Cleaning efficacy study for Bottle Air Cleaner

How to conduct study to check effectiveness of bottle cleaning machine? in solid container pack line or liquid bottle line?


It would depend on whether it is part of an asepctic filling or not. I will asuume it is for sterile filling.

Most of these machines are intended to remove particles from the inner surfaces of the container that are in direct contact with the product, since sterilization is typically done in a dry heat or depyrogenization tunnel or oven. Make sure that the final rinse is done with fresh WFI and not recirculated.

Therefore, Iā€™d recommend that at least, samples must be taken to measure the amount of particles of certain diameter range. I can think of a conductivity measurement and particle determination.

If containers are not recieved clean, then the equipment must be challneged also to remove any cleaning chemical residue that is leftover. That would require a cleaning approach as well, as for removing chemical residues that would contaminate the product, and not just physical particles.

Hope this helps.

Thank for the response,
Its understood in case of terminal sterilization.
So, furthermore i want to ask in case of eye drops LDPE bottle, what item can be used as challenge?

Also in case of solid dosage forms as tablets, capsule jar filling machine,or oral syrups and drops what item can be used for challenge the efficiency of bottle cleaning machine?


Oh, sorry, I thought you were referring to sterile powders and solutions. For sterile and non-sterile products a typical approach is to use a material like to cover the container beforehand, and then test for resdidues after cleaning. A common design is to perofrm a riboflavin test.

However, it will depend on the actual CQA of the product and a risk asessment should be performed to determine the scope of the study and tests; but generally, a riboflavin test should be sufficient for non-sterile products.

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Thank you so much