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Validation is the final step of our R&D activity to offer good, innovative and reliable solutions.

CLEANLINESS EVALUTATION IS PERFORMED BY:

• Manual count (filtering membranes + vacuum)

• Chemical reaction (red dye)

MICROBIOLOGICAL EVALUTATION (LOG REDUCTION) IS PERFORMED BY:

• VDMA count method in cooperation with University and private laboratories

WE ALSO OFFER PREVENTIVE BENCH TESTS TO DISCLOSE:

• Heating performances

• Shrinkage

• Water residuals after treatment

CLEANLINESS VALIDATION EXAMPLE

EVALUATION WITH COLOR (RED DYE METHOD)

1. Consider the cleaning cycle as a diluting process
2. Use a coloring powder (i.e. 2-naphthalenesulfonic acid) as foreign matter
3. Create a reference curve (quantity of matter in water solution; color). A spectrophotometer may be used for higher precision
4. Reference containers:
a. Put a stated quantity of dye into the container, shake
b. Put a stated volume of water and shake
c. State the powder concentration through its color
5. Treated containers:

 

a. Put a stated quantity of dye into the container, shake
b. Carry out the cleaning cycle
c. Put a stated volume of distilled water and shake
d. State the powder concentration through its color
6. Compare ‘Reference’ and ‘Treated’ containers’ values

MICROBIOLOGICAL VALIDATION EXAMPLES

COUNT REDUCTION METHOD:

  1. State the challenge (i.e. Bacillus Subtilis)
  2. . Inoculate a set of containers to be treated and some ‘positive control’ containers with a known quantity of colonies forming unit (CFU)
  3. Carry out the decontamination process on a test bench simulating the project’s treatment times and modes
  4. Recover the challenge in a microbiological laboratory
  5. Count the recovered CFU
  6. Calculate the Log Reduction

END POINT METHOD:

  1. State the challenge (i.e. Aspergillus Niger, Bacillus Subtilis)
  2. Inoculate a set of containers to be treated and some ‘positive’ containers (control) with certain quantities of colonies forming unit (CFU)
  3. Carry out the decontamination process
  4. Recover the challenge in a microbiological laboratory
  5. Count the sterile containers
  6. Calculate the Log Reduction