C&D Validation

What do you currently know about our 12 steps C&D Validation Masterplan?

• Never heard of it

• Just recall the name

• I know the basics

• I'm an expert

What is the correct definition of the purpose of cleaning?

• Removal of soil, dirt, residues and debris from equipment and utensils

• Make the utilities and equipment ready for next production

• Sanitize the equipment by removing all unwanted contamination

What is the definition of disinfection of process equipment or utensils?

• removal of debris, soil, dirt and residues from equipment and utensils

• inactivate, eliminate or reduce micro-organisms to an acceptable level

• Using heat and of chemicals to completely clean the surfaces

When to do a Cleaning and Disinfection validation?

• For a new line and repeat every year

• For a new line and repeat every 3 years

• For a new line and in case of important changes in process / cleaning

• Only for high risk products

What is the purpose of cleaning verification?

• Check the cleaning process and prove all is according to documentation

• To check cleaning and disinfection on a regular basis

• Weekly sampling and trending of the results

• Obtain evidence that the cleaning process is effective

I cannot start my 12 step validation if my technical documentation (e.g. P&ID's) is not up to date...

• TRUE

• FALSE

What to do in case leakages in the process are found (step 2 or 4)?

• List all findings and mark them as sampling locations

• List all findings and have them repaired before validation starts

• Leakages always happen and do not influence our C&D

How many products should I use for a line validation?

• Ideally one - select a worst case

• Validation must be done for every product

• Validation must be done for every product containing allergens

• Always at least two, so you can compare the results

ATP is very useful as main test for micro during the C&D validation

• TRUE

• FALSE

A separate validation exercise must be done for each contaminant (e.g. allergens, micro-organisms, product residues)

• TRUE

• FALSE