Even in a pilot plant consisting of a small laminar flow area where the apparatus for filter sterilization of
solutions are set up, it is an unacceptable practice to gown in there. A change room should be available
besides their sterile pilot plant production area.
Based on the assumption that the pilot plant will produce drugs for sale – including clinical studies – then the
same principles and considerations that apply to full scale production operations must also be utilized in pilot
plant facilities.
