean standard cleaning procedures to verify equipment cleanliness

• Should be written, detailed and meticulous
• Must include the order in which the operations are performed
• The time required for each step must be included
• Record the results of key operations
• Equipment combinations

Clean Verify SOP content

• Clear responsibility staff
• Operators in the cleaning process of protection
• The degree of equipment removal
• Detailed cleaning steps
• Monitoring during cleaning
• Clean record

Clean Verify SOP content

• Indicate the cleanliness and expiration date of the equipment
• Inspection after cleaning and disposal of expired cleaning equipment
• Equipment storage and conditions after cleaning
• Equipment before use check

Cleaning Verify the cleaning program execution check

• Control SOP requirements, check whether the effective implementation
• Ensure that all key steps are monitored and documented
• Confirmed by different operators
• Revise SOP and train all operators

Cleaning Verify the choice of cleaning agent

• The cleaning agent is chosen according to the residue to be removed
• Compatible with the material
• Safe, non-hazardous
• economical
• No impact on the environment
• non-toxic
• Effective for removing microorganisms
• It is very easy to remove itself
• Low foaming
• Should be the control of the recipe

Ways to verify the sampling method

• Visual inspection of equipment after cleaning
• Chemical sampling
• Cotton swab sampling
• Rinse solvent sampling
• Final flushing water sampling
• Microbiological sampling
• Cotton swab sampling
• Final flushing water sampling

Cleaning Validation Cleaning Validation Strategy

• The conditions for the decision
• Product grouping
• Device grouping
• Limit calculation options
• Analytical method
• Sampling location selection

Cleaning Validation Cleaning Validation Strategy

• Quality, manufacturing and technical departments must be scientifically
• Validation
• Determine the file support you need during validation

Cleaning validation product grouping

• According to the equipment used to produce products for product grouping
• Verify the product
• Similar toxicity
• A similar prescription
• Solubility in cleaning solvents
• Similar management practices and levels of risk
• The product is produced on similar equipment and phase is used
• Same cleaning procedure

Cleaning validation equipment grouping

• Prove the equivalence of cleaning validation
• The same geometry
• The same characteristics
• Equipment material composition
• Different size

Cleaning Verification Confirmation of sampling points for cleaning validation

• Sampling points to determine the basis:
• The most difficult equipment to clean the site
• Key parts
• The most representative parts
• Different parts of the structural material
• Convenience and reproducibility of sampling points
• The total size of the device
• Draw a sampling map

Cleaning verification cleaning verification testing methods

• The test method is specific to the analyte
• The test method must be verified to prove:
• Appropriate sampling method
• Effective test method

Cleaning Validation of residue limits

• According to different standards require different calculation methods;
• Allowable concentration of residue X The next product batch
• Product activity on the human body X The next product volume
• Daily dosage

Cleaning validation

• Worst case determination (product group)
• Product identification
• The most difficult to clean products
• Determination of residue limits
• Minimum batch
• The most active product
• Increase the daily dose

Cleaning Verify the content of the cleaning validation program

• Identify the aspects involved
• Determine the purpose of verification
• Equipment definition
• file:
• Equipment cleaning IQ / OQ
• Cleaning procedures and training
• Analytical method validation
• Sampling methods and verification

Cleaning Verify the content of the cleaning validation program

• Carry out cleaning studies
• Use the worst case
• Including the maximum shelf life
• Provide cleaning operation records
• Determine the sampling point
• Confirm acceptance of standard limits
• Determine the validity of the results after verification or re-verification