This message was posted by a user wishing to remain anonymous
Hi RAPS Professionals,
Can anyone point me to the regulation/guidance that explains the requirements of cleaning requirements for non-product contact equipment?
According to EC Guide to GMP Annex 15 specifies cleaning validation requirements for all product contact equipment, in this particular case the product is not in direct contact with the equipment. We have a non-sterile product going to a Lyophiliser.
A procedure is in place to clean (wipe with a damp cloth) and dry the trays.
Do we need to validate our cleaning process for the trays? In the event, spillage of the liquid product happens due to an unusual event does this means the equipment has been in contact with the product.
Thanks in advance!